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. Each donor has been continually resident and free from any quarantine restriction for the 90 days immediately prior to collection in Norway which was recognised by the Australian Government and the Office International des Epizooties (OIE) as free from foot and mouth disease (FMD) where vaccination is not practised and met the OIE Code Article definitions of country freedom from:

   • vesicular stomatitis
   • rinderpest
   • contagious bovine pleuro pneumonia
   • lumpy skin disease
   • Rift Valley fever
   • epizootic haemorrhagic disease of deer [meeting the same requirements of disease freedom that apply to bluetongue].

2. 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:

   · The semen was collected, processed and stored in accordance with Council Directive 88/407/EEC.

3. Bluetongue
   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.]
     
     [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. All applicable laboratory reports for each semen donor in this consignment must be attached to the veterinary certificate.]
     
     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 …………………………………………….
4. 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 neutralisation test (VNT) or approved indirect ELISA for antibody to the Schmallenberg virus on a blood sample collected either:
   · Between 14 and 60 days after last collection of semen from the donor for this consignment with negative results.
   
   or
   
   · Between 14 and 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.]
5. Johne’s disease (M. paratuberculosis)
   Each donor showed no clinical signs of Johne’s disease during the collection period.

6. 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 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.
   • 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.

7. 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.]

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 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.]

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…………………………………...............