How the Public Health Agency of Canada implements the Human Pathogens and Toxins Act
On this page
- Importance of the Act
- Modernization of the Act in 2026
- What has changed
- New changes coming into force later
- Guidance
- Supporting activities
- Contact us
Importance of the Act
Human pathogens and toxins can pose a significant risk to human health and safety, either through accidental or deliberate release. Accidental release can result from inadequate oversight of controlled activities such as possession, use, transfer or disposal. A deliberate release could be possible if there are inadequate security measures in place. To address these concerns, the Public Health Agency of Canada (PHAC) established a national safety and security program to protect the health, safety and security of the public against risks posed by human pathogens and toxins.
The Human Pathogens and Toxins Act (HPTA or the Act) and the associated Human Pathogens and Toxins Regulations (HPTR) are the key authorities for Canada's biosafety and biosecurity program for human pathogens and toxins. The main objective of the program is to promote health, safety and security with respect to human pathogens and toxins. These are supported by the Canadian Biosafety Standard, Third Edition (CBS), as well as supporting activities, such as training programs, compliance audits and outreach.
The Act applies to the public and the program regulates the conduct of all of the following controlled activities with human pathogens and toxins, whether imported or domestically acquired:
- production
- possession
- handling
- use
- storage
- permitting access
- transfer
- disposal
- release
- abandonment
- import or export
PHAC uses a risk-based approach, with more stringent requirements for controlled activities involving Risk Group 3 and 4 human pathogens or regulated toxins with bioweapon potential, compared to requirements for lower-risk agents (such as Risk Group 2 human pathogens). The Act contains a number of obligations and prohibitions, such as:
- an obligation to take all reasonable precautions to protect the health, safety and security of the public when knowingly conducting any activity with human pathogens and toxins
- a ban on any activity with human pathogens and toxins listed in the schedule
- a prohibition on intentionally releasing human pathogens or toxins without lawful authority
PHAC implements the HPTA requirements through the following:
- licensing and conditions of licence
- security clearances for access to security sensitive biological agents
- granting exemptions and exclusions
- inspections
- powers and functions of licence holder representatives and biological safety officers
Learn more:
- Licensing program
- HPTA Security Clearance Program
- Human Pathogens and Toxins Act
- Human Pathogens and Toxins Regulations
- Canadian Biosafety Standard, Third Edition
- Biosecurity Addendum to the Canadian Biosafety Standard, Third Edition
Modernization of the Act in 2026
Amendments to the HPTA received Royal Assent on March 26, 2026, bringing many of the changes into effect. This marks the first major update since the Act was fully implemented in 2015. These changes strengthen Canada's ability to detect, prevent, and respond to evolving biosafety and biosecurity risks, while continuing risk-mitigated and innovative research.
The amendments aim to:
- protect the health, safety and security of people in Canada from modern biosecurity threats
- enhance oversight of work involving human pathogens and toxins, including those with bioweapon potential
- improve regulatory clarity that enables innovation as more private organizations seek to work with higher risk human pathogens and toxins
- supports both the growing domestic biomanufacturing and life sciences sectors and the global health security agenda
Amendments to the Act were informed by a five-year review of the HPTA and HPTR and through online thematic consultation with regulated and interested parties in August 2023. A report based on the findings from the consultation was published in early 2024.
Learn more:
- Biomanufacturing and Life Sciences Strategy
- What we heard: Consultation on potential amendments to the Human Pathogens and Toxins Regulations
What has changed
Below are key highlights of the amendments to the HPTA that took effect upon Royal Assent, with links to specific guidance documents for more information. A full presentation is available on the PHAC Training Portal to explain the changes in detail.
People and roles
Canadian residency requirements
Licence holders (if an individual), Licence Holder Representatives (when representing an organization), and Biological Safety Officers must now all be ordinarily resident in Canada. Organizations must be incorporated, formed or otherwise organized in Canada. These amendments help to validate that a facility has representation in Canada at all times, especially in case of emergencies, legal proceedings and issues related to health, safety and security.
There's a grace period of up to 60 days to address this new requirement if you're an existing licence holder and your licence is expiring within 30 days of Royal Assent.
Learn more:
Formalization of the Licence Holder Representative
The amended HPTA now requires the designation of a person who may act as the agent on behalf of an organization as its licence holder representative. Previously this was required by policy but was not in the Act.
Learn more:
Activities and operations
Transportation and export licensing requirements for higher-risk human pathogens and toxins
Licences authorizing work with higher-risk human pathogens and toxins (Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4, or toxins that are prescribed by regulation) may now be subject to additional licence conditions relating to the transfer, export, or import of these human pathogens or toxins.
These amendments help to reduce the risks of theft and diversion involving the movement of higher risk human pathogens and toxins.
This requirement applies to individuals or organizations who also conduct other controlled activities with human pathogens or toxins but does not generally apply to courier companies (unless they also conduct other controlled activities with human pathogens and toxins). Existing licence holders will have 90 days to vary their licence accordingly.
We're preparing guidance to help understand these changes. It will be shared on this page as soon as it's ready.
List of persons with remote access
Effective with this new amended HPTA, along with the requirement to keep track of all persons authorized to access the physical premises of a facility by maintaining a list, the licence holder must now also keep a list of all persons who have remote access to the facility.
We're preparing guidance to help understand these changes. It will be shared on this page as soon as it's ready.
Detailed scope of inspector powers
These amendments clarify roles and responsibilities, modernize the language concerning inspector access (for example specific mention of virtual inspections), and clarify inspectors' authorities to enter and verify activities during the pre-licensing phase upon receipt of an application for a licence. These changes facilitate the efficient performance of inspectors' duties.
Exclusion of certain devices from the application of the HPTA
Devices that are permitted or otherwise authorized for sale under the Food and Drugs Act, or a human pathogen or toxin contained in such a device, are now excluded from the HPTA.
Contact the Licensing Program for more information on how to vary or cancel a licence if this exclusion now applies to your facility.
Learn more:
Human pathogens and toxins
The introduction of a Registry of Human Pathogens and Toxins and new toxin definition
These amendments replace outdated Schedules 1 to 4 with the introduction of the Registry of Human Pathogens and Toxins (Registry), which is a subset of the existing ePATHogen database. The Registry better reflects the evergreen nature of toxin and human pathogen risk assessments and allows for timely updates that keeps pace with evolving biological science. It provides an accessible list of human pathogens and toxins regulated under the HPTA and its regulations, including an exhaustive list of toxins that pose a bioweapon risk. Schedule 5 – Prohibited Human Pathogens and Toxins remains in place but is renamed as the "the schedule".
Learn more:
A new toxin definition was introduced in the amended HPTA. A toxin is now defined as a substance that is produced by, or derived from, a micro-organism and that falls into one of the following 3 types of risk categories:
- those posing "a moderate to high risk to the health of individuals"; these toxins will be listed non-exhaustively in the new registry and may include a minimum trigger quantity;
- those 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 bioweapon,"; these toxins will be listed exhaustively in the registry and must include a minimum trigger quantity; or
- those for which all activity is prohibited; these toxins will continue to be listed exhaustively in "the schedule".
Learn more:
Compliance and enforcement
Increased fines and imprisonment terms
Amendments were made to modernize the penalties under the HPTA to reflect today's risk environment and align with other federal laws. These updates include simplified offence categories and increased consequences (fines and terms of imprisonment) for serious contraventions.
Learn more:
Reporting threshold shift from "reasonable grounds to believe" to "reasonable grounds to suspect"
Reporting certain incidents is a legal requirement under the HPTA. The language regarding notification for when a licence holder, person conducting controlled activities under the authority of a licence, or other person must notify of inadvertent release, inadvertent production, incident causing disease, or missing human pathogen or toxin has been revised as per the example below:
Before: "If a licence holder has reasonable grounds to believe that…"
Now: "If a licence holder has reasonable grounds to suspect that…"
This change lowers the threshold for when a person or licence holder is obliged to report the event to PHAC (or to the licence holder, as applicable), meaning that even reasonable suspicion of the event triggers the notification requirement.
The shift reflects a more proactive approach to risk management, emphasizing early detection and timely reporting of potential threats to public health and safety.
We're preparing guidance to help understand these changes. It will be shared on this page as soon as it's ready.
Other updates
Language precision, clarifications, refinements, corrections and other minor changes
There are several other amendments to improve clarity, update terminology and introduce new definitions as appropriate. These include, but are not limited to:
- adding "security" of the public as a clear purpose of the Act
- amending "Her Majesty" to "His Majesty" throughout the Act
- amending "shall" to "must" throughout the Act to align with modern drafting conventions
- introduction of definitions for "foreign entity", "terrorist group"
- consequential amendments to the HPTR to align with HPTA amendments
New changes coming into force later
Certain new provisions will not come into force immediately on Royal Assent as they are dependent on enabling regulatory amendments. Further development is necessary before they can be implemented. These include:
- provision of information concerning Foreign Ownership, Control, and Influence requirements in relation to licence applicants and holders working with higher risk biological agents
- expanded biosecurity notification obligations in relation to higher risk biological agents
- specific security screening requirements for physical and remote access to the facility and sensitive information, for those not accessing a facility for the purpose of conducting controlled activities, in relation to higher risk biological agents
- new offence of knowingly and unlawfully communicating sensitive information to a foreign entity or terrorist group
- administrative monetary penalties
PHAC will engage in public consultations to inform proposed changes to the HPTR.
Guidance
The Canadian Biosafety Standard, Third Edition is a condition of all HPTA licences and of applicable permits under the Health of Animals Regulations (HAR) and is the primary reference for biosafety and biosecurity requirements in Canada. PHAC has also developed additional guidance documents and tools to support its implementation and help regulated parties and the public comply with the HPTA and HPTR, including resources that address the new amendments coming into force upon Royal Assent.
These documents are not a substitute for the Act that is currently in effect. In the event of an inconsistency between guidance documents and the Act, what is stated in the Act will prevail.
Consult the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations.
Core guidance
- Canadian Biosafety Standard, Third Edition (CBS): Mandatory biosafety and biosecurity conditions of an HPTA licence to conduct controlled activities (and of applicable HAR permits).
- Biosecurity Addendum to the CBS: Additional requirements for Containment Level 4 facilities which came into effect as a condition of Risk Group 4 HPTA licences (and of applicable HAR permits) on January 5, 2026.
The current CBS (Third Edition) and Biosecurity Addendum referred to above continue to apply, pending updates to align them with the amended HPTA.
Learn more:
- Canadian Biosafety Standard, Third Edition
- Biosecurity Addendum to the Canadian Biosafety Standard, Third Edition
Guidance linked to new requirements
- Guidance for Organizations and Individuals regarding Canadian Residency Requirements under the Human Pathogens and Toxins Act
- ePathogen and the Registry of Human Pathogens and Toxins: what's the difference
- Toxin Talks: What's new about toxin oversight in the amended HPTA
- Roles and responsibilities of individuals associated with a Pathogen and Toxin Licence
- Changes to offence and punishment provisions
Existing supporting guidance
- Canadian Biosafety Guidelines
- Biosafety advisories and directives
- Exclusions from the Human Pathogens and Toxins Act
- Defining the term Micro-organism in the context of the Human Pathogens and Toxins Act
- The Human Pathogens and Toxins Act Application to Helminths
- Determining if Cells and Cell Lines are under the authority of the Human Pathogens and Toxins Act
- Exemptions from the Licensing Requirements of the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations
- Scientific Research Policy for Human Pathogens and Toxins
Supporting activities
PHAC's biosafety and biosecurity program also includes:
- an advisory committee that provides technical advice to the Minister on the Registry
- training and support through the PHAC Training Portal
- compliance promotion, verification, and monitoring
- pathogen safety data sheets that describe the hazardous properties of a human pathogen and provide recommendations for work involving these agents in a laboratory setting
- capacity-building across the biosafety and biosecurity community
- the Plan for Administrative Oversight to support research institutions
Learn more:
- Advisory Committee on Human Pathogens and Toxins
- Pathogen Safety Data Sheets
- PHAC Training Portal
- Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting
Contact us
Questions or comments related to how PHAC implements the HPTA, please contact cb.engagement-mobilisation.cb@phac-aspc.gc.ca.