Sanitary requirements for export of Foetal Bovine Serum (FBS) for in-vitro medicine uses from Canada to Japan
HA 2148 (Amended June 2, 2010)

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  1. The country of origin of the products been free of FMD, vesicular stomatitis, swine vesicular disease, rinderpest, hog cholera, African swine fever, peste des petits ruminants, contagious bovine pleuropneumonia, rift valley fever, and lumpy skin disease within the six (6) months prior to export.
  2. In the country of origin, BSE is a reportable disease and the Competent Authority of the country has an eradication policy with regard to BSE.
  3. The country of origin has a mandatory national cattle identification program that permits traceability from birth to slaughter.
  4. In the country of origin, it is prohibited to feed ruminants with meat and bone meal and greaves from ruminant.
  5. The animal product for export originates from animal(s) slaughtered in slaughterhouse(s) approved by the Competent authority of the country of origin and which were presented to ante and post mortem inspection. The animal(s) were found free from animal infectious diseases and fit for humane consumption.
  6. FBS product is from fetus from cattle not known to be related to any bovine herd affected by BSE.
  7. The FBS exported to Japan is exclusively of Canadian origin or legally imported into Canada.
  8. The end product was,
    • Either packed in new sterilized bags,
    • Or transported in bulk containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved in Canada before use.
  9. The animal product for export has been produced, processed, stored and transported in such a manner as to prevent contamination by communicable animal disease pathogens up to the point of departure from Canada.
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