Restrictions on germinal product from bluetongue-susceptible animals

Restrictions on germinal product

Movements within a control zone (CZ)(CZ)

MovingYou can move germinal product between premises within the same control zone (CZ)(CZ) or temporary control zone (TCZ)(TCZ) where it is collected, processed, or stored is permitted if you comply with the conditions of a licence.

Movements within a restricted zone (RZ),(RZ), surveillance zone (SZ),(SZ), protection zone (PZ)(PZ)

1. MovingYou can move germinal product within the same zonezone, is permitted, subject to the donor animal not showing clinical signs of bluetongue at the time of collection or subsequently (where known).

2. Any germinal product intended for fresh transfer, including on farm or within the same bluetongue zone, will not require testing or licensing.

3. Any germinal product intended for freezing and storage must comply with the requirements of a licence and testing of donor animals.

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

Movements out of a control zone (CZ),(CZ), restricted zone (RZ),(RZ), surveillance zone (SZ),(SZ), protection zone (PZ),(PZ), bluetongue prevention zone (BTPV)(BTPV)

1. Any germinal product moved off a premises for movement out of a bluetongue zone will need to go direct to a designated centre for use, freezing, or storage.

2. The donor animal must be tested in accordance with the Testingtesting Regime (below).regime.

3. Movements of germinal product out of a zone intended for fresh transfer is prohibited.

4. If the Germinalgerminal Productproduct collected in any bluetongue zone is to be frozen, you must comply with the Testingtesting Regimeregime (see below) for the donor animal.

5. Where testing is required, germinal product should not be used until negative results are received.

Freezing of Germinalgerminal Productproduct

1. No germinal product can be frozen within a bluetongue zone unless the donor animal is tested in accordance with a licence. The Testingtesting Regimeregime (see below) applies whether or not the germinal product is being moved.

Testing regime

TheThere followingare 2 testing regimes will be available to demonstrate that collected germinal product is bluetongue free. UseYou must use one orof thethese other.regimes.

1. Testing for absence of virus by polymerase chain reaction (PCR) test

Prior to the collection of germinal product, the licensee must ensure that:

• Donordonor animals must not show any clinical signs of bluetongue on the day of collection.collection

• Samplessamples must be taken no more than 10 days prior to the commencement of the collection period (including the day of collection).collection)

ItWe isrecommend recommended that you take the pre-collection sample is undertaken 3 days in advanceadvance, and obtain negative results obtained prior to collection to reduce the risk of positive germinal product being stored.collection.

• Samplingsampling is permitted on the day of collection.collection

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

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

• Thethe donor animal is sampled at from 6 days to 28 days after the final collection for this consignment.consignment

• Ifif a collection period lasts longer than 28 daysdays, a PCR will be required every 28 days.days

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

• Thethe collected germinal product will be ineligible for use until both the prepre- and postpost-collection collection tests return negative results.results

Or:

2. Testing for the absence of antibody (ELISA)via enzyme-linked immunosorbent assay (ELISA)

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

• Donordonor animals must not show any clinical sign of bluetongue on the day of collection

• Donordonor animal is sampled between 28 and 60 days after the collection date

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

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

Further guidance on testing

1. Collected germinal product should be quarantined from other germinal product, and stored separately in straws or in another isolated container awaiting negative results to avoid cross contamination with other germinal product.

2. A positive result will lead to an APHA 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 is suspected, this could result in the entire contents of a tank being destroyed.

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

Germinal product produced before a zone is imposed

1. Germinal product at a premises in a zone that was produced before the zone was put in place must still comply with the germinal product restrictions and movement licence conditions.

2. Any germinal product produced and frozen more than 60 days before the date a bluetongue disease control zone is imposed will not need the donor animal to be tested,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 within 60 days prior to the imposition of a zone, the donor animal must comply with one of the followingtwo testing requirements.  

Either:These testing requirements are:

• a post-collection samplesample, collected between 28 and 60 days after the collectioninitial andcollection, the sample is subject to an ELISA serological test for the detection of antibody to the bluetongue virus with negative results

Or:

• routine sampling of the donor animal (recommended every 28 days if collecting from the donor animal continuously) or pre-collection sampling (if it is a one-off germinal product collection) and stored with clear labelling and auditable records to confirm the animal and date of collection. collection. These These samples only need testing if a zone is imposed and a movement licence is required.required

If the latter option is selected, there must be at least 6 full days between the pre- and post-collection PCR samples.

Day zero samples

 IfIf a zone is imposed, a ‘day zero’ sample must be collected from the donor animal within 6 days of the zone being put in place.

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

 AuditableAuditable 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 live animals into or out of collection centres

1. The movement of live animals must comply with the general movement rules in place at that time.

2. Any collection of germinal product from an animal moved out of zone must not be used until the post-movement results return negative results. Additionally, they should be quarantined separately from other germinal product in straws or another isolated container with effective labelling and auditable records. Collection centres where this occurs will be served a restriction notice.

3. Where testing is not required as a condition of the movement, where the premises is within a control zone or temporary control zone, but testing is not required as a condition of the movement, germinal product movesthat is moved may still require testing.

Premises designation

1. All sites where germinal product collection, processing or storage take place within a BTV zone, and those to which germinal product are licensed, will require designation.

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

3. The following conditions must be met for a premises to be designated:

• Compliancecompliance with product testing regime.regime

• Separationseparation of restricted germinal product, including quarantining pending negative test results, and biosecurity measures to avoid cross contamination.contamination

• Germinalgerminal product labelling.labelling

• Effectiveeffective record keeping to allow traceability and audit.audit

To apply for designation, you must complete a designation application form and a conditions confirmation document which confirms the business compliance with the designation conditions.