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.

This certificate may be prepared by the veterinarian responsible for the colony and must be countersigned by an official veterinarian.

The following information must be displayed:

1. Number of embryos in the consignment.
2. Number of ampoules, straws or vials in the consignment.
3. Ampoule, straw or vial identification.
4. The following information must be displayed against each embryo donor:

4.1. Species

4.2. Institution of donor residence

4.3. Colony identification

4.4. Dates on which embryos were collected.

Veterinary certification requirements

1. Embryos are derived from donors bred and housed for their lifetime in premises that are part of a bona fide scientific institution (evidenced by the existence of an animal ethics committee or equivalent arrangement within the organisation) and all preparation and processing of donors and embryos occurred within the same facility.
   Note: The term ‘donors’ refers to donors of all reproductive material including, embryos, ova and semen.
2. The donors were housed in a facility for which there was a control program in place designed to preclude access by wildlife, including rodents and insect vectors.

3. There was no clinical, epidemiological or other evidence of the following diseases or infectious agents in any barrier maintained room where the donor mice were bred or housed during the 12 months before, or 30 days after, the date of collection:
   

   3.1. hantaviruses
   

   3.2. ectromelia virus
   

   3.3. rabies.
   Note: The term ‘barrier maintained room’ refers to an individual room within the facility with protocols in place to exclude any potential sources of unwanted microbiological contamination.

4. Reproductive tracts (uteri, oviducts, ovaries, testes, epididymis and vas deferens) were removed either at a site separate from the embryo processing laboratory or within a biological safety cabinet before processing.
5. Collection of reproductive material including ova and sperm and embryo recovery was performed in aseptic conditions.
6. During processing of embryos for export no embryos from donors of a lesser health status or of other species were handled.
7. After washing the zona pellucida of each embryo was examined over its entire surface at not less than 50 X magnification and was intact and free from adherent material.
8. Biological product of animal origin used in the media and solutions for collection, processing, washing or storage of embryos were free of pathogenic micro-organisms. Media and solutions used in the collection and storage of embryos were sterilised by approved methods according to the latest edition of the International Embryo Transfer Society (IETS) manual and handled in such a manner as to ensure that sterility is maintained. Antibiotics may be added to collection, processing, washing and storage media.
9. All equipment used to collect and process reproductive material (embryos, ova or semen) and which the reproductive material (embryos, ova or semen) comes into direct contact with was new or sterilised before use as recommended in the latest edition of the IETS manual.
10. The embryos were frozen and stored in sealed, sterile ampoules, straws or vials. Only embryos from donors of the same health status are stored together in the same ampoule, vial or straw.

11. Ampoules, straws or vials were sealed at the time of freezing and are clearly identified with a unique legible and non-erasable identifier according to, or similar to, the system described in the IETS manual. The following details were recorded and are included with the veterinary certificate:
    

    11.1. Species and strain of the donors.
    

    11.2. Collection date.
    

    11.3. Number and developmental stage of the embryos.
    

    11.4. Laboratory of origin.

12. At the time of embryo collection the donors were examined under the direction of the veterinarian in charge of the colony and found to be clinically healthy.

Transport

1. The transport container must be sealed in a tamper proof manner using either official seals or seals supplied by the source institution. The seal number or identifying mark must be recorded on the accompanying veterinary certificate.

2. Either
   

   2.1. the shipping container was new, or
   

   2.2. before loading, the shipping container was emptied and inspected and any loose materials/receptacles removed. The shipping container including all surfaces in contact with the straw, ampoules or vials were disinfected with one of the following disinfectants: 2% available chlorine (chlorine bleach), Virkon® or irradiated at 50 kGy.
   

   Note: 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 veterinary certificate.

3. Only new liquid nitrogen was added to the tank.