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.
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.
Notification must be provided to the Public Health Agency of Canada (PHAC) without delay in the following circumstances:
Notification must be provided to the PHAC in the following circumstances:
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.