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Exclusions from the Human Pathogens and Toxins Act

This guidance is intended to clarify the exclusions from the application of the Human Pathogens and Toxins Act.

A. Natural Environment

The Human Pathogens and Toxins Act states in Section 4 (a) that a human pathogen or toxin that is in an environment in which it naturally occurs is excluded from the Human Pathogens and Toxins Act as long as it has not been cultivated or intentionally collected or extracted.

The Human Pathogens and Toxins Act does not apply to:

  • A human pathogen and toxin that is still in the environment in which it naturally occurs if it remains in the medium (in other words, humans, animals, and/or the environment) from which it was collected, even if the sample has been modified by other ingredients, such as stabilizers; and,
  • Any samples that have been processed, as long as the pathogen or toxin itself has not been extracted.

The Human Pathogens and Toxins Act does apply to any human pathogens and toxins that have been:

  • extracted
  • immunoprecipitated
  • concentrated
  • collected
  • amplified
  • cultivated
  • refined
  • cultured, and/or
  • grown from such samples.

B. Regulated Drug or Device

Paragraph 4(b) of the Human Pathogens and Toxins Act states that the Act does not apply to a drug in dosage form, or a device, whose sale is permitted or otherwise authorized under the Food and Drugs Act or a human pathogen or toxin contained in such a drug or device.

The following are some examples of when the Human Pathogens and Toxins Act would not apply to a drug or device under the Food and Drugs Act or a human pathogen or toxin contained in such a drug or device:

  • The Human Pathogens and Toxins Act would not apply to a drug in respect of which a Notice of Compliance and/or a Drug Identification Number has been issued.
  • The Human Pathogens and Toxins Act would also not apply to a medical device for which a medical device licence has been issued.

If you have any questions about paragraph 4(b) or the exclusion, please contact the Public Health Agency of Canada by phone at 613-957-1779 or by email at licence.permis@phac-aspc.gc.ca.