Biosafety and biosecurity for pathogens and toxins news: Q1, May 2024 issue
On this page
- Online learning opportunities
- Accurate profile information in the biosecurity portal
- Roles and responsibilities of people holding a pathogen and toxin licence
- Updated guideline for Containment Level 1: Physical Design and Operational Practices
- Changes to the HPTA security clearance application process
- Incident risk mitigation
- RegFacts: #DYK: HPTA licences are valid for a specific maximum period
Online learning opportunities
The Public Health Agency of Canada’s (PHAC) Training Portal was updated on April 15, 2024. It’s now easier to find relevant courses. The portal is also faster, mobile friendly and fully accessible.
For questions or feedback, please email trainingandlearning-formationetapprentissage@phac-aspc.gc.ca.
Previous webinars
On February 29, 2024, the Centre for Biosecurity (CB) held a 60-minute webinar entitled “Biocontainment considerations: Systems and equipment”. The goal of the webinar was to explore the system considerations that guide the selection process for safe and efficient laboratory operation. The presentation included considerations such as:
- transfer equipment
- controlled activity equipment
- activities of the Biocontainment Engineering Science Working Group
On March 21, 2024, CB held a webinar entitled “Plan for administrative oversight (the Plan) for scientific research involving human pathogens and toxins”. The presentation was an overview of:
- the program and the 10 elements of the plan
- defining "scientific research" (basic and applied research and experimental development), including research scenarios
- dual-use oversight and identifying dual-use potential
- identifying biosafety and biosecurity risks and controls to mitigate risks from research
- common plan deficiencies
On April 16, 2024, CB held a webinar entitled “Developing a training plan”. The goal of the webinar was to bring more clarity to section 4.2 of the Canadian Biosafety Standard, Third edition (CBS3). The presentation included:
- what a training needs analysis is and how to create one
- considerations for the training plan
Access webinar recordings through the PHAC training portal.
Upcoming webinars
CB is pleased to offer the following webinars for stakeholders and regulated parties:
- May 30, 2024: What we heard - Supporting stakeholders through training
- June 19, 2024: A webinar on research security, offered by Innovation, Science and Economic Development Canada and Public Safety Canada
We’ll send an email to subscribers once registration is open.
Updated e-learning courses
The following e-learning courses have been updated in the PHAC training portal:
- General safety for containment labs
- Personal protective equipment
- Local risk assessment
- Insider and outsider threats
- Biomedical waste
The new Roles and responsibilities under HPTA (video series) has recently been added to the portal.
E-learning courses are open to everyone. You can create a free account on the PHAC training portal. You can also print and share certificates with managers or supervisors as proof of completion. If you retake a course, you’ll receive a new certificate with an updated course completion date.
Accurate profile information in the biosecurity portal
CB’s biosecurity portal is a centralized electronic system where you can:
- apply for and manage your pathogen and toxin licence
- apply for and manage your Human Pathogens and Toxins Act (HPTA) security clearance
- submit reports of laboratory incidents and other events requiring notification
You can access the biosecurity portal if you’re a:
- HPTA security clearance holder
- alternate biosafety contact (ABC)
- designated biological safety officer (BSO)
- licence holder (LH) or licence holder representative (LHR)
As part of the registration process, you’ll provide information about your organization. Not all fields are mandatory, but by completing them you provide a more complete representation of your organization and interests.
The "sector" field is mandatory and you must select the sector that best represents your industry in the context of what you do with pathogens (for example, you can be a manufacturer of a product but only do quality control with pathogens). There are 8 options under ‘principal area of focus’ including research, diagnostic and manufacturing. You can select multiple options.
The field for “type of information to receive” allows you to select the CB products you wish to receive by email, such as:
- the newsletter
- notifications of new advisories
- directives and guidelines
- training, including webinars
- pathogen safety data sheets
- updates to risk group classifications
To comply with Canada’s anti-spam legislation, we’ll only send you email updates about topics you subscribe to. Update your profile in the biosecurity portal to continue receiving information of interest.
We use the information submitted through the biosecurity portal to guide our engagement activities. You must provide accurate information when you register and update it regularly to ensure that it remains accurate and current.
As a reminder, we introduced a new condition of licence which requires the LH to keep current contact details for people associated with the licence. For more information, please see the article in our February issue.
Roles and responsibilities of people associated with a pathogen and toxin licence
We created a flyer to clarify the roles and responsibilities of individuals associated with a pathogen and toxin licence. The flyer has separate sections for:
- the LH or LHR
- the BSO
- the ABC
- anyone conducting controlled activities under the authority of a pathogen and toxin licence
- anyone conducting controlled activities with security sensitive biological agents (SSBAs)
You can post the relevant section of the flyer to the wall of your laboratory or office as a handy reference.
To get a copy of the flyer, visit Roles and responsibilities of individuals associated to a pathogen and toxin licence.
Updated guideline for Containment Level 1: Physical Design and Operational Practices
PHAC and the Canadian Food Inspection Agency have revised the Containment Level 1 (CL1) guideline to align with the CBS3, which came into effect on April 1, 2023. The updated CL1 guideline was published on April 18, 2024.
The CL1 guideline outlines risk-based recommendations and best practices for facilities where Risk Group 1 (RG1) biological material is handled. Since CL1 facilities often fall outside the regulatory scope of the CBS3, this update helps stakeholders follow current biosafety and biosecurity practices. RG1 biological material can sometimes cause infection, such as in people with a compromised immune system.
The CL1 guideline now also includes:
- tailored recommendations and best practices for CL1 zones to reflect CBS3 updates
- CBS3 explanatory notes adapted for RG1 biological material, to make the CL1 guideline a standalone document for most CL1 facilities
- updated information and references
- updated preface, glossary terms and formatting to align with CBS3
For questions about the updated CL1 guideline, please email pathogens.pathogenes@phac-aspc.gc.ca.
Changes to the HPTA security clearance application process
CB updated its policy for HPTA security clearance applications. As of January 1, 2024, new applicants must submit a copy of:
- their birth certificate
- foreign police record checks for any non-Canadian residential addresses listed in their HPTA security clearance application
For more information on the HPTA security clearance process:
- visit the biosecurity web page
- contact us at hpta.screening-filtrage.lapht@phac-aspc.gc.ca
Incident risk mitigation
Laboratory Incident Notification Canada (LINC) collects and processes incident reports from licensed facilities conducting controlled activities under the HPTA.
Many follow-up reports to incidents reported in 2023 demonstrated that applying risk mitigation strategies minimizes the chances of reoccurrence.
For example, an incident that occurred during a routine laboratory procedure illustrated the importance of biosafety protocols and emergency response planning.
The incident involved a small spill of a RG3 pathogen in a CL3 laboratory and a potential exposure. The technician immediately contained the pathogen and decontaminated the area according to the laboratory's procedures. They immediately reported the incident to a supervisor, who took steps to reduce risks and protect the safety of personnel. Although 4 other people were potentially exposed during the incident, the risk of infection was low as they were all wearing proper personal protective equipment. They received immediate medical consultation in accordance with the laboratory’s emergency response plan and incident response protocol. As required, they quickly reported the incident to PHAC, who reviewed it to assess the risks.
After this incident, laboratory safety management implemented dedicated spill response training. They recognized that ongoing safety training is crucial for all personnel to be prepared for any situation that may arise. While the possibility of another spill can’t be eliminated, they continue to prepare staff members to handle similar future situations.
This echoes a core principle in laboratory safety: the focus on continuous learning and improvement. By learning from such incidents, laboratories can be better prepared. This can benefit their staff and help set a standard for the wider scientific community. Inspectors can offer guidance on possible mitigation strategies and actions to prevent future incidents.
LINC’s review of reported incidents revealed the importance of another common risk mitigation strategy. Standard operating procedures (SOPs) can be modified following incidents to minimize hazards or to add steps to improve biosafety.
These reported incidents show that exposures to human pathogens and toxins can be minimized with the following supports:
- ongoing compliance of LHs with legislation and licence conditions
- regular BSO and PHAC inspections
- resources to support LHs
- CB’s commitment to continuous improvement and collaboration with licensed facilities
For additional guidance, refer to the CBS3 and the Notification and Reporting Under the HPTA and HPTR guideline.
For question related to incident reporting, email biosafety.biosecurite@phac-aspc.gc.ca.
RegFacts: #DYK: Pathogen and toxin licences are valid for a specific maximum period
Did you know that pathogen and toxin licences are only valid for a specific period of time?
Under the Human Pathogens and Toxins Regulations (HPTR) subsection 2(2), depending on the type of pathogens and toxins you’re working with, the maximum period in which your licence is valid is:
- 5 years for RG2 pathogens, prions and non-SSBA toxins
- 3 years for RG3 pathogens and SSBA toxins
- 1 year for RG4 pathogens
The period is determined at the outset of the licence period according to the following factors outlined in HPTR subsection 2(1):
- the applicant’s history of compliance, during the previous 10 years, with the provisions of the:
- HPTA/HPTR
- Health of Animals Act (HAA) and regulations (HAR)
- the risks associated with the controlled activities authorized by the licence
- any other factor relevant to protecting public health and safety
Pathogen and toxin licences are subject to various conditions, including:
- maintaining compliance with applicable CBS3 requirements
- keeping contact information up to date at all times
If you have questions regarding the licensing program, please email licence.permis@phac-aspc.gc.ca.
For more information on RG classifications, Acts, Regulations and standards related to pathogen and toxin licences: