COVID-19: Biosafety Information for laboratories
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. While our focus is the COVID-19 response, I can assure you that we continue to provide support for our stakeholders under the Human Pathogens and Toxins Act (HPTA) and Regulations. Please continue to verify the Biosafety Advisory for SARS-CoV-2 page online for the most up to date information.
Centre for Biosecurity
Q1. What containment level do I need to conduct research work with SARS-CoV-2?
SARS-CoV-2 is classified as a Risk Group (RG) 3 human pathogen. Unless exempted under the Human Pathogens and Toxins Regulations (HPTR), all in vitro and in vivo activities with SARS-CoV-2 are to be performed in accordance with a Pathogen and Toxin Licence issued under the HPTA and in a facility that meets the minimum applicable requirements for containment level 3 (CL3), as specified in the Canadian Biosafety Standard (CBS). Please refer to PHAC’s Biosafety Advisory for SARS-CoV-2.
Q2.What containment level do I need to conduct diagnostic work with patient samples possibly or known to be infected with SARS-CoV-2?
Primary specimens (i.e., sputum, blood, plasma, feces, and tissues that are collected directly from patients) are excluded from the HPTA and are not regulated by the PHAC, as long as the pathogen will not be cultivated or intentionally collected or extracted (e.g., concentrated, cultured).
When conducting non-propagative diagnostic activities that do not result in the concentration or extraction of SARS-CoV-2, it is recommended to follow routine good microbiological laboratory practices and universal precautions in work areas where primary specimens are handled.
When conducting non-propagative diagnostic activities that may result in the inadvertent concentration or extraction of SARS-CoV-2, it is recommended that facilities meet the minimal applicable requirements for containment level 2 (CL2), as specified in the CBS.
Q3. Do I require a Health of Animals Regulations (HAR) permit to import SARS-CoV-2?
No, at this time, a permit to import SARS-CoV-2 is not required under the HAR. The emerging pathogen risk assessment will be updated as new information becomes available. Should new information result in the classification of SARS-CoV-2 as an emerging animal pathogen, the Canadian Food Inspection Agency’s regulatory role will be clarified.
Q4. Do laboratory personnel require an HPTA Security Clearance to work with SARS-CoV-2?
No, a HPTA Security Clearance is not required to work with SARS-CoV-2 as it is not classified as a Security Sensitive Biological Agent (SSBA). It is important to note, however, that SARS-CoV (the causative agent of severe acute respiratory syndrome) is classified as a SSBA and therefore, a HPTA Security Clearance is required to work with SARS-CoV.
Q5. My organization has a laboratory that was previously certified to an older Canadian biosafety guideline for CL3 activities but is now being used as a CL2. We are considering reactivating this lab in order to do work with SARS-CoV-2. What do we need to do?
A. Please reach out to the CB at email@example.com so that we can provide you with the best possible guidance on the requirements necessary for reactivation and subsequent HPTA licensing of your CL3 laboratory to work with SARS-CoV-2. Include the following in your correspondence:
- What type of work is expected to be done with SARS-CoV-2? In vitro and/or in vivo?
- Do you plan to work with RG3 human pathogens other than SARS-CoV-2 in this laboratory?
- Was this laboratory initially certified as a CL3 Laboratory Work Area only, CL3 Small Animal Zone or CL3 Large Animal Zone?
- Which Canadian Guideline(s)/Standard(s) was this laboratory initially certified to?
This information is necessary in determining the compliance documentation that will need to be submitted and potential performance and verification testing that may need to be completed in order for PHAC to authorize a RG3 Pathogen and Toxin licence for work at CL3.
Q6. With the current pandemic, my organization is having difficulty completing its performance and verification testing of containment equipment and systems as required in the CBS. Will CB take this into consideration during future inspections?
A. Yes, CB acknowledges the challenges your organization may be facing. CB’s inspectors are aware of these challenges and will take this under careful consideration when assessing compliance with the relevant CBS requirements.
The ultimate goal is for our regulated parties to have a safe and secure work environment when handling human pathogens. To this end, there are two requirements from the CBS that may be helpful in managing these circumstances:
- 4.10.6 Records of building and equipment maintenance, repair, inspection, testing, or certification, including performance verification and testing records, in accordance with containment zone function, to be kept on file.
We recommend that for any equipment for which certification is expiring and testing must be delayed, ensure that records are drafted and maintained that clearly indicate the COVID-19 pandemic as the reason for the delay. Where relevant, refer to the requirement below (4.1.8) and describe the interim measures that will be taken to mitigate risk until the equipment can be tested.
- 4.1.8 A local risk assessment (LRA) to be conducted to examine each task involving infectious material or toxins so that the risks are identified and safe work practices developed and documented.
We recommend conducting a local risk assessment (LRA) for all containment equipment that must continue to be used when certification has expired and testing has been delayed due to the COVID-19 pandemic. This LRA should clearly identify all potential risks that will need to be mitigated through an alternative mechanism until such time the equipment can be tested. We describe these as “potential” risks, as equipment may in fact still be safe to use but cannot be confirmed without testing.
Examples of mitigation measures for biological safety cabinets:
- Use a smoke pencil or other visual aid to confirm inward directional airflow at the face of a biological safety cabinet.
- Post signage to clearly identify equipment whose certification/testing has expired, and limit the use of such equipment when possible.
- Consider using additional personal protective equipment (PPE) where applicable.
Each organization’s situation and challenges in the face of COVID-19 will be different, however we encourage our regulated parties to follow best practices and take proactive measures like those recommended above. As always, where additional guidance is needed, please contact CB at firstname.lastname@example.org.
Q7. I work in a CL2 laboratory that now requires personnel to wear a non-medical mask because of COVID-19. What precautions do I need to take?
A. Information on how to safely use a non-medical mask or face covering is available.
We recommend the following additional precautions to ensure biosafety is maintained:
- face coverings used in the laboratory should not be used outside of containment in common areas (hallways, restrooms, cafeterias, administrative areas, etc.)
- face coverings should not be used more than once in the laboratory; used face coverings may become contaminated from lab activities and reapplying them to the face introduces additional risk
- face coverings can be laundered at home between uses, provided they are transported home in a closed plastic bag and handled with caution
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