Biosafety and biosecurity for pathogens and toxins news: Q3, February 2024 issue
On this page
- Report on the Human Pathogens and Toxins Regulations consultation
- Canadian Biosafety App version 3.0
- Laboratory Incident Notification Canada's 2022 annual report
- Online learning opportunities
- New printable tools
- RegFacts: #DYK: Your legal obligations to notify the Centre for Biosecurity
- Types of controlled activities conducted under your licence
- Responsibilities of the HPTA security clearance holder
- New condition of licence: Keep contact information up to date
- Protecting facilities: Personnel and visitors
- Risk groups: What they are and why they matter
Report on the Human Pathogens and Toxins Regulations consultation
The Centre for Biosecurity (CB) recently completed a thematic consultation to help shape potential changes to the Human Pathogens and Toxins Regulations (HPTR). We were pleased to receive responses from a broad range of partners and stakeholders, including individuals and organizations. They provided insight from a number of perspectives, including:
- regulated facilities
- professional associations
- consumer and industry organizations
- provincial, territorial and municipal governments
In keeping with the Government of Canada's commitment to greater transparency and accountability, we published a ‘What we heard' report. This report summarizes the feedback and outlines how this information will be used to shape the development of HPTR amendments. The report is now available on the What we heard: Consultation on potential amendments to the Human Pathogens and Toxins Regulations web page.
Canadian Biosafety App version 3.0
The Canadian Biosafety Standard (CBS), Third Edition came into effect on April 1, 2023. The Canadian Biosafety App version 3.0 is now available in both online and mobile versions. It's a practical tool that makes it easier to see the CBS requirements for your facility, based on specific activities and regulated materials.
The online version lets you:
- filter requirements for a:
- laboratory
- prion work area
- large scale production area
- small or large animal containment zone
- filter biosecurity requirements
- use checkboxes to verify requirements
- sort requirements by status
- add notes to the displayed requirements
- search keywords within a list of requirements
- save and export requirement checklists for different locations
In addition to the features described above, the mobile version provides the full text of the CBS, a link to the Public Health Agency of Canada (PHAC) Training Portal, and links to content such as biosafety guidelines, directives and advisories. Most features in the mobile app can also be used offline. It's a free download for both Android and Apple devices.
We will update the app as new content becomes available.
Contact us at pathogens.pathogenes@phac-aspc.gc.ca if you have any questions.
Laboratory Incident Notification Canada's 2022 annual report
Laboratory Incident Notification Canada (LINC) published its 2022 annual report in September 2023. It describes laboratory exposure incidents in Canada and those affected by these incidents.
Online learning opportunities
On September 27, 2023, the Centre for Biosecurity (CB) held a 60-minute webinar titled “Laboratory Incidents: How, when and what to report”. The goals of the webinar were to summarize and clarify best practices for reporting laboratory incidents, and to answer participants' questions. In this webinar presented by LINC, speakers outlined the mandatory and voluntary reporting process for laboratory incidents under the Human Pathogens and Toxins Act (HPTA) and Human Pathogens and Toxins Regulations (HPTR).
On November 23, 2023, CB held the ‘What's new in the Centre for Biosecurity' webinar. The aim of the presentation was to raise awareness and share information about the most common types of exposure incidents in Canada.
Some highlights included:
- a summary of the annual report about laboratory exposures to human pathogens and toxins reported to LINC in 2022
- some changes made to the licensing program at PHAC
- a demonstration of both the online and mobile versions of the Canadian Biosafety App v3.0
- information about the biosafety directive for risk group 3 (RG3 ) fungi
On January 25, 2024, CB held a webinar on Biocontainment considerations: design, operation and commissioning. The purpose of this webinar was to discuss topics related to biocontainment design and operational considerations, including:
- the basics of biocontainment
- laboratory design factors relating to operational and physical containment
- considerations during system and equipment selection (for example, specific considerations around animal work)
Presenters also discussed the laboratory commissioning process and how it adds to the overall building commissioning.
You can access webinar recordings through the Public Health Agency of Canada's Training Portal.
Upcoming webinars
- February 29, 2024: Biocontainment considerations: Systems and equipment
- Registration email to come
- March 21, 2024: Plan for administrative oversight for scientific research involving human pathogens and toxins
New printable tools
CB has developed new resources to support laboratories with their reporting obligations for exposure incidents involving human pathogens and toxins. These are in addition to the existing printable laboratory biosafety signage and information sheets.
The new resources include:
- a laboratory exposure reporting poster
- This poster can be customized, printed and posted in laboratories to remind employees of the appropriate internal laboratory authority to report exposure incidents
- a checklist resource for the lab reporter
- This fillable form outlines the incident information that facilities need to gather to report to PHAC in the event of an exposure
- a checklist resource for an affected person
- This fillable form outlines the necessary information needed about anyone affected in a laboratory exposure incident before submitting the exposure follow-up report to PHAC
You must still submit incident reporting forms using the Biosecurity Portal.
You can access these printable tools through the PHAC Training Portal.
RegFacts: #DYK: Your legal obligations to notify
If you conduct controlled activities under the HPTA or HPTR, you have a legal obligation to notify CB when certain situations occur in your facility.
The following resources can help you understand situations that require notification:
- The Notifications Guideline lists situations that require notification.
- The Guideline for Notification and Reporting Under the HPTA and HPTR provides comprehensive guidance on how to complete and submit a notification report.
- The CBS (Appendix A, table A-2) provides context for when you need to notify CB.
Remember to include the applicable requirements for notification in your emergency response plan.
Types of controlled activities conducted under your licence
The biological safety officer (BSO) is responsible for overseeing biosafety and biosecurity practices related to a Pathogen and Toxin Licence (PTL). As the primary contact, the BSO communicates with CB on behalf of the licence holder.
The BSO must be fully aware of all controlled activities involving human pathogens or toxins that take place in their organization, including:
- possessing, handling or using a human pathogen or toxin
- producing a human pathogen or toxin
- storing a human pathogen or toxin
- permitting any person access to a human pathogen or toxin
- transferring a human pathogen or toxin
- importing or exporting a human pathogen or toxin
- releasing or otherwise abandoning or disposing of a human pathogen or toxin
Unless exempted or excluded, you must not conduct a controlled activity without a licence issued by the Minister to authorize that activity. The BSO must ensure that every activity is authorized under the organization's PTL.
If your organization wishes to conduct an activity that isn't listed on the PTL, the BSO must submit a request for a licence variation through the Biosecurity Portal. To report an activity not authorized by the PTL, the BSO must submit a notification report through the Biosecurity Portal.
- Access the Biosecurity Portal
Contact the licensing team at licence.permis@phac-aspc.gc.ca if you have any questions.
Responsibilities of the HPTA security clearance holder
You need a valid security clearance issued under the HPTA to access without escort any part of a facility where security sensitive biological agents (SSBAs) are used to conduct controlled activities. These areas are called SSBA zones. Before issuing a security clearance, PHAC verifies that the person won't pose a security risk if they are granted unescorted access to a SSBA zone. The licence holder is responsible for ensuring that HPTA security clearance holders can fulfill their obligations.
As a HPTA security clearance holder, you:
- can only enter a SSBA zone unescorted after you've verified that you've been endorsed for that particular SSBA zone (HPTR 12(2)(m))
- must verify if you can enter an SSBA zone unescorted by contacting your facility's delegated authority which may be your:
- licence holder or their representative
- BSO or
- alternate biosafety contact
- must apply to renew your HPTA security clearance at least 80 days before your security clearance expires if you still need unescorted access to a SSBA zone
- must notify PHAC at hpta.screening-filtrage.lapht@phac-aspc.gc.ca if you're convicted of a criminal offence in accordance with HPTR 19
- must not enter SSBA zones unescorted if your HPTA security clearance has expired
Other obligations as a HPTA security clearance holder include:
- following all applicable biosecurity procedures when entering or exiting a SSBA zone and follow all operational procedures that support your facility's biosecurity plan
- only performing controlled activities in a SSBA zone if you have been authorized by your facility's delegated authority
- never conducting controlled activities:
- for non-peaceful purposes, and
- that may pose an unmitigated risk to public health, safety and security.
- verifying with your facility's delegated authority that you're allowed to supervise individuals without a HPTA security clearance in a SSBA zone before doing so
- following and actively observing any individual under your supervision while in the SSBA zone
- notifying your facility's delegated authority if you
- suspect loss, theft, misuse, diversion or intentional release of a SSBA or related asset has occurred or may occur
- notice an SSBA shipment has not been received within 24 hours of expected delivery, or
- are planning to prepare or schedule the transportation of a parcel containing an SSBA
As a HPTA security clearance holder, you also have responsibilities related to sensitive information. You must:
- keep your access codes and account passwords private, including your Biosecurity Portal account information
- inform the appropriate authority of your facility immediately if you lose the access ID card or the key that gives you access to a SSBA zone
- keep documentation about controlled activities confidential, following your facility's information management and security policies
As a HPTA security clearance holder, you must also comply with any other obligations developed by your facility.
For more information about your responsibilities and obligations, please consult:
For questions about applying for a HPTA security clearance:
- Consult the Biosecurity frequently asked questions
- Contact hpta.screening-filtrage.lapht@phac-aspc.gc.ca
New condition of licence: Keep contact information up to date
The PTL's new format came into effect on June 26, 2023. It's now organized by location rather than by authorized activities. As such, authorized biological agents, animal species and controlled activities are listed directly under each approved facility location in a single table.
A new condition of licence was introduced to require that the licence holder keep contact details of individuals associated with the licence up to date at all times. This information must also be provided to PHAC. This requirement existed in a previous CBS edition (4.1.3, CBS2), but was removed from the third edition, and is now a standard condition for all licences. Individuals associated with the licence include the:
- licence holder or their representative
- BSO
- alternate biosafety contacts
If you have any questions on how to update your contact details, please contact licence.permis@phac-aspc.gc.ca.
Protecting facilities: Personnel and visitors
All licensed organizations in Canada must develop a comprehensive biosecurity plan, in accordance with the CBS. This biosecurity plan must be based on a biosecurity risk assessment. The assessment is designed to protect and secure assets, including:
- pathogens and toxins
- related sensitive information, and
- documentation about controlled activities
People are vital to your facility's success, safety, and security. The licence holder is responsible for establishing measures to protect the health and well-being of personnel and anyone visiting their facilities. This responsibility includes putting measures in place to ensure the success of the biosafety and biosecurity measures in place.
Comprehensive screening and background checks for all people in the facility helps prevent security violations. They help assess the risk that someone in the facility may be targeted or the facility's biosafety and biosecurity may be compromised or threatened by bad actors. Organizations should implement strong visitor policies and procedures related to personnel security in their biosecurity plans, including:
- validating that visitors have legitimate need for site access
- providing all visitors with ID badges for easy identification
- keeping a log of all visitors to the laboratory and making this registry available to PHAC upon request
- establishing a procedure for visitors to notify the organization of regulated material that they may be bringing to the facility
- identifying any threat objects that a visitor may be transporting or bringing with them to the facility
- providing clear expectations to personnel when visitors are in the facility (for example, securing sensitive information and identifying suspicious activities such as visitors taking pictures)
- encouraging the reporting of suspicious behaviour, theft, or sabotage by visitors
- adopting a “see something, say something” approach among staff
In addition, organizations should consider:
- restricting visitors from accessing the facility during off-hours
- inspecting and keeping inventory of materials removed from the laboratory by visitors
- obtaining authorization from senior management or designated individuals before allowing visitor entry into:
- a containment zone, or
- restricted zones where sensitive information or critical support systems are found
- ensuring visitors are abiding by the instructions of senior management or designated individuals
- ensuring visitors are escorted at all times while on site
- ensuring individuals responsible for escorting visitors understand their responsibilities
For more information, please refer to:
- Canadian Biosafety Guideline: Developing a comprehensive biosecurity plan
- Identifying assets in biosecurity risk assessments
- Canadian Biosafety Guideline: Conducting a biosecurity risk assessment
If you have questions about preparing for visitors or conducting a risk assessment, please contact biosafety.biosecurite@phac-aspc.gc.ca.
Risk groups: What they are and why they matter
Biological agents are classified into 1 of 4 risk groups (RG) based on factors such as:
- virulence
- infectivity
- communicability
- availability of effective prophylactic or therapeutic interventions
Biological agents can be:
- proteins
- microorganisms
- nucleic acids, or biological material containing parts of them
Biological agents classified as RG1 are considered to present the lowest risk whereas those classified as RG4 are considered to present the highest risk to individuals and communities.
| Type of risk | RG 1 | RG 2 | RG 3 | RG 4 |
|---|---|---|---|---|
| Individual | Low | Moderate | High | High |
| Community | Low | Low | Low | High |
The RG classification of a biological material generally dictates the laboratory containment level (CL) required for handling it (for example RG2 pathogens are handled at CL2), with some exceptions.
- For more information about exceptions, please consult: Biosafety directives and advisories.
Unless excluded or exempt, facilities that conduct controlled activities with RG2, RG3 and RG4 human or animal pathogens or toxins require 1 or both of:
- a PTL administrated by PHAC and issued under the HPTA and HPTR or the Health of Animal Act (HAA) and Health of Animal Regulations (HAR), or
- an import permit from the Canadian Food Inspection Agency (CFIA) and issued under the HAA and HAR
Well-characterized biological materials with a pathogen risk assessment completed by PHAC or the CFIA have been assigned a RG and CL. The RG classification of thousands of biological agents is available in the online ePATHogen database. It provides a comprehensive and up-to-date list of biological agents and their RG classifications, CL requirements and other regulatory information.
Most of the RG classifications listed in the ePATHogen database are shown at the species level, or they may refer to a particular:
- strain
- isolate
- variant
- subspecies
RG classifications are also shown at the genus-level. However, unless a lack of information requires your pathogen to be classified at the genus level, best practices for determining the RG of a pathogen are to classify it at the strain or isolate level. For example Escherichia spp. are classified as RG2 for humans and animals at the genus-level (see table). However, certain species within the genus are classified as RG1 for humans and animals (for example, E. blattae). Others are classified as RG2 for humans and animals (for example, E. coli). Similarly, E. coli is classified as RG2 for humans and animals at the species-level. However, certain strains or isolates are classified as RG1 for humans and animals (for example, strain K12).
| Genus | Genus RG | Species | Species RG | Isolate / Strain | Isolate / Strain RG |
|---|---|---|---|---|---|
| Escherichia spp. | RG2 | E. blattae | RG1 | - | - |
| Escherichia spp. | RG2 | E. coli | RG2 | E. coli K12 | RG1 |
To find out the RG classification for a biological agent not listed in the ePATHogen database, complete a pathogen risk assessment using the template below.
Submit the completed risk assessment to PHAC at pathogens.pathogenes@phac-aspc.gc.ca for validation.
Regulation of cells and cell lines under the HPTA and HPTR
Some cells or cell lines may also be regulated under HPTA and HPTR. Cell lines with a PHAC-completed risk assessment are listed in the ePATHogen database. A Statement of Administrative Intent clarifies the circumstances under which cells or cell lines are controlled under the HPTA. Generally, they don't meet the definition of a pathogen. However, if they contain or produce an intact RG2, RG3, or RG4 human pathogen or toxin, they're controlled under the HPTA.
If it's unclear to a facility whether the cell or cell line contains an intact RG2, RG3, or RG4 human pathogen or toxin, then a risk assessment should be conducted. It should consider whether the cell or cell line:
- contains elements (for example, nucleic acids or proteins) derived from a pathogen, and
- whether these elements are capable of producing an infectious or replication-competent pathogen
Always consult PHAC about the RG classification and CL requirements for cells and cell lines.
Don't use RG or biosafety level classification published by other organizations
RG or biosafety level (BSL) classifications published by other organizations (for example, culture collections, distributors, manufacturers, and other countries) have no regulatory significance under the HPTA and HPTR. They may, but don't always, align with Canadian RG classifications and CL requirements. Always consult the ePATHogen database to determine the RG and CL of your biological agent or cell line.
If in doubt, ask us
If you have any questions about risk assessments or RG classifications, including biological agents or cell lines not listed in the ePATHogen database, contact us at pathogens.pathogenes@phac-aspc.gc.ca.
Page details
- Date modified: