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Annex

Certificate: Veterinary certification for bovine semen from the UK and member states of the EU

Effective 22 June 2021 to 26 November 2021

NOTE: Veterinary certificates are negotiated directly between relevant government authorities. In cases where a veterinary certificate has not been negotiated, this annex can be used as the basis for developing a suitable document.

1. Each donor has been continually resident and free from any quarantine restriction for the 90 days immediately prior to collection in the United Kingdom, or a EU member state or states, which is recognised by the Australian Government and the OIE as foot and mouth (FMD) free where vaccination is not practised and met the OIE Code Article definitions of country freedom from:

  • rinderpest
  • vesicular stomatitis
  • contagious bovine pleuropneumonia
  • lumpy skin disease
  • Rift Valley fever.

2. Semen not permitted due to disease outbreaks

a. Foot and mouth disease

The semen was NOT collected in:

France: between 5 February 2001 and 23 June 2001 (inclusive of these dates).

Netherlands: between 12 February 2001 and 25 August 2001 (inclusive of these dates).

Republic of Ireland: between 1 February 2001 and 22 June 2001 (inclusive of these dates).

United Kingdom: between 1 January 2001 and 15 January 2002 and between 1 July 2007 and 18 February 2008 (inclusive of these dates).

Cyprus: between 24 September 2007 and 21 February 2008 (inclusive of these dates).

Bulgaria: from 2 December 2010 (inclusive of this date).

b. Lumpy skin disease

The semen was NOT collected in:

Cyprus: from 8 October 2014 (inclusive of this date).

Greece: from 25 June 2015 (inclusive of this date).

Bulgaria: from 16 February 2016 (inclusive of this date).

Croatia: from 8 August 2016 (inclusive of this date).

[These declarations need only be made if the semen is collected in one of the above countries]

3. The semen in this consignment was collected, processed and stored under conditions that comply with the standards laid down in Council Directive 88/407/EEC and updating legislation.

4. Johne's disease (M. paratuberculosis)

Each donor showed no clinical signs of Johne’s disease during the collection period.

5. Bluetongue (BT)

Prior to the export of this consignment each semen donor must be certified as follows for Bluetongue:

(a)

  • A competitive enzyme linked immunosorbent assay (cELISA) for antibody to the bluetongue virus group on a blood sample, with negative results, at least every 60 days throughout the semen collection period and between 28 and 60 days after the final semen collection for this consignment.

    or

  • An agent identification test for bluetongue virus on blood samples drawn from each donor at commencement and conclusion of, and at least every seven days (virus isolation test) or at least every 28 days [approved polymerase chain reaction (PCR) test*] during semen collection for this consignment, with negative results.

    * Real time reverse transcriptase- polymerase chain reaction (RT-PCR) tests must be approved by the competent authority and be able to detect all known 24 BTV serotypes. These tests must use primer sequences directed against highly conserved segments of the bluetongue virus (BTV) genome which code for BTV serogroup (not serotype). An example of an appropriate test is the TaqMan real time RT-PCR test according to the method of Shaw et al. (2007), which uses two primers directed against segment 1 of BTV ribonucleic acid (RNA).

    [Serological testing for BTV antibodies with agar gel immunodiffusion (AGID) tests should not be used.]

    [All tests for BTV should be validated according to the current OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, calibrated to a diagnostic sensitivity of at least 98.0% and carried out in a laboratory approved by the competent authority of the exporting country.]

    AND

    (b) Donors vaccinated against BTV: Yes / No

    If Yes, vaccines against BTV administered to semen donors must be:

    · inactivated, and

    · approved by the competent authority in the exporting country, and

    · administered more than 60 days before semen collection for this consignment.

    Name of BTV vaccine used:.......................................................................................................

    Date of administration of BTV vaccine to semen donor:............................................................

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

6. Epizootic haemorrhagic disease of deer (EHD)

  • The semen was collected from donors resident in an EHD free country or zone for at least 60 days prior to, and during, semen collection.

    or

  • Blood samples drawn from each donor between 28 and 60 days after final semen collection for this consignment, gave negative results to either an agar gel immunodiffusion (AGID) test or a virus neutralisation test for EHD antibodies.

    or

  • Blood samples were drawn from each donor at the commencement and conclusion of semen collection and at least every 7 days during semen collection and gave negative results to a virus isolation test for EHD.

    or

  • Blood samples were drawn from each donor at the commencement and conclusion of semen collection and at least every 28 days during semen collection and gave negative results to a polymerase chain reaction test for EHD.

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

7. Infectious bovine rhinotracheitis/ Infectious pustularvulvovaginitis (IBR/IPV)

  • The semen in this consignment complies with requirements for IBR/IPV laid down in Council Directive 88/407/EEC and updating legislation,

    or

  • The semen was collected from donors whose serological status is unknown or positive for IBR/IPV, and from which an aliquot of each semen collection for export was subjected to a virus isolation test (by cell culture inoculation and a minimum of 2 passages if no cytopathic effect observed on first passage) or real-time polymerase chain reaction (RT-PCR) assay, with negative results. Only collections that have been tested as described above are eligible for importation to Australia. Semen from bulls collected in periods between tests is not eligible.

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

    NOTE: Diagnostic tests and interpretation of test results for IBR/IPV must comply with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Chapter on Infectious bovine rhinotracheitis / Infectious pustular vulvovaginitis.

8. Schmallenberg virus

Prior to the export of this consignment each semen donor must be certified as follows for Schmallenberg virus either:

The semen was collected before 1 June 2011

or

For semen collected on or after 1 June 2011, a virus neutralisations test (VNT) or approved indirect ELISA for antibody to the Schmallenberg virus on a blood sample collected either

· between (14) and sixty (60) days after last collection of semen from the donor for this consignment with negative results

or

· between fourteen (14) and sixty (60) days before first collection of semen from the donor for this consignment with positive results

[The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used and test results. Laboratory reports for all Schmallenberg virus testing must be provided and attached to the veterinary health certificate.]

9. All blood tests for disease were carried out at a laboratory approved by the veterinary administration of the exporting country or member state to perform the test required for that disease.

10. Approval of semen collection centre for export to Australia

Name of approved centre where the semen was originally collected:

Name of centre veterinarian:

Address of approved centre:

Telephone:

Fax:

11. An approved veterinarian:

  • ensured the isolation of the donors from all other ruminants not of equivalent health status prior to semen collection;
  • supervised the isolation period;
  • supervised the collection of specimens for testing;
  • supervised the collection and processing of the semen in accordance with the standards laid down in Council Directive 88/407/EEC and updating legislation;
  • ensured that suitable antibiotics were added to the diluent and that diluents were prepared in accordance with the standards laid down in Council Directive 88/407/EEC and updating legislation, and
  • verified the permanent identification of the semen straws with the identification details of the donor and date of collection or a code from which this information could be determined.

12. For sex sorted semen, either:

  • Sex sorted semen is NOT included in this shipment,

    or

  • Sex sorted semen IS included in this shipment, and:

    - equipment used for sex-sorting sperm was cleaned and disinfected between animals according the sex semen licensor’s recommendations; and

    - where seminal plasma, or components thereof, was added to sorted semen prior to cryopreservation and storage, it was derived from animals of same or better health status.

    [The veterinary certificate must indicate the option that applies.]

13. Storage at approved centre(s) or laboratory(ies)

From the time of collection until export, the reproductive material in this consignment was stored:

  • in sealed containers (e.g. straws, ampoules or vials) and identified in a legible and non-erasable manner as specified in this veterinary certificate
  • only with other embryos or semen collected for export to Australia, or of equivalent health status
  • in a secure place within an approved centre or laboratory and under the direct supervision of the approved veterinarian(s), and
  • in containers containing only new, unused liquid nitrogen.

14. Further processing or aggregation

For this reproductive material, either:

  • After leaving the approved centre under seal in shipping containers (liquid nitrogen shippers/tanks), the reproductive material was NOT removed from sealed containers (e.g. straws, ampoules or vials) for further processing or removed from the shipping container(s) for aggregation with other reproductive material.

    or

  • Reproductive material was shipped to another approved centre or laboratory under seal in shipping containers (liquid nitrogen shippers/tanks) and removed from sealed containers (e.g. straws, ampoules or vials) for further processing (e.g. sex sorting) or for aggregation:

- with other reproductive material collected for export to Australia, or of equivalent health status

- at an approved centre or laboratory and

- under the direct supervision of the approved veterinarian(s).

The date(s) of transfer between the approved centre(s) or laboratory(ies), reason for transfer(s) (e.g. for sex sorting), name(s) of the approved centre(s) or laboratory(ies) and the Government approved veterinarian(s) are listed against the shipping container/s on this certificate before departure from the approved centre or laboratory. The unique seal number of each shipping container is included in this documentation.

NOTE: For transfers to another approved centre or laboratory, the approved veterinarian must ensure the shipping containers are transferred under seal as described below:

Date of transfer...................................

Reason for transfer.................................................................................................................

Name of approved centre/laboratory......................................................................................

Approved veterinarian(s)........................................................................................................

Shipping container seal number(s).........................................................................................

[The veterinary certificate must indicate the option that applies.]

15. Shipping containers (Liquid nitrogen shippers/tanks)

The shipping container was new

or

Prior to loading, the shipping container was emptied and inspected and any loose straws removed. The shipping container, including all surfaces in contact with the straws, ampoules or vials was then disinfected with one of the following disinfectants: 2% available chlorine (e.g. chlorine bleach), 2% Virkon, 2.4% Prevail or irradiated at 50 kGy.

Date of disinfection/ irradiation………………………………………………………...

Disinfectant used/ active ingredient…………………………………………………….

[The veterinary certificate must indicate the option that applies. For used shipping containers, the date of disinfection, the disinfectant used and its active chemical must be recorded on the health certificate.]

16. Official Government Seals

Under the direct supervision of an official veterinarian prior to export to Australia:

· the containers (e.g. straws, ampoules or vials) for reproductive material in this consignment were checked as being sealed.

· the identity of the reproductive material was checked prior to being placed into new, unused liquid nitrogen in a shipping container for export that was new or disinfected as specified in this veterinary certificate

· Only reproductive material that met Australian import conditions was added to the shipping container

· The shipping container was sealed with an official government seal and the number or mark on the seal recorded on the certificate.

Shipping container official government seal number…………………………………...............