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Annex

Certificate: Veterinary certification for mice semen and ova for artificial reproduction

Effective 6 June 2023 to 6 October 2023

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.

If importing semen, the following information must be displayed:

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

3.1. Species

3.2. Institution of donor residence

3.3. Colony identification

3.4. Date of semen collection

3.5. The dates of sampling for hantavirus testing, type of testing used and test results.

If importing ova, the following information must be displayed:

  1. Number of ova 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. Date of ova collection

4.5. The dates of sampling for hantavirus testing, type of testing used and test results.

Veterinary certification requirements

  1. Donors were 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).
  2. The colony of origin of the donors is housed in accommodation that precludes access by wildlife including rodents and insect vectors and is free of infestation with ectoparasites.
  3. In the 30 days prior to the date of collection all donors and any animals in contact with them have remained isolated by means of micro-isolators or other similar biologically secure means from animals not of equivalent health status.
  4. There has been no clinical or other evidence of hantaviruses, ectromelia virus, rabies or other infectious agents in the colony of origin during the 12 months prior to the date of collection.
  5. During the 30 day pre-collection isolation period there were no new introductions to the isolation unit and the animals remained clinically healthy and free from evidence of hantaviruses, ectromelia virus or rabies.
  6. Either

    6.1. The colony was tested with negative results for hantavirus by enzyme-linked immunosorbent assay (ELISA) during the six months immediately prior to collection. The number of animals tested provided 99% confidence of detecting disease at 25% prevalence. Laboratory reports must be attached and include the date of blood sampling, number of animals tested and the number of animals in the colony, or


    6.2. Sentinels of the same species, 8-12 weeks of age were placed in the boxes with the donor animals (other forms of contact may occur where the Department of Agriculture, Fisheries and Forestry has provided written advice). An appropriate number of sentinels were tested to 99% confidence of detecting disease at 25% prevalence. (The number of sentinels to be used is indicated in the table provided as part of the import permit. The number of sentinels to be tested is calculated from the number of animals in the original colony. A few additional animals should be added to the colony to allow for incidental losses.) The sentinels remained in contact for a minimum of 45 days but not more than 120 days prior to testing. Sentinels were tested with negative results for hantavirus by enzyme-linked immunosorbent assay (ELISA) during the six months immediately prior to export. Laboratory reports must be attached and include the date of introduction of sentinels, date of blood sampling, number of animals tested and the number of animals in the colony.

  7. No new animals were introduced to the donor colony (unless from a colony tested negative for hantavirus) between the time of testing for hantavirus and collection of reproductive material.
  8. Ova and semen in the consignment were collected and processed in accordance with the World Organisation of Animal Health (OIE) Code “Laboratory rodent and rabbit embryos/ova”.
  9. At the time of collection of reproductive material, the donors were 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.