AsFind ofout 1how Julyto 2025,apply thefor wholegerminal ofproduct Englandgeneral islicences inon athe bluetongue restrictedmovement zonelicences and designated slaughterhouses. page.

MovingMovement of germinal product within a bluetongue zone

YouGerminal product collected from any animal showing clinical signs of bluetongue must not be used or moved until the donor animal has been assessed by a veterinarian.

Within a Restriction Zone (RZ), Surveillance Zone (SZ) or Protection Zone (PZ) you can move fresh or frozen germinal product within the bluetonguesame restricted zone without a licence,licence.

Within asa longControl asZone the(CZ) donoror animala doesTemporary notControl haveZone signs(TCZ) ofyou bluetongue.can Thismove includesgerminal product within the same zone under general licence.

Movement of germinal product thatinto wasa collectedbluetongue andzone

You can move fresh or frozen atgerminal product from the free area into a premisesRZ, inSZ Englandor beforePZ 1without July.a licence.

You mustcan not move fresh or usefrozen germinal product collected from anythe animalfree showingarea signsinto ofa bluetongueCZ untilor aTCZ veterinariansubject hasto assesseda thegeneral animal.licence.

Moving

Freezing of germinal product towithin Walesa orbluetongue Scotland

zone

YouFreezing needof germinal product is prohibited within a CZ, TCZ, RZ, SZ or PZ unless undertaken with a specific licence or at a designated premises for the collection and processing of germinal products. The licence or designation conditions require bluetongue testing of the donor animal, whether or not the germinal product is being moved.

Voluntary testing of donor animals

If your business wishes to movetest donor animals, this may be done through The Pirbright Institute: Non-Vesicular Reference Laboratory (The Pirbright Institute).

Movement of germinal product out of thea restrictedbluetongue zone tozone

Germinal Walesproduct orcan Scotland.only Followbe moved out of a bluetongue zone if you comply with the guidanceconditions on:of a licence. Conditions include but are not limited to:

• movingfrozen germinal product fromproduced Englandmore than 60 days before a bluetongue zone was declared can move under licence to Scotlandany premises outside the zone without testing of the donor animal
• movingfrozen germinal product produced from Englandanimals that have completed all testing requirements with negative results, as set-out below, can move to Walesany premises outside of the bluetongue zone

Freezing

frozen germinal product

To freezecollected germinalup productto in60 thedays before a bluetongue restrictedzone was declared can only be moved out of the zone youif mustthe either:

• applydonor animal has been tested – blood samples may be taken from the donor animal at the time of collecting the germinal product and stored for asubsequent specifictesting licenceif required
• havefresh itgerminal doneproduct atcan only move under licence to a designated premises approved for the collection and processing of germinal products where it must be frozen – the donor animal will need testing before the product can be used
• any germinal product where the donor animal has not complied, or cannot comply, with the testing regime is ineligible to move out of the zone
• fresh germinal product collected inside the zone cannot be moved to premises outside the zone for use

RegardlessGerminal product should be quarantined separately from germinal product of whethera different health status. If straws are not used the storage container should only contain product from one animal. The straw or container must have effective labelling and the licensee must keep auditable records. Quarantine of frozen germinal product must be maintained until post-movement testing is beingcompleted moved,with whenthe return of negative results.

Testing regime: germinal product moves and freezing

There are two testing regimes available for donor animals to demonstrate that collected germinal product youis bluetongue free. 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. You must use one of these two regimes:

Virus test animalsregime: aftertesting collectionfor absence of virus by either:polymerase chain reaction (PCR) test

Prior to the collection of germinal product:

• donor animals must not show any clinical signs of bluetongue PCRon wherethe day of collection
• samples must be taken from the donor animal isno sampledmore 6than 10 days prior to 28the commencement of the collection period
• sampling is permitted on the day of collection
• we recommend that you take the pre-collection sample 3 days afterin advance and obtain negative results prior to commencing collection
• bluetonguethe ELISAsample must be submitted to the national reference laboratory and be subject to an agent identification test (a PCR test) wherewith 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 28once during the period from 6 days to 6028 days after  collectionthe –final notecollection thatfor this optionconsignment
• the issample notmust suitablebe 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 vaccinateduse animals 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, you will need a PCR will be required every 28 days
• the sample is subject to an agent identification test (a PCR test) with anegative results
• the collected germinal product will be ineligible for use until both the pre- and post-collection tests results are received with negative resultresults

Antibody –test regime: testing for the lastabsence PCRof antibody via enzyme-linked immunosorbent assay (ELISA)

After testthe collection of germinal product, the licensee must beensure that:

• donor animal must not show any clinical sign of bluetongue on the day of collection
• donor animal is sampled atonce leastfrom 628 days to 60 days after the last collection date
• youthe mustsample notis usesubject to an ELISA serological test for the detection of antibody to the bluetongue virus with negative results
• the collected germinal product untilwill yoube haveineligible receivedfor theuse negativeuntil the post-collection test returns a negative result

All

Storage donorof animalsgerminal mustproduct complyuntil withnegative testingtest requirements.

results are obtained

KeepersCollected aregerminal responsibleproduct forshould thebe costquarantined offrom sampling,other postagegerminal product and testing. 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.

YouA mustpositive clearlyresult indicatewill RT-PCRlead and/orto ELISAan APHA veterinary (antibody)investigation testingto fordetermine bluetonguewhat virusaction is needed. The veterinary inspector will determine which germinal product must be destroyed and specifywhich ‘germinalmight be eligible for use.

If cross contamination of the germinal product freezing’collected inis boldsuspected, atthis could result in the topentire contents of thea form.tank being destroyed.

StoringGerminal germinal product collected before a zone is imposed

YouSome shouldgerminal quarantineproduct may have been collected and stored in the zone before the zone was declared. This germinal product collectedalso fromrequires ana animallicence whoseto exit the zone.

Any germinal product produced and frozen more than 60 days before the date a bluetongue infectiondisease statuscontrol zone is unknowndeclared fromwill otherbe germinaleligible productfor untila testinglicence to exit the zone without the need for the donor animal to be tested. This is completesubject andto youthe havegerminal receivedproduct negativebeing results.kept Youseparate shouldfrom storeother itgerminal separatelyproduct in straws or another isolated containercontainer, (suchwith asauditable records to prove this and that the collection occurred more than 60 days before.

For germinal product that is collected and stored within 60 days a hexi-goblet).zone Thisis avoidsdeclared, crossin contamination.order to be eligible for a licence to exit the zone, the donor animal must comply with one of these two testing regimes:

Testing of the donor animal using bluetongue RT-PCR

If youtesting areusing notbluetongue usingRT-PCR, straws,the licensee must ensure that:

• a single pre-collection sample of the storagedonor containeranimal should onlybe containtaken if it is a one-off or limited germinal product fromcollection. oneA animal.second Thesample strawis needed 6-28 days after the collection. If this second sample hasn’t been collected a sample (Day 0) should be taken within 6 days of the zone being declared.
• for a donor animal in collection for an extended period or containercontinuously samples should be collected every 28 days, including a sample at least 6 days after the collection period ends.
• samples must havebe stored with clear labelling and auditable records to confirm the licenseeanimal mustand keepdate auditableof records.

  Acollection. positiveThese resultsamples willonly leadneed totesting an APHA veterinaryif investigationa tozone determineis whatimposed, actionand a movement licence is needed.required. The samples should be retained for at least 60 days.

• a veterinary inspectorattestation will determinealso whichbe germinalrequired productto demonstrate blood samples are collected and stored appropriately – upright in a refrigerator at +4˚C

Testing of the donor animal using bluetongue ELISA

If testing using bluetongue ELISA, the licensee must ensure that:

• a post-collection sample should be destroyedcollected between 28 and which60 mightdays beafter eligiblethe collection and the sample is subject to a bluetongue ELISA serological test for use.
  the detection of antibody to the bluetongue virus with negative results.

Day zero samples

If crossa contaminationpost collection sample was not taken, then a day “0” sample must be taken within 6 days of the zone being imposed and tested by PCR in addition to the pre-collection sample.

Where a germinal product collectedmovement licence is suspected,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) with negative results.

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

A resultveterinary 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 entiredonor contentsanimal is within a zone at the time of collection, or in an area that later becomes a tankzone beingwithin destroyed.60 days of the collection.

VoluntaryMovement testingof an animal out of donora animalsbluetongue zone for germinal product collection

IfLive youranimals businessmoved wouldout likeof a zone for germinal product collection must comply with the movement rules in place at that time, including pre- and post-movement testing.

The destination premises is expected to be a designated premises for collection of germinal products where testing and movement rules apply. Where this is not the case 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 until a post movement test is completed with negative results. 

Testing requirements for moving live animals out of a bluetongue zone

You must test before and after moving live animals out of a bluetongue zone:

1. Pre-movement testing of donor animals,animal yousampled 3-5 day prior to move, with the return of negative results before the move can arrangetake privateplace.
2. Post-movement testing. of donor animal sampled 6-10 days after the move. The animal and collected germinal product remain under restriction until a negative test is returned.

Where animals are intended to only stay for a short period (routinely up to 24 hours but we will accept up to 5 days) as specific licence is available to permit movement to a designated premises for collection of germinal product and for return to the 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 until a post movement test is completed with negative results. This may alternatively be a condition of designation of a premises.

DesignatedPremises premisesdesignation

Any premises can be designated tofor collect,the process,purpose handleof collecting, processing, handling or storestoring germinal product. These will normally be specialist artificial breeding centrescentres, or others such as veterinary practices specialising in artificial breeding services.

To apply for designation, you must contact APHA at outbreak.designations@apha.gov.uk to request:

• request a designation application form
• and a separate form to detail how the business meets the designation conditions

and return this to them when completed.

If youryou are a premises that regularly freezes and stores germinal product,product you should,should as a contingency applyapplying 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.

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

A full list of conditions is recorded on the designation application form.form Conditions for designation include,includes but are not limited to:

• complyingcompliance with germinal product donor animal testing regime
• followingseparation biosecurityof measuresrestricted togerminal avoidproduct, cross contamination including quarantining and detaining the germinal product ofpending unknownnegative healthtest statusresults, untiland hasbiosecurity ameasures negativeto testavoid resultcross contamination
• permission to freeze germinal product
• clear germinal product labelling
• effective record keeping allowing traceability and audit