Importing and Transferring Biohazardous Material into Canada
Any Risk Group 2 or higher biohazardous material imported into Canada requires an import permit from the Public Health Agency of Canada and/or the Canadian Food Inspection Agency. In addition, they and the Tri-Council granting agencies, require the tracking of all materials transferred in or out of the laboratory. This is for all products, whether they are ordered from commercial vendors or from another university.
There are several documents required to obtain the biohazardous materials, that include human cell lines, toxins, and RG2 pathogens.
PHAC requires that the Biosafety Officer or their designate sign all permit applications. CFIA does not require a signature on the permit application, but requires another form called the Facility Certification form, which does require the signature of the Biosafety Officer or their designate.
When ordering ATCC human and some animal cell lines from Cedarlane they often send a waiver and CDR111 form. Cedarlane has obtained an import permit for ATCC cell lines and by filling out these forms they are able to add PIs to their approved permit.
- Permits are still required for all in vivo work.
- CL2 Checklists are still required.
- Signature of the Biosafety Officer or designate is required for the CDR111 form (the witness is the Biosafety Officer)
Containment Level 2 (CL2) Checklist:
In conjunction with the Import Permit documentation, PHAC and CFIA also require a valid CL2 Checklist for your laboratory space. These checklists will be completed by RMS as part of the Laboratory Review System. Once completed and signed by RMS, the document can be submitted to PHAC and/or CFIA. Once approval is obtained, a copy of the Compliance letter is to be forwarded to RMS and is valid for 2 years. In January 2016, the system using CL2 checklists will change.
The Tri-Council, PHAC and CFIA require that the movement of all RG 2 (or higher) biological materials be tracked, as these shipments may fall under Transportation of Dangerous Goods (TDG). In order to gain compliance, the BioSafety Committee supports the drafting of a material transfer agreement (MTA) and an internal material tracking program.
All movement of RG2 or higher biological materials must be tracked as part of a biological inventory keeping. This includes (but is not limited to): human cells, tissues and body fluids, microorganisms, recombinant viral vectors, toxins and prions. How the material is tracked can be determined by the individual labs, but you must be able to provide written evidence as to the movement of materials. Also note that if the material was obtained using a PHAC or CFIA import permit, then transfer approvals will have to be obtained from the relevant organization(s).
When preparing to internally transfer biological materials, please refer to the Biological Material Transfer Form (WORD) sample, which may be used or modified.
For all RG2 or higher biological materials either entering or leaving a UBC research lab, researchers must fill out the new External Biological Transfers Form (WORD). This is in addition to any other import permits, forms from other institutions, or forms relating to intellectual property. Researchers are asked to keep these documents on file and provide a copy to Risk Management Services.