Are You Exempt or Excluded From Requiring a Licence

You may be exempt or excluded from requiring a pathogen and toxin licence under the Human Pathogens and Toxins Act and its regulations if you're working with:

•         Risk Group 1 micro-organisms
•         a pathogen contained in an environment in which it naturally occurs (such as human tissue, blood, plant, soil, water), and it will not be extracted and propagated
•    if this pathogen is a terrestrial animal pathogen that will be imported, you may require a Health of Animals Regulations import permit, issued by the Public Health Agency of Canada
•    if the pathogen is in an animal or animal product or by-product, the import permit will be issued by the Canadian Food Inspection Agency
•         any nucleic acid (such as cDNA or fragmented nucleic acids) except the full genome of a regulated virus composed of positive sense single stranded RNA
•         a protein that is not a prion
•         a toxin that is not listed in Schedule 1 of the Human Pathogens and Toxins Act
•         a cell line that does not contain an intact pathogen
•         a drug in dosage form

or:

•         you're conducting diagnostic testing as defined in section 27(1) of the Human Pathogens and Toxins Regulations and:
•    the pathogen is not cultivated or produced, or
•    any production uses a sealed container that prevents its release

If you have any questions or are unsure if you're exempt or excluded under the Human Pathogens and Toxins Act and its regulations, please contact the licensing program by email at licence.permis@phac-aspc.gc.ca or by phone at 613-957-1779.