Licensing program

The Public Health Agency of Canada (PHAC) is responsible for the administration and enforcement of the Human Pathogens and Toxins Act (HPTA), the Human Pathogens and Toxins Regulations (HPTR) and the administration of specific sections of the Health of Animals Regulations (HAR).

Applying for a Human Pathogens and Toxins Act licence: what you need to know

On December 1, 2015, the HPTR came into effect and the Human Pathogens Importation Regulations (HPIR) was repealed. Unless you are excluded or exempted, you are required to apply for a licence under the Human Pathogens and Toxins Act (HPTA) to conduct controlled activities (possessing, handling, using, producing, storing, permitting any person access, transferring, importing, exporting, releasing, abandoning, disposing of a human pathogen or toxin). This licence requirement replaces the requirement to register under the HPTA. It should be noted that there is no fee for licensing activities under the HPTA (including applying for, amending, renewing, etc.).

Additional information on the HPTA exclusions and HPTR exemptions can be found on the Human Pathogens and Toxins Act web page.

Additional information on Roles and Responsibilities of Individuals Associated to a Pathogen and Toxin Licence is available to help your organization to better understand the implications of holding a licence.

Applying for an HAR importation permit

If you import pure cultures of terrestrial animal pathogens and toxins, with the exception of non-indigenous animal pathogens and pathogens causing emerging animal disease, you will need to apply to PHAC for an importation permit under the authority of the Health of Animals Regulations (HAR). If you do not have the appropriate importation permit you will be considered non-compliant and subject to enforcement actions.

For the purpose of this program the term "terrestrial animal" includes avian and amphibian animals but does not include aquatic animals, bees and invertebrates.

Please note: The authority under the Health of Animals Act and its Regulations the Health of Animal Regulations to issue importation permits for animals, animal products and by-products (e.g., tissue, serum), aquatic animal pathogens, bee pathogens, pathogens causing foreign animal diseases and pathogens causing emerging animal diseases remains with the Canadian Food Inspection Agency (CFIA).

The Agency issues a "Pathogen and Toxin Licence document" for both a HPTA licence and HAR Importation Permit using a risk-based approach. The licensing process includes an assessment of the application submission and the applicant's or organisation's past compliance history.

Types of Human Pathogen and Toxin Act licences

Different Human Pathogen and Toxin Act (HPTA) licences will be granted for controlled activities according to pathogen risk groups and according to the Security Sensitive Biological Agent (SSBA) status for toxins. Separate licences will grant authority to perform activities with:

• all RG2 human pathogens, prions, and all toxins that are not SSBAs in a broad area of the organisation,
• specific prescribed toxin(s) in a defined part of a facility,
• specific list of RG3 pathogens in a defined laboratory space (the list may or may not include SSBA), and
• specific list of RG4 pathogens in a defined laboratory space (the list may or may not include SSBA).

Note: Most organisations performing work with Human Immunodeficiency Virus (HIV) or Mycobacterium tuberculosis (TB) as indicated in the Biosafety Directive for Human Immunodeficiency Virus (HIV) and Human T-cell Lymphotropic Virus Type 1 (HTLV-1) or the Biosafety Directive for Mycobacterium tuberculosis Complex (MTBC) will need a RG3 licence for activities with these human pathogens. The licence conditions will mirror the containment requirements from the Directives.

The maximum term of a Pathogen and Toxin Licence varies depending on the risk group of the pathogen(s). The maximum licence term is 5 years for risk group 2 pathogens, prions, and non-SSBA toxins. The maximum term is 3 years for risk group 3 pathogens and SSBA toxins and a 1 year term for risk group 4 pathogens. Licences are subject to various conditions. The conditions include an obligation for ongoing compliance with the applicable requirements described in the Canadian Biosafety Standard (CBS).

Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting: required elements and guidance

If you are a licence applicant who intends to carry out scientific research you will need to provide a plan known as the "Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting" (the Plan). PHAC developed the Plan, through discussions with multiple research institutions across Canada. The purpose of the Plan is to facilitate the development of internal accountability structures and support accountability structures that currently exist by bridging gaps in the oversight of pathogens at an institutional level. The guidance (attached) is composed of ten common administrative elements that are required to be included in Plan submissions. PHAC has provided the required elements for inclusion and guidance information for each element of a Plan submission to facilitate the compliance with this regulatory requirement.

Plans are intended to be very high level and are not intended to include or repeat any regulatory elements already captured through other means (e.g., Canadian Biosafety Standard (CBS) requirements). A licence will not be issued without the submission of a Plan for areas where scientific research is undertaken.

More details can be found in the following documents:

• Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting - Required Elements and Guidance
• Scientific Research Policy for Human Pathogens and Toxins

New facilities / renovation of existing facilities

Specific documentation may be required by the Agency as part of the licence application for newly constructed containment laboratories or renovation of containment level 3 and level 4 facilities, large scale and/or prion facilities. Please contact our office early in your planning process for guidance.

HPTA Security Clearance

A small list of prescribed dangerous Risk group 3 and 4 human pathogens and toxins (above trigger quantities) identified in the Human Pathogens and Toxins Act (HPTA) are commonly referred as Security Sensitive Biological Agents (SSBA).

There is a requirement to obtain a HPTA Security Clearance if you work with, or have access to SSBAs. Information on how to obtain an HPTA Security Clearance can be found in the Biosecurity section.

Contact information

If you have questions regarding our Pathogen and Toxin licensing program, please contact us:

• by phone at 613-957-1779,
• by facsimile at 613-941-0596 OR
• by email at licence.permis@phac-aspc.gc.ca

Application process

The Biosecurity Portal is a centralized electronic system that allows users to apply for both their HPTA licence and HAR Importation Permit online. The Biosecurity Portal also allows users to notify PHAC of reportable events such as exposures or laboratory acquired infections. Only those of you who have been identified as the Licence Holder Representative or designated Biological Safety Officer for your organization can register for a Biosecurity Portal account to perform these roles.

When registering for an account on our Biosecurity Portal page, you will be prompted to register or login to a Government of Canada GCKey account followed by the completion of your Biosecurity Portal profile, this is a necessary step to ensure the security of your information. Before being granted full access to the Portal, there will be a short waiting period to allow PHAC time to validate the submitted information. After validation is complete, you will receive a validation code from PHAC that you will need to enter when you login to your Biosecurity Portal account for the first time. For security purposes, those of you applying for Risk Group 3, Risk Group 4 and Security Sensitive Biological Agents (SSBAs) licences will also require a second level of authentication, a grid authenticator, which you will need to use each time you log in to your account. Only once you have received the validation code and the grid authenticator (for those requiring it) will you have access to the full functionality of the portal, such as applying for a licence. For step by step instructions see the User Guide.

Important: you will be required to have a valid email account and a GC Key in order to use the online licence application process. If you cannot submit your application through the electronic portal, please contact us at licence.permis@phac-aspc.gc.ca.

Summary of key steps in the application process

1. Create a GC Key account (if required) following the onscreen instructions.
2. Go to the Biosecurity Portal.
3. Complete your profile information and specify the type(s) of licence(s) you require.
4. Onboarding: The Agency will verify the information you have provided and, if acceptable, will allow you into the application side of the portal. Organizations working with higher risk pathogens will receive an additional security feature to log into the portal.
5. Complete the online pages with the appropriate information.
6. Review information submitted.
7. Provide your attestation and electronic signature.
8. Processing: The Licensing Program at the Agency will validate and review the application details. It will verify past compliance history and will set the appropriate licence conditions.
9. Approval and Licence issuance: Once your application has been approved, you will be notified by email and, if you wish, you can download and print your Pathogen and Toxin Licence.
10. Amendments and Renewal: Should you need to amend or renew your licence login to your account in the electronic portal and fill in the appropriate information and submit it to the Agency.
11. Processing: The Licensing Program at the Agency will validate and review the amendments or renewal application details. It will verify past compliance history and will set the appropriate licence conditions.
12. Approval and Licence issuance: Once the amendments or renewal to your licence application has been approved, you will be notified by email and, if you wish, you can download and print your updated Pathogen and Toxin Licence.

Compliance and enforcement

The Compliance and Enforcement Policy has been updated to reflect the delivery of the compliance and enforcement Program under the HPTA, HPTR, and select provisions of the Health of Animals Act and Health of Animals Regulations. The Compliance Activities and Enforcement Continuum provide an overview of the activities employed by the Agency to achieve a coherent Compliance and Enforcement Program.