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Annex

Certificate: Veterinary certification requirements for bovine embryos from Switzerland

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 (both male and female) has been continually resident and free from any quarantine restriction for the 90 days immediately prior to collection in Switzerland which is recognised by the Australian Government and the OIE as a foot and mouth disease (FMD) free country where vaccination is not practised according to the World Organisation for Animal Health (OIE) Code Article and which meets the OIE Code Article definitions for country freedom from the following diseases:

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

2. Bluetongue (BT)

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 (BTV) group 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 (RT- PCR) test* on a blood sample taken on the day of collection of embryos 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 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.]

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

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

3. Bovine pestivirus (bovine viral diarrhoea virus)

Prior to the export of the embryos each female donor gave a negative result to one of the following tests for bovine pestivirus:

  • an antigen-capture enzyme-linked immunosorbent assay (ELISA) on peripheral blood leucocytes

    or

  • an approved virus isolation test on blood or serum.

    [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.]

4. Schmallenberg virus

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

The embryos were collected before the 1 June 2011

or

 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.]

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

Name of premises where the embryos

were originally collected:

Name of approved team veterinarian:

Address of premises:

Telephone:

Fax:

6. The embryos must be fertilised in vivo, collected and processed in accordance with EU Council Directive 89/556/EEC and meet the requirements in Section 2 of this document. This must be certified in the veterinary certificate.

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

8. 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.

9. 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 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.]

10. 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.]

11. 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…………………………………...............