Biosafety and biosecurity for pathogens and toxins news: Q3, October 2022 issue
On this page
- Human Pathogens and Toxins Act and Regulations: Evaluation report and consultations
- Resources to support compliance with the Human Pathogens and Toxins Act and Regulations
- How to change a biological safety officer and add or remove an alternate biosafety contact
- LINC data 2021: Laboratory exposure incidents
- Cybersecurity awareness: Malicious cyber actors continue to exploit vulnerabilities
- RegFacts: #DYK: Notice to minister before making changes
- The modernized Pathogen and Toxin Licence: stay tuned
Human Pathogens and Toxins Act and Regulations: Evaluation report and consultations
The Human Pathogens and Toxins Act (HPTA) and associated regulations (HPTR) came into full effect on December 1, 2015. Their purpose is to protect the health and safety of the public from risks posed by human pathogens and toxins.
The Public Health Agency of Canada (PHAC) committed to a legislative review every 5 years as part of the regulatory life-cycle of the Human Pathogens and Toxins Act and Regulations (HPTA/R) to ensure that the regulations continue to be appropriate and effective, and achieve their intended policy objectives. The COVID-19 pandemic delayed the first review.
PHAC's Office of Audit and Evaluation (OAE) led an evaluation on the HPTA/R, which focused primarily on issues of effectiveness and efficiency related to the implementation of the HPTA/R from 2015 to 2021. The evaluation identified 3 recommendations related to:
- security clearance requirements
- virtual inspections
- roles and responsibilities of Biological Safety Officers (BSOs) and Licence Holders (LHs)
The Centre for Biosecurity (CB) developed a Management Action Response Plan (MRAP), which identified key actions to address the recommendations. This included a commitment to complete a comprehensive legislative review of the HPTA/R in these areas.
The final HPTA/R evaluation report, including the MRAP, is now available.
In accordance with the Cabinet Directive on Regulations, PHAC will consult with stakeholders and interested parties about the policy development and proposed regulatory amendments to the HPTA/R. We'll keep you posted as we plan these consultations.
Resources to support compliance with the Human Pathogens and Toxins Act and Regulations
We've developed several resources to support compliance with the HPTA/R. This will help reduce the risks posed by human pathogens and toxins, and expand your knowledge on the subject. The following online biosafety and biosecurity training resources are in PHAC's e-Learning portal:
- Laboratory biosafety and biosecurity courses
- CB stakeholder biosafety and biosecurity webinar series
- recordings and transcripts are available in the portal within weeks of each webinar delivery. The most recent is the Biosecurity Plans webinar from June 22, 2022.
You can access these courses by creating a free account in the PHAC e-Learning portal.
Other CB resources include:
- Biosafety guidelines
- biosafety plans, handling, best practices and more
- Biosafety directives and advisories
- containment requirements for the safe handling of specific pathogens
- Pathogen Safety Data Sheet database
- hazardous properties of specific human pathogens, and recommendations for working with them
- ePATHogen risk group database
- Pathogen risk assessment template and guidance
- Canadian Biosafety Standard (CBS)
- requirements for regulated laboratories and other containment zones handling human or animal pathogens and toxins
- Canadian Biosafety Handbook
- companion document to the CBS for Canadian facilities that handle human and terrestrial animal pathogens
Legislative and regulatory requirements
Under the HPTA/R, facilities conducting controlled activities involving human pathogens or toxins have specific legislative and regulatory requirements, in addition to the requirements described in the CBS, 2nd Edition. Section 1.3 of the CBS outlines a non-exhaustive summary of these requirements. Facilities are responsible for understanding their obligations under both the HPTA and HPTR, in addition to the applicable requirements set out in the CBS, and their conditions of licence.
For more information, refer to the HPTA and HPTR, and the Understanding the HPTA/HPTR course in the PHAC e-learning portal.
Under the Health of Animals Act (HAA) and the Health of Animals Regulations (HAR), facilities have legislative and regulatory requirements beyond those in the CBS if they import:
- animals
- animal pathogens or part of an animal pathogen that retains its pathogenicity
- animal products or by-products
- other substances that may carry an animal pathogen, or part of an animal pathogen that retains its pathogenicity
Section 1.4 of the CBS, 2nd edition includes a partial summary of these requirements. Facilities are responsible for understanding their obligations under:
- the HAA
- the HAR
- applicable requirements set out in the CBS
- their import permit conditions
For more information, please visit our biosafety and biosecurity website or contact us at pathogens.pathogenes@phac-aspc.gc.ca.
How to change a biological safety officer and add or remove an alternate biosafety contact
It is the responsibility of the LH or BSO to ensure their licence information is up to date.
You must notify PHAC within 30 days of a change to the designated BSO. Refer to section 36(6) of the HPTA for BSO notification obligations.
You can initiate the change of BSO and add or remove alternate biosafety contacts (ABCs) in the Biosecurity Portal. To help reduce the administrative burden, upon request CB can now complete the change of BSO as well as add or remove ABCs in the portal.
In order for CB to change your BSO or ABC upon request, you must meet the 2 following criteria:
- the new BSO/ABC must have an authenticated Biosecurity Portal account
- the role of the new BSO/ABC must be confirmed by the LH (or BSO) via email or phone call, or through a Change of Licence Holder Request submitted in the Biosecurity Portal.
If you have any questions, please contact the licensing program by email at licence.permis@phac-aspc.gc.ca or by phone at 613-957-1779.
LINC data 2021: Laboratory exposure incidents
The annual Laboratory Incident Notification Canada (LINC) report describes laboratory exposure incidents in Canada, as well as the individuals affected by these incidents. This year's report describes the incidents that occurred in 2021, the sixth year of LINC's operation. We will publish the full report in fall 2022 in the Canadian Communicable Disease Report (CCDR).
In 2021, LHs reported 43 exposure incidents involving 72 individuals. 3 of these incidents resulted in suspected or confirmed laboratory-acquired infections (LAIs). Of the 72 exposed individuals, most worked as:
- technicians or technologists (70.8%)
- students (13.9%)
- researchers (6.9%)
The most common education levels among them were:
- Technical or trades diploma (65.3%)
- Bachelor's (13.9%)
- Master's (5.6%)
- MD/PhD (4.2%)
Most were exposed through inhalation (52.8%) or sharps-related incidents (16.7%), which is similar to 2020.
Among the 43 exposure incidents, common root causes were issues relating to human interactions (67.4%) or standard operating procedures (SOPs) (46.5%).
Microbiological research was the most common laboratory activity leading to exposure incidents (41.9%), followed by in vivo animal research (27.9%).
Among the 44 pathogens and toxins involved, most exposure incidents involved non-security-sensitive biological agents (86.4%), or human risk group 2 (RG2) pathogens (61.4%). This was similar to 2020 results.
The most common implicated RG2 agents were Neisseria meningitides and Streptococcus agalacitiae (6.8% each). The most common human risk group 3 (RG3) agent was SARS-CoV-2 (13.6%).
The 2021 annual incident exposure rate was 4.2 incidents per 100 active licenses. This was similar to 2020, which saw 3.9 incidents per 100 active licenses.
Cybersecurity awareness: Malicious cyber actors continue to exploit vulnerabilities
Sensitive information related to human pathogens and toxins is often stored electronically on internal computer networks and cloud storage solutions. You should routinely review and update cybersecurity measures in your biosecurity plan based on Canadian Centre for Cyber Security (CCCS) alerts to ensure access to this information remains restricted to authorized individuals (CBS 4.10.12).
In June 2022, CCCS issued an alert update on previously reported Log4j-related vulnerabilities. This alert update highlighted that malicious, state-sponsored advanced persistent threat (APT) actors routinely exploit Log4Shell vulnerabilities in VMware products. In one confirmed compromise, these APT actors were able to collect and extract sensitive data.
CCCS and its partners recommend the following actions:
- review the Joint Cybersecurity Advisory on mitigating Log4Shell released in December 2021, and the guidance material
- review the most recent Cybersecurity and Infrastructure Security Agency and United States Coast Guard Cyber Command Alert for more information
- update all affected systems to the latest version
- use tactics, techniques and procedures to examine and fix affected systems
You can also contact Public Safety at ps.rrap-perr.sp@canada.ca to test your IT systems for vulnerabilities and identify improvements. They offer optional assessments and free Review and Analysis Tools. If a private company assesses your IT system, please ensure they have the appropriate security clearance to have access to information about your access control methods.
CCCS is Canada's national authority for cybersecurity. If you have a question about your systems, CCCS is your first point of contact. For more information, please contact health-par-sante@cyber.gc.ca or refer to The Canadian Centre for Cyber Security.
RegFacts: #DYK: Notice to Minister before making changes
Did you know that section 6 of the HPTR requires that a LH (for those authorized to conduct controlled activities with human pathogens that fall under RG 3, RG 4, or prescribed toxins) must give notice to the Minister before making any change to:
- the physical structure of the facility
- any equipment
- SOPs that could affect biocontainment
Additionally, if an LH makes any changes to their name, they must notify the Minister in writing, within 30 days of the name change. These notifications can be made through the Biosecurity Portal.
If you have any questions about whether you need to report a change, please contact CB at biosafety.biosecurite@phac-aspc.gc.ca.
The modernized Pathogen and Toxin Licence: Stay tuned
CB will soon release a redesigned and modernized Pathogen and Toxin Licence (PTL).
The new PTL will:
- be bilingual
- contain 1 condensed version, with essential information only, to share without compromising sensitive information
- contain 1 detailed version, with all the usual information
- highlight important information
- ensure conditions are easier to understand and are grouped with their definitions
- be divided by location(s) rather than authorized activities: All information for each location will be grouped in a single table
When the release is official, the modernized version will replace the old version, and will be available on the Biosecurity Portal. Following the approval of a licence variation or a renewal, we'll include a note with the confirmation email to let you know that the modernized version is now in force.
The old version will remain valid until its expiry date, but we recommend using the modernized version once it's available.
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