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Biosafety and biosecurity for pathogens and toxins news: Q1, April 2020 issue

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A message from the Centre for Biosecurity’s Director General

With the current situation of COVID-19 evolving rapidly around the world, we would like to assure you that the Public Health Agency of Canada (PHAC) is continuing to monitor and assess the situation to provide Canadians with evidence-based information and guidance. Our main priority for the Centre for Biosecurity is the COVID-19 response but I can assure you that we are still here to provide support for our stakeholders under the Human Pathogens and Toxins Act (HPTA) and its regulations. We will work together to protect our community. Please continue to verify the biosafety advisory page online for the most up to date information.

We sincerely hope you and your families remain safe during this time.

Kimby Barton
Director General
Centre for Biosecurity

Your role in COVID-19

As COVID-19 continues to spread globally, it is important for Canadians to understand our roles in mitigating its impact. PHAC is continuing to monitor and reassess the public health risk. Important practices include:

Please check the coronavirus disease update page in order to stay informed on the most recent information.

Tips to avoid delays of international pathogen or toxin shipments

Thanks to the Canada Border Services Agency’s (CBSA) Single Window Initiative, you can benefit from the timely movement of pathogens across the border. At this time, there may additional delays due to the recent changes at the U.S.-Canada border related to COVID-19. It is important to follow the proper procedures to keep your shipments moving. By providing your licence number in the description or to your broker, your shipment can pre-clear customs.

Only parties with a valid pathogen and toxin licence can import regulated material. During border importation monitoring, PHAC encounters many scenarios of possible non-compliance, such as:

It is important that you provide your licence number, or even better, a copy of your licence, with a detailed description of the material you wish to import. You should specify the quantity, whether the material is active/inactive, purified, or contained in a human/animal sample. An example of an appropriate description would be: 3 lyophilized tubes containing live Staphylococcus aureus, Licence # L-R2-12345-20-AA-00. You should also include the delivery address for the shipment. This must be the same address listed on your licence.

If you are importing prescribed Security Sensitive Biological Agent toxins, it is especially important to specify the quantity of the toxin, to ensure that your shipment does not get detained by CBSA.

For further information, please contact the Licensing Program by email at licence.permis@phac-aspc.gc.ca or by phone 613-957-1779.

RegFacts: #DYK 

A trigger quantity is not the same as a threshold. All toxins listed in Schedule 1 and Part 1 of Schedule 5 of the HPTA have thresholds, but only some of the toxins have a trigger quantity. These toxins are listed in the Human Pathogens and Toxins Regulations (HPTR).

The threshold quantity listed in section 10(2) of the HPTR identifies the amount of that toxin that a facility can possess at any given time. If a toxin listed in this section is present in the facility in a quantity above or equal to the trigger quantity, it becomes a “prescribed toxin” under the HPTA. This will require an HPTA Security Clearance to have possession. If the amount of toxin present in the facility is below the trigger quantity, it is not a security sensitive biological agent; however, it remains a regulated toxin and is subject to the requirements of the Canadian Biosafety Standard (CBS) under the associated minimum containment level.

If you have any questions about your licensing requirements under the HPTA and HPTR, please contact us by email at licence.permis@phac-aspc.gc.ca.

Basics of biological safety cabinets

Biological safety cabinets (BSC) are a vital piece of equipment for laboratories, especially during a response such as the COVID-19. Basic knowledge of BSCs is key to protecting those working in labs and the general public.  

The CBS (3.7.1) states that certified BSCs and other primary containment devices are required in your lab based on work activities. It is up to individual labs to determine what work activities would require a BSC, and which BSC class is most suitable for this work.

There are different classes of BSCs to choose from based on your work requirements. Below are the three (3) classes of BSCs along with brief descriptions. The Canadian Biosafety Handbook (CBH) and the National Sanitation Foundation (NSF) 49 standard provides more information:

  1. Class I, offers personnel and environmental protection from the samples
  2. Class II, offers personnel, environmental and product protection
    • Class II can be further separated into 4 types (A1, A2, B1, B2, and C1)
    • Each type offers variable safety parameters (most common Class of BSC selected)
  3. Class III, offers personnel, environmental and product protection as it is a sealed chamber

Some factors to consider when selecting a BSC for your lab include physical footprint, operational requirements, and testing requirements. When it comes to physical footprint, consider the size and the process required to operate it properly (i.e. doors, vents, and diffusers). Standard operating procedures and specialized training will need to be developed. Testing considerations are also crucial due to the importance and danger of the work done in a BSC. BSCs used for work with pathogens or toxins must be tested annually and after any repairs, modifications or relocation.  

This article is only a brief overview of biological safety cabinets. Detailed training is available through our e-learning portal. If you have any questions, please contact the Centre for Biosecurity at biosafety.biosecurite@phac-aspc.gc.ca.

An Analytical Approach for the Development of a National Biosafety and Biosecurity Framework

Both anecdotal and empirical evidence has shown that biosafety and biosecurity capacity is a relatively weak area of health security globally, with many countries having little or no oversight or governance in place. In response, and in support of Canada’s international commitments, the Centre for Biosecurity developed An Analytical Approach for the Development of a National Biosafety and Biosecurity System (the Analytical Approach), with funding from Global Affairs Canada’s Weapons Threat Reduction Program.

The Analytical Approach is a detailed “how to” policy analysis tool that walks through the entire process of developing, modernizing or refining a policy framework for biosafety and biosecurity. It is composed of 9 modules, each comprised of theory and examples, as well as workshop tools such as draft agendas and worksheets to guide the users’ work. It provides a structure for critical thinking that assists with defining country-specific issues and identifying feasible policy solutions to root causes, and supports risk management for moderate and high-risk pathogens and toxins using safety and security lenses. The Analytical Approach is available both as an online course and as a downloadable manual in English and French on PHAC’s e-learning portal.

Online learning opportunities

The Centre for Biosecurity has released 2 new online courses on our e-learning portal to help promote biosafety and biosecurity for you and your team especially as we work to respond to the COVID-19 pandemic.

Insider and Outsider Threats

This course explores some important considerations related to the motives, tactics, and indicators of insider and outsider threats. It will spark insight into elements to include in your Biosecurity Plan and will keep you engaged with scenario-based examples to apply your learning on the spot.

Local Risk Assessment Course

The newly released Local Risk Assessment course will expand your knowledge on elements to consider, how to complete this type of risk assessment, and how to fulfill the requirements of the Canadian Biosafety Standard.

Accessing training records in the e-learning portal

With the current situation around COVID-19, it is important that training for staff working in laboratories is up to date and should continue even when working remotely. If you are completing a training audit for your team or preparing a training needs assessment, our e-learning portal has a feature that allows users to request access to the training records of another user. This feature will allow you to compile data on completion rates of staff training.

Simply follow these steps to access training records:

  1. Log in to your e-learning portal account
  2. Go into your dashboard and select “Training Coordinator Request”
  3. Enter the username or email address of the user whose training record you want to view
  4. Click “Send Request”

The user will then receive an email asking to confirm whether they grant permission to access their training records. When granted access, the training coordinator can view the person’s training records in the “Training Coordinator Request” section of their dashboard.

Affected persons in exposure incidents in fall 2019

Individuals who work in laboratory settings face an inherent risk of exposure to the human pathogens and toxins that they handle on a daily basis. Licence holders must report information regarding laboratory incidents and persons affected by laboratory exposures to the Laboratory Incident Notification Canada (LINC), a national surveillance system housed at PHAC’s Center for Biosecurity.

LINC examined incident reports received during the months of September to December 2019 to characterize persons affected in exposure incidents. As a result, nineteen individuals in laboratories across Canada were identified as being affected. Among these individuals, inhalation of aerosols containing a human pathogen or toxin was the most common route of exposure (63%) followed by inoculation or injection by a potentially contaminated needle or sharp object (21%). The other routes of exposure were ingestion and absorption via contact with skin or mucus membrane (16%).

Most laboratory activities leading to exposure occurred during microbiology (68%), autopsy or necropsy (11%), and in vivo animal research (11%) activities. Exposures through laboratory activities such as animal care and cell cultures were less frequent (10%).

LINC performs further analysis based on annual surveillance data to identify potential areas for laboratory safety improvement. In the context of the COVID-19 pandemic, it may be prudent to take extra precautions particularly during microbiology activities in laboratories to prevent future personal exposures to SARS-COV-2 and other pathogens. For diagnostic activities, these precautions include: the use of a biological safety cabinet, gloves, eye protection and centrifugation in a safety cup.

New mobile app: International Biosafety and Biosecurity Oversight

In the current COVID-19 pandemic, it is important to stay updated on how other countries approach the oversight of human pathogens and toxins. The Compendium of International Biosafety and Biosecurity Oversight Systems for Human and Animal Pathogens and Toxins (the Compendium) was launched in December 2019 as a complementary publicly accessible mobile application in the Google Play store.

Funded by Global Affairs Canada, the Compendium provides detailed information on national biosafety and biosecurity regulatory oversight from the 11 member countries of the International Experts Group of Biosafety and Biosecurity Regulators (IEGBBR). Countries that aim to develop or strengthen their national biosafety and biosecurity capacities can use the Compendium, hand in hand with other available reference tools, such as An Analytical Approach for the Development of a National Biosafety and Biosecurity System, and therefore can remove the necessity for extensive legwork prior to the development and implementation of regulatory oversight.

Refer to IEGBBR’s new public website for more information.

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2021-11-02