Annex

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. The semen in this consignment was collected, processed and preserved in accordance with Annex D Chapter III of Council Directive 92/65/EEC.

2. Approval of semen collection centre for export to Australia

·         The semen collection centre must meet the requirements detailed in Annex D Chapter I of Council Directive 92/65/EEC.

3. The Centre Veterinarian must be accredited by the Government of the Member State to supervise the collection of semen.

4. Each semen donor must be isolated from other ruminants not of the equivalent health status, for 30 days prior to the first collection, on the centre used for the collection of semen for this consignment [the pre-collection isolation period].

5. Each semen donor has been continually resident and free from any quarantine restriction for the 90 days prior to the first collection of semen in part of the territory of a Member State or States, recognised by the OIE as a foot and mouth disease (FMD) free zone where vaccination is not practised and which meets the OIE Code Article requirements for freedom from the following diseases:

• rinderpest [free country]
  

• Rift Valley fever
  

• vesicular stomatitis
  

• which is free of epizootic haemorrhagic disease of deer by meeting the same criteria of disease freedom that apply to bluetongue as detailed in the Code and
  

• from which there have been no reports of Borna disease for 12 months.
  

6. Foot and mouth FMD

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: after 2 December 2010 (inclusive of this date).

7. 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.]

8. Chronic wasting disease of deer (CWD)

Each donor has lived only in Member States where there have been no reports of CWD.

9. Tuberculosis

At the time of collection each donor was free from clinical signs of bovine tuberculosis and came from herds free from bovine tuberculosis in which:

• all animals over 8 months of age had reacted negatively to two intradermal tuberculin tests, the first of these tests being six months after the entire herd gave a negative test result and the second test six months later.
  

  and
  

• all the animals in the herds gave a negative result to an annual intradermal tuberculin test.
  

During the pre-collection isolation period each semen donor was subjected to either:

• a Blood Tb test (BTB) with a negative result for bovine tuberculosis
  

  or
  

• a mid-cervical intradermal tuberculin test with a negative result
  

[Tests for bovine tuberculosis must be carried out at least 90 days after any previous tuberculin test]

[For testing in the pre-collection period:

 the veterinary certificate must indicate the option that applies.

All applicable laboratory reports for the donors or their semen must be attached to the veterinary health certificate.]

For all tuberculosis testing:

[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 for donors only.]

10. Brucellosis

Each donor must come from herds free from bovine brucellosis either:

• in part of the territory of a Member State where all bovine and cervine herds have been qualified as officially free from bovine brucellosis and where there has been no reports of bovine brucellosis for five years prior to final collection for this consignment.
  

  or
  

• in which there has been no reports of clinical brucellosis for at least six months prior to final collection for this consignment and in which all animals have given a negative results to two official complement fixation tests (CFT) for bovine brucellosis at intervals of at least three months and at most 12 months.
  

During the pre-collection isolation period each semen donor was subjected to a complement fixation test (CFT) for bovine brucellosis with negative results.

[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.]

11. Louping ill

During the pre-collection isolation period each semen donor was subjected to a specific haemagglutination inhibition test (HI) for louping ill with negative results.

[The attached table must include dates of sampling for test, type of tests used, test results.]

12. Johne’s disease (M. paratuberculosis)

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

13. Cervine herpes virus

For each individual donor a pooled sample of at least 10% of the semen from all the ejaculates used in this consignment was tested (with a minimum of 5 straws) for the presence of cervine herpes virus (CHV1), by tissue culture inoculation (in cells demonstrated to support growth of CHV1) with at least one blind passage, with negative results.

[The attached table must include dates of sampling for test, type of tests used, test results.]

14. Schmallenberg virus

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

For semen collected on or after 1 June 2011, a virus neutralisation 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.]

15. Sex sorted semen

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.]

16. 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 supervision of the Approved Veterinarian(s), and
  

·         in containers containing only new, unused liquid nitrogen.

17. 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 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 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.]

18. 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 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.]

19. Official Government Seals

Under the 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…………………………………...............