2021 Record of decisions: Advisory Committee on Human Pathogens and Toxins

The Chair welcomed members to the first meeting of the 2021 Virtual Spring Forum and introduced the Director General (DG), Centre for Biosecurity (CB) and Executive Secretary of the committee, Kimby Barton.

Discussion summary

The Vice President, Health Security and Regional Operations, and the Director General, Centre for Biosecurity, Public Health Agency of Canada (PHAC), gave opening remarks. They both acknowledged the contributions of the Committee since the last face-to-face meeting in 2019 (note: the 2020 annual meeting was cancelled due to COVID-19 response efforts and travel restrictions).

The DG introduced the new acting Director of the Office of Stakeholder Engagement as well as an update of other changes to senior management in CB.

Discussion summary

The Chair confirmed to members that due to the ongoing pandemic, the Virtual Spring Forum will be taking place weekly for the month of May and will fulfill the annual face-to-face requirement.

Members were asked to declare any affiliations or interest which would impact the integrity and objectivity of their participation. A member made a declaration, however it was determined that it did not warrant recusal from any portion of the planned agenda. The committee reviewed and approved the meeting agenda.

Discussion summary

The Centre for Biosecurity, PHAC, presented current work on predicting incident exposures using mathematical modelling.

Suggestions of the Committee

Members provided input on improving the model by exploring the effect of management oversight, examining the day of the exposure, implementing a Bayesian paradigm and increasing sample size by using additional data sources. In addition, it was suggested that the term 'human error' be avoided and instead, that root causes be exhaustively tracked.

Centre for Biosecurity action

CB is currently exploring the options and suggestions of the Committee to improve the base model.

Discussion summary

The Centre for Biosecurity, PHAC, provided an update on the regulation of SARS-CoV-2 RNA under the Human Pathogens and Toxins Act (HPTA) and Health of Animals Regulations (HAR). Following a risk assessment, SARS-CoV-2 RNA is classified as RG1 for animals and RG2 for humans, with containment level requirements dependent on the types of activities being conducted. With this decision, SARS-CoV-2 RNA is no longer regulated under the HAR.

Suggestions of the Committee

There were no questions or comments from members.

Centre for Biosecurity action

CB continues to work with the CFIA to amend the HAR to allow exclusions and exemptions similar to what exists in the HPTA.

Discussion summary

The Centre for Biosecurity, PHAC, provided an update on the pilot of the borderline agent decision tree, and sought input from members to answer questions that have arisen concerning the definition of immunocompromised, modes of transmission in nosocomial infections, and sources of information for accurate reporting data. The difficulty of risk assessors accessing secondary literature was also highlighted.

Suggestions of the Committee

Members indicated that healthy neonates should not be included in the definition of immunocompromised, and that air handling systems should be considered in the context of transmission of nosocomial infections. Members also indicated that secondary literature sources should be considered for accurate reporting data.

Centre for Biosecurity action

CB will consider member or expert input in the absence of reporting (primary and secondary) data, if required.

Discussion summary

The secretariat informed members to expect some administrative housekeeping to occur related to the upcoming meetings.

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

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

Discussion summary

The Centre for Biosecurity, PHAC, provided an update on the work of the Toxin Risk Assessment Subcommittee (TRAS) in preparation for the update of Schedule 1 of the Human Pathogens and Toxins Act. The toxin risk assessment methodology was also presented.

Suggestions of the Committee

Members recommended that clarification be provided when looking at classes of toxins listed on Schedule 1 (e.g. hemolysin and endotoxin), and agreed with the approach to include toxin threshold values.

Centre for Biosecurity action

CB to provide periodic updates on the work of the TRAS to the AC-HPT and questions from the TRAS can be brought forward to the AC-HPT at any time.

Discussion summary

The Centre for Biosecurity, PHAC, introduced the Virtual Inspection program developed because of the inability to travel and hold on-site inspections due to COVID-19. CB consulted other regulators who had already implemented similar programs to obtain their lessons learned. Virtual inspections are limited to RG2/CL2 facilities. CB conducted four pilot inspections and feedback was positive. Virtual inspections will not replace on-site inspections but will be used as an additional tool going forward.

Suggestions of the Committee

One member was part of a pilot inspection and commended the team on the great program.

Discussion summary

The Centre for Biosecurity, PHAC, notified the AC-HPT that PHAC closed out its Regulatory Openness and Transparency Framework (ROTF) in March 2021 to maintain its focus on higher impact regulatory initiatives, while continuing to contribute to federal Open Government objectives. Under the Government of Canada's "open by default" approach, the Centre for Biosecurity continues to support and engage stakeholders regulated under the biosecurity regulatory framework by developing regulatory guidance and training webinars to address identified needs.

Centre for Biosecurity action

CB will continue to contribute to PHAC's Open Government objectives including the posting of inspection information online.

Discussion summary

Members brought no round table items forward.

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

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

Discussion summary

The Centre for Biosecurity, PHAC, presented several approaches to establishing a baseline for incident exposure reporting including annual average, cumulative incident rate and monthly average.

Suggestions of the Committee

A member suggested examining rates by containment levels (CL) and type of laboratory as the number of students tend to fluctuate depending on CL and laboratories. Currently, CB does a breakdown by sector (university vs. government vs. private laboratories). Further work will be done to see what type of activities are performed to get a better idea of the incident rate in each of these sectors.

A member enquired as to the intended use of the metrics. CB noted that these metrics are in addition to what LINC currently does in which it examines each report and liaises with the Office of Biosafety and Biocontainment Operations to ensure continued safety and compliance of laboratories and workers. These metrics would allow LINC to get a better understanding of the monthly and yearly reporting tendencies and act accordingly.

Members noted that a rate of 6 exposure incidents in 100 active licenses is low although a limitation of this metric is when there is one license but with a number of different labs, such as for universities. LINC will list this as a limitation with this metric moving forward in the annual report.

A member suggested reaching out to workplace safety networks that have conducted similar data analysis and offered to provide a contact from his organization.

A member suggested asking individual reporters about the number of staff they have during an incident exposure, which may give LINC an idea of the risk of exposure at the individual level.

Centre for Biosecurity action

CB will consider and investigate the suggestions made by the AC-HPT to improve the considerations around establishing a baseline. CB will also use these considerations and note limitations in developing the LINC annual report.

Discussion summary

The Centre for Biosecurity, PHAC, provided an overview of the Agri-food and Aquaculture Regulatory Roadmap. Through a suite of initiatives and proposed timelines, this roadmap will help advance regulatory modernization in this sector. PHAC is leading item 10, which focuses on addressing the misalignment and duplication between Canada's regulatory regimes for human and animal pathogen oversight.

Suggestions of the Committee

A member questioned whether plant pathogens will be added to the ePATHogen (ePATH) risk group database. The ex-officio member from CFIA confirmed that they will not be added at this time.

Members expressed concerns related to the challenges of obtaining additional import permits for animal pathogens and questioned whether CFIA can acknowledge HPTA licences to avoid requiring a separate HAR permit. The ex-officio member was able to provide answers to their questions from a CFIA perspective.

Members were pleased to learn that aquatic animal pathogens and bee pathogens will be identified in ePATH.

Centre for Biosecurity action

CB will continue to work with CFIA on the regulatory alignment priorities.

Discussion summary

The Centre for Biosecurity, PHAC, presented an update of the risk assessment of Cryptococcus gattii. C. gattii remains classified as a RG 3 human and animal pathogen.

The Centre for Biosecurity, PHAC, presented an update on the Biosafety Directive for Risk Group 3 Fungi. The Directive identifies fungal species (including C. gattii), specimen types, and activities that can be safely performed at CL2 with additional operational practices in place.

Suggestions of the Committee

Members had questions regarding licensing requirements for diagnostic labs where RG 3 fungi may be cultured unintentionally.

One member suggested adding a RG 2+ classification for pathogens that are borderline between RG 2 and RG 3, which would require "enhanced CL2".

Centre for Biosecurity action

Members expressed interest in seeing the updated Directive. CB will share the Directive once finalized and ready for publication.

Discussion summary

The Centre for Biosecurity, PHAC, presented an overview of the Biocontainment Engineering Science Working Group (BESWG). Members of BESWG will discuss and develop methods to investigate and/or test various biocontainment engineering issues within the biocontainment industry to allow the biocontainment engineering requirements to evolve from prescriptive requirements to performance based requirements. They will provide recommendations to CB to be incorporated in the next edition of the Canadian Biosafety Standard.

Suggestions of the Committee

Members did not have any questions or concerns.

Discussion summary

One member raised a question related to respiratory protection to be used in point of care molecular testing (POCT) for SARS-CoV-2: Although respiratory protection is usually interpreted as a respirator (N95), is a surgical mask + eye protection sufficient for POCT?

Suggestions of the Committee

Many members agreed that a surgical mask and eye protection would be sufficient and that is what is being used in their facility.

A member confirmed Ontario defines respirators in the Occupational Health and Safety Act, and CSA Standard Z94.4 governs respiratory protective programs in Canada. CB confirmed this last point.

Centre for Biosecurity action

CB offered to reach out to members for comments on future biosafety advisories related to SARS-CoV-2.

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

Discussion summary

The Centre for Biosecurity, PHAC, presented the findings of the risk assessment on Emergomyces spp. (E. pasteurianus, E. canadensis, E. europaeus) resulting in a risk group (RG) 2 classification for humans and animals. Since assigning the RG classification, CB received a request to revisit the RG assigned by a member due to concerns regarding the risks posed by these fungi.

Suggestions of the Committee

There was no clear consensus from the committee on the RG 2 or 3 classification; some members indicated they would rather err on the side of caution and were supportive of a RG 3 classification, while other members were not convinced that there was sufficient scientific evidence to support a RG 3 classification, and supported a RG 2 classification.

Centre for Biosecurity action

CB will obtain additional information relating to Emergomyces from experts in the field and organize an ad-hoc meeting with the committee to further discuss this topic and obtain a clear consensus for their recommendation on the RG classification for Emergomyces spp.

Discussion summary

The Centre for Biosecurity, PHAC, presented the key considerations for the development of a risk assessment tool to objectively assess the risks associated with genetically modified microorganisms. The committee was extremely interested in this topic, and expressed the importance and timeliness of the development of this tool given the anticipated increase in attention on biosafety and biosecurity oversight due to SARS-CoV-2.

Suggestions of the Committee

Members expressed their appreciation that CB is creating a document that considers the risks associated with technology used to create genetically modified microorganisms, and not just the final product. In addition, members noted that there should be oversight of gene synthesis.

Members noted that it is important to provide guidance for work involving genetically modified organisms, especially those with "Gain-of-function". However, a member raised concerns related to the potential overregulation of specific genetic modifications (e.g. transformation in which an antibiotic resistance gene is used as a selectable marker), which could be considered "Gain-of-function" when in fact these modifications do not pose an increased biosafety or biosecurity risk.

Centre for Biosecurity action

CB will move forward with the development of the risk assessment tool to evaluate genetically modified microorganisms, and explore piloting the tool with Biosafety Officers to conduct their own pathogen risk assessments on genetically modified strains created in their organizations.

Discussion summary

The Centre for Biosecurity, PHAC, presented an update on the work of The International Experts Group of Biosafety and Biosecurity Regulators (IEGBBR) including the virtual meeting held in March 2021 to discuss challenges encountered with the regulatory biosafety and biosecurity oversight during the COVID-19 pandemic.

CB also presented an update on the Analytical Approach and the Centre's international priorities. The priorities include promoting international capacity building and advancing the domestic regulatory mandate by incorporating lessons learned from dialogue with other international regulators to promote best practices in alignment into our domestic program.

Suggestions of the Committee

The members had no concerns on CB's international priorities.

Centre for Biosecurity action

CB will share the virtual IEGBBR SARS-CoV-2 meeting report with members once published.

Discussion summary

The Centre for Biosecurity, PHAC, presented an overview of the WHO project, which aims to produce an "international framework" and "foresight function" to provide member states and stakeholders (Member States, Researchers, Public health professionals, Academia etc.) with the knowledge, tools and capacity to mitigate the risk posed by dual use at the global health-security interface.

Suggestions of the Committee

The members raised no questions or concerns on the work for this project.

Discussion summary

The Chair and the Director Office of Stakeholder Engagement, Centre for Biosecurity, gave closing remarks. The Director thanked the Chair for her role in the meeting and to members for adjusting their schedules to accommodate the virtual weekly meetings. He also mentioned the secretariat will share the record of discussions with members.

The Chair thanked the AC-HPT for their active participation in the meeting, as well as the Centre for Biosecurity for organizing a productive annual meeting.