The Registry of Human Pathogens and Toxins

The Registry of Human Pathogens and Toxins

The biological agents listed in the Registry of Human Pathogens and Toxins (Registry) are those for which a pathogen or toxin risk assessment has been completed by the Public Health Agency of Canada or the Canadian Food Inspection Agency, as well as certain legacy entries with previously assigned classifications. Each entry includes assigned Risk Groups (for pathogens) or regulatory status (for toxins) and containment level. Regulated and interested parties are responsible for knowing the risk group and regulatory status of biological agents in their inventory under both the Human Pathogens and Toxins Act and the Health of Animals Act.

Before beginning any work with a biological agent, always consult the Registry and the schedule of prohibited pathogens and toxins in the Human Pathogens and Toxins Act to determine the regulatory status of the human pathogen or toxin. Learn how to access the Registry here: Searching the Registry of Human Pathogens and Toxins.

If your biological agent(s) cannot be found in the Registry, you should:

• search the larger ePATHogen database to confirm whether it is unregulated under the Human Pathogens and Toxins Act (for example, human Risk Group 1 or unregulated toxin); and
• confirm its regulatory status under the Health of Animals Act (for example, a human Risk Group 1 that is also a terrestrial animal Risk Group 3 or identified as an aquatic animal pathogen).

If your biological agent is not listed in the Registry, the ePATHogen database, nor the Human Pathogens and Toxins Act schedule, it should not be assumed that the biological agent is unregulated or otherwise exempt from oversight. Until a pathogen or toxin risk assessment is completed, all reasonable precautions must be taken to protect the health, safety, and security of the public against risks posed by human pathogens and toxins (Human Pathogens and Toxins Act section 6).

Should this situation arise:

• Contact the Public Health Agency of Canada at pathogens.pathogenes@phac-aspc.gc.ca and/or visit the Canadian Food Inspection Agency permit webpage to discuss the regulatory status of your biological agent(s). You may be required to submit a pathogen risk assessment template that is completed using available guidance, and peer-reviewed publications and scientific literature as sources of information.

Importantly, the regulatory status, Risk Group, or Biosafety Level classifications of microorganisms, biological agents, and toxins determined by anyone other than the Public Health Agency of Canada or the Canadian Food Inspection Agency (for example, culture collections, distributors, manufacturers, other countries, etc.) have no regulatory significance under the Human Pathogens and Toxins Act or Health of Animals Act.

The following table includes some, but not all, recent changes to the Registry.

To maintain compliance with licensing requirements under both the Human Pathogens and Toxins Act and Health of Animals Act, it is essential to frequently verify the regulatory status of biological agents in your inventory or facility by visiting the online Registry and ePATHogen database often. Major changes to the Registry, for example an increase in Risk Group, will continue to be communicated to regulated and interested parties via email. Consider subscribing here to ensure you are receiving these important communications. Individuals in the roles of licence holder, licence holder representative, biological safety officer or alternate biosafety contact associated with a Pathogen and Toxin Licence will continue to automatically receive these emails. Should you have any questions regarding the Registry or ePATHogen, please do not hesitate to contact us at pathogens.pathogenes@phac-aspc.gc.ca.