Guidance

Restrictions on germinal product from bluetongue-susceptible animals

In the event of a bluetongue outbreak, controls will be imposed to prevent the spread of disease via semen, ova and embryos from bluetongue-susceptible animals.

• From: Department for Environment, Food & Rural Affairs
• Published: 5 July 2024
• Last updated: 23 September 2024 — See all updates

Applies to England

Restrictions on germinal product under bluetongue controls do not remove your obligations to comply with other germinal product regulations.

Find out how to apply for germinal product specific licences on the Apply to freeze or move germinal product from bluetongue zones page.

Find out how to apply for germinal product general licences on the bluetongue movement licences and designated slaughterhouses page.

Movement of germinal product within a bluetongue zone

Germinal 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 same zone without a licence.

Within a control zone (CZ) or a temporary control zone (TCZ), you can move fresh or frozen germinal product within the same zone under general licence.

Movement of germinal product into a bluetongue zone

You can move fresh or frozen germinal product from the free area into a RZ, SZ or PZ without a licence.

You can move fresh or frozen germinal product from the free area into a CZ or TCZ subject to a general licence.

Freezing of germinal product within a bluetongue zone

Freezing of 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.

Movement of germinal product out of a bluetongue zone

Germinal product can only be moved out of a bluetongue zone if you comply with the conditions of a licence. Conditions include, but are not limited to:

• frozen germinal product produced more than 60 days before a bluetongue zone was declared can move under licence to any premises outside the zone without testing of the donor animal
• frozen germinal product produced from animals that have completed all testing requirements with negative results, as set-out below, can move to any premises outside of the bluetongue zone
• frozen germinal product collected up to 60 days before a bluetongue zone was declared can only be moved out of the zone if the donor animal has been tested – blood samples may be taken from the donor animal at the time of collecting the germinal product and stored for subsequent testing, if required
• fresh germinal product can 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

Testing regime for donor animals

There are 2 testing regimes available for donor animals to demonstrate that collected germinal product is 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 2 regimes:

Virus test regime: testing for absence of virus by polymerase chain reaction (PCR) test

Prior to the collection of germinal product:

• donor animals must not show any clinical signs of bluetongue on the day of collection
• samples must be taken from the donor animal no more than 10 days before the start of the collection period
• sampling is permitted on the day of collection
• we recommend that you take the pre-collection sample 3 days in advance and obtain negative results prior to commencing collection
• 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

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 PCR will be required every 28 days 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

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

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

• the donor animal must not show any clinical sign of bluetongue on the day of collection
• the donor animal is sampled once from 28 days to 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

Storage of germinal product until negative test results are obtained

Collected germinal product should be quarantined from other germinal product with a different health status and stored separately in straws or in another isolated container (for example, hexi-goblet) while awaiting negative results. This avoids cross contamination with other germinal product.

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-collection testing is completed with the return of negative results.

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

Germinal product collected before a zone is imposed

Some germinal product may have been collected and stored in the zone before the zone was declared. This germinal product also requires a licence to exit the zone.

Any germinal product produced and frozen more than 60 days before the date a bluetongue disease control zone is declared will be 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.

For germinal product that is collected and stored less than 60 days before a zone is declared, in 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 testing using bluetongue RT-PCR, the licensee must ensure that:

• a single pre-collection sample of the donor animal should be taken if it is a one-off or limited germinal product collection
• a second sample is needed 6 to 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 continuously, samples should be collected every 28 days, including a sample at least 6 days after the collection period ends
• samples must be 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 - they 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 testing using bluetongue ELISA, the licensee must ensure that:

• a post-collection sample should be collected between 28 and 60 days after the germinal product collection
• the sample is subject to a bluetongue ELISA serological test for the detection of antibody to the bluetongue virus with negative results

‘Day 0’ samples

If a post-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 movement licence is required, you must prove the negative disease status of the donor prior to the movement. To do this, the day 0 sample, together with the samples collected in the previous 60 days, must be subject to an agent identification test (PCR test) with negative results.

You must keep auditable records as evidence that the samples were collected within this period.

You will also require a veterinary attestation 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 an animal out of a bluetongue zone for germinal product collection

Live animals moved out of 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 should 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, as follows:

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

Where it is intended that animals will only stay for a short period (routinely up to 24 hours but we will accept up to 5 days) a specific licence is available to permit movement to a designated premises for collection of germinal product. The same licence will permit their return to the original source premises where post-movement samples must be taken 6 to 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.

Voluntary 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).

Designated premises

Any premises can be designated for the purpose of collecting, processing, handling or storing germinal product. These will normally be specialist artificial breeding centres, 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:

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

If your premises regularly freezes and stores germinal product, you should, as a contingency apply 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. Conditions for designation include, but are 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 allowing traceability and audit

Published 5 July 2024
Last updated 23 September 2024 + show all updates

1. 23 September 2024

   This page has been updated to clarify the current requirements for movement and storage of germinal product in the event of a bluetongue outbreak.

2. 11 July 2024

   We have updated the information on this page for clarity.

3. 5 July 2024

   First published.