Risk Groups and Risk Assessment
Laboratory Biosafety and Biosecurity
The Public Health Agency of Canada (PHAC) regulates human pathogens and toxins under the authority of the Human Pathogens and Toxins Act (HPTA) and associated Regulations (HPTR). Controlled activities (e.g., using, storing, importing) with human pathogens that are classified as Risk Group 2-4, or with toxins listed in Schedule 1 of the HPTA, require a licence, issued by PHAC. PHAC is also responsible for issuing permits for the importation or transfer of pure cultures of terrestrial animal pathogens and toxins under the authority of the Health of Animals Regulations (HAR).
Please note: The Canadian Food Inspection Agency (CFIA) has the authority under the Health of Animals Act and the Health of Animals Regulations to issue importation permits for animals, animal products and by-products (e.g., tissue, serum), aquatic animal pathogens, bee pathogens, pathogens causing foreign animal diseases, and pathogens causing emerging animal diseases.
For questions regarding the use of a biological agent in Canada, please contact your licence holder representative or biological safety officer.
ePATHogen: Risk Group Database
ePATHogen is the Public Health Agency of Canada’s biological agent search tool. ePATHogen contains a searchable list of biological agents with their associated human and animal risk group classifications, as well as the associated containment level (CL), Security Sensitive Biological Agent (SSBA) status, regulatory authority, and containment considerations. A list of regulated toxins is also included.
If a biological agent of interest is not listed in ePATHogen, a pathogen risk assessment will need to be conducted to determine the human and animal risk group classifications. Please complete the pathogen risk assessment template and email it to email@example.com for validation.
Pathogen Risk Assessment template and guidance
For questions regarding the use of a biological agent in Canada, please contact your licence holder representative or biological safety officer. If you need to know the human or animal risk group of a biological agent that is not listed in ePATHogen, you can complete the Pathogen Risk Assessment template below and email it to firstname.lastname@example.org for validation. The Editable Word template allows you to use your own referencing software. Guidance for completing a pathogen risk assessment can be found in the Pathogen Risk Assessment Guideline.
- For information about infectious diseases, visit Infectious Diseases
- For those working with animal pathogens, visit Canadian Food Inspection Agency's Disease Agent Information page.
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