RegFacts: #DidYouKnow

Did you know that the Human Pathogens and Toxins Act and associated regulations do not apply to the following specimens:

•         a primary specimen, which is a human pathogen or toxin in an environment where it naturally occurs, as long as it has not been cultivated or intentionally collected or extracted
•         a drug in dosage form whose sale is permitted under the Food and Drugs Act, or a human pathogen or toxin contained in such a drug

When working with such specimens (specifically primary specimens not regulated by the Public Health Agency of Canada) you are not required under the Human Pathogens and Toxins Act to report exposure incidents in a laboratory setting. This includes specimens of SARS-CoV-2 collected directly from patients.

However, there have been increasing reports of exposure incidents involving primary specimens, including SARS-CoV-2, and such incident reports may be significant in the Public Health Agency of Canada's data collection. We encourage you to disclose these incidents as part of voluntary reporting.