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. This consignment consists of frozen semen in straws or semen pellets collected from sheep that immediately prior to the pre-collection period were living in Canada. [The pre-collection period is the 30 day period immediately prior to the first collection of semen for this consignment.]

2. The semen was collected and processed in a semen collection centre (SCC) meeting the Office International des Epizooties (OIE) Code requirements for accreditation presented in Article 3.2.2.1. of Appendix 3.2.2. The ovine semen in this consignment was collected, handled and stored in accordance with the OIE Code (Appendix 3.2.2.).

3. Approval of semen collection centre for export to Australia:

·         Semen collections were performed under the direct supervision of either the centre veterinarian or the official veterinarian.

[The information in this table must be presented on the veterinary health certificate]

4.  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.]

5. Scrapie – freedom assurance

The semen donors have lived only in a country or zone where:

• scrapie has been compulsorily notifiable during the previous 6 years.
• an effective and continuous national surveillance system is practiced
• brains from clinically suspect animals are examined in a laboratory in accordance with the diagnostic techniques set out in the OIE Manual of Standards for Diagnostic Tests and Vaccines or the USDA Voluntary Scrapie Flock Certification Program Standards, Appendix 1
• the feeding of ruminant derived meat-and-bone meal to sheep and goats is banned
• scrapie-affected sheep and goats are slaughtered and their carcasses disposed of in a manner that would reliably preclude the spread of scrapie infective agent (such as complete incineration)
• all scrapie affected animal can be traced back to their flock of birth.

The semen donors originate from flocks in which no case of scrapie has been confirmed or suspected during the 5 years immediately prior to semen collection. All animals were identified and can be traced back to their flock of birth. Records of parentage, and movements of animals in and out of the flock, are maintained for a minimum period of 5 years. During the previous 5 years, introductions were only permitted from flocks with equivalent scrapie status. No animals have commingled with flocks of lower scrapie status during the previous 5 years.

[Applications will also be considered where information is available which would provide equivalent security for flock freedom for scrapie. Applications for this option must be made to Department of Agriculture, Water and the Environment through the veterinary administration of the exporting country.]

6. Foot and mouth

Immediately prior to the pre-collection period each donor was living in Canada, recognised by the World Organisation for Animal Health (OIE) as being free from foot and mouth disease.

7. Sheep and goat pox

The exporting country meets the OIE Code Article definitions for country freedom from sheep and goat pox (capripox virus).

8. Enzootic abortion of ewes (EAE)

Each donor has lived on premises in which EAE had not been diagnosed during the 2 years immediately prior to the pre-collection period and gave a negative result to a CFT test for EAE during the pre-collection period.

9. Contagious agalactia (CA)

Each donor has lived on premises in which contagious agalactia had not been diagnosed during the 6 months immediately prior to the pre-collection period.

10. Schmallenberg virus

No cases of disease caused by Schmallenberg virus have been detected or reported in Canada.

11. Microchip

Prior to entry into quarantine each donor was individually identified by microchip implanted midline between the shoulder blades or behind the ear.

12. Isolation

Each donor was isolated from all ruminants, except other donors of equivalent health status, during the pre-collection and the collection periods.

13. Vaccinations

Donors were not vaccinated against any diseases, except tetanus using a killed vaccine, during the pre-collection period nor during collection.

14. Clinical examination

Donors were clinically inspected at least each week during the pre-collection period and on each day blood samples were collected and, at each inspection, were found to be free from signs of contagious and infectious diseases (by the accredited SCC veterinarian, official veterinarian or a registered veterinarian appointed by the centre veterinarian and acting under written instruction).

15. Testing

Blood and/or fleece samples were collected from each donor for diagnostic tests or DNA testing by the centre veterinarian, the official veterinarian or a registered veterinarian appointed by the centre veterinarian and acting under written instruction. [The testing program may be subject to direct audit by Department of Agriculture, Water and the Environment at any time.]

All tests were performed at laboratories, and using tests, approved by the veterinary administration of the exporting country.

16. Bluetongue (BT)

Donors were either:

• subjected to a serological test to detect antibody to the BT virus group, such as the BT competition enzyme-linked immunosorbent assay (ELISA) or the BT agar gel immunodiffusion (AGID) test, between 28 and 60 days after final semen collection, with negative results

or

• subjected to a BT virus isolation test or polymerase chain reaction (PCR) test on a blood sample taken on the day of collection, 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.]

17. Johne’s disease (M. paratuberculosis)

Donors either:

• gave a negative result to an absorbed ELISA or AGID for JD between 90 days before the first collection of semen and export

or

• has been kept in a flock in which no clinical sign of paratuberculosis was officially reported during the 5 years immediately prior to collection.

[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.]

18.Brucella ovis infection

Donors either:

• lived only in countries in which B. ovis infection has not been reported

or

• has lived only in flocks recognised as accredited free by the veterinary administration

or

• gave a negative result to a complement fixation test (CFT) or an absorbed enzyme-linked immunosorbent assay (ELISA) for B. ovis between 90 days before the first collection of semen and export.

[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.]

19. Brucella melitensis infection

Donors either:

• lived only in a country or zone which meets Code requirements for country freedom (Article 2.4.2.2.)

or

• immediately prior to the pre-collection period, was part of a flock officially free from B. melitensis infection (Article2.4.2.3.) and gave a negative result to a CFT and a Rose Bengal plate agglutination test for B. melitensis infection on the same blood sample taken during the pre-collection period or at autopsy.

[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.]

20. Maedi-visna (MV)

Donors were either:

• part of an accredited MV free flock immediately prior to semen collection as recognised by the veterinary administration

or

• immediately prior to semen collection, part of a flock in which MV had not been diagnosed during the previous 3 years. During this 3 year period the donors had no physical contact with goats (apart from incidental contact with goats off the flock premises such as occurs at shows and sales). No animals were introduced from flocks with a lesser disease status and each donor gave a negative result to either an approved ELISA, for MV antibodies on two blood samples collected 30 days apart during the pre-collection period, at the time of collection or at autopsy.

or

• sourced from a closed flock where the flock tested negative for MV using an approved AGID or ELISA and a sample size sufficient to provide 95% probability of detecting MV at 10% prevalence. Testing of the flock took place within the 6 months immediately prior to export.

[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.]

21. Jaagsiekte

Each donor has only lived in flocks that include animals older than 5 years.

After due enquiry and examination of official records, all animals in flocks which included the donor remained free from Jaagsiekte, based on the absence of clinical signs, for at least 5 years immediately prior to collection of semen.

During the 5 year period immediately prior to the collection of semen, no animals were introduced from flocks with a lesser Jaagsiekte status.

Each donor gave a negative result to a pathological examination or immune or nucleic acid test for jaagsiekte virus/viral components in lung and associated lymphoid tissues in accordance with procedures approved by the veterinary administration for the detection of Jaagsiekte.

[Testing must be carried out at a laboratory approved by the veterinary administration to carry out histopathological diagnosis and/or immune or nucleic acid detection testing.]

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

22. Scrapie – post mortem

The semen donors were at least 5 years of age at the time of post mortem.

Before the export of semen each donor was autopsied under the direct supervision of an official veterinarian or a registered veterinary pathologist employed at a veterinary laboratory approved by the veterinary administration and acting under written instruction from the official veterinarian.

The donors gave a negative result to tests for scrapie prion protein (PrPsc) on specimens of brain, brain stem, spinal cord, palatine tonsils, spleen, mesenteric lymph nodes and distal ileum using immunohistochemical methods or techniques of equivalent sensitivity in accordance with procedures laid down by the veterinary administration for the detection of scrapie infective agent.

[This testing must be carried out at a laboratory approved by the veterinary administration to carry out testing for scrapie prion protein (PrPsc).]

23. Scrapie - genotype

The semen donors are of a homozygous PrP genotype known to be susceptible to scrapie, in relation to the particular breed of sheep (approved by Department of Agriculture, Water and the Environment), as verified in the attached certificate/s from a laboratory/laboratories officially approved by the veterinary administration to do PrP genotype testing.

[Breeds and genotypes permitted without consultation with the department: Suffolk – QQ at Codon 171, East Friesian - ARQ/ARQ at Codons 136/154/171, Valais Blacknose – ARQ/ARQ at Codons 136/154/171, and Cheviot, Texel, and Charollais – VRQ/VRQ at Codons 136/154/171. Requests for the importation of semen from other breeds will be considered by the department after receiving details of breed specific PrP genotype and scrapie susceptibility through the veterinary administration of the exporting country.]

24. Disinfection of equipment - Scrapie

Equipment that came in contact with the semen was either new or treated by a process recommended for the disposal of TSE infective agents in accordance with the recommendations of the veterinary administration prior to contacting the semen.

[TSE disinfection processes include autoclaving at 136 degrees C for 1 hour or soaking in a 2 percent available chlorine solution (equivalent to 20,000 ppm) for 1 hour. (from Appendix 2 USDA Voluntary Scrapie Flock Certification Program Standards)]

25. 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.

26. 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.]

27. 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.]

28. 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…………………………………...............