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Biosafety and biosecurity for pathogens and toxins news: Q3, September 2020 issue

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Building national containment level 3 capacity in a pandemic

As COVID-19 evolved from a public health event of international concern to a global pandemic, organizations across Canada expressed their desire to respond to this event through research and innovation. Many funding opportunities for COVID-19 related research became available through a variety of sources, including the Canadian Institutes of Health Research and various provincial organizations.

This funding supports research into:

On January 28, 2020, the Centre for Biosecurity (CB) issued the first pathogen and toxin licence for work with SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2). CB proactively reached out to regulated Canadian laboratories with COVID-19 biosafety information. This included:

These laboratories may wish to reactivate a previously certified laboratory to containment level (CL) 3, so they can work with SARS-CoV-2. Over the last 6 months, more than 30 Canadian organizations have expressed an interest in working with SARS-CoV-2.

As of October 6, 2020, 24 organizations have been authorized to work with SARS-CoV-2 in Canada. Approximately half of these are capable of performing research with the virus in animals. Some of these organizations had previously established the capacity to work with other coronaviruses, such as MERS-CoV and SARS-CoV. CB worked with them to expedite the licence variation process to include SARS-CoV-2.

Other organizations had previously demonstrated capacity to work with a variety of risk group (RG) 3 pathogens but not coronaviruses. CB has applied regulatory flexibility by authorizing licences for SARS-CoV-2 for these laboratories on the condition that they demonstrate compliance with the most relevant Canadian Biosafety Standard requirements within a given timeframe. The focus of this compliance review has been on:

Three organizations have successfully reactivated their previously certified laboratories in order to work with SARS-CoV-2. CB inspectors have been in discussion with 6 other organizations that are contemplating building a new CL3 lab or upgrading an existing lab to meet the necessary requirements. CB remains committed to working with these regulated parties to bring them into compliance in a timely manner. This will continue to increase Canada's capacity to respond to the COVID-19 pandemic.

Expiry of your Human Pathogens and Toxins Act security clearance

The Human Pathogen and Toxin Act (HPTA) Security Clearance Program is an integral component of human pathogens and toxins legislation in Canada. You must have a valid HPTA Security Clearance if you work in a part of a facility where security sensitive biological agents are handled and stored. Clearances are valid for up to 5 years. If you applied for a clearance in 2015 or 2016, it will soon expire.

Intake of HPTA Security Clearance renewal applications will be completed in 2 waves.

Please contact the HPTA screening team at phac.hpta.screening-filtrage.lapht.aspc@canada.ca with any questions.

RegFacts #DYK

Did you know that someone with a security clearance may accompany and supervise one person (and only one person) without a security clearance into a controlled part of a facility?

This means that a person without a security clearance may enter the part of a facility in which controlled activities are authorized in relation to RG3 or RG4 human pathogens or toxins prescribed under the Human Pathogens and Toxins Regulations.

Laboratory exposure incident rate per licence: A new metric

HPTA licence holders must report information regarding laboratory incidents and persons affected by laboratory exposures to the Laboratory Incident Notification Canada (LINC). LINC is a national surveillance system housed at PHAC's Center for Biosecurity.

Since 2016, LINC has produced annual reports that highlight surveillance findings on exposure incidents in licensed laboratories across Canada. The fall 2020 report explores incidents that occurred in 2019, and marks the fourth year of complete data.

A new measure was introduced in this year's report. Exposure incident rate is the number of incidents that occurred for every 100 active laboratory licences. In 2019, the exposure incident rate was 6 incidents per 100 active laboratory licences. Incident rates by sector were as follows:

There is discussion of the varying exposure incident rates among sectors in the annual report.

This incident rate is a more appropriate metric than total number of incidents for comparisons over time and between sectors. For instance, a sector with more licences likely has more laboratories and a larger workforce, which puts it at an increased chance of reporting more incidents. Therefore, analyzing exposure incident rate is a better indicator of how laboratory safety varies between sectors or over time, because it considers this difference.

However, there are limitations to consider when interpreting these exposure incident rates because they employ number of licences as a proxy for the size of the work force. The gold standard metric for incident rate would capture the number of incidents per number of laboratory workers, as this would provide a more accurate picture than per number of licences alone.

The size of the workforce operating under a given licence can include one or more containment zones, and each laboratory has different workforce capacities. LINC continues to enhance the surveillance system to capture workforce size per laboratory licence and improve the accuracy of the measure of exposure incident rate.

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