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Biosafety and biosecurity for pathogens and toxins news: Q2, July 2020 issue

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Update of the biosafety advisory for severe acute respiratory syndrome-related 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 includes:

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

Incident reporting during the COVID19 pandemic

During the SARS-CoV-2 pandemic, laboratories are intensively carrying out diagnostic tests and research activities. Laboratory workers face the risk of exposure to biological agents.

Under the HPTA, it is mandatory to report exposure incidents in a laboratory setting through activities involving human pathogens and toxins outside their natural environment. Such activities include cultivating or intentionally collecting or extracting a human pathogen or toxin.

From January to March 2020, 14 exposure incidents were reported to the Laboratory Incident Notification Canada surveillance system (LINC). They included 3 inadvertent productions of a human pathogen or toxin. These incidents involved 14 biological agents, of which:

The most commonly implicated RG2 biological agent was Neisseria meningitidies with 2 exposures. Burkholderia pseudomallei was the most frequently reported RG3 agent with 2 exposures and the only security sensitive biological agent (SSBA) involved in an exposure incident during this first quarter of 2020.

During this quarter, an incident involving SARS-CoV-2 occurred through animal care activities. The causes of the incident were a lack of compliance to standard operating procedures (SOPs) and inadequate personal protective equipment. These 2 factors are generally common to exposure incidents in Canadian laboratories.

Because of the pandemic, activities in certain laboratories are at their highest intensity. Laboratories are encouraged to strengthen their safety measures and report incidents without delay. A focus on root causes could be highly valuable. Root causes identified in previous laboratory incident reports include:

RegFacts: #DYK

The CB has classified SARS-CoV-2 as a RG3 human pathogen.

Laboratories with a RG3 Pathogen and Toxin Licence issued under theHPTA can obtain and work with samples of SARS-CoV-2 in a minimum containment level 3 (CL3) facility. This licence is only required for laboratories where SARS-CoV-2 samples are intentionally handled, for example all in vitro and in vivo activities.

Primary specimens found in the natural environment are excluded from the HPTA and associated regulations, and are therefore not regulated by PHAC. This includes specimens of SARS-CoV-2 collected directly from patients. Facilities are not obligated to comply with any requirements when conducting diagnostic and clinical activities with primary SARS-CoV-2-infected specimens. However, we recommend that all facilities meet a minimum of good microbiological laboratory practices for working with primary specimens.

Refer to SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2)
for more information on:

If your laboratory is seeking to expand to include SARS-CoV-2 work, contact the CB's licensing team at: licence.permis@phac-aspc.gc.ca

Biosecurity considerations for virtual tours of facilities

During these unprecedented times, academia and organizations have been modifying their approach to distance education and remote work arrangements. As such, virtual tours of laboratories for training purposes have become more popular. Before publishing virtual tours, it is important to hide from view any biosecurity elements that aim to reduce the risk of unauthorized access to laboratories and confidential information.

Published virtual tours should show parts of a facility that your organization deems appropriate for public release. Information that should not be publicly released includes biosecurity elements such as physical security systems and sensitive facility areas. Elements that should not be included in your published virtual tours include:

By concealing this information from public view, your organization is reducing the risk of biosecurity events in your facility. Learn more about developing a biosecurity plan for your organization.

Send questions to the CB at pathogens.pathogenes@phac-aspc.gc.ca.

Analysis of risk group 3 term inspections

June 2019 marked the end of the first 3-year cycle of RG3 Licences term inspections. Between June 2016 and June 2019, CB inspectors conducted 63 compliance monitoring and verification inspections. Out of this total:

The CB identified 404 deficiencies that required corrective action (395 minor and 9 major) with an average of 7 deficiencies per inspection. Many of the deficiencies were related to new regulatory requirements. In 6 RG3 facilities, no deficiencies were observed during their inspection.

The 3-year cycle analysis of the inspections also helped identify areas where further clarification and guidance would be beneficial. For example, CBS requirement 4.4.7 was subject to various interpretations by regulated parties. To minimize misunderstanding, the CB has used the feedback to develop better guidance and clearer requirements in the upcoming editions of the standards.

Tips to achieve compliance:

2020 iGEM Giant Jamboree virtual event: The Centre for Biosecurity is here to help

This year's International Genetically Engineered Machines (iGEM) Competition will be held from October 29 to November 2, 2020. Due to the COVID-19 pandemic, the competition will be hosted virtually. Many iGEM teams are still planning projects as they navigate the options available to them this year. As a member of the iGEM Safety Committee and a competition judge, the Centre for Biosecurity contributes to the development of iGEM's safety policies and the promotion of biosafety and biosecurity practices.

In 2019, this premier synthetic biology competition attracted more than 350 teams from over 40 countries. They competed, using Standard Biological Parts, with their innovative applications on various tracks, such as:

Last year, 16 Canadian teams, including university and high school teams, successfully competed.

If your institution is competing in the 2020 iGEM Giant Jamboree, we encourage you to contact Cody Anderson from the Centre for Biosecurity by email at pathogens.pathogenes@phac-aspc.gc.ca for:

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2021-11-03