Types of Mandatory Notification Reports

Types of Mandatory Notification Reports and How to Submit Them

Under the Human Pathogens and Toxins Act (Act) and the Human Pathogens and Toxins Regulations, incidents and other events related to certain activities require mandatory notification to the federal Minister of Health. Notifications can be reported using either the Public Health Agency of Canada’s Biosecurity Portal or an online Biosecurity Incident Notification Report form, depending on the nature of the report.

In 2026, the Act was amended to shift the reporting threshold for incidents from “Reason to Believe” to “Reasonable Grounds to Suspect”. The change reflects a proactive approach to risk management, emphasizing early detection and timely reporting of potential threats to public health, safety or security. More information on this will be available soon.

There are three types of mandatory reports that must be submitted using the Biosecurity Portal:

• The Exposure Report includes contact with, or close proximity to, pathogens or toxins that may result in infection or intoxication, respectively
• The Non-Exposure Report includes either inadvertent possession, inadvertent production or inadvertent release of infectious material or toxins, missing or lost biological agents, stolen biological agents, and security sensitive biological agents not received within 24 hours of expected arrival
• The Other Report includes changes affecting biocontainment, prohibiting the holder of a security clearance from having access to the facility to which the licence applies or a risk group reduction

Other types of mandatory reports, such as biosecurity incidents, must be reported through the Biosecurity Incident Notification Report, as the Biosecurity Portal does not support this type of reporting.

It is important that reporters select the appropriate reporting platform and report type beforehand to ensure that the information submitted can be properly assessed. A webinar on How, When, and What to Report is available through the PHAC Training Portal. If you are unsure of which report type to complete, please contact Laboratory Incident Notification Canada for assistance at biosafety.biosecurite@phac-aspc.gc.ca prior to submission.

Licence holders must report all incidents involving regulated human pathogens and toxins without delay. Failure to do so is an offence under the Act and may result in enforcement action, including notices of non-compliance, increased inspection frequency, or changes to licence conditions.

Incidents that fall outside the scope of the Act involve:

• primary samples
• Risk Group 1 pathogens
• pathogens or toxins in their natural environment
• facilities exempt from licence requirements

Such incidents can be reported voluntarily through the Biosecurity Portal (licensed facilities) or manually (unlicensed facilities).