Biosafety Frequently Asked Questions

Overview of Regulatory Authority for the Import or Domestic Movement of Possibly Biohazardous Material

Item for import or Domestic Movement	PHAC Licence Required?	CFIA Permit Required?
Human Pathogen	Yes	No
Toxin derived from Human Pathogen	Yes	No
Zoonotic Pathogen	Yes	No
Terrestrial Animal Pathogen	Yes	No
Toxin derived from Animal Pathogen	Maybe	Yes
Aquatic Animal Pathogen	Maybe	Yes
Living Animal (including GMO)	No	Maybe*
Animal Product or Part	No	Yes
Plant Pathogen	No	Yes
Plant or Plant Part (including GMO)	No	Maybe*
Soil Pathogen	No	Yes
Soil	No	Yes
*Environment and Climate Change Canada approval may also be required

Frequently Asked Questions

Biosafety regulations are often confusing due to the many overlapping agencies involved in the regulation of biohazardous materials. The main two agencies involved in biohazardous materials regulations are the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA). To help alleviate some of the confusion around biosafety regulations, this Biosafety FAQ page has been developed.

What do I do if I want to bring in a human or animal pathogen or a toxin from outside Canada (import) or have a pathogen transported from another facility within Canada (transfer)?

Before making any arrangements to either import or transfer a human or animal pathogen or toxin, the BSO must be notified. This is to ensure that sufficient safety precautions for handling the human or animal pathogen or toxin are in place.

What do I need to do if I want to transfer a human or animal pathogen or toxin to a facility outside of Canada (export) or within Canada (transfer)?

Before making any arrangements to either export or transfer a human or animal pathogen or toxin within Canada, the BSO must be notified. In addition, persons transferring human pathogens or toxins within Canada must take reasonable care to ensure that the intended recipient is licensed to work with the agent or otherwise exempted from the requirement to hold a licence. In order to export pathogens or toxins, reasonable care must be taken to ensure that the intended recipient will follow applicable biosafety and biosecurity standards and policies in the foreign jurisdiction. To that end, prior to exporting or transferring the pathogen or toxin, a Biohazardous Agent Transfer Notification form must be filled out and submitted to the BSO. The BSO will then provide further advice and instruction.

Do I need a license in order to work with biohazardous material at Nipissing University?

No. Nipissing University has a single site licence that covers all laboratory space for work with RG2 human or animal pathogens and toxins. However, before any work with human or animal pathogens or toxins can begin, approval for that work must be granted by the Biosafety Committee. To obtain approval a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO.

What do I need to do if I want to work with samples derived from human or animal tissues or fluids?

Before beginning any work the BSO must be notified and a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO. The Biosafety Committee will assess the hazards and risks associated with the proposed work and determine the appropriate safety measures that need to be incorporated into the work. A permit or letter will be issued, depending on the containment level required to do the work.

My laboratory has never done work with RG2 material before. What steps do I need to do in order to be granted permission to do work with RG2 material?

The laboratory must first be assessed by the BSO to ensure that the space is suitable for working with RG2 material. If the BSO is satisfied that RG2 work can be safely accommodated in the laboratory space, the licence holder (Provost and Vice President, Academic and Research) will be notified and the license will be updated to include the new RG2 work space. Once the licence update has been approved by PHAC, a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO. The Biosafety Committee will assess the hazards and risks associated with the proposed work and determine the appropriate safety measures that need to be incorporated into the work. A permit or letter will be issued, depending on the containment level required to do the work.

What do I need to know before I take steps to isolate and culture a pathogen from natural sources?

Contact the BSO to ensure that the risk group of the pathogen will allow the organism to be cultured under the terms of our PHAC licence.

I have isolated and cultured a pathogen that I though was RG1, but it turns out to be another, more pathogenic organism. What do I need to do?

You must immediately notify the BSO and ensure that the organism is handled and stored appropriately. Within 30 days it must either be transferred to a licenced laboratory authorized to conduct controlled activities with that organism or it must be destroyed.

What type of training is required in order to work with biohazardous material?

The training required depends on what you will be working with. Please contact the Laboratory Safety Coordinator to arrange for your training (training requirements outlined below).

RG1 material: WHMIS 2015, Basic Laboratory Safety Training and CL1 Biosafety Training.
RG2 material: WHMIS 2015, Basic Laboratory Safety Training and CL2 Research Biosafety Training.
Human blood or Other Potentially Infectious Material (OPIM) including saliva: WHMIS 2015, Basic Laboratory Safety Training, CL1 Biosafety Training and Blood Borne Pathogen Safety Training.
Animals: you will also require Animal Care Training.

I want to begin work with a RG1 organism. Is there any regulations that cover this work?

While RG1 organisms are not specifically covered by the Canadian Biosafety Guidelines, Nipissing University policy requires any research involving a human or animal pathogen or toxin to be approved by the Biosafety Committee. To obtain approval a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO.

For more information please contact the HR Generalist: Health, Safety & Wellness Ext. 4811

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