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Biosafety and biosecurity for pathogens and toxins news: Q4, January 2023 issue

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Canadian Biosafety Standard, third edition

The Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency are pleased to announce the publication of the Canadian Biosafety Standard, third edition (CBS3).

The CBS3 outlines the physical containment, operational practice, and performance and verification testing requirements for facilities where regulated materials are handled or stored.

The CBS has been revised to:

For more information, please refer to:

The CBS3 comes into full effect on April 1, 2023.

The CBS3 webinar series, part 2, will be held February 8th, 2023. This webinar will include a short presentation on CBS3 as well as a dedicated question and answer period. The intent of this session is to guide facilities in implementing and achieving compliance with CBS3 requirements.

How to register:

Registration is limited for this event. If you’ve registered but can’t attend, please cancel your registration so that others may register.

How to cancel your licence

If you no longer perform controlled activities with pathogens and toxins, you can request to cancel your licence at any time in the Biosecurity Portal. The Centre for Biosecurity (CB) will process your request to cancel your licence after you:

The status of your licence will change from “issued” to “cancellation request in progress,” and you will receive a confirmation email. 

We may require additional information, such as confirmation that you’ve destroyed or transferred the regulated material, or that you’ve decommissioned the worksite. When we formally cancel the licence, you’ll receive an email notification.

If you have any questions regarding this process, please contact the licensing team at licence-permis@phac-apsc.gc.ca. 

Licence Holder and Licence Holder Representative: Defining terms in the context of the Human Pathogens and Toxins Act

CB is clarifying 2 important terms in relation to your Pathogen and Toxin Licence issued under the Human Pathogens and Toxins Act (HPTA): licence holder (LH) and licence holder representative (LHR). Since 2015, the terms have been used interchangeably, which can cause confusion.

The LH, whether an individual or an organization, assumes legal responsibility for complying with the Human Pathogens and Toxins Act (HPTA), the Human Pathogens and Toxins Regulations (HPTR) and licence conditions.

Section 7 of the HPTA states that no person shall knowingly conduct controlled activities unless a licence has been issued by the Minister that authorizes the activity. Subsection 18(5) of the HPTA specifies that a licence must set out the licence holder’s name. You must therefore name a LH before the facility can be authorized to conduct activities regulated under the HPTA and the HPTR.

Meaning of Licence Holder  

Under the HPTA, a “person” is an individual or an organization as defined in section 2 of the Criminal Code. Under the Criminal Code, an organization can be a corporation or a company, among other things.

Meaning of Licence Holder Representative 

The term LHR does not appear in the HPTA or the HPTR. For administrative purposes, where the LH is an organization (not an individual), the LHR is the individual appointed by the organization to act on its behalf to fulfill the responsibilities described in the HPTA and the HPTR. The LHR supports the designated biological safety officer (BSO) to ensure ongoing compliance with the HPTA, the HPTR, and licence conditions.

We expect to launch the redesigned licence in April 2023, but we’ve already begun to use these terms in all of our communications. There is no action required on your end.

A Statement of Administrative Intent has been published to clarify the meaning and use of LH and LHR in the context of the HPTA and HPTR.

HPTA security clearance reminders

To start the application process for an HPTA security clearance, create a user profile in the Biosecurity Portal. To obtain clearance, you must be endorsed in the Biosecurity Portal by your facility’s LH (or LHR where applicable) or the BSO. Their endorsement in the Biosecurity Portal means they confirm your need for access to a specific zone where security sensitive biological agents (SSBAs) are handled or stored. To gain unsupervised access to such an area, you must have a valid HPTA security clearance.

Records of valid HPTA security clearances are kept by LH, LHR and BSO

The LH or LHR is responsible for:

HPTA security clearances are portable 

Once an HPTA security clearance has been issued to you, it’s portable to other licenced facilities that endorse you. You can be endorsed by multiple facilities at the same time.

For more details, contact the HPTA screening team at hpta.screening-filtrage.lapht@phac-aspc.gc.ca

Withdrawing an endorsement  

The LH or LHR is responsible for withdrawing endorsements when access to SSBAs is no longer required. They must also inform the HPTA screening team at PHAC of the reason for the withdrawal. Examples of reasons for withdrawal include:

The LH or LHR must inform PHAC without delay if a withdrawal of endorsement is due to a potential or realized security concern by contacting the HPTA screening team at hpta.screening-filtrage.lapht@phac-aspc.gc.ca.

HPTA security clearance expiry

HPTA security clearance holders, LHs and LHRs are responsible for maintaining a record of HPTA security clearance issuance and expiry dates. You should apply to renew your HPTA security clearance at least 6 months before the expiry date, to avoid disrupting your access to SSBAs.

You are in non-compliance with the HPTA if your HPTA security clearance has expired and you continue to conduct unsupervised, controlled activities with SSBAs in Canada.

To check the expiry of your HPTA security clearance

If you applied for clearance after April 1, 2021, you can access your Biosecurity Portal account to find the expiry date of your security clearance.

If you applied before April 1, 2021 (using the PDF application form), check your most recent HPTA security clearance issuance letter for the expiry date. You can also email the HPTA screening team at hpta.screening-filtrage.lapht@phac-aspc.gc.ca for help.

For more information about HPTA security clearances, please refer to the Biosecurity web page or contact hpta.screening-filtrage.lapht@phac-aspc.gc.ca.

RegFacts: #DYK Biosafety for veterinary practices

Did you know that the HPTA and HPTR allow certain exemptions for veterinarians providing care to animals in clinical practice? These exemptions may include anyone under their supervision who is registered under provincial or territorial laws.

Provincially registered veterinarians and people under their supervision may perform laboratory analyses or diagnostic testing of a risk group 2 (RG2) human pathogen without a licence.

To be exempt, you must be conducting controlled activities with the RG2 pathogen while providing care to animals in clinical practice in the specified province (HPTR 27[2]). This includes the following diagnostic activities to identify an infection with an RG2 pathogen that may also infect humans (that is, human or zoonotic pathogens):

The exemption does not apply to:

It remains a requirement under Section 6 of the HPTA to take all reasonable precautions to protect the health and safety of the public from risks posed by activity.

PHAC provides risk-based biosafety precautions and additional recommendations for veterinary facilities performing laboratory analyses and diagnostic testing with RG2 human pathogens.

For more information, please refer to:

It is considered best practice to follow the physical and operational practice requirements in the Canadian Biosafety Standard and Canadian Biosafety Handbook.

Online biosafety and biosecurity resources

Thank you to those who participated in the mpox (monkeypox) virus webinar (October 25, 2022), and in the first CBS3 webinar (December 7, 2022). You can find the English and French recordings of both webinars, and copies of the presentations, in the PHAC Training Portal: Centre for Biosecurity Webinar Series.

The following biosafety and biosecurity posters, also available in the portal, have been updated for accessibility:

Global guidance framework for the responsible use of the life sciences

Early in 2022, the World Health Organisation (WHO) published a draft framework for dual use research of concern, and invited public feedback. CB shared the link to the WHO’s request for input. Thank you to everyone who provided comments on the draft framework.

The WHO published the final version, Global guidance framework for the responsible use of the life sciences: Mitigating biorisks and governing dual-use research (PDF only) in September 2022.

The framework identifies values, principles, tools and mechanisms for the governance of biorisks. It’s a useful tool to guide you in developing mechanisms to mitigate biorisk related to dual use research.

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