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. Foot and mouth disease (FMD)
   Immediately prior to the pre-collection period each donor was living in Canada and the United States of America in a country or zone recognised by the World Organisation for Animal Health (OIE) as being free from foot and mouth disease.
2. The exporting county meets the Code Article definitions for country freedom from sheep and goat pox (capripox virus) and contagious caprine pleuropneumonia.

3. The embryos were derived from female donors and male semen donors five years of age or older prior to export of the embryos which had lived only in a country or zone where:

   • scrapie has been compulsorily notifiable during the previous six years
   • an effective and continuous national surveillance system is practiced;
   • brains from clinically suspect animals which are slaughtered or die 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
   • 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)
   • procedures are followed which allow tracing of each scrapie affected animal back to its herd of birth.

4. The embryos were derived from female donors and male semen donors five years of age or older prior to export of the embryos which originated from herds:

   • of Certified status in the USDA Voluntary Scrapie Flock Certification Program
     
     or
     
   • in which no case of scrapie has been confirmed or suspected during the five years immediately prior to collection
   • in which no animals have commingled with sheep during the five years immediately prior to collection; (commingled is defined as animals grouped together having physical contact. This does not include incidental contact between animals away from the flock’s premises, such as occurs at shows and sales).
   • in which all animals are identified and can be traced back to their herd of birth
   • for which records of parentage, and movements of animals in and out of the herd, are maintained for a minimum period of five years
   • into which, during the previous five years, introductions of goats were only permitted from herds of an equivalent scrapie status
   • in which no animals have commingled with herds of lower scrapie status during the previous five years
     
     or
     
   • for which confirmed information is available which would provide equivalent security to the above.*
     
     *[Note: Applications for this option must be made to Department of Agriculture, Fisheries and Forestry through the competent authority of the exporting country.]
     
     [The veterinary certificate must indicate the option that applies.]
5. Each embryo donor was isolated from all ruminants, except other embryo donors of equivalent health status, during the pre-collection and the collection periods. Prior to entry into quarantine each embryo donor and each semen donor was individually identified by microchip [6] implanted midline between the shoulder blades or behind the ear. The microchip or electronic implant is any radio frequency identification device approved for use by the exporting country veterinary administration which is tamper resistant and readable by equipment available to the veterinary administration. The embryo donors and semen donors must be identified by scanning the microchip at each process which requires certification.

6. Embryo donors and semen donors must be isolated for at least 30 days at a place specifically approved for this purpose by the USDA prior to admission to the embryo collection facility and until completion of donor pre-collection testing requirements.  This is the pre-collection period.

   [The start date of the pre-collection period must be listed on the veterinary health certificate.]

7. Embryo donors and semen donors were:

   • not vaccinated against any diseases, except tetanus using a killed vaccine, during the pre-collection period nor during collection
   • 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 team veterinarian, official veterinarian or a registered veterinarian appointed by the team veterinarian and acting under written instruction).
8. All animal health testing, to meet these conditions, was performed at laboratories and using tests, approved by the veterinary administration of the exporting country.

9. Bluetongue (BT)
   Each embryo donor and semen donor was:

   • 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 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.]

10. Brucella melitensis infection
    Each embryo donor and semen donor:

    • has lived only in a country or zone which meets OIE Code requirements for country freedom
      
      or
      
    • immediately prior to the pre-collection period, was part of a herd officially free from B. melitensis infection according to the OIE Code Article definitions and gave a negative result to a complement fixation test (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.]
11. Contagious agalactia (CA)
    Each embryo donor and semen donor has lived on premises in which contagious agalactia has not been diagnosed during the 6 months immediately prior to the pre-collection period.
12. Caprine arthritis/encephalitis (CAE)
    Each embryo donor:
    
    12.1 a) immediately prior to embryo collection was part of an accredited CAE free herd recognised by the veterinary administration of the exporting country
    
    OR
    
    12.1 b) immediately prior to embryo collection was part of a herd in which CAE had not been diagnosed during the previous three years and during this three year period no commingling with sheep occurred and no animals were introduced from herds with a lesser disease status
    
    AND
    
    12.2 gave a negative result to either an approved ELISA for CAE antibodies on two blood samples collected 30 days apart during the pre-collection period, at the time of embryo collection or at autopsy or was sourced from a flock which tested negative within the 6 months immediately prior to export. (A flock which “tested negative” is defined as a closed flock in which a sample, sufficient to provide 95% probability of detecting evidence of CAE at 10% prevalence, tested negative to a approved AGID or ELISA).
    
    [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.]

13. Enzootic abortion of ewes
    Each embryo and semen donor:

    • has lived on premises in which enzootic abortion of ewes (EAE) had not been diagnosed during the two years immediately prior to the pre-collection period
      
      and
      
    • gave a negative result to a CFT test for EAE during the pre-collection period.
      
      [The attached table must include dates of sampling for test, type of tests used, test results.]
14. Schmallenberg virus
    Each embryo and semen donor has only lived in a country where no cases of disease caused by Schmallenberg virus has been detected or reported.

15. The semen donors were of equivalent tested health assurance standards to those prescribed for the female donors and the embryos were produced:

    • by insemination with fresh semen collected from identified males
      
      or
      
    • by insemination with semen collected, processed and stored at centres registered under the competent authority of the exporting country.
      
      *[Note: This testing must be carried out at a laboratory approved by the veterinary administration to carry out testing for scrapie prion protein (PrPsc).]
      
      [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.]

16. Before the export of embryos each embryo and semen 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
    • 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.
      
      *[Note: This testing must be carried out at a laboratory approved by the veterinary administration to carry out testing for scrapie prion protein (PrPsc).]
      
      [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. The embryos were collected, handled and stored in accordance with the OIE Code. Materials of animal origin used during the collection, handling or storage of the embryos contained no living micro-organisms, were sourced from Australia or New Zealand and were subjected to quality control methods in accordance with the latest version of the Manual of the International Embryo Transfer Society (IETS). Equipment which came in contact with the embryos, or the reproductive organs of the donors, 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 of the exporting country*.
    
    *[Note: Processes include autoclaving at 136 degrees C for one hour or soaking in a two percent available chlorine solution (equivalent to 20,000 ppm) for one hour. (From Appendix 2 USDA Scrapie Flock Certification Program Standards.)]

18. The embryos:

    • have been fertilised in vivo
    • were collected and processed by an embryo collection team supervised by an approved team veterinarian and meet the requirements specified in World Organisation for Animal Health (OIE) Code and veterinary certificate section of this document,
    • were not subjected to micromanipulation involving breaching of the zona pellucida
    • all had an intact zona pellucida at the time of storage.

19. 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:

20. 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.

21. 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.]
22. 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.]

23. 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…………………………………...............