2024 Record of decisions: Advisory Committee on Human Pathogens and Toxins

The Advisory Committee on Human Pathogens and Toxins (AC-HPT) held the 2024 annual meeting in person.

On this page

• Annual meeting Day 1: May 15, 2024
• Annual meeting Day 2: May 16, 2024

Day 1: May 15, 2024

Members present: Dr. Margo Moore (Chair), Ms. Ingrid Abbott-Permell, Dr. Lionel Berthoux, Mr. Kevin Cassidy, Dr. Sandra Isabel, Dr. Jason Kindrachuk, Dr. Ayush Kumar, Ms. Becky McGirr, Dr. Momar Ndao, Dr. James Scott, Dr. Chandrika Senthilkumaran, Dr. Manal Tadros

Ex-Officio member: Mr. Neil Vary

Secretariat present: Kimby Barton (Executive Secretary), Natasha Kuran, Shannon Chard, Daniele Rocher, Nandy Okraku

Public Health Agency of Canada (PHAC): Dr. Samuel Bonti-Ankomah, Jennifer Whitteker, Tiffany Coulter, Katelynn Rowe, Christine Abalos

Observers: Jennifer Mihowich, Basia Schreuders, Lise Murphy, Valerie Bergeron, Alexa Carroll, Sabrina Dupere, Jad Hajj, Maya Nait Ammar, Judy Green, Robyn Kenwell, Tony Oliveira, Karishma Chopra, Kayla Monaghan, Emilie Joly

Agenda item: Welcome

Presenter: Dr. Margo Moore, Chair

Discussion summary

The Chair welcomed members to the 2024 annual meeting and introduced the Director General (DG), Centre for Biosecurity (CB) and Executive Secretary of the committee, Kimby Barton.

Agenda item: Vice President/Director General opening remarks

Presenters: Kimby Barton, Director General, Centre for Biosecurity

Discussion summary

Cindy Evans, Vice President (VP), Regulatory, Operations and Emergency Management Branch (ROEMB) welcomed the new members to the committee.

The DG, CB, PHAC, gave opening remarks and acknowledged the contributions of the Committee since the last meeting.

Agenda item: Review of AC-HPT Mandate and Operation

Presenter: Dr. Margo Moore, Chair

Discussion summary

The Chair had the committee conduct a roundtable of introductions so that everyone in the room could present themselves, their home organization and the expertise they bring to the Committee. The Chair provided a brief overview of the Human Pathogens and Toxins Act (HPTA) and operations of the committee.

Agenda item: Agenda and Logistics

Presenters: Dr. Margo Moore, Chair and Kimby Barton, Director General, Centre for Biosecurity

Discussion summary

Members were asked to declare any affiliations or interests, which could impact the integrity and objectivity of their participation. There were no declarations made by any member. The committee reviewed and approved the meeting agenda.

The DG, CB, PHAC, gave a summary of work completed by the AC-HPT since the last meeting, and highlighted the Centre's key milestones over the last year, including: the addition of a temporary Quality Management Systems (QMS) team in CB's Director General's Office; publishing the "What We Heard Report" with regards to the Human Pathogens and Toxins Regulations public consultation; updating both the Containment Level 1 (CL1) guideline to align with the Canadian Biosafety Standard, Third Edition (CBS3), as well as implementing new policies to request CVs and birth certificates for all HPTA security clearance applications; and continued advancement of the work on Modernizing Canada's Biosecurity Oversight Framework, i.e. achieving a major milestone with support to amend the HPTA to strengthen oversight of human pathogens and toxins, as announced in Budget 2024.

The DG, CB, PHAC also gave a brief summary of the changes to the Centre and to the Secretariat team.

Finally, the DG, CB, PHAC delivered a list of logistical items and turned it over to the Chair to introduce the first presenter.

Agenda item: Modernized Toxin Regulation under the Human Pathogens and Toxins Act

Presenter: Jennifer Whitteker, Manager, Biosafety Risk Assessment, Centre for Biosecurity

Discussion summary

CB, PHAC provided an overview of potential modernization of toxin regulation under the HPTA. The current definition of a "toxin" was reviewed, as well as the status of the update of Schedule 1. An overview of the concept of minimum quantities for a risk-based toxin regulatory approach was introduced.

Suggestions of the Committee

• The AC-HPT noted this approach to toxin regulation is well aligned with the pathogen risk assessment framework, and operational risks can be addressed with local risk assessments (LRA).
• Given this approach is based on publicly available literature, the AC-HPT noted a potential gap in how to deal with new substances or toxins with complete absence of data, as well as the interpretation of toxicity based on animal models, and inclusion of exposure route.
• The AC-HPT suggested the inclusion of clinical data and incidental reports in the analysis of toxicity.
• The AC-HPT noted that the standard of evidence in law versus in science is different and it should be reasonable to assume that something derived from a toxin will have similar properties.
• The AC-HPT discussed including some of this quantitative thinking into other aspects of licensing facilities.
• The AC-HPT noted that CB should consider repeated chronic exposure, not just accidental/acute exposure.
• The AC-HPT recommended increasing the rigour and standardization of training of Biological Safety Officers (BSOs). It was noted there is a gap in the level of training for BSOs and capacity to complete LRAs.

Centre for Biosecurity actions

• CB to continue to explore specific training for BSOs and training on LRA.
• CB to target promotion of LRA resources already available.
• CB will continue to seek AC-HPT advice and opinion as it works towards alignment of toxin regulation to pathogen regulation.

Agenda item: Update on the Canadian Biosafety Handbook (CBH)

Presenter: Katelynn Rowe, Acting Manager, Biosafety Standards and Guidelines, Centre for Biosecurity

Discussion summary

CB, PHAC provided an update on the plan to restructure the CBH into standalone guidelines. This included the advantages of restructuring the guideline, the common sections in each guideline, which chapters will be merged into guidelines, which chapters would be made into their own guideline, and the prioritization for publication of each of the proposed standalone guideline.

Suggestions of the Committee

• The AC-HPT noted that it can be difficult to find exact information in a hurry, and the new structure may make finding information more difficult. It was recommended that the overarching risk assessment diagram be used as a portal to retrieve the desired guidelines.
• The AC-HPT observed that it might be useful to include more specifics and real-life scenarios for the purpose of teaching risk assessments.
• The AC-HPT suggested adding links to Pathogen Safety Data Sheets and more specific information for decontamination and waste.
• The AC-HPT suggested that guidelines on facility design, animal work, and inactivation and validation (i.e., decontamination and waste guideline) should be prioritized for publication.

Centre for Biosecurity actions

• CB to review and publish priority (<4) guidelines derived from CBH chapters. Publication dates are subject to competing priorities
• CB to take AC-HPT feedback into consideration for CBH standalone guideline prioritization (i.e., order of publication).
• CB to consider strategies to allow easier navigation of published standalone guidelines.

Agenda item: Data dissemination and Knowledge Translation and Exchange activities

Presenter: Christine Abalos, Epidemiologist, Laboratory Incident Notification Canada, Centre for Biosecurity

Discussion summary

CB, PHAC provided a summary of the Laboratory Incident Notification Team's 2023/2024 fiscal year data sharing activities, both with internal and external audiences. These activities included publications, internal reports, presentation at conferences, webinars, publications in the Biosafety and Biosecurity Newsletter, and promoting the laboratory incident reporting signage.

Suggestions of the Committee

• The AC-HPT suggested using "regulated facilities" as more encompassing language in resources to cover more than just laboratories (e.g., vaccine manufacturing facilities)
• The AC-HPT observed that there is underreporting of incidents by facilities not regulated under the HPTR (e.g., diagnostic facilities) and enquired if there was a way to encourage voluntary reporting of incidents by these facilities
• The AC-HPT suggested changes to photos on the incident reporting signage to have more balanced gender roles and display proper lab safety. The AC-HPT suggested considering engagement of biological safety officers and laboratory experts to review signage and photos before publication.
• The AC-HPT suggested targeting communications and promotion of specific resources to sectors with higher reported incidents.

Centre for Biosecurity actions

• CB to review incident reporting signage to incorporate more gender balanced images, and use more encompassing language in resources (such as "regulated facilities"), where applicable.
• CB to consider the relevance of images for use in external resources when choosing from pre-approved selection.
• CB to continue to encourage voluntary reporting by stakeholders not regulated by HPTA/R via the Biosecurity Portal through the newsletter, in presentations, webinars and other means as appropriate.

Agenda item: Training to Support Compliance Education

Presenter: Tiffany Coulter, Education Specialist, Biosafety Learning and Knowledge, Centre for Biosecurity

Discussion summary

CB, PHAC's Biosafety Learning and Knowledge team delivered a presentation outlining the PHAC Training Portal, and an overview of the recent updates to the portal. They provided an overview of the type of material available on the portal to users, what the team does, the team's recent accomplishments in response to stakeholder suggestions and the need for modernization of training materials. They sought input into topics for future training development.

Suggestions of the Committee

• The AC-HPT suggested topics to be included in upcoming webinars, such as: Health Check Protocols, Zoonotic Risk Research, Safeguarding from Exposure with Laboratory Animals, Creating an Inventory, How to Report laboratory incidents, and Protecting Pregnant Workers.
• The AC-HPT suggested hosting a webinar utilizing more specific problem-based scenarios to provide step by step guides for risk assessments.
• The AC-HPT discussed suggestions on where to find courses and which courses to suggest for different learning requirements (e.g. high school student, university student).
• The AC-HPT suggested the promotion of available online resources for biosafety professionals, such as printable resources.
• The AC-HPT supports publicizing and promoting the modernized training portal.

Centre for Biosecurity actions

• CB to consider topics proposed at AC-HPT for future webinars and training.
• CB to continue to promote training portal and webinars when possible.

Agenda item: Publication of Laboratory Incident Dataset via the Open Government Portal

Presenter: Dr. Samuel Bonti-Ankomah, Director, Office of Biosafety Programs and Planning, Centre for Biosecurity

Discussion summary

CB, PHAC presented a proposal to publish laboratory incident report data on the Open Government portal including the criteria to be met and what data is currently shared through other publications. A discussion was held to determine which data could be shared that would be of business value to support transparency and accountability, while also respecting privacy, confidentiality and security.

Suggestions of the Committee

• The AC-HPT discussed finding a balance between how much is shared on the Open Government Portal and privacy to protect individuals.
• The AC-HPT noted that transparency without context can be more dangerous than non-transparency at times and discretion should be used in the approach to data publication.
• The AC-HPT discussed how reporting non-exposures could also be useful.
• The AC-HPT discussed the frequency that the laboratory incident data should be posted to the open government portal
• There were no major concerns regarding the proposed data release on open government and quarterly publication was deemed sufficient.
• The AC-HPT discussed the possibility that people might be able to identify their own cases as being the "lab exposed person" and enquired if there are ways to avoid self-identification. Aggregation of data will make individual identification less likely.
• The AC-HPT noted that the term "near miss" can vary widely from person to person and the definition should be included so that the data properly reflects the incident.

Centre for Biosecurity actions

• CB to continue working on "near miss" definition and scope. CB to work towards posting laboratory incident data quarterly to the open government portal, with the goal of publishing the first release by May, 2025, subject to competing priorities.

Agenda item: Root Cause Analysis

Presenter: Dr. Samuel Bonti-Ankomah, Director, Office of Biosafety Programs and Planning, Centre for Biosecurity

CB, PHAC provided a review of the root cause questions currently captured in the exposure incident follow-up report form and shared proposed improvements for discussion.

Suggestions of the Committee

• The AC-HPT noted that "state of mind" and "workload" are both important and subjective measurements for root cause analysis.
• The AC-HPT noted that there are human factors in all incidents but there is a need to consider the complete system on a deeper level, i.e., how workplace, controls and people come together in an accident or near miss. Suggested approach is to start with the immediate cause and continue to probe deeper to identify the underlying / root cause.
• The AC-HPT noted that language should be broadened to encompass more than employer/employee relationships, such as students, as many exposures happen at this level.
• The AC-HPT noted that sometimes the individuals filling out the incident report questionnaire are not necessarily experienced and that questionnaires can be both taxing and time consuming.

Centre for Biosecurity actions

• CB to further revise the incident report root cause questions with a follow-up discussion with the AC-HPT subcommittee
• CB to bring this back for discussion at the ad-hoc AC-HPT meeting in the Fall.

Agenda item: Cell Line Risk Assessment Methodology

Presenter: Jennifer Whitteker, Manager, Biosafety Risk Assessment, Centre for Biosecurity

Discussion summary

CB, PHAC provided information on the challenges regarding regulation of cell lines under the HPTA, reviewed the Statement of Administrative Intent regarding the regulation of cell lines under the HPTA, reviewed the cell line risk assessment template, and provided examples of cell line risk assessments.

Suggestions of the Committee

• The AC-HPT indicated the need for a clear definition of 'infectious' and 'intact pathogen.'
• The AC-HPT discussed the preference for clarification regarding the regulation of cell lines by the Canadian Food Inspection Agency under the Health of Animals Act (noting this is a CFIA lead).
• The AC-HPT discussed considerations for the activities conducted when determining containment level for cell lines, e.g., the use of cell lines for viral rescue.
• The AC-HPT discussed benefits of rescuing for studying purposes and the risks should this not be permitted.

Centre for Biosecurity actions

• CB to clarify the definition of "infectious" and "intact" pathogen to reduce stakeholder confusion when publishing the risk assessment template and guidance document.
• CB will review and update the cell line risk assessment template, create a guidance document, and publish these documents on the PHAC website for stakeholder use subject to competing priorities.

CB will include considerations for containment of cell lines in ePATHogen database

Agenda item: Round table items from Members

Suggestions of the Committee

• US MPXV Diagnostic Samples and Waste safety advisory release in March 2024 indicates that clinical samples and waste from both Clade I and II MPXV are designated as Category B infectious substances; only Clade I viral cultures need to be designated as Category A infectious substance. In Canada, the temporary shipping certificate allowing mpox diagnostic specimens as Category B infectious substance expires on July 25, 2024.
  • The AC-HPT noted their preference that Canadian requirements align with CDC requirements.
  • CB noted this authority lies under Transport Canada, Transportation of Dangerous Goods Regulations, not the HPTA.
• Recommendations for Lab Handling of Low Risk Specimens from patients under investigation for Creutzfeldt–Jakob disease (CJD)/Risk assessments for CJD specimens.
  • The AC-HPT noted that when there is a specimen from a patient labelled as potential CJD, testing stops in the diagnostic laboratory i.e. no one wants to handle the specimen
  • The AC-HPT discussed the need for clarification on the risk of cerebrospinal fluid (CSF) specimens from patients with CJD
  • The AC-HPT noted that there is a need to update CJD information online
  • AC HPT noted that the prion is handled in very few labs
  • CB noted that human diagnostic specimens are not subject to the HPTA/R and we have little control over information made available outside of CB

Centre for Biosecurity actions

CB will continue to work on updates to prion PSDS(s) subject to competing priorities. CB will work with applicable partners (NML, CFIA) for review of an updated prion PSDS and request during this consultation, the alignment of relevant information available on-line (outside of CB's control) with respect to prions.

Agenda item: Closing Remarks

Presenter: Dr. Margo Moore, Chair

Discussion summary

The Chair thanked all members for taking the time to participate in the meeting and for their thorough and engaging comments. The meeting was adjourned at 4:00 p.m.

Day 2: May 16, 2024

Members present: Dr. Margo Moore (Chair), Ms. Ingrid Abbott-Permell, Dr. Lionel Berthoux, Mr. Kevin Cassidy, Dr. Sandra Isabel, Dr. Jason Kindrachuk, Dr. Ayush Kumar, Ms. Becky McGirr, Dr. Momar Ndao, Dr. James Scott, Dr. Chandrika Senthilkumaran, Dr. Manal Tadros

Ex-Officio member: Mr. Neil Vary

Secretariat present: Kimby Barton (Executive Secretary), Natasha Kuran, Shannon Chard, Daniele Rocher, Nandy Okraku

Public Health Agency of Canada (PHAC): Dr. Samuel Bonti-Ankomah, Ryan Clarkin, Jennifer Whitteker

Observers: Jennifer Mihowich, Basia Schreuders, Lise Murphy, Alexa Caroll, Valerie Bergeron, Sabrina Dupere, Maya Nait Ammar, Karishma Chopra

Agenda item: Welcome

Presenter: Dr. Margo Moore, Chair

Discussion summary

The Chair welcomed members to day 2 of the annual meeting and provided a recap of the discussions held on day 1.

Agenda item: Synthetic Biology Risk Assessment Methodology

Presenter: Ryan Clarkin, Scientific Evaluator, Biosafety Risk Assessment, Centre for Biosecurity

Discussion summary

The Centre for Biosecurity (CB), PHAC provided a recap of the 2022 presentation on the Synthetic Biology Risk Assessment (SBRA) Methodology and provided an update on the progress following the pilot of the tool. The presentation also included proposed changes to the SBRA template and some examples of risk assessments conducted using the SBRA template for discussion.

Suggestions of the Committee

• The AC-HPT suggested the SBRA template should be accompanied by a guidance document that specifies when the SBRA template needs to be completed.
• The AC-HPT noted the benefits of posting completed SBRAs and pathogen risk assessments (PRAs) for training purposes.
• The AC-HPT discussed gain of function experiments, and the need to complete an SBRA and the dual use decision tree.

Centre for Biosecurity actions

• PHAC to consider training or a webinar on the Synthetic Biology Risk Assessment (SBRA) template
• PHAC to revise SBRA template as per AC-HPT comments
• CB will develop a guidance document to accompany the SBRA template, ultimately publishing these tools online for stakeholder use, subject to competing priorities.

Agenda item: Parking Lot

Presenter: Dr. Margo Moore, Chair

Discussion summary

Item #1: Open government publication of lab data:

• To finalize the discussion on publication of laboratory incident data via the Open Government Portal

#2: Root Cause Analysis

• This item was revisited to finalize the discussion.

#3: Cell Lines/Foreign Animal Disease

• The ex-officio member provided clarification on a question from day 1 related to Cell Line Risk Assessments

#4: Influenza B/Yamagata strain

• This item was revisited to discuss the risk group classification of Influenza B/Yamagata, the status of the risk assessment, and to discuss what type of vaccine is used for Influenza B in Canada

Suggestions of the Committee

Item #1: Open government publication of lab data:

• The AC-HPT discussed concerns with publishing data related to stolen agents
• A formal motion was put forward to accept the proposed data to publish related to lab incidents, the frequency to be quarterly and to not include data regarding stolen agents. Eleven were in favour, one was opposed, and there were zero abstentions. The motion passed.

#2: Root Cause Analysis

• A member sent some information on root cause analysis to CB for consideration
• A member volunteered to provide direct assistance as work progresses on this subject.

#3: Cell Lines/Foreign Animal Disease

• A member questioned if foreign animal disease is present in cell lines, does CFIA quarantine them?
  Answer provided by CFIA ex-officio: yes, via the Health of Animals Act and Health of Animals Regulations

#4: Influenza B/Yamagata

• Discussed that:
  • WHO has recommended to handle the virus with increased containment level since this strain is no longer in circulation.
  • It has not been identified globally for several years
  • There is a global transition from the use of quadrivalent to trivalent seasonal influenza vaccines

Centre for Biosecurity actions

• CB to re-circulate the spreadsheet on incident reporting for members to provide any further input on data that could be included or should not be included for publication.
• CB to engage with the member who volunteered to assist on the root cause analysis of incidents.
• CB to consult with AC-HPT once Influenza B/Yamagata risk assessment is ready for review.

Agenda item: Changes/Amendments to Terms of Reference

Presenter: Natasha Kuran, Director, Office of Stakeholder Engagement and Regulatory Affairs, Centre for Biosecurity

Discussion summary

CB, PHAC, provided an overview of upcoming administrative changes to the AC-HPT Terms of Reference (ToR), for adoption. CB also presented questions for discussion on proposed changes to the ToR.

Suggestions of the Committee

• Members noted that they like the flexibility of a range of 2-5 years for the term of membership.
• Members preferred CB to seek potential agenda items from members early in the agenda development and to allow time for emerging issues to be discussed if necessary (i.e., parking lot).
• Members prefer a minimum of 2-4 weeks to receive advance meeting materials (agenda, briefing materials, presentations) prior to the meeting date.

Centre for Biosecurity actions

• CB to circulate revised Terms of Reference for Member review and comment once available.

Agenda item: Advisory Committee Work Plan for 2024-2025

Presenter: Jennifer Whitteker, Manager, Biosafety Risk Assessment, Centre for Biosecurity

Discussion summary

CB, PHAC presented a summary of upcoming items that will likely be coming to the AC-HPT for review in the next year. Action items for CB and AC-HPT were also detailed.

Suggestions of the Committee

The AC-HPT agreed with the recommended workplan.

Centre for Biosecurity actions

• CB to provide the AC-HPT with updates to the 2024-2025 workplan as required.

Agenda item: Closing Remarks

Presenters: Dr. Margo Moore, Chair and Kimby Barton, Director General, Centre for Biosecurity

Discussion summary

The Director General, CB thanked all members for their participation in the annual meeting.

The Chair thanked all members for taking the time to participate in the meeting and for their thoughtful and respectful comments.

The meeting was adjourned at 12:00 p.m.