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Biosafety and biosecurity for pathogens and toxins news: Q3, November 2021 issue

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Update of the biosafety advisory for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

The Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) have updated the biosafety advisory for severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2). The advisory now describes the risk group classification for full length SARS-CoV-2 RNA as:

Use this guideline in conjunction with the Canadian Biosafety Standard (CBS).

Changes to risk group classifications for some biological agents

The Centre for Biosecurity (CB) recently completed risk assessments on the following biological agents. This resulted in increases in the human RG classification from RG 1 to RG 2, and in one case, an increase in the animal RG classification from RG 1 to RG 2.

These changes are in effect immediately, and we have updated the ePATHogen database accordingly. These 4 biological agents are now regulated under the Human Pathogens and Toxins Act (HPTA). Aerococcus sanguinicola is now regulated under the Health of Animals Act (HAA). An HPTA licence is required to conduct controlled activities with these pathogens.

For questions or comments, contact the Biosafety Risk Assessment group at pathogens.pathogenes@phac-aspc.gc.ca.

New Canadian biosafety guideline: Incident investigation

PHAC and the CFIA have published a new Canadian biosafety guideline on incident investigation. The guideline outlines the steps required to perform a comprehensive incident investigation to identify root cause(s) of biosafety and biosecurity incidents and to prevent reoccurrence. More specifically, this guideline describes how to:

Use this guideline in conjunction with the Canadian Biosafety Standard (CBS).

National Security Guidelines for Research Partnerships come into effect

In July 2021, the Government of Canada issued a press release regarding the protection of research and intellectual property in Canada.

To ensure that the Canadian research ecosystem is as open as possible and as secure as necessary, the Government of Canada is introducing the National Security Guidelines for Research Partnerships. These guidelines were developed in consultation with the Government of Canada-Universities Working Group. The new guidelines integrate national security considerations into the development, evaluation and funding of research partnerships.

The National Security Guidelines for Research Partnerships apply to Natural Sciences and Engineering Research Council of Canada’s (NSERC) Alliance Grants Program. The government intends to expand the application of the guidelines to all granting councils and the Canada Foundation for Innovation in the near term.

In addition to the Safeguarding Your Research portal, the new guidelines are another tool to consult for information on how to mitigate risks to your research.

For questions on the application of the national security guidelines related to NSERC’s Alliance Grants Program, please contact alliance@nserc-crsng.gc.ca.

Addition of aquatic animal and bee pathogens in the ePATHogen risk group database

The ePATHogen risk group database provides information for safe laboratory handling practices for various pathogens and toxins. To make ePATHogen a more comprehensive source of pathogen information, we are updating the database to include information on aquatic animal and bee pathogens regulated by CFIA.

In ePATHogen’s 'considerations for containment' data field, we provide additional information related to a specific biological agent.. With the update of ePATHogen, a comment in this field will indicate the aquatic animal and bee pathogens regulated by the CFIA. Biological agents with a comment in this field will have “yes” in the 'info' column in the search results table. Click on the biological agent name to view the complete record. 

We will continue to use the 'CFIA' column to identify pathogens categorized as Foreign and Emerging Animal Disease (FAD/EAD) agents under CFIA’s authority. Note, all terrestrial animal pathogens (risk group 2, 3, or 4) imported into Canada as animal, animal product or animal by-products are also under CFIA’s authority. This applies regardless of whether  a  yes or no appears in the 'CFIA' column.

Please contact the CFIA at ImportZoopath@inspection.gc.ca for risk group classifications and for containment and import requirements for FAD, EAD, aquatic animal and bee pathogens included in ePATHogen.

Note that this update is a work in progress and we will send notifications once it is complete.

The Advisory Committee on Human Pathogens and Toxins annual meeting

As set out in the HPTA, PHAC established the Advisory Committee on Human Pathogens and Toxins (AC-HPT) in 2015 to provide scientific expertise and advice regarding pathogens and toxins. The committee consists of 13 members including the Chair. The AC-HPT meets in person annually and by teleconference throughout the year, as required.

Due to travel restrictions associated with the COVID-19 pandemic, this year’s AC-HPT meeting was a series of virtual meetings held weekly throughout May. The record of decision from the 2021 AC-HPT annual meeting is now available.

The AC-HPT provides advice on the inclusion or deletion of human pathogens or toxins to Schedules 1 to 5 of the HPTA. The AC-HPT may also provide scientific advice regarding the characteristics and risks of human pathogens and toxins, and recommendations to help address domestic and international biosafety and biosecurity risks, such as:

A majority of committee members must endorse the advice and recommendations provided to PHAC. As required by the HPTA, the advice from the AC-HPT pertaining to additions and deletions to Schedules 1 to 5 of the act are posted on PHAC’s website.

For any questions or inquiries, please contact the AC-HPT secretariat at cb.engagement-mobilisation.cb@phac-aspc.gc.ca.

Updates to Schedule 1 of the Human Pathogens and Toxins Act

Schedule 1 of the HPTA lists the toxins regulated under the act. We have planned the next update for fall 2023. To inform that update, the schedule is currently under review by CB and toxin risk assessments are in process. Stakeholder consultations will occur before the updates are complete.

Updates to Schedule 1 may include:

The Toxin Risk Assessment Subcommittee (TRAS) is comprised of toxinology experts from academia, industry, and various government departments. It was created to provide technical expertise and support CB and the AC-HPT in making recommendations regarding updates to Schedule 1 of the HPTA. TRAS also supports the review of toxin risk assessments and makes recommendations to the AC-HPT based on its assessments regarding the addition or deletion of toxins to Schedule 1.

For questions or concerns, please contact the Biosafety Risk Assessment program at pathogens.pathogenes@phac-aspc.gc.ca.

LINC data 2020: A description of laboratory exposure incidents and affected persons

Laboratory work involving biological agents poses an inherent risk of exposure to personnel and the community. Both exposure and non-exposure laboratory incidents are reported to Laboratory Incident Notification Canada (LINC), along with information regarding the affected persons. LINC is a nationally mandated surveillance system that gathers real time data from reports submitted by licensed laboratories describing laboratory incidents involving human pathogens and toxins.

LINC produces annual reports that describe laboratory incidents involving exposures in Canada and the individuals affected by them. The 2020 LINC annual report marks the program’s fifth year of operation.

In 2020, HPTA licence holders reported 42 exposure incidents involving 57 individuals with no laboratory-acquired infections. Among these individuals:

The most commonly cited root causes of the 42 exposure incidents were issues related to:

Microbiology research was the most common laboratory activity leading to exposure incidents (52.4%), followed by in vivo animal research (11.9%).

Among the 42 biological agents implicated in incidents, most were non-security-sensitive biological agents (88.1%) and human RG 2 agents (54.8%). RG 3 agents accounted for 43% of exposure incidents, with the most common agents being Blastomyces (ajellomyces) dermatitidis (16.7%) and SARS-CoV-2 (9.5%).

The annual incident exposure rate was 4.2 incidents per 100 active licences in 2020, which was less than that reported in 2019 (6.0 per 100 active licences). This decrease may be due to reduced laboratory activities because of stay at home orders and other public health measures implemented during the COVID-19 pandemic.

RegFacts: #DYK

Did you know that when you apply for a licence to carry out scientific research (as defined in the HPTR) you must first develop a plan for managing biosafety and biosecurity risks? This applies for any pathogen or toxin regulated under the HPTA.

To meet this requirement, you must submit a Plan for Administrative Oversight (PAO). PHAC has provided guidance for each of the required elements for a PAO.  We have also developed a Scientific Research Policy for Human Pathogens and Toxins. This policy clarifies the interpretation of scientific research that would require submission of a PAO.

Rescinding 6 risk group 2 pathogens on the Domestic Substances List

Part 5 of the Canadian Environmental Protection Act, 1999 (CEPA) focuses on understanding and reducing the risks posed by new and existing substances, including living organisms. The Domestic Substances List (DSL) is an inventory of substances manufactured in Canada, or imported into Canada on a commercial scale. Substances not on the DSL are considered new to Canada. You must complete a notification form before importing or manufacturing new substances over a certain threshold, to assess if they are toxic or could become toxic.

Substances on the DSL don’t require notification unless they are subject to significant new activity (SNAc) provisions. These provisions protect the general population from exposure through potential and future uses. If a SNAc captures the proposed activities with a substance, you must submit a SNAc notification to Environment and Climate Change Canada (ECCC). The Minister of ECCC and the Minister of Health will assess the information to determine if the substance could pose a risk to the environment or human health. They will also determine whether further risk management considerations are needed.

On June 19, 2021, the Government of Canada published a notice of intent to vary or rescind the SNAc provisions for 3 risk group 2 (RG2) pathogens on theDSL pursuant to subsection 112(3) of CEPA:

As assessed under CEPA, these pathogens don’t pose a risk to the general population, because they are no longer in commerce (manufactured in, or imported into Canada on a commercial scale). The SNAc requirements for these pathogens should be rescinded because the risks of these living organisms to human health and the environment are both:

No risk was identified for 3 other RG 2 pathogens on the DSL:

Existing licencing requirements under the HPTA are sufficient to manage the potential risk to humans and to protect them from exposure through potential future uses.

Current SNAc requirements for these pathogens remain in effect until a final notice of the rescissions is published in the Canada Gazette, Part I.

What does this mean for you?
If you are conducting controlled activities, as defined in Section 7 of the HPTA, with any of these 6 pathogens listed above, you will still require an RG 2 Pathogen and Toxin Licence issued by PHAC. Any controlled activities must take place in a facility that meets the requirements described in the CBS for Containment Level 2.

For more information, please contact us at pathogens.pathogenes@phac-aspc.gc.ca.

Update to the Australia Group’s common control list of dual use biological equipment

The Australia Group (AG) is an informal forum of countries that seeks to ensure that exports don’t contribute to the development of chemical or biological weapons. It does this through the harmonisation of export controls.

The AG establishes “control lists.” Member countries are expected to deny export licence requests for items on the lists when there is a concern that the items might be used in a chemical or biological weapons program. The dual-use biological equipment and related technology list contains controls on items that can be used for both peaceful research and biological weapons production, such as:

The AG has recently modified the controls on:

Global Affairs Canada (GAC) will incorporate these changes in the next version of A guide to Canada’s export control list. If you wish to export these items, you will need an export permit from GAC.

For questions on export controls and how to apply for export permits, please contact tie.reception@international.gc.ca.
For questions on policy, contact expctrlpol@international.gc.ca.
You can also consult GAC’s export controls website at www.exportcontrols.gc.ca or contact them at +1 343-203-4331.

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