The Human Pathogens and Toxins Act (HPTA) and Human Pathogens and Toxins Regulations (HPTR) set out reporting and notification requirements for licence holders, biological safety officers and persons conducting controlled activities authorized under a licence. These requirements are outlined below.
Notifications to Licence Holders and Biological Safety Officers
The Licence Holder and the Biological Safety Officer (BSO) must be notified whenever the Licence Holder or any person who is conducting controlled activities authorized under a licence intends to increase the virulence, pathogenicity, communicability of a human pathogen, or the resistance of a human pathogen to preventive or therapeutic treatments, or to increase the toxicity of a toxin.
Every person conducting controlled activities under authority of a licence must inform the Licence Holder and the Biological Safety Officer without delay of any inadvertent release or production of a human pathogen or toxin, of any incident involving a human pathogen or toxin that has caused, or may have caused disease, in an individual, or if a pathogen or toxin has been stolen or is otherwise missing. Records of these notifications and follow up actions must be made available if asked by an inspector.
Notifications to the Public Health Agency of Canada
Notification must be provided to the Public Health Agency of Canada (PHAC) without delay in the following circumstances:
- when a Licence Holder has reason to believe that a human pathogen or toxin has been released inadvertently from a facility;
- when a human pathogen or toxin that a person is not authorized to possess is inadvertently produced or otherwise comes into their possession;
- when an incident involving a human pathogen or toxin has caused, or may have caused, disease in an individual;
- when there is reason to believe that a human pathogen or toxin has been stolen or is otherwise missing;
- when a Licence Holder decides to prohibit the Holder of an HPTA Security Clearance from accessing a licensed facility, including the reasons for that decision;
- when the designated Biological Safety Officer has changed;
- where an Security Sensitive Biological Agent (SSBA) is not received within 24 hours of the date and time when it was expected to be received; and
- where the holder of an HPTA Security Clearance is convicted of a criminal offence.
Notification must be provided to the PHAC in the following circumstances:
- before making any of the following changes, if they could affect biocontainment, where controlled activities with Risk Group 3 or 4 human pathogens or SSBA toxins are conducted:
- changes to the physical structure of their facility;
- changes to any equipment; or
- changes to their Standard Operating Procedures (SOPs); and
- within a reasonable time of a licence holder making a name change.
To facilitate notification to PHAC, an online reporting module is available for secure creation, storage and submission of laboratory incident reports through the online biosecurity portal. Incident reports can be submitted electronically to PHAC through the portal, which is accessible through the PHAC website.
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