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Biosafety and biosecurity for pathogens and toxins news: Q4, February 2022 issue

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Voluntary reporting of incidents involving primary specimens

Primary specimens are pathogens or toxins existing in their natural environment. They are commonly collected and analyzed for clinical, diagnostic, and research purposes, but have not yet been extracted or cultured. They can be collected from the environment, such as water and soil, or directly from humans or animals, such as:

Under the HPTA, reporting laboratory incidents involving primary specimens is voluntary, regardless of their risk level.

In contrast, the HPTA requires all licensed facilities to report laboratory incidents involving risk group 2 (RG2) pathogens or above for:

Reporting incidents involving RG1 pathogens is also voluntary. While exposures to primary specimens and RG1 pathogens generally pose little risk to humans, reporting them can help detect real-time trends and identify potential gaps in biosafety, such as:

In fact, these examples are involved in most laboratory exposure incidents. By collecting data on all exposures, we hope to prevent or mitigate biosafety risks for all who work in laboratory settings.

Of the 38 exposure incidents reported to the Laboratory Incident Notification Canada (LINC) between January and October 2021:

As of November 2021, PHAC's Biosecurity Portal offers a new function to help you voluntarily report incidents involving primary specimens and RG1 pathogens. Submitting primary specimen exposures is similar to submitting mandatory exposure incidents via the Biosecurity Portal. We demonstrated this process during a webinar in December 2021. A recording of the webinar will be available in the PHAC e-learning portal in January 2022.

LINC is updating the reporting guidelines to include the recommendation of reporting all primary specimen and RG1 exposure incidents. Ultimately, this will allow PHAC to:

For any questions on voluntary reporting or submitting exposure incidents via the Biosecurity Portal, contact CB at biosafety.biosecurite@phac-aspc.gc.ca.

Delays in completing testing of containment equipment and systems

CB acknowledges that unforeseen circumstances, such as the COVID-19 pandemic, can delay your performance and verification testing of containment equipment and systems. CB will consider these challenges when assessing your compliance with Canadian Biosafety Standard (CBS) requirements.

CB's ultimate goal is for you to maintain a safe and secure work environment when handling pathogens and toxins. To that end, the CBS has 2 requirements that may be helpful in managing these circumstances.

1. Under requirement 4.10.6 of the CBS, you must keep records, including performance verification and testing records, in accordance with containment zone function of:

When there are delays in testing of any certified equipment, we recommend that you create and maintain records that clearly indicate the unforeseen circumstance as the cause for delay. Where relevant, refer to requirement 4.1.8 of the CBS to conduct a local risk assessment (LRA) and examine each task involving infectious material or toxins to:

In your LRA, you can describe any interim measures that will mitigate risk until the equipment is tested.

2. Conduct an LRA for activities with containment equipment if:

This LRA should clearly identify all potential risks that need mitigation through an alternative mechanism until your equipment can be tested. We describe these as potential risks, since equipment may still be safe to use but you can't confirm it without testing.

For biological safety cabinets, some examples of mitigation measures include:

While we acknowledge that each organization faces different challenges from unforeseen circumstances, we encourage you to follow best practices and take proactive measures such as those recommended above. As always, if you need more guidance, please contact CB at biosafety.biosecurite@phac-aspc.gc.ca.

Construction, renovation or re-commissioning of a containment level 3 laboratory

We recommend that you contact CB at the first stage of containment level 3 (CL3) laboratory projects, such as:

We can provide the latest information, and verify that your plans and specifications meet current CBS requirements. We'll provide input throughout the process regarding:

This will allow all stakeholders to be involved from the outset to guide you through the project. Guidance will vary depending on the pathogens you plan to use and the work you will do, such as:

Re-commissioning existing spaces

Before you re-commission an existing CL3 lab, we require certain information as indicated in the HPTA, including:

This information will allow us to give you the best possible guidance on the requirements. It will also help identify:

For any questions or concerns, contact CB at biosafety.biosecurite@phac-aspc.gc.ca.

Online learning opportunities: CB's dual-use training

Did you know that all research with pathogens and toxins has some level of dual-use potential? Would you like to learn how to identify dual-use potential and implement risk mitigation strategies? If so, the PHAC's CB has dual-use training for you.

Online course

CB offers a free course on our e-learning portal: Introduction to Dual-use in Life Science Research. PHAC developed the course in collaboration with the Canadian Institutes of Health Research (CIHR) Standing Committee on Ethics and the CIHR's Ethics Office.

This course aims to increase awareness on dual-use and promote the responsible conduct of research among:

After completing this course, participants will be able to:

Webinar

CB is delivering a webinar on dual-use on March 23rd, 2022. This interactive session will give you an overview of the concepts of dual-use in life sciences research. It will show you ways to identify, assess, and mitigate dual-use risks. It will also present dual-use examples as they relate to:

The target audience for this webinar include:

We'll notify you by email once registration for this session is open.

For any questions, please contact the Biosafety Learning and Knowledge team at pathogens.pathogenes@phac-aspc.gc.ca.

New tool to identify poliovirus potentially infectious material samples

In the global campaign for polio eradication, all World Health Organization (WHO) member states have an international commitment for the containment of polioviruses. This includes the establishment of a national poliovirus inventory. CB is Canada's National Authority for Containment (NAC). We maintain and update the National Poliovirus Inventory for facilities that handle or store poliovirus and potentially infectious material (PIM).

PIM includes any human faecal, respiratory, or concentrated sewage samples that were collected:

For more information on poliovirus PIM, please see our July 2021 newsletter article.

The WHO has developed a new sample identification tool to help determine if the samples stored in your laboratory may be PIM. This tool compliments the existing Guidance to minimize risks for facilities collecting, handling, or storing materials potentially infectious for polioviruses (PIM Guidance 2nd edition, 2021) (PDF).

Depending on where and when the sample was collected, the tool can tell you the poliovirus type and serotype for your PIM sample.

You must report retention of PIM to PHAC. If you believe you have poliovirus PIM, contact the Public Health Agency of Canada (PHAC)'s CB at biosafety.biosecurite@phac-aspc.gc.ca.

RegFacts: #DYK

Did you know that under section 36 of the HPTA, a licence applicant may appoint any person of their choosing (including themselves) to be a biological safety officer (BSO) provided they meet the requirements set out in the regulations?

The BSO should have knowledge of the:

If the licence holder appoints themself as the BSO, PHAC recommends identifying an alternate biosafety contact (ABC) to:

BSOs may refer to the CBS, HPTA and HPTR for information about controlled activities involving human pathogens and toxins.

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