1. Australia is free from foot-and-mouth disease, rinderpest, contagious bovine pleuropneumonia, lumpy skin disease, bovine spongiform encephalopathy (BSE), vesicular stomatitis, bovine brucellosis and bovine tuberculosis.
2. The embryo transfer (ET) centres for export were_______________________ and were located at_______________________ in a bluetongue free zone where a surveillance and monitoring program has demonstrated that:
2.1. there has been no clinical evidence of bluetongue in any ruminant;
2.2. no bluetongue virus has been isolated from any ruminant, and
2.3. no bluetongue seroconversion has occurred in any ruminant that has remained in this zone for at least the previous 14 days.
3. All donor cows originated from farms located in areas which have not been under any restrictions with respect to contagious or infectious disease.
4. Neither tuberculosis nor paratuberculosis has been confirmed on the farm or ET centre during the past two years.
5. The following diseases have not been confirmed during the past six months on the farms or ET centres from which donor cows originate; bovine viral diarrhoea, camplyobacteriosis, trichomoniasis, chlamydial abortion, infectious bovine rhinotracheitis and enzootic bovine leucosis.
6. The donor cow was not an animal which had been imported into Australia from countries which had a case of BSE subsequent to January 1, 1982, nor was it an embryo imported from countries which had a case of BSE subsequent to January 1, 1982.
7. Each donor cow has been tested for the following diseases between twenty one and sixty days after collection of embryos with negative results:
7.1. Camplyobacteriosis: If bred by natural service:
7.1.1. serum immunofluorescent antibody test; or
7.1.2. culture of vaginal mucus.
7.2. Trichomoniasis: If bred by natural service: Culture of vaginal mucus.
7.3. Bovine viral diarrhoea:
7.3.1 antigen capture ELISA on peripheral blood lymphocytes; or
7.3.2. virus isolation test on whole blood serum involving two passages in tissue cultures. Cultures were checked by immunofluorescence test or an immunoperoxidase staining technique.
7.4. Akabane: Serum neutralisation test at 1:4 dilution.
7.5. Paratuberculosis:
7.5.1. absorbed ELISA; or
7.5.2. faecal culture if ELISA positive.
8. The embryos were washed with antibiotics recommended by the IETS as effective against leptospirosis.
9. The semen used to inseminate each donor cow met the conditions of the protocol between AQIS and AQSIQ on quarantine and health requirements for bovine semen to be exported from Australia to the People's Republic of China.
10. The collection and processing of embryos has been done by an embryo collection team approved by Australian authorities in accordance with the recommendations of the Manual of the International Embryo Transfer Society (IETS) (most recent edition) and the standards of the Office International des Epizooties (OIE).
11. The embryos were transferred through five (5) washes of phosphate buffered saline containing bovine serum albumin or non-animal protein, then through two washes of 0.25% trypsin (pH 7.6-7.8) for a total time in trypsin of 60-90 seconds and finally, through five (5) washes that contained serum or non-animal protein. Each of the washes was a 100-fold dilution of the previous one, and a fresh pipette was used for each of the transfers.
12. The embryos have been confirmed to have an intact zona pellucida and to be free of adherent material.
13. The embryos were placed into straws and sealed, and the straws identified in accordance with the recommendations of the Manual of IETS (most recent edition).
14. The embryos were stored in a secure location approved by AQIS while the embryos were certified for export.
PROTOCOL ON QUARANTINE AND HEALTH REQUIREMENTS FOR BOVINE EMBRYOS TO BE IMPORTED FROM AUSTRALIA TO THE PEOPLE'S REPUBLIC OF CHINA BETWEEN THE AUSTRALIAN GOVERNMENT DEPARTMENT OF AGRICULTURE, FISHERIES AND FORESTRY OF AUSTRALIA AND THE GENERAL ADMINISTRATION FOR QUALITY SUPERVISION, INSPECTION AND QUARANTINE OF THE PEOPLE'S REPUBLIC OF CHINA
The General Administration for Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) and the Australian Government Department of Agriculture, Fisheries and Forestry (DAFF) of Australia through friendly negotiations, have agreed to the following quarantine and health requirements for bovine embryos to be exported from Australia to China.
Article 1
(1) DAFF will be responsible for the quarantine and inspection procedure for donor cows and embryos. After having confirmed that the Chinese importer has received the import permit for importation of bovine embryos issued by AQSIQ, DAFF may start to implement the quarantine and inspection procedures for donor cows and embryos in accordance with the present protocol.
(2) Each import permit can only allow for importation of one consignment of bovine embryos.
Article 2
An Australian official veterinarian will be responsible for confirming the compliance of the donor female and sire with the prescribed conditions, for accrediting the embryos to the People's Republic of China; and DAFF will be responsible for issuing the health certificate.
Each consignment of bovine embryos must be accompanied by a health certificate issued by DAFF.
1. DAFF will provide a model health certificate to AQSIQ for endorsement before it becomes valid.
2. The health certificate consists of one original and at least two copies. The relevant testing reports must be attached.
3. The health certificate will be typed. Handwritten or altered versions are invalid.
4. The health certificate must be signed by the team veterinarian responsible for collection and processing the embryos and the health certificate must be validated with the official stamp of DAFF and the signature of an Australian official veterinarian.
5. The health certificate shall accompany each shipment of the embryos.
6. Should the embryos arrive at the Chinese port of entry with an invalid health certificate or without a health certificate, the embryos shall be returned or destroyed.
Article 3
AQSIQ either:
1. will send veterinarians to the embryos transfer (ET) centers and the relevant DAFF approved laboratories to co-operate with the Australian official veterinarians in conducting the health certification procedures; OR
2. may send veterinarians to approve the ET centres, for a specified period, in advance of embryo collection.
Article 4
Australia officially confirms that it is free from foot-and-mouth disease, rinderpest, contagious bovine pleuropneumonia, lumpy skin disease, bovine brucellosis, vesicular stomatitis, bovine spongiform encephalopathy (BSE) and bovine tuberculosis.
If there is an outbreak of any of the diseases mentioned above in Australia, DAFF will immediately:
1. Notify AQSIQ with the details of the outbreak within 24 hours, including the name of the disease, name and address of the farm in which the outbreak occurs, number and species of the animal involved in the outbreak, and the control measures that have been taken by DAFF, and
2. Refrain from exporting bovine embryos to the People's Republic of China.
Article 5
The ET centers must be located in the bluetongue free zone where a surveillance and monitoring program has demonstrates that:
1. there has been no clinical evidence of bluetongue in any ruminant;
2. no bluetongue virus has been isolated from any ruminant, and
3. no bluetongue seroconversion has occurred in any ruminant that has remained in the bluetongue free zone for at least the previous 14 days.
Article 6
The donor cows must:
1. Originate from the farms located in areas which have not been under any restrictions with respect to the presence of infectious or contagious disease.
2. Originate from embryos transfer centres or farms in which the following diseases have not been confirmed during the time frames specified:
a) tuberculosis/paratuberculosis - 2 years
b) bovine viral diarrhea - 6 months
c) campylobacteriosis - 6 months
d) trichomoniasis - 6 months
e) chlamydiosis (abortion) - 6 months
f) infectious bovine rhinotracheitis - 6 months
g) enzootic bovine leucosis - 6 months
3. The donor cow was submitted to testing for the following diseases between twenty-one (21) and sixty (60) days post collection with negative results:
a) Campylobacteriosis: Using an immunofluorescent antibody test or culture of vaginal mucus on donor cows if bred by natural service.
b) Trichomoniasis: Using culture of vaginal mucus if bred by natural service.
c) Bovine viral diarrhea: Using either an antigen capture ELISA on peripheral blood lymphocytes or a virus isolation test on whole blood involving two passages in tissue cultures, cultures shall be checked for virus by an immunofluorescence test or immunoperoxidase test.
d) Akabane: Using a serum neutralization test, negative at serum dilution 1:4.
e) Paratuberculosis: Using: EITHER:
An absorbed ELISA; OR
A faecal culture if ELISA is positive.
4. The embryos must be washed with antibiotics known to be effective against leptospirosis.
5. The donor cow was not an animal which had been imported into Australia from countries which had a case of BSE subsequent to January 1, 1982, nor was it an embryo imported from countries which had a case of BSE subsequent to January 1, 1982.
Article 7
The semen used to inseminate the donor cows shall meet the conditions of the Protocol between DAFF and AQSIQ on Quarantine and Health Requirements for Bovine semen to be exported from Australia to the People's Republic of China.
Article 8
The collection and processing of embryos shall be done in accordance with the recommendations of the Manual of the International Embryos Transfer Society (IETS) (most recent edition), by an embryo collection team approved by DAFF for the export of bovine embryos and which operates in accordance with the standards of the Office International des Epizooties (OIE).
Article 9
All embryos must be transferred through five (5) washes of phosphate buffered saline containing bovine serum albumin, then through two (2) washes of 0.25% trypsin, pH 7.6-7.8, for a total time in trypsin of 60-90 seconds and finally, through five (5) washes that contain serum instead of bovine serum albumin. Each of the washes must be a 100-fold dilution of the previous one, and a fresh sterile pipette shall be used for each of the transfers. A product of non-animal origin may be substituted for serum or bovine serum albumin.
The embryos shall be confirmed to have an intact zona pellucid and free of adherent material.
Article 10
The embryos to be exported shall be placed into straws and sealed and the straws identified in accordance with the recommendations of the Manual of the IETS (most recent edition).
Article 11
The embryos shall be stored in a secure location approved by DAFF for this purpose until the eligibility of the embryos to be certified for export has been confirmed.
