Biosafety and biosecurity for pathogens and toxins news: Q2, October 2023 issue

On this page

• Thematic consultation on potential amendments to the Human Pathogens and Toxins Regulations
• Online learning opportunities and updates
• New printable, fillable biohazard signage
• Biosecurity portal access change as of July 31, 2023
• Changes to the HPTA security clearance application process
• Mandatory and voluntary reporting of laboratory incidents
• Biosecurity risk assessment: Protecting your assets
• Tips on adding information when applying for a licence
• RegFacts: #DYK: Accompaniment and supervision
• Working with animals

Thematic consultation on potential amendments to the Human Pathogens and Toxins Regulations

The Centre for Biosecurity (CB) recently completed a thematic consultation to inform potential amendments to the Human Pathogen and Toxins Regulations (HPTR). This consultation aimed to gather input, feedback and expertise from interested and affected parties to ensure their perspectives are considered in the regulatory development process. We want to thank all those who provided input to help shape potential updates to the HPTR. A consultation summary report will be published once available. There may be other opportunities to provide input as we continue the development of potential regulatory amendments.

Online learning opportunities and updates

Webinars

CB is pleased to offer the following webinar for stakeholders and regulated parties. We’ll send an email to subscribers once registration is open.

What’s new in the Centre for Biosecurity?

November 23, 2023

This webinar will provide updates on 4 topics:

1. Updates to licensing requirements
   • The latest changes to the licensing program and the most common deficiencies identified during virtual and on-site inspections
2. Canadian Biosafety Standard, Third Edition (CBS3) app updates
   • Updates to the web and mobile versions of the Canadian Biosafety Application, v3.0
3. LINC 2022 annual report
   • Overview of LINC’s 2022 annual report, which summarizes information about exposure incidents reported in 2022
4. Risk Group 3 (RG3) fungi directive
   • A review of the new directive on RG3 fungi which outlines requirements for safely handling certain RG3 fungi, including:
     • operational practice
     • physical containment
     • performance and verification testing

Recordings of previous webinars

Transportation of Dangerous Goods Regulations

We delivered the webinar on ‘Transportation of Dangerous Goods Regulations’ on October 12, 2023. Recordings and transcripts will be available soon in the Public Health Agency of Canada (PHAC) training portal.

Laboratory incidents: How, when and what to report?

We delivered the webinar on 'Laboratory incidents: How, when and what to report?' on September 27, 2023. Recordings and transcripts will be available soon in the PHAC training portal.

Updated e-learning courses

Several e-learning courses in the PHAC training portal have been updated:

• Containment Level 1: Operational Practices
• Containment Level 2 Operational Practices
• Containment Level 3 Operational Practices
• Biosecurity Plan
• Working with Small Animals in Containment
• Working with Large Animals in Containment
• Autoclaves
• What to Expect When You are Inspected

E-learning courses are open to everyone. Create a free account on the PHAC training portal. You can print and share certificates with managers or supervisors as proof of completion.

New printable, fillable biohazard signage

Signage is one of the most common non-compliance issues found during inspections. To help you to comply with the CBS, fillable templates for biohazard warning signage are now available through the PHAC training portal. These should be used at access points and for freezer storage.

Biosecurity portal access change as of July 31, 2023

As a proactive security measure, the user sign-in process to access the Biosecurity Portal has changed as of July 31, 2023. As such, all users will now need to complete a multi-factor authentication process to sign in and access the portal.

The first time you sign in to the Biosecurity Portal after July 31, 2023, you'll be provided with instructions on how to use the new process. Once the setup is completed, you'll then be able to access the portal via the new multi-factor authentication sign-in process.

If you experience issues during the process, reach out directly to the GCKey help desk support for assistance: 1-855-438-1102 (in Canada and the United States). Customer service representatives are available to assist you by phone, year-round, 24 hours a day, 7 days a week.

Changes to the HPTA security clearance application process

CB has updated its policy for Human Pathogens and Toxins Act (HPTA) security clearance applications as part of strengthened risk management. As of September 1, 2023, all new HPTA security clearance applicants will need to submit a copy of their curriculum vitae in the biosecurity portal.

For more information on the HPTA security clearance process:

• visit the biosecurity website
• contact us at hpta.screening-filtrage.lapht@phac-aspc.gc.ca

Mandatory and voluntary reporting of laboratory incidents

Under the HPTA, only licenced facilities may conduct controlled activities with human pathogens and toxins in Canada. Once licensed, you must report all incidents involving RG2, RG3 and RG4 human pathogens and toxins to PHAC in the following instances:

• exposures and suspected or confirmed laboratory-acquired infections or intoxications
• inadvertent possession, production or release of a human pathogen or toxin
• missing, lost or stolen human pathogens or toxins, including security sensitive biological agents (SSBAs) not received within 24 hours of expected arrival

You must report these incidents without delay to meet your notification obligation under the HPTA and HPTR. Report incidents by completing the standardized form in the online Biosecurity Portal.

In some cases, reporting is voluntary and isn’t required under the HPTA, such as incidents involving:

• primary specimens
• pathogens that aren’t RG2, RG3 and RG4 or toxins
• unlicensed laboratories operating out of the scope of the HPTA

We encourage you to report these types of events, whether you’re licenced or not.

In November 2021, we updated the Biosecurity Portal to support voluntary reporting by active licence holders. Non-licence holders can submit voluntary reports by email to biosafety.biosecurite@phac-aspc.gc.ca.

This data allows LINC to assess the magnitude and risk of various types of incidents, and helps stakeholders mitigate the risks in these scenarios. In 2022, 32 voluntary reports and 113 mandatory reports were submitted.

For more information on incident reporting, please refer to the Canadian Biosafety Guideline:

• Notification and Reporting under the HPTA and HPTR using the Reporting Module of the Biosecurity Portal

Biosecurity risk assessment: Protecting your assets

All licensed facilities in Canada must develop a comprehensive biosecurity plan based on a biosecurity risk assessment. This helps protect and secure assets, including:

• human pathogens and toxins
• related sensitive information
• documentation about controlled activities

It’s important to implement security measures to protect and secure assets that could be used for unlawful, illicit and non-peaceful purposes. Examples of tangible, intangible and people assets can be found in Appendix B of the Biosafety Guideline on Conducting a biosecurity risk assessment.

The licence holder is responsible for protecting the health and well-being of personnel and visitors. This includes ensuring that personnel and visitors don’t participate in activities that threaten biosafety and biosecurity measures in place. For example, some espionage activities in the Canadian Security Intelligence Service 2021 public report pose a threat to biosecurity and national security.

You can help prevent security violations by conducting comprehensive screening and background checks for all people accessing the facility, both onsite and virtually, including:

• visitors
• students
• personnel
• contractors

Screening and background checks can help detect, deter and prevent security incidents that could pose a risk to public health safety, such as:

• theft of assets
• misuse of assets
• diversion of assets
• intentional release of assets
• sabotage of assets or biocontainment
• espionage compromising controlled activities
• terrorism involving assets or compromising biocontainment

Comprehensive screening and background checks defend against insider threats. They help to assess the risk that someone in the facility may be targeted or compromised by individuals or groups intending to threaten the facility’s biosafety and biosecurity. Comprehensive screening isn't limited to criminal records checks. It also includes non-criminal record checks covering:

• credit reports
• published works
• reference checks
• social media searches
• employment verification
• professional licence verification
• affiliations (such as a potential conflict of interest)

In addition to comprehensive screening and background checks, you should implement strong policies and procedures related to personnel security in your biosecurity plans. These could include:

• restricting off-hour access to laboratories
• keeping entry logs at building and laboratory access points
• adopting a 'see something, say something' approach among staff
• inspecting and taking inventory of materials removed from the laboratory
• providing all staff and visitors with ID badges for easy identification
• encouraging reporting of suspicious behaviour, theft or sabotage
• screening personnel before providing access to sensitive materials or information
• increasing the situational awareness of laboratory personnel (for example, paying attention to who’s in the lab and identifying suspicious activity)
• getting authorization from senior management or designated individuals before allowing visitors into the containment zone
• ensuring individuals with supervised restricted access abide by the instructions of senior management or designated individuals
• escorting visitors, guests and other non-staff members while on site

Robust personnel security strategies support all other security measures in the biosecurity plan. Biological safety officers should review their biosecurity plan annually (and according to the changing threat landscape) with security experts to determine if other measures may also be necessary. These could include:

• detailed policies and procedures for screening employees
• policies and procedures on who can handle sensitive human resource information
• strict procedures for internal moves within the organization and departures (such as employee exit plans)
• biosecurity training to people outside the containment zone, such as security guards
• policies regarding the sharing of information related to controlled activities (such as social media policies for all staff)
• training to address organization-specific threats and security controls
• policies and procedures for monitoring and logging actions (for example, tracking who accesses sensitive information and when)
• security agreements with partners and third parties on how to handle and store sensitive information related to:
  • controlled activities
  • emergency contingency plans
  • new constructions or changes to infrastructure (such as floorplans and security measures)

For more information on conducting a biosecurity risk assessment and identifying and safeguarding assets:

• consult the Canadian Biosafety Guideline: Conducting a Biosecurity Risk Assessment
• contact us at biosafety.biosecurite@phac-aspc.gc.ca

Tips on adding information when applying for a licence

When you submit a Pathogen and Toxin Licence application in the Biosecurity Portal, you’ll see a comment text box in the application. You can use it to add any extra information about your licence application that could be important for our review. The licensing team will assess this information and act accordingly when possible.

Examples include the following:

• For a new licence application, you can provide additional information regarding the type of controlled activities you wish to conduct.
  • You can also include a list of known pathogens that will be manipulated.
• For a request to change your licence, you can specify what changes you’re making and include the date these changes will come into effect.
• If you plan to import regulated material, you can confirm the anticipated date of importation and specify if your licence should be updated before or after the importation.

We’ll do our best to accommodate these types of requests. Please note that our service delivery standard for RG2 licences is 80 business days.

If you have questions, please contact the licensing team by:

• email at licence.permis@phac-aspc.gc.ca
• phone at 613-957-1779

RegFacts: #DYK: Accompaniment and supervision

Did you know that under certain circumstances a person can’t access parts of a facility where controlled activities with SSBAs are authorized, even when accompanied and supervised?

Under section 23 of the HPTR, individuals without HPTA security clearance may access these areas if:

• they’re accompanied and supervised by someone with a valid security clearance
• the person accompanying and supervising them isn’t accompanying and supervising anyone else at the same time

Importantly, section 24 of the HPTR outlines situations where individuals cannot access controlled areas, even when accompanied and supervised. These situations include:

• when their HPTA security clearance has been suspended
• when they’ve previously been refused a security clearance
• when their security clearance has been revoked, and a new one hasn’t yet been issued

Working with animals

In the context of the CBS3, 'regulated animals' refers only to:

• animals experimentally infected or intoxicated with a human pathogen or toxin (under the HPTA and HPTR)
• animals naturally or experimentally infected or intoxicated with a terrestrial animal pathogen or part of one (under the Health of Animals Act and Health of Animals Regulations)

This definition of regulated animals applies to domestic animal species already in Canada, as well as imported animal species, regardless of how they became infected or intoxicated.

The term 'animals' refers to all live animals within a containment zone or moving across a containment barrier. Given the increased risk of working with animals, whether regulated or not, special considerations and handling techniques are required to:

• protect personnel from exposure
• prevent the spread of contamination
• protect the health and safety of the public

For example:

• preventing the entry and exit of animal pests protects against the release of regulated materials outside the containment zone (CBS3 requirement 3.1.1)
• restricting viewing of animals to authorized personnel reduces risk of theft, misuse, diversion or intentional release of regulated materials and related assets such as animals (CBS3 requirement 4.6.1)
• conducting inoculation, surgical, and necropsy procedures on animals in the appropriate primary containment device protects personnel and the environment from potentially infectious aerosols and aerosolized toxins (CBS3 requirement 4.6.5)
• restricting the movement of animals within a containment zone and preventing their escape limits their potential exposure to regulated materials and the spread of contamination (CBS3 requirement 4.6.10)

For guidance on animal work considerations with respect to CBS3, please contact:

• PHAC at biosafety.biosecurite@phac-aspc.gc.ca
• the Canadian Food Inspection Agency at biocon@inspection.gc.ca