Restrictions on germinal product from bluetongue-susceptible animals

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Restrictions on germinal product

Movements within a control zone (CZ)

Moving germinal product between premises within the same control zone (CZ) or temporary control zone (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), surveillance zone (SZ), protection zone (PZ)

Moving germinal product within the same zone is permitted, subject to the donor animal not showing clinical signs of bluetongue at the time of collection or subsequently (where known).
Any germinal product intended for fresh transfer, including on farm or within the same bluetongue zone, will not require testing or licensing.
Any germinal product intended for freezing and storage must comply with the requirements of a licence and testing of donor animals.
If your business wishes to test donor animals this may be done through The Pirbright Institute: Non-Vesicular Reference Laboratory (The Pirbright Institute)

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

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.
The donor animal must be tested in accordance with the Testing Regime (below).
Movements of germinal product out of a zone intended for fresh transfer is prohibited.
If the Germinal Product collected in any bluetongue zone is to be frozen, you must comply with the Testing Regime (see below) for the donor animal.
Where testing is required, germinal product should not be used until negative results are received.

Freezing of Germinal Product

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

Testing regime

The following testing regimes will be available to demonstrate that collected germinal product is bluetongue free. Use one or the other.

1. Testing for absence of virus by PCR

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

Donor animals must not show any clinical signs of bluetongue on the day of collection.
Samples must be taken no more than 10 days prior to the commencement of the collection period (including the day of collection).
It is recommended that the pre-collection sample is undertaken 3 days in advance and negative results obtained prior to collection to reduce the risk of positive germinal product being stored.
Sampling is permitted on the day of collection.
The sample is subject to an agent identification test (PCR) with negative results.

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

The donor animal is sampled at from 6 days to 28 days after the final collection for this consignment.
If a collection period lasts longer than 28 days a PCR will be required every 28 days.
The sample is subject to an agent identification test (PCR) with negative results.
The collected germinal product will be ineligible for use until both the pre and post collection tests return negative results.

Or:

2. Testing for the absence of antibody (ELISA)

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

Donor animals must not show any clinical sign of bluetongue on the day of collection
Donor animal is sampled between 28 and 60 days after the collection date
The sample is subject to an ELISA 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 guidance on testing

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.
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.
If cross contamination 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 Vet who must attest that the samples were collected in accordance with APHA guidance.

Germinal product produced before a zone is imposed

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.
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, 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.
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 following testing requirements.

Either:

a post-collection sample collected between 28 and 60 days after the collection and 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. These samples only need testing if a zone is imposed and a movement licence is required.
If the latter option is selected, there must be at least 6 full days between the pre- and post-collection PCR samples.

If 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.

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

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 live animals into or out of collection centres

The movement of live animals must comply with the general movement rules in place at that time.
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.
Where testing is not required as a condition of the movement, where the premises is within a control zone or temporary control zone, the germinal product moves may still require testing.

Premises designation

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.
Designation of the source or destination premises may also be required as a condition of a movement licence.
The following conditions must be met for a premises to be designated:

Compliance with product testing regime.
Separation of restricted germinal product, including quarantining pending negative test results, and biosecurity measures to avoid cross contamination.
Germinal product labelling.
Effective record keeping to allow traceability and 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.

Restrictions on germinal product from bluetongue-susceptible animals