Human Pathogens and Toxins Act Amendments Webinar Questions and Answers

Thank you to everyone who attended the Human Pathogens and Toxins Act Amendments 2026 webinar on March 31, 2026. We received a high volume of thoughtful questions, including some that we were unable to address during the session or that were raised by multiple participants. Note that the questions are presented below with the original text, which may contain typographical errors.

To support clarity and consistent information is available to all regulated parties, we have compiled responses to key questions below. A recording of the webinar and presentation materials are available 2026 Human Pathogens and Toxins Act Amendments | PHAC Training Portal.

You are encouraged to consult the implementation guidance and training resources developed to support understanding and consistent application of the changes, including:

How the Public Health Agency Implements the Human Pathogens and Toxins Act
the Training Portal’s Amendments to the Human Pathogens and Toxins Act main page

For any complex or specific questions, please contact us at cb.engagement.mobilisation.cb@phac-aspc.gc.ca.

Additional guidance and resources will continue to be released. Individuals in the roles of licence holder, licence holder representative, or biological safety officer associated with a Pathogen and Toxin Licence will automatically receive updates, including new or revised guidance, training, resources, and notifications of changes to the Registry of Human Pathogens and Toxins. Others working in the facility may subscribe to the distribution list to receive the same information and stay up to date.

General

Q1. Anything to do for biosafety level 2?

Yes, while many of the changes related to biosecurity are targeted only to higher risk containment facilities, there are amendments which affect all licence holders. Please refer to the PHAC Training Portal where you can find a summary of the key changes, associated guidance and supporting materials.

Canadian Residency

Q2. Could you clarify why the Licence Holder must be a physical person, but the Biological Safety Officer does not necessarily have to be a physical person?

The Licence Holder may be an individual or an organization, as the legal term “person” refers to either of these. When the licence holder is an organization, the organization must designate an individual as the Licence Holder Representative. The biological safety officer must always be an individual.

For more information, please consult the guidance on Canadian Residency Requirements.

Q3. For clarity, existing Biological Safety Officer and Licence Holder Representative on Risk Group 2 licence/NO Security Sensitive Biological Agents shall update the residence information on the Biosecurity Portal?

The Licence Holder (when an individual), the Licence Holder Representative and Biological Safety Officer associated with a current valid Pathogen and Toxin Licence are not required to update residency information on the Biosecurity Portal at this time. Confirmation of residency status will be requested when an application for a new licence, a licence renewal or a licence variation is submitted or upon request by the Public Health Agency of Canada. Once an application is submitted, the Licensing group will contact the applicant or the Licence Holder Representative by email – in a timely manner – to obtain confirmation of residency status.

Nevertheless, it is mandatory that the Licence Holder (when an individual), the designated Licence Holder Representative and the Biological Safety Officer meet the residency requirements at all times, as failure to comply with the requirements could result in the suspension or revocation of an active Pathogen and Toxin Licence.

For more information, please consult the guidance on Canadian Residency Requirements.

Licence Holder/Licence Holder Representative responsibilities

Q4. Can the Licence Holder Representative be the same person as the Biological Safety Officer?

While not required, it is recommended that two distinct individuals carry out these roles. The biological safety officer and Licence Holder Representative have distinct responsibilities, as described in the guidance on Licence Holder Roles and Responsibilities. If only one person is designated for these two roles, it is recommended to designate an Alternate Biosafety Contact.

While one person can hold both roles, doing so may create a real or perceived conflict of interest, as the biological safety officer is responsible for monitoring compliance while the Licence Holder Representative is accountable for addressing it. For this reason, keeping the roles separate is generally considered best practice to maintain independence and effective oversight.

Q5. Does the Biological Safety Officer already on the licence count as the Licence Holder Representative? Otherwise everyone is required to send in this new declaration if we are not. How do we inform the Public Health Agency of Canada who is the Licence Holder Representative for our institution?

No, the biological safety officer does not automatically count as the Licence Holder Representative. The Primary Contact listed for your licence in the Biosecurity Portal is the Licence Holder Representative and is identified as such on your Pathogen and Toxin Licence. If you wish to change this person, you can do so through the Biosecurity Portal or you can contact the Licensing team via email licence.permis@phac-aspc.gc.ca.

For more information, please consult the guidance on Licence Holder Roles and Responsibilities.

Q6. For Containment Level 2 labs, do you need Licence Holder Representative? or Licence Holder is sufficient

For all types of licence, if the Licence Holder is an individual, there is no obligation to designate a Licence Holder Representative. However, if the Licence Holder is an organization, an individual must be designated as Licence Holder Representative.

For more information, please consult the guidance on Licence Holder Roles and Responsibilities.

Registry

Q7. Will the non-exhaustive toxins registry now mean that some chemistry lab spaces might need to become full containment labs?

The move to a non-exhaustive toxins registry does not automatically mean that chemistry laboratory spaces will need to transition to full containment laboratories. Containment and licensing requirements will continue to be based on the specific toxins in use, their quantities, and the nature of the activities being conducted.

As would have been done under the prior version of the Human Pathogens and Toxins Act, stakeholders will be made aware of any addition to the list of regulated toxins. Such changes will continue to be informed by advice from the Advisory Committee on Human Pathogens and Toxins.

Q8. When will the Registry be available?

The Registry is available now. To conduct a search of the Registry of Human Pathogens and Toxins, you must first click the Registry of Human Pathogens and Toxins link found on the ePATHogen database page. Clicking this link will automatically conduct an advanced search of the ePATHogen database to generate a list that includes only human pathogens in Risk Group 2, 3 and 4 and regulated human toxins which are subject to the Human Pathogens and Toxins Act. We have prepared a short video: how to access and use the Registry. For more information, please consult the guidance on The Registry of Human Pathogens and Toxins.

Q9. 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 Human Pathogens and Toxins 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 Human Pathogens and Toxins Act and the Health of Animals Act. 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 Human Pathogens and Toxins Act.

For more information, please consult the guidance on The Registry of Human Pathogens and Toxins.

Q10. Are there any new regulated toxins? Or changes to risk groups or toxin regulatory status? For example, certain mycotoxins such as Aflatoxin B1

No, at the time of the new Human Pathogens and Toxins Act coming into effect and the Registry being created on March 26, 2026, there were no new regulated toxins or changes in pathogen risk group.

It is noted that the following toxins previously regulated under the former Human Pathogens and Toxins Act are no longer regulated human toxins in Canada (the animal toxin regulatory oversight remains unchanged):

Aerolysin
Bacillus anthracis oedema toxin
Bordetella pertussis adenylate cyclase toxin
Clostridium botulinum C3 toxin
Escherichia coli cytolethal distending toxin
Escherichia coli heat-labile enterotoxin (LT)
Escherichia coli heat-stable enterotoxin (ST)
Enteroaggregative heat-stable toxin / Enteroaggregative Escherichia coli heat-stable enterotoxin 1 (EAST1)
Exfoliative toxin
Streptococcal pyrogenic exotoxins
Tetanolysin

In addition, the following Security Sensitive Biological Agent toxin trigger quantities have increased:

“Staphylococcal enterotoxin - Type B” has increased from >1mg to >10mg. This in change can be found reflected in the Registry under the Staphylococcal enterotoxins entry.
Staphylococcal toxic shock syndrome toxin -1 has increased from >5mg to >10mg.

As a reminder and per our eBLAST sent June 10, 2024, the prescribed or Security Sensitive Biological Agent status of Cholera toxin and Clostridium botulinum C2 toxin has been removed, although both continue to be regulated as non- Security Sensitive Biological Agent human toxins. The animal toxin regulatory oversight status remains unchanged.

We encourage you to subscribe here to receive email updates and notifications of the Public Health Agency of Canada’s activities, including activities, advisories, notifications, training opportunities, and other regulatory information.

Q11. Can you confirm that only the pathogens listed in the registry are regulated?

The Registry is a subset of the ePATHogen database that contains a non-exhaustive list of human pathogens and toxins that are subject to the Human Pathogens and Toxins Act. It should not be assumed that the absence of a biological agent from the Registry means that the agent is not regulated. The biological agents listed in the Registry are those for which a pathogen or toxin risk assessment has been completed by the Public Health Agency of Canada and/or the Canadian Food Inspection Agency, as well as certain legacy entries with previously assigned classifications. Each entry includes an assigned Risk Group (for pathogens) or regulatory status (for toxins, indicating whether the toxin is subject to regulatory requirements) and containment level. However, given the rapidly evolving nature of biological agents and new scientific discoveries, there may be some agents that have not yet been assessed.

Until such a time as a pathogen or toxin risk assessment is completed, there is a requirement to take all reasonable precautions 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).

If you would like more information about the risk group or regulatory status of a biological agent, please contact us at pathogens.pathogenes@phac-aspc.gc.ca. This includes biological agents that are listed in, or absent from, the ePATHogen database or the Registry.

Q12. Does the transfer of materials from schedules to the registry mean that a defined pathogen or toxin's quantity limits can be changed by the government without consultation?

The Human Pathogens and Toxins Act requires that an Advisory Committee on Human Pathogens and Toxins be established to provide advice to the Minister in respect of the Registry on a periodic basis, and also states the Minister may request this advice at any time. While the amended Human Pathogens and Toxins Act does not require consultation before each individual change to a regulated pathogen or toxin status, the Public Health Agency of Canada intends to continue to use the Ministerial power to seek expert advice through the Advisory Committee as necessary and appropriate.

Q13. Will toxins be included in ePATHogen? Will they have Safety Data Sheets?

Yes, toxins will be included in both ePATHogen and the Registry, as appropriate for their regulatory status. At this time, there are no plans to make “toxin safety data sheets” available. Most commercial suppliers of toxins have made Material Safety Data Sheets available for their material.

Q14. If there is a change to a biological agent's risk group in the registry, will there be a notification that is communicated to the public/regulated parties? Would you consider a 'notification subscription' on agents a person could select from e-pathogen? This would automate the notifications on change of a specific agent we would like to track.

Changes to Risk Group levels will continue to be shared with stakeholders via email when the requirements become more stringent or are considered high impact, for example, an increase in Risk Group, a change in Security Sensitive Biological Agent status, or a decrease from Risk Group 4 or 3 to lower.

Regulated parties are expected to stay informed of the classification of biological material in their possession by consulting ePATHogen, the Registry, and the Schedules on a regular basis to ensure continued compliance. We encourage you to subscribe here to receive email updates and notifications of the Public Health Agency of Canada’s activities, including activities, advisories, notifications, training opportunities, and other regulatory information.

We appreciate and have noted the suggestion for future consideration; however, due to resource demands there are no plans to offer a “notification subscription” for either ePATHogen or the Registry at this time.

Q15. Will vectors, recombinants be included in registry?

All micro-organisms, including vectors and genetically modified biological agents, can be included in ePATHogen and the Registry, as appropriate for their regulatory status. Thousands of well-characterized biological agents that have had a pathogen or toxin risk assessment completed by the Public Health Agency of Canada 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 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.

Inadvertent possession

Q16. If a change occurs in the registry that impacts a regulated party, I understand there will be an eblast by the Public Health Agency of Canada to notify, but what will be the timeline for the regulated party to come into compliance with the change?

The introduction of the Registry in the amended Human Pathogens and Toxins Act means that the Centre for Biosecurity officials (on behalf of the Minister) 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:

hold a licence for the appropriate pathogen risk group (2, 3, or 4) or regulated toxin; and
meet the applicable biosafety and biosecurity requirements found in the Canadian Biosafety Standard, third edition and/or Biosecurity Addendum (specific to Containment Level 4 facilities).

Under the amended Act, 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, a Licence Holder will need to do one of the following within 30 days after the addition or change is publicly accessible:

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 Public Health Agency of Canada; or
- dispose of the biological agent in accordance with applicable regulations.
If you intend to conduct controlled activities with the biological agent in order to remain compliant with the Human Pathogens and Toxins Act you must:
- Verify that controlled activities with the biological agent are authorized under your existing Pathogen and Toxin Licence if not,
- obtain a new Pathogen and Toxin Licence or request a Pathogen and Toxin Licence variation authorizing controlled activities with the biological agent.

Failure to take the required action within 30 days after the addition or change becomes publicly accessible could result in a person conducting unauthorized controlled activities under the Human Pathogens and Toxins Act. Such activities may constitute non-compliance with the Act and could lead to compliance and enforcement measures, including, but not limited to, notices of non-compliance, licence suspension or revocation, orders, or prosecution, as appropriate.

Visit Licensing program - Canada.ca to learn more about the application process.

Q17. For a clinical lab Containment Level 2 lab that may inadvertently culture a Risk Group 3 Security Sensitive Biological Agent, such as Brucella suis, from a patient's clinical sample, would we need to connect with the licensing program to update licence?

There are a few options depending on the circumstances. Under Human Pathogens and Toxins Act subsection 12(2) all persons are required to inform the Minister if they are in possession of a human pathogen or toxin as a result of inadvertent production. The obligation to inform the Minister under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations means providing information to the Public Health Agency of Canada via the submission of a notification report. The Public Health Agency of Canada online Biosecurity Portal facilitates notification and detailed reporting in accordance with the Human Pathogens and Toxins Act, Human Pathogens and Toxins Regulations, and the respective operational practice requirements specified in the Canadian Biosafety Standard. To learn more about this process please consult the guideline: Notification and Reporting Under the HPTA and HPTR Using the Reporting Module of the Biosecurity Portal.

In the case of inadvertent production or possession of an Security Sensitive Biological Agent in a non- Security Sensitive Biological Agent -licensed facility the licence holder can transfer to a facility that is authorized for that agent, or destroy the human pathogen or toxin.

Regulations

Q18. What is the timeline on when the regulations will come out?

Amendments to the Human Pathogens and Toxins Regulations are anticipated within the next 2 years and will go through the Government of Canada’s standard regulatory development process, including a public comment period in Canada Gazette, Part I. The Public Health Agency of Canada will also provide targeted engagement opportunities where implicated regulated parties can submit comments for consideration.

Q19. Will the Public Health Agency of Canada be working with Canadian Food Inspection Agency to update the Health of Animals Act/Health of Animals Regulations as well? There was a mention that strict animal pathogens were not covered here.

The Canadian Food Inspection Agency leads on administering the Health of Animals Act and any related amendments. The Public Health Agency of Canada and the Canadian Food Inspection Agency work together to the extent possible to align regulatory approaches on pathogens and toxins that fall within our respective mandates. We will share your comments with the Canadian Food Inspection Agency for consideration.

Remote Access

Q20. Can you define remote access? Can you provide an example of persons who have remote/telecommunications access to facilities? Ex, would it include broad groups such as IT personnel?

The Public Health Agency of Canada is in the process of preparing guidance to help understand and apply the requirement to maintain a list of persons with remote access to the facility introduced in the amended section 31. We will notify all regulated parties as soon as this becomes available.

Note that other new remote access provisions (for example, section 33.1) require new regulations to be created. The definition and scope of remote access for this purpose will form part of the consultation on regulatory development.

Security Clearance

Q21. The facility access applies only to Security Sensitive Biological Agents as well, correct?

Persons are prohibited from entering a part of a facility in which controlled activities with Security Sensitive Biological Agents are authorized (unless they hold a valid Human Pathogens and Toxins Act Security Clearance issued by the Public Health Agency of Canada, or are accompanied and supervised by a person who holds a Human Pathogens and Toxins Act Security Clearance. This prohibition does not apply if there are no Security Sensitive Biological Agents in that part of the facility, or if any Security Sensitive Biological Agents that are present are locked up and inaccessible. These requirements and exceptions remain in effect under the amended Human Pathogens and Toxins Act until regulations are made.

Regulations will be required to bring new provisions relating to entering a facility, remotely accessing that facility by a means of telecommunication for any individual who does not conduct controlled activities, as well as access to sensitive information by any means relating to Security Sensitive Biological Agents.

Once new regulations come into effect, individuals must hold a security clearance to conduct controlled activities in the part of the facility where Security Sensitive Biological Agents are authorized.

Q22. Will there be additional resources to ensure Human Pathogens and Toxins Act Security Clearance applications are processed in a timely fashion due to the possible influx of applications?

As part of the regulatory development process, the Public Health Agency of Canada will consult (or seek input) from regulated parties most impacted by this amendment. Input received will inform the development of the regulatory proposal, including the design of a tiered security regime, and provide insight into operational requirements for both the Public Health Agency of Canada and regulated parties.

The Public Health Agency of Canada is also assessing operational impacts, including potential changes in application volumes, and will continue to make adjustments to processes and internal capacity as needed to support timely service delivery. As with all Government of Canada programs, resource considerations are managed through established planning and budgeting processes.

Sensitive information

Q23. What is considered sensitive information? Does the list of pathogens fall under this category?

The amendments to the Human Pathogens and Toxins Act introduce the concept of sensitive information and the authority to protect access to this information. Regulations will be required to bring new provisions relating to sensitive information.

Q24. Will the new offence of knowingly disclosing sensitive information to foreign entities allow for research collaboration with other nations?

The Public Health Agency of Canada recognizes the importance of balancing public health and security objectives with regulatory efficiency and support for research and innovation. Regulations will be required to bring new provisions relating to this new offence.

Amendments to the Human Pathogens and Toxins Regulations are anticipated within the next 2 years and will go through the Government of Canada’s standard regulatory development process, including a public comment period in Canada Gazette, Part I. The Public Health Agency of Canada will also provide targeted engagement opportunities where implicated regulated parties can submit comments for consideration.

Transport/Export

Q25. Do transport and export licence also apply to Risk Group 2 Security Sensitive Biological Agent toxins?

Toxins are not classified by Risk Group as they are not able to proliferate in the same way as pathogens. Transportation requirements under the amended Human Pathogens and Toxins Act apply to Security Sensitive Biological Agent toxins. As a result, these requirements can apply in Containment Level 2 settings where Security Sensitive Biological Agent toxins are handled.

The Public Health Agency of Canada is in the process of preparing guidance to help understand and apply the new transportation and export requirements. We will notify all regulated parties as soon as this becomes available.

Q26. Will there be any coordination with Transport Canada and International Air Transport Association regarding the sections that impact Human Pathogens and Toxins Act and Transportation of Dangerous Goods?

Yes, the Public Health Agency of Canada will be further developing the Transportation Security framework in collaboration with other Government of Canada departments and agencies. Under the new Human Pathogens and Toxins Act, the Minister of Health must always consult with the Minister of Transport prior to imposing any additional conditions of licence on Security Sensitive Biological Agents or Risk Group 4 pathogens.

Q27. For the transportation and export licence, does it apply to Security Sensitive Biological Agent toxins under trigger quantity?

The Minister may apply additional transportation or export-related conditions to a licence which authorizes controlled activities with Security Sensitive Biological Agent toxins regulated under the Human Pathogens and Toxins Act. No additional requirements would apply to Security Sensitive Biological Agent toxins under their identified regulatory trigger quantity pursuant to the Human Pathogens and Toxins Act. Noting that at this time, only facilities handling Risk Group 4 pathogens are subject to the additional conditions of licence presented in the Biosecurity Addendum to the Canadian Biosafety Standard, Third Edition.

Q28. If schedule 4 is repealed then how does that impact Transportation of Dangerous Goods Regulations and Emergency Response Assistance Plan? Transportation of Dangerous Goods bases Emergency Response Assistance Plan on the schedule (g) any quantity of dangerous goods that are Risk Group 4 human pathogens within the meaning of the Human Pathogens and Toxins Act.

With the removal of the older Schedule 4 and amended Human Pathogens and Toxins Act, Risk Group 4 pathogens are now non-exhaustively identified in the Registry. The amended Human Pathogens and Toxins Act now states that Risk Group 4 means a category of human pathogens that pose a high risk to the health of individuals and a high risk to public health, and includes the human pathogens listed under Risk Group 4 in the registry. This can now be applied to section 7.2(g) of the Transportation of Dangerous Goods Regulations and you can consult the Registry.

Q29. Do you anticipate any implications for diagnostic labs that do not have Security Sensitive Biological Agent licences, but have an inadvertent production of a Risk Group 3 Security Sensitive Biological Agent (for example when transferring to a properly licenced lab for additional testing)

Inadvertent production or possession of a Security Sensitive Biological Agent in a non- Security Sensitive Biological Agent-licensed facility would be subject to the requirements under subsection 12(2), whereby the licence holder must inform the Public Health Agency of Canada and can either transfer to a facility that is authorized for that agent or destroy the human pathogen or toxin. The obligation to inform the Minister under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations means providing information to the Public Health Agency of Canada via the submission of a notification report. The Public Health Agency of Canada online Biosecurity Portal facilitates notification and detailed reporting in accordance with the Human Pathogens and Toxins Act, Human Pathogens and Toxins Regulations, and the respective operational practice requirements specified in the Canadian Biosafety Standard. To learn more about this process please consult the guideline: Notification and Reporting Under the HPTA and HPTR Using the Reporting Module of the Biosecurity Portal

Note that as of January 5, 2026 transport, export, and import of a Risk Group 4 pathogen is subject to the conditions of licence set out in the Biosecurity Addendum to the Canadian Biosafety Standard, Third Edition. Should additional conditions of licence be considered for Security Sensitive Biological Agents classified as Risk Group 3 pathogen or prescribed toxins, there will be a consultation with affected regulated parties. The Centre for Biosecurity will be sure to take this scenario into consideration as part of this process.

Other

Q30. Can you give an example of a medical device? (regarding Exemption)

An example of medical devices that are now excluded from the Human Pathogens and Toxins Act include any in vitro diagnostic device that contains a human pathogen or toxin as a control, such as a toxin detection test kit.

Q31. Does the new update incorporate any new roles or collaborations with the occupational health and safety team within the organization?

Occupational health and safety oversight falls to the provincial authorities in Canada. In developing the Human Pathogens and Toxins Act amendments, the Government of Canada has endeavoured to avoid any overlap with the provincial occupational health and safety mandate.

August 2026