Restrictions on germinal product from bluetongue-susceptible animals

commencing collection

• samplingthe issample permittedmust onbe submitted to the daynational ofreference collection

• thelaboratory sampleand isbe subject to an agent identification test (a (a PCR test) test) with negative results

• the collected germinal product will be ineligible for use until both the pre- and post-collection tests results are received with negative results

After the collection of germinal product, the licensee must ensure that:

• the donor animal is sampled once during the period from 6 days to 28 days after the final collection for this consignment

• the sample must be submitted to the national reference laboratory and be subject to an agent identification test (a PCR test) with negative results
• the collected germinal product will be ineligible for use until both the pre- and post-collection tests results are received with negative results

When you are collecting germinal product regularly from the same animal:

• if a collection period lasts longer than 28 days, a a PCR will will be required every 28 days

• the sample is subject to an agent identification test (a (a PCR test) test) with negative results

• the collected germinal product will be ineligible for use until both the pre- and post-collection tests returnresults are received with negative results

2.Antibody Testingtest regime: testing for the absence of antibody via enzyme-linked immunosorbent assay (ELISA)

After the collection of germinal product, the licensee must ensure that:

• donor animalsanimal must not show any clinical sign of bluetongue on the day of collection

• donor animal is sampled betweenonce from 28 anddays to 60 days after the collection date

• the sample is subject to an an ELISA serological serological test for the detection of antibody to the bluetongue virus with negative results

• the collected germinal product will be ineligible for use until the post-collection test returns a negative result

Further

Storage guidanceof ongerminal testing

1. Collected germinal product should be quarantined from other germinal product,product and stored separately in straws or in another isolated container (for example, hexi-goblet) while awaiting negative results to avoid cross contamination with other germinal product.

2. A positive result will lead to an an APHA veterinary veterinary investigation to determine what action is needed. The veterinary inspector will determine which germinal product must be destroyed and which might be eligible for use.

3. If cross contamination of the germinal product collected is suspected, this could result in the entire contents of a tank being destroyed.

All sampling must be organised by the keeper, and taken by an MRCVS veterinarian who must attest that the samples were collected in accordance with APHA guidance.

Germinal product producedcollected before a zone is imposed

1. GerminalSome germinal product atmay ahave premisesbeen incollected aand zonestored thatin wasthe producedzone before the zone was putdeclared. This in place must still comply with the germinal product restrictionsalso andrequires movementa licence conditions.to exit the zone.

2. Any germinal product produced and frozen more than 60 days before the date a bluetongue disease control zone is imposeddeclared will notbe eligible for a licence to exit the zone without the need for the donor animal to be tested. This is subject to the germinal product being kept separate from other germinal product in straws or another isolated container, with auditable records to prove this and that the collection occurred more than 60 days before.

3. For germinal product that is collected and stored within 60 days priora zone is declared, in order to thebe impositioneligible offor a licence to exit the zone, the donor animal must comply with one of thethese two testing requirements.regimes:

Testing of the donor animal using bluetongue RT-PCR

TheseIf testing requirementsusing are:bluetongue RT-PCR, the licensee must ensure that:

• a post-collectionsingle sample,pre-collection collectedsample betweenof 28the anddonor 60animal daysshould afterbe thetaken initialif collection,it subjectis toa anone-off ELISAor serologicallimited testgerminal forproduct thecollection. detectionA ofsecond antibodysample tois needed 6-28 days after the bluetonguecollection. If virusthis withsecond negativesample results

• routinehasn’t samplingbeen ofcollected thea donorsample (Day animal0) (recommendedshould everybe 28taken dayswithin if6 collectingdays fromof the zone being declared.

• for a donor animal continuously)in collection for an extended period or pre-collectioncontinuously samplingsamples (ifshould itbe iscollected every 28 days, including a one-offsample germinalat productleast collection)6 anddays after the collection period ends.
• samples must be stored with clear labelling and auditable records to confirm the animal and date of collection. Thesecollection. These samples only need testing if a zone is imposedimposed, and a movement licence is required
  required. The samples should be retained for at least 60 days.
• a veterinary attestation will also be required to demonstrate blood samples are collected and stored appropriately – upright in a refrigerator at +4˚C

Testing of the donor animal using bluetongue ELISA

If thetesting latterusing optionbluetongue isELISA, selected,the therelicensee must ensure that:

• a post-collection sample should be atcollected leastbetween 628 fulland 60 days betweenafter the pre-collection and post-collectionthe PCRsample is subject to a bluetongue ELISA samples.
  serological test for the detection of antibody to the bluetongue virus with negative results.

Day zero samples

If a zonepost iscollection imposed,sample was not taken, then a ‘dayday zero’“0” sample must be collectedtaken from the donor animal within 6 days of the zone being putimposed and tested by PCR in place.addition to the pre-collection sample.

Where a germinal product movement licence is required, you must prove the negative disease status of the donor prior to the movement. To do this, the day zero sample, together with the samples collected in the previous 60 days, must be subject to an agent identification test (PCR test) test) with negative results.

Auditable records must be kept evidencing the date of collection to be within this period.

A veterinary attestation will also be required to demonstrate blood samples are collected and stored appropriately – upright in a refrigerator at +4˚C.

Testing is only required if the donor animal is within a zone at the time of collection, or in an area that later becomes a zone within 60 days of the collection.

Movement of livean animalsanimal into or out of collectiona centresbluetongue zone for germinal product collection

1. TheLive movementanimals moved out of livea animalszone for germinal product collection must comply with the general movement rules in place at that time.time, including pre- and post-movement testing.

2. AnyThe destination premises is expected to be a designated premises for collection of germinal productproducts fromwhere antesting animaland movedmovement outrules ofapply. Where zonethis mustis not the case a restriction notice will be usedserved untilat the post-movementdestination resultspremises, returnpreventing negativethe results.movement Additionally,of theythe shouldanimal beand quarantinedthe separatelymovement fromand otheruse of the collected germinal product inuntil strawsa orpost anothermovement isolatedtest containeris completed with effectivenegative labellingresults. 

   Testing andrequirements auditablefor records.moving Collectionlive centresanimals whereout thisof occursa willbluetongue bezone

   You servedmust test before and after moving live animals out of a restrictionbluetongue notice.zone:

   1. Pre-movement testing of donor animal sampled 3-5 day prior to move, with the return of negative results before the move can take place.

   2. WherePost-movement testing of donor animal sampled 6-10 days after the move. The animal and collected germinal product remain under restriction until a premisesnegative test is withinreturned.

   Where animals are intended to only stay for a controlshort zoneperiod or(routinely temporaryup controlto zone,24 hours but testingwe iswill notaccept requiredup to 5 days) as specific licence is available to permit movement to a conditiondesignated premises for collection of germinal product and for return to the movement,original source premises where post movement samples must be taken 6-10 days after they originally left the premises.

   A restriction notice will be served at the destination premises, preventing the movement of the animal and the movement and use of the collected germinal product thatuntil a post movement test is movedcompleted with negative results. This may stillalternatively requirebe testing.a condition of designation of a premises.

Premises designation

1. AllAny sitespremises wherecan be designated for the purpose of collecting, processing, handling or storing germinal productproduct. These collection,will processingnormally be specialist artificial breeding centres, or storageothers takesuch placeas withinveterinary apractices BTVspecialising in artificial breeding services.

   To apply for designation, you must contact APHA zone,at outbreak.designations@apha.gov.uk to request a designation application form and thosea separate form to whichdetail how the business meets the designation conditions and return this to them when completed.

   If you are a premises that regularly freezes and stores germinal product areyou licensed,should willas requirea designation.contingency applying for designation to minimise future disruption. Personnel employed or contracted to a designated premises may collect and freeze germinal product under a licence issued to the business, subject to conditions.

2. Designation of the source or destination premises may also be required as a condition of a movement licence.

3. TheA followingfull list of conditions mustis berecorded meton the designation application form Conditions for adesignation premisesincludes tobut beare designated:not limited to:

• compliance with germinal product donor animal testing regime

• separation of restricted germinal product, including quarantining and detaining the germinal product pending negative test results, and biosecurity measures to avoid cross contamination

• permission to freeze germinal product

• germinal product labelling

• effective record keeping toallowing allow traceability and audit

To