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Veterinary Biologics Memorandum 2003-01

December 31, 2003

On December 25, 2003, the Office Internationale des Epizooties (OIE) BSE world reference laboratory in Weybridge, England confirmed the USDA’s preliminary diagnosis of BSE in a single non-ambulatory dairy cow in Washington State. A case of BSE was previously reported in a cow in Canada on May 20, 2003. As a precautionary measure, to avoid the risk of spreading BSE in Canada through bovine origin components of veterinary biologics (i.e., specified risk materials defined below), the following restrictions have been implemented, effective immediately.

On December 23, 2003, the CFIA applied interim import restrictions to a broad range of animals and animal products imported from the United States. This interim measure effectively suspended all currently issued import permits for animal vaccines containing ruminant-derived products from the United States.

All previously issued import permits for the importation of veterinary biologics ("Canadian Food Inspection Agency IMPORT PERMIT FOR THE IMPORTATION OF: Veterinary Biologics") are revoked, effective December 31, 2003. In addition, Canadian Food Inspection Agency Veterinary Biologics Product Licences for ruminant vaccines and ruminant antibody products manufactured in Canada are suspended, pending a review of bovine specified risk material used in the manufacturing process for each product, as described below.

The Veterinary Biologics Section (VBS) will reissue all import permits. The amended import permits will be dated on, or after, January 5, 2004. Veterinary biologics import permits for all animal species other than ruminants will be reissued at that time. This includes permits for vaccines and antibody products intended for further manufacture, permits for products used on a restricted basis for research or emergency use. For some amended import permits, the only change will be the new issuance date. Import permits for vaccines and antibody products intended for use in ruminants will be issued as soon as the requested documentation is reviewed and approved by the Veterinary Biologics Section. These amended permits, dated on or after January 5, 2004, will facilitate continued importation of classes of low-risk products, while removing all veterinary biologics intended for use in ruminants which may contain specified risk material of bovine origin. There will be no charge for these administrative amendments.

According to the CFIA BSE import policy (APHD-DSAE-IE-2005-9-1), veterinary biologics containing material of bovine origin for animal administration may be imported from countries designated free from BSE. Importation from countries not designated free of BSE is prohibited. Requests for exemptions from this prohibition are reviewed on a case-by-case basis, considering product, source of material of animal origin, manufacturing methods and intended use.

To conform with the above policy, all manufacturers of veterinary biological products intended for use in ruminants in Canada must provide evidence that appropriate measures have been taken to minimize the risk of contamination of their product by animal transmissible spongiform encephalopathy (TSE) agent(s). In particular, the CFIA Veterinary Biologics Section will require an updated Declaration of Compliance For Ruminant Veterinary Biologics to ensure that these vaccines or antibody products do not contain any specified risk material of United States or Canadian origin. If ruminant vaccines do contain specified risk material originating from a country considered to be free of BSE (eg., Australia, New Zealand), the Veterinary Biologics Section will require a copy of the certificate from the supplier confirming the source of this material. If the specified risk materials originate from the United States or Canada, the VBS will require a certificate from the supplier indicating that the animals are under 30 months of age. Background information is available on the VBS website.

Specified Risk Material is defined in the Health of Animals Regulations (Section 6.1) as:
(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and
(b) the distal ileum of cattle of all ages.

The Declaration of Compliance For Ruminant Veterinary Biologics should be printed on company letterhead and signed by a designated officer (ie., head of regulatory affairs or quality assurance) of the manufacturer. It should be submitted to VBS for approval prior to the reissue of import permits on vaccines and antibodies for ruminants, and include the manufacturer name, assigned and trade name of the product and VBS product file number.

Sample text for the updated Declaration of Compliance For Ruminant Veterinary Biologics is as follows:
This is to confirm that the above veterinary biologic has been prepared and tested in accordance with the Production Outline, and associated Outlines or Special Outlines filed with the Veterinary Biologics Section of the Canadian Food Inspection Agency. The animal species, supplier’s sources, countries of origin, and supporting documentation for all materials of animal origin used in the preparation of this product have been examined by the manufacturer of this product. These materials originated from sources considered to be safe from animal TSE infection or contamination. In particular, vaccines and antibody products intended for use in ruminant species do not contain any Specified Risk Material originating from a country not considered to be free of BSE.

These permit amendments will be processed on a priority basis, with a target date for completion of the initial permit issuance phase by January 16, 2004. Importers may contact the Veterinary Biologics Section to advise of any urgent requirements.

G.A. Gifford, DVM, MSc.
National Manager
Veterinary Biologics Section
Animal Health and Production Division

Additional information about the requirements for licensing veterinary biologics in Canada is available by contacting VBS, or from our website http://www.inspection.gc.ca/english/anima/vetbio/vbpbve.shtml

Additional information about the BSE situation in North America is available from our website
http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/bseesbindexe.shtml