ePATHogen and the Registry of Human Pathogens and Toxins: what’s the difference?

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Introduction

Prior to the Human Pathogens and Toxins Act (Act) amendments, Schedule 1 to the Act listed all toxins regulated by the Act, whereas Schedules 2 to 4 listed some but not all human pathogens subject to the Act. As well, Schedule 5 listed those human pathogens and toxins for which all activities are prohibited. Until now, the ePATHogen database has provided a more up to date, non-exhaustive list of regulated human pathogens. The database also contains supplementary information outside of the scope of the Act, including unregulated materials (identified as Risk Group 1 or Unregulated Toxins) and the regulatory status of animal pathogens and toxins under the authority of the Health of Animals Act.

The amended Act better reflects the evergreen nature of human pathogens and toxins with the removal of outdated “Schedules 1 to 4” and the introduction of the Registry of Human Pathogens and Toxins (Registry), which is now a subset of the existing ePATHogen database. The Registry contains a non-exhaustive list of human pathogens subject to the Act and also newly includes a non-exhaustive list of toxins subject to the Act (except toxins posing a bioweapon risk, which are listed exhaustively). Human pathogens and toxins formerly in Schedule 5 are still excluded from the Registry and ePATHogen and are now listed exhaustively in a single schedule to the Act.

Simply put, the new Registry and the ePATHogen database serve different functions but will co-exist on the same platform.

What’s the key difference between the existing ePATHogen database and the Registry of Human Pathogens and Toxins?

The Registry is a filterable subset or “list” of human pathogens and toxins found in the ePATHogen database that are subject to the Act. By contrast, the ePATHogen Database is a larger list of biological agents which includes but is not limited to the human pathogens and toxins found in the Registry. It also contains supplementary information that does not fall within scope of the Act (for example, unregulated materials identified as Risk Group 1 or Unregulated Toxins, and the regulatory status of animal pathogens and toxins under the authority of the Health of Animals Act).

It is possible that a pathogen or toxin could be subject to both the Act and Health of Animals Act at the same time (for example, biological agents that are zoonotic, meaning they are both human and animal pathogens and toxins). The Registry contains only those that are subject to the Act.

Where can I find the Registry of Human Pathogen and Toxins?

The Registry appears as a separate link within the existing ePATHogen database. When selected, this link automatically performs an advanced search of ePATHogen that includes only human pathogens classified as Risk Group 2-4 and regulated human toxins (the Registry includes only those biological agents that are subject to the Act).

ePATHogen is great, why introduce this new Registry?

The introduction of the Registry under the amended Act provides stakeholders greater clarity and ease with a “one stop shop” list of Act-regulated human pathogens and toxins, whereas the ePATHogen database is a larger comprehensive scientific database of biological agents assessed by the Public Health Agency of Canada (Agency) and/or the Canadian Food Inspection Agency.

Introduction of the Registry and the removal of Schedules 1-4 to the Act means that the Agency can respond more nimbly to add, remove, or vary the regulatory status of a human pathogen or toxin to keep pace with evolving science and potential threats.

How do I search in the new Registry?

For information about searching the new Registry, see the following video.

Does the Registry of Human Pathogens and Toxins change how pathogens are assessed and assigned a risk group or how the regulatory status of a toxin is determined?

Pathogens and toxins will continue to be assessed in the same manner as done to date. Well-characterized biological agents that have had a pathogen or toxin risk assessment completed by the Agency and/or the Canadian Food Inspection Agency will continue to be assigned a Risk Group or toxin regulatory status and a containment level, and this information can be found in the online Registry or ePATHogen database. In addition, the Agency will continue to consult and seek the expertise of the external Advisory Committee on Human Pathogens and Toxins when conducting risk assessments.

It is important to highlight that the definition of a toxin in the amended Act indicates that toxins posing a moderate to high risk to the health of individuals will be listed non-exhaustively in the Registry, along with the minimum quantity at which they pose such a risk. In listing most toxins non-exhaustively, this means that, generally, toxin regulation under the amended Act has been aligned with that of pathogen regulation. However, a noteworthy difference is that the new toxin definition also introduces a new class of toxins, known as bioweapon toxins (toxins posing a “moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon”), and these toxins are clearly identified and listed exhaustively in the Registry, along with the minimum quantity at which they pose that risk. For more details on toxin regulation under the amended Act, see our Toxin Talks section of the learning portal.

Finally and as always, it is important to note that the regulatory status, Risk Group, or Biosafety Level classifications of human pathogens and toxins determined by entities other than the Agency or Canadian Food Inspection Agency (for example, culture collections, distributors, manufacturers, other countries, etc.) have no regulatory significance under the Act or the Health of Animals Act. You should always consult the ePATHogen database, Registry, and the “schedule” (see above and below for explanation) to determine the regulatory status of any biological agent(s).

The Registry includes all these new trigger quantities for toxins. What’s that about and what happened to the Security Sensitive Biological Agent trigger quantities in the Human Pathogens and Toxins Regulations?

A brief summary of toxin trigger quantities is provided here, but for a detailed overview, we recommend that you see our Toxin Talks section of the learning portal.

The new toxin definition and Registry provisions in the amended Act allow for the publication of two (2) separate minimum trigger quantities related to toxins. The first is the minimum quantity at which a toxin is considered captured by the Act – it can be thought of as the quantity below which a toxin is not a moderate to high human health risk – and it is not mandatory to publish this “Human Pathogens and Toxins Act exclusion quantity” in the Registry. That being said, it is fundamental in regulation that if no exclusion quantity is displayed, then any quantity of toxin (no matter how small the volume) becomes regulated. The second is the minimum quantity at which a toxin becomes a bioweapon risk, and this quantity will always be published in the Registry.

As shown in the table below, two (2) separate trigger quantities may be published in the Registry for any given regulated toxin. Typically, all toxins that pose a bioweapon risk will also pose a moderate to high individual health risk; however, a toxin that poses a moderate to high individual health risk may not necessarily pose a bioweapon risk.

Table 1: Toxin trigger quantity, Human Pathogens and Toxins Act exclusions and bioweapons

 Toxin Trigger Quantity

Act Exclusion

Bioweapon

Published in Registry?

Maybe

Yes

Function

Indicate toxins at this quantity or more are captured under Act legislation

Indicate toxins at this quantity or more pose a bioweapon risk; triggers the need for additional security practices

Currently, all bioweapon toxins listed in the Registry are also included on the List of Human and Animal Pathogens and Toxins for Export Control as published by the Australia Group. As such, they are all also considered prescribed toxins, or Security Sensitive Biological Agent toxins. However, that may not always necessarily be the case (for example, there could be a bioweapon toxin that is not prescribed, on occasion). Consequential amendments made by the amended Act include changes to the definition of prescribed toxins in paragraph 10(1)(b) of the Human Pathogens and Toxins Regulations (Regulations) and removing the Security Sensitive Biological Agent toxin trigger quantity table in subsection 10(2) of the Regulations, as Security Sensitive Biological Agent toxin trigger quantities will now be considered the same as those published in the Registry as “bioweapon toxin trigger quantities”. Should there be a scenario where bioweapon toxins identified in the Registry are not prescribed, then clear differentiation will be made in the Registry.

Schedules 1 to 4 are removed and replaced with the Registry, but the old Act had a “Schedule 5”. What happened to it?

In the amended Act, “Schedule 5” is renamed “the schedule”. It will continue to exhaustively list prohibited biological agents. In addition to the Registry and ePATHogen, you should always consult the schedule when determining the regulatory status of any biological agent(s).

Interested parties should consider subscribing here for updates from the Agency on biosafety and biosecurity. These include notifications about new or updated Advisories, biosafety training opportunities, changes in regulatory information including risk group classifications or microbial toxin regulatory status, and other regulatory information.

The Registry better reflects the evergreen nature of human pathogens and toxins. What happens when a new biological agent is added to the Registry or when a biological agent listed in the Registry changes risk group or regulatory status? Do I need to do anything?

The introduction of the Registry in the amended Act means that the Agency can respond more nimbly to add, remove, or vary the status of a biological agent to keep pace with evolving science and the biological threat landscape. To conduct controlled activities with any biological agent included in the Registry, you must:

The amended Act formalizes the ability to obtain or vary a licence to legally conduct controlled activities when a new biological agent is added to the Registry, or when a biological agent included in the Registry changes risk group or regulatory status. Previous to this amendment, the biological agent had to be destroyed or transferred to a facility that held the appropriate licence.

When a new biological agent is added to the Registry, or when a biological agent already included in the Registry changes risk group or regulatory status, you will need to do one of the following within 30 days of the addition or change:

  • If you do not intend to conduct controlled activities with the biological agent, you must either:
    • transfer the biological agent to a facility that holds the appropriate Pathogen and Toxin Licence issued by the Agency; or
    • dispose of the biological agent in accordance with applicable regulations.
  • If you intend to conduct controlled activities with the biological agent and remain compliant with the Act you must:
    • verify that controlled activities with the biological agent are authorized under an existing Pathogen and Toxin Licence; or, if not,
    • obtain a new licence or licence variation authorizing controlled activities with the biological agent.

Visit Licensing program to learn more about the application process.

I can’t find a biological agent in either the Registry or ePATHogen. What do I do next?

Thousands of well-characterized biological agents that have had a pathogen or toxin risk assessment completed by the Agency and/or the Canadian Food Inspection Agency can be found in the online Registry or ePATHogen database with an assigned Risk Group or regulatory status and containment level. However, given the rapidly evolving nature of biological agents and new scientific discoveries, there may always be something that has not yet been assessed.

Should you wish to know the regulatory status of a biological agent that is not listed in the ePATHogen database or the Registry, or if you would like to further discuss a biological agent that is listed, please contact us at pathogens.pathogenes@phac-aspc.gc.ca.

Unsure About ePATHogen or the Registry? Ask Us!

Should you have any questions regarding ePATHogen or the Registry, including biological agents not listed, Risk Groups, or toxin regulatory status, please do not hesitate to contact us at pathogens.pathogenes@phac-aspc.gc.ca.