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Annex

Veterinary certification for importation of cervine embryos from member states of the European Union

Effective 14 July 2015 to 8 October 2016

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 embryos in this consignment were collected, processed and stored under conditions that comply with the standards laid down in Council Directive 89/556/EEC Annex A Chapters I and II.

2.      Approval of embryo collection team veterinarian for export to Australia

Name of approved centre where the embryos

were originally collected:

Name of centre veterinarian:





Address of approved centre:

Telephone:



Fax:



3. The Team Veterinarian must be specifically approved by an Official Veterinarian to supervise the Collection Team, in accordance with Council Directive 89/556/EEC and amendments.

4. All sample collections for diagnostic tests, all collections of embryos and all servicing of storage containers prior to export must be performed under the direct supervision of either the Team Veterinarian or the Official Veterinarian.  The program may be subject to direct audit by Department of Agriculture at some stage during the collection period.

5. The embryos in this consignment were fertilised either

  • by natural service

or

  • by semen collected, processed and preserved in accordance with Annex D Chapter III of Council Directive 92/65/EEC; at a centre which meets the requirements detailed in Annex D Chapter I of Council Directive 92/65/EEC.

6. The embryos in this consignment were not subjected to micromanipulation involving breaching of the zonapellucida and all had intact zonapellucida at the time of storage.

7. Male and female donors have been continually resident and free from any quarantine restriction for the 60 days prior to the commencement of the 30 day pre-collection centre residency period, 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

  • bluetongue

  • 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 Code

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

8. Foot and mouth (FMD)

The embryos were 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).

9. Chronic wasting disease of deer (CWD).

Male and female donors have lived only in Member States where there have been no reports of CWD.

10. Tuberculosis

At the time of collection each male and female 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 period male and female donors gave a negative result to either:

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

or

  • an 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 both male and female donors must be attached to the veterinary health certificate.]

For all tuberculosis testing:

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

11. Brucellosis

Male and female donors came 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

or

  • in which there has been no reports of clinical brucellosis for at least six months 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 period male and female donors gave a negative result to a CFT for bovine brucellosis.

[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.]

12. Louping ill

During the pre-collection period male and female donors gave a negative result to a specific haemaglutination 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.]

13. Cervine herpes virus

A pooled sample of at least 10% of the semen from all the ejaculates from each male donor (with a minimum of 5 straws) used for the production of embryos in this consignment was examined 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. Bluetongue virus

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

(a)

  • A competitive enzyme- linked immunosorbent assay (cELISA) for antibody to the bluetongue virus group (BTV) on a blood sample, with negative results, between 28 and 60 days after the collection of embryos for this consignment.

or

  • A bluetongue virus isolation test or an approved real time reverse transcriptase- polymerase chain reaction (PCR) test* on a blood sample taken on the day of collection of embryos for this consignment, with negative results.

* Real time 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 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).

[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 embryo donors must be:

·         inactivated, and

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

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

Name of BTV vaccine used: ……………………………………………………………………………

             Date of administration of BTV vaccine to embryo donor ………………………………………

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

15. Schmallenberg virus

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

For embryos collected on or after 1 June 2011, a virus neutralisation test or approved indirect ELISA for antibody to the Schmallenberg virus on a blood sample collected

either

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

or

·         between fourteen (14) and sixty (60) days before first collection of embryos 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.]

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…………………………………...............