Certain Biological Agents now Regulated and Pathogens Requiring a Licence to Import

The Public Health Agency of Canada (PHAC) is responsible for the administration and enforcement of the Human Pathogens and Toxins Act (HPTA), the Human Pathogens and Toxins Regulations (HPTR) and the administration of specific sections of the Health of Animals Regulations (HAR).

The Centre for Biosecurity (CB) recently completed risk assessments on the following biological agents, resulting in an increase in the human risk group (RG) classification from RG 1 to RG 2.

  • Suid alphaherpesvirus 1 is now classified as RG 2 for humans and remains classified as RG 3 for animals.
  • Candida auris is now classified as RG 2 for humans and remains classified as RG 1 for animals.
  • Klebsiella oxytoca is now classified as RG 2 for humans and RG 2 for animals.

These biological agents are now regulated under the Human Pathogens and Toxins Act (HPTA).

 Also completed is the risk assessment for Fusarium solani, which remains classified as RG 2 for humans and is now classified as RG 1 for animals.

These changes are now in effect, and is updated the ePATHogen database accordingly. You will require a licence under the HPTA if you are conducting controlled activities with the pathogens listed above.

In addition, if you wish to import Suid alphaherpesvirus 1 or K. oxytoca, you will need to contact CFIA at cfia.permission.acia@canada.ca for an import permit.

ePATHogen is updated weekly with newly added biological agents and, occasionally, with changes to RG classifications. Consult ePATHogen often to confirm that the RG of the biological agents you are using have not changed. Regulated parties will be notified of any database update that results in either:

  • an increase in RG of a biological agent, or
  • a decrease from RG 4 to RG 3 or from RG 3 to RG 2

Learn more on licences and permits for pathogens and toxins.

For questions or concerns, contact us at:

Public Health Agency of Canada
100 Colonnade Road
Ottawa, ON K1A 0K9
Telephone: 613-957-1779
Email: PHAC.pathogens-pathogenes.ASPC@canada.ca

Learn more on licences and permits requirements for pathogens and toxins.