#DidYouKnow: Reporting & Notification Requirements

Did you know that the Human Pathogens and Toxins Act (the Act) and Human Pathogens and Toxins Regulations (the Regulations) set out reporting and notification requirements for Licence Holders, Licence Holder Representatives, Biological Safety Officers, and persons conducting controlled activities authorized under a Pathogen and Toxin Licence?

The 4 categories of situations that require mandatory notification, as specified in the Act or Regulations are:

•        laboratory incidents
•        changes requiring the issuance of a new licence
•        changes that may require an amendment or revocation of an existing Human Pathogens and Toxins Act security clearance
•        other events

Laboratory incidents that require mandatory notification include:

•        exposures and laboratory-acquired infections or intoxications [the Act 13]
•        inadvertent possession, production, or release [the Act 12(1),(2), and the Regulations 9(1)(c)(ii)]
•        missing, stolen or lost biological agent (pathogen or toxin) [the Act 14], including a security-sensitive biological agent not received within 24 hours of when it was expected [the Regulations 9(1)(c)(iii)]

Other events requiring notification include:

•        changes that could affect biocontainment [the Regulations 6(1)]
•        exemptions based on risk group reduction [the Regulations 26(4)]
•        prohibiting a Human Pathogens and Toxins Act Security Clearance holder from accessing a part of the facility where security-sensitive biological agents are handled or stored [the Act 32]

Notification and reporting are done through the Public Health Agency of Canada's online Biosecurity Portal. The guideline Notification and Reporting Under the Act and Regulations Using the Reporting Module of the Biosecurity Portal provides comprehensive information on completing and submitting a notification report or a subsequent follow-up report as per the Act or Regulations and the Canadian Biosafety Standard, Third Edition. The guideline is currently being updated.

You must report incidents without delay to meet your notification obligation under the Act and Regulations.

Incidents (mandatory or voluntary) can be reported through the Biosecurity Portal. If the Biosecurity Portal is unavailable or inaccessible (or for voluntary reporting by non-license holders), email pathogens.pathogenes@phac-aspc.gc.ca.