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Sanitary requirements for export of embryos (fresh or frozen in vivo and in vitro) and oocytes from Canada to the United States of America from bos taurus, bos indicus or bison bison
HA1447 (Amended 2022-10-13)

1. Canada is free of foot-and-mouth disease, rinderpest, contagious bovine pleuropneumonia and ephemeral fever.

2. The donor dam (and donor sire if the semen was collected in Canada, or natural service performed) was:

  1. born and reared in Canada; Or
  2. legally imported into Canada from a country recognized to be free of foot-and-mouth disease and rinderpest by the United States Department of Agriculture (USDA) in Title 9, Code of Federal Regulations, Part 94, Section 94.1, and has been released from any post-entry restrictions, and has been able to move freely within the national herd of Canada for a minimum of 60 days prior to collection of the embryos/oocytes; Or
  3. legally imported into Canada from a country not recognized to be free of foot-and-mouth disease and rinderpest by the USDA in Title 9, Code of Federal Regulations, Part 94, Section 94.1, and has been released from any post-entry restrictions or quarantine requirements, and has been able to move freely within the national herd of Canada for a minimum of 90 days prior to the collection of embryos/oocytes destined to the United States; Or
  4. imported into Canada from the United States.

3. During the 60 days prior to collection of the embryos or oocytes for export to the United States, the donor dam (and donor sire, if natural service or fresh semen is used) was inspected by the approved team veterinarian and found to be clinically free of contagious diseases.

4. During the 60 days prior to collection of germplasm for export to the United States, the donor dam (and donor sire, if natural service or fresh semen is used) were not corralled, pastured or held with animals that are not of equal health status or under any restrictions which would make them ineligible for export to the United States.

5. All donor animals resided in herds considered by the Government of Canada as free of tuberculosis and brucellosis, and these herds have maintained this status for at least two years preceding the collection of embryos/oocytes for export to the United States.

6. In vitro produced embryos were produced using oocytes that were either: (*strike out and initial as necessary)

  1. sourced from donor dams that met the conditions in Section 2 through 5 above*, Or
  2. legally imported from the United States on health certificate(s)* space

7. The approved team veterinarian has verified the source of the semen used to fertilize the embryos for export to the United States. The semen used for the insemination of the donor or for the in vitro fertilization of the collected ova was eligible as a result of being:

  1. semen collected in Canada at an approved semen production centre; Or
  2. semen which was legally imported into Canada from a third country from a centre approved by the Government of Canada at a time when that country was recognized by the USDA to be free from foot-and-mouth disease and rinderpest; Or
  3. semen which was legally imported into Canada from the United States of America; Or
  4. semen introduced through natural service or fresh semen collected from a donor bull in Canada which satisfies the requirements under articles 2, 3, 4, and 5 above.

8. If more than one donor sire or heterospermatic semen was used to inseminate the donor dam or in the fertilization of the ooctyes; each donor sire must meet the conditions in Section 7 above and be identified on this certificate.

9. The approved team veterinarian is responsible for the supervision of the embryo collection team flushing the embryos from the donor dam and the processing and storage of said embryos or collecting and processing oocytes.

10. All equipment used to process the embryos or oocytes was new or was sterilized between each procedure. Standard sterilization and sanitary procedures were observed.

11.

  1. The embryo was washed at least 10 times and underwent trypsin treatments.
  2. Each wash was accomplished by transferring the embryo into an aliquot of fresh medium that is 100 times the volume of the embryos plus any fluid transferred from the previous wash.
  3. No more than 10 embryos from the same in vivo flush or in vitro production batch were washed together.
  4. A sterile micropipette was used for each transfer and the embryos were well agitated throughout the entire volume of the wash before the next transfer.
  5. Only embryos from the same in vivo donor or in vitro culture batch were washed together.

Note: this article does not apply to oocytes.

12. The embryo was examined, following washing, over its entire surface at not less than 50× magnification and found to be intact and free of adherent material prior to micromanipulation of the embryo which involved penetration of the zona pellucida and before freezing or shipment.

Note: this article does not apply to oocytes.

13. After washing and examination of the zona pellucida, the embryos were individually packaged in sterile ampoules or straws marked in a permanent manner with the following information and frozen in liquid nitrogen:

  1. the donor dam and sire identification and breed;
  2. the date of embryo collection;
  3. the identity of the embryo collection team;
  4. the identification number of the straw or ampoule.

If any of the above details are given in code, then deciphering information must be attached to the health certificate.

Note: this article does not apply to oocytes.

14. Embryos contained in this consignment include: (*strike out and initial as necessary)

  1. single donor dam and single donor sire in vivo derived embryos,* or
  2. single donor dam and multi donor sire in vivo derived embryos,* or
  3. single donor dam and single donor sire in vitro produced embryos,* or
  4. multi donor dam and/or multi donor sire in vitro produced embryos,* or

15. Each donor dam used in the production of multi donor dam in vitro produced embryos must meet the conditions of Sections 2 through 6 above and be identified on this certificate.

16. In the case of oocytes, all those from the same donor may be packaged together in sterile ampoules or straws marked with the donor dam identification and breed, the date of oocyte collection and identity of the embryo collection team. Ampoules/straws should be numbered sequentially starting at 1(one) if more than one ampoule/straw per donor dam is included in the shipment.

17. The embryo or oocyte is contained in a shipping container which at the time of export was sealed with an approved seal, and the seal markings are recorded in the certificate.

18. The storage and shipping container was examined by the approved team veterinarian and found to be empty of embryos or oocytes and other biological materials prior to use for exporting embryos to the United States.

19. The embryos or oocytes were maintained under approved conditions under the supervision of the approved team veterinarian until they were placed in the shipping container and sealed by a full-time salaried veterinarian with the seals approved by the Government of Canada.

Notes:

  1. The U.S. importer is responsible for obtaining an import permit from the USDA, Animal and Plant Health Inspection Service, Veterinary Services, Strategy & Policy, 4700 River Road, Unit 39, Riverdale, Maryland, 20737-1231.
  2. The shipment must be routed directly to the United States with no stops en route other than those provided for on the USDA import permit.
  3. An official health certificate is required. The official health certificate must be issued by the veterinarian approved by the Government of Canada responsible for the embryo/oocyte collection team, and must be endorsed by an official salaried of the Government of Canada veterinarian attesting to the certifications required in this protocol. The health certificate must accompany the embryos or oocytes to the port of entry designated on the USDA import permit.
  4. The embryos or oocytes must be collected by an embryo/oocyte transfer team recognized by the country of origin as approved to collect and process embryos/oocytes for export to the United States.
  5. It is acceptable if other embryos and/or semen are shipped in the same container, so long as all contents of the container meet U.S. importation requirements, and that the integrity of the total shipment can be certified by the Government of Canada at the time the approved seal is applied. When oocytes are shipped, no embryos or semen are allowed in the same shipping container.

This certificate is valid for 30 days following the date of endorsement by the official veterinarian.

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