2022 Record of decisions: Advisory Committee on Human Pathogens and Toxins

Discussion summary

The Chair welcomed members to the annual meeting 2022 and introduced the Director General (DG) of the Centre for Biosecurity (CB) and Executive Secretary of the committee, Kimby Barton, and the Vice President (VP), Health Security and Regional Operations Branch (HSROB), Jennifer Lutfallah.

Discussion summary

The VP, HSROB, and the DG, CB, Public Health Agency of Canada (PHAC), gave opening remarks. They both acknowledged the contributions of the Committee since the last meeting, which was held virtually, once every week for two hours during the month of May in 2021.

Discussion summary

The Chair provided a brief overview of the Human Pathogens and Toxins Act (HPTA) and operations of the committee.

Discussion summary

Members were asked to declare any affiliations or interests, 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.

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. She also gave a brief summary of the work coming up related to the Government of Canada's investments in both the biomanufacturing and global health security agendas, which have lead to an exponential increase of new laboratories. CB is critical to supporting these agendas in its role in licencing and providing oversight of all laboratories in Canada that work with human pathogens and toxins.

Discussion summary

The Centre for Biosecurity, PHAC, and Dr. Ingrid Abbott-Permell provided an update on the work of the Toxin Risk Assessment Subcommittee (TRAS) and the completion strategy for the review of the 35 toxins listed in Schedule 1 of the Human Pathogens and Toxins Act (HPTA) as well as the 131 other toxins identified for review. A preliminary list of toxins to be regulated (inclusions and deletions) was presented for AC-HPT input. CB presented a completion strategy with several options for feedback from AC-HPT members.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT suggested increasing the members of TRAS to increase the number of reviews they are able to complete.
• AC-HPT Members suggested verifying lists of regulated toxins from other countries and looking into accessing these assessments to expedite the completion of TRAs. CB could then focus conducting TRAS on toxins that are not listed by other countries.

Centre for Biosecurity actions:

• The Centre for Biosecurity to continue updating the AC-HPT on the progress of TRAS and the list of toxins to regulate.
• CB to solicit the AC-HPT members and other contacts to increase membership in TRAS. 
• CB to engage with other organizations to share risk assessments on toxins.

Discussion summary

Dr. Tadros (AC-HPT member) raised a question on the emerging issue of Monkeypox in Canada. She wanted to know what would be the recommendations when working with specimen samples from a patient with a suspected case of Monkeypox and whether hospital labs should hold off other blood work until the National Microbiology Lab (NML) has ruled out monkeypox by PCR. This can cause significant delays in receiving results of other tests to be able to treat the patient properly and promptly.

Suggestions of the Committee

The AC-HPT and CB discussed their experiences and recommendations related to the handling of patient specimens in this scenario. CB is in close contact with the NML in relation to this issue, and confirmed that biosafety information coming out of the NML was developed in consultation with CB. CB advised that the Human Diagnostic Activities Guideline can be followed in this case. Additional information can also be found in the Monkeypox virus pathogen safety data sheet. A risk assessment on Monkeypox virus is currently underway.

Centre for Biosecurity actions:

• CB to determine if a Biosafety Advisory is required for Monkeypox, depending on how the situation evolves.
• CB to share the link to the Human Diagnostic Activities Guideline and the Monkeypox PSDS with the AC-HPT. The link was shared immediately by CB during the meeting.

Discussion summary

The Centre for Biosecurity, PHAC provided an update on the completion of the Policy on the Interpretation of Production. The AC-HPT previously reviewed the draft policy and provided recommendations for clarification. CB has revised the policy to include better defined examples, update language to clarify that activities that pose a low risk or are not intended to result in the production of human pathogens and toxins are not regulated, and clarify that activities already exempted under the HPTA are not included in the scope of the policy.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT suggested clarifying if increasing infectivity is captured in the policy.
• The AC-HPT suggested including a reference to conducting a local risk assessment for certain scenarios in the policy.

The Chair sought consensus from the AC-HPT for CB to finalize the policy based on the changes presented. All members were in favor of finalizing the policy.

Centre for Biosecurity actions:

• CB to verify the licensing requirements for disposal of a human pathogen or toxin.
• CB also to consult with Health Canada's Biological and Radiopharmaceutical Drugs Directorate (BRDD) on the policy before finalizing.

Discussion summary

The Centre for Biosecurity, PHAC presented an overview of the Laboratory Incidents Notification Canada surveillance system comparing 4 years of data with a focus on the data for 2021. CB analysed the data by sector, by occurrence type and root causes, types of agents involved in the incidents, and years of experience of the affected individuals. CB also provided information on potential and ongoing projects in progress.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT suggested looking further into the root cause attributed to 'human error', because without delving deeper, the actual cause of the incident may be missed. Factors such as failures in the program, standard operating procedures, workload etc. may have impacted the occurrence of the incident.
• To allow more robust comparisons between sectors, the AC-HPT suggested including the number of users under a licence or the number of working hours under a licence in the data analysis.

Centre for Biosecurity Actions:

• CB to consider collecting more details on reported incidents in order to improve root cause analysis and have targeted questions for incidents involving SSBA's to capture the security aspect.
• CB to explore ways to capture number of individuals working under a licence in data analysis.

Discussion summary

The Centre for Biosecurity, PHAC presented an update on the development and publication of the Canadian Biosafety Standard 3rd edition (CBS3). CB also presented the outcomes of the public consultation on the CBS3 including statistics of respondents, key findings and changes. The CBS3 is slated for publication in the fall of 2022.

Suggestions of the Committee

A member enquired whether the Canadian Biosafety Handbook (CBH) will also be updated. CB noted that the CBH requires updating and work will begin on this following the publication of the CBS3.

Centre for Biosecurity Actions:

CB will engage the AC-HPT once work progresses on the CBH.

Discussion summary

The Centre for Biosecurity, PHAC presented an update on CB's international engagement and collaboration activities including:

• the World Health Organization project: "Reducing Biological Proliferation Risks Posed by Dual Use Research of Concern (DUR/C)"
• The International Expert Group of Biosafety and Biosecurity Regulators
• An Analytical Approach for the Development of a National Biosafety and Biosecurity System
• The 2021 Global Health Security Index Report

Suggestions of the Committee

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

Centre for Biosecurity Actions:

CB to share the link to the Global Health Security index.

Discussion summary

The Centre for Biosecurity, PHAC sought feedback from the AC-HPT on the apps that are currently available to stakeholders including:

• The Canadian Biosafety Standard (CBS) app
• The Pathogen Safety Data Sheets (PSDS) app

CB also sought feedback on the development of an ePATHogen app.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• Members had high praise for both apps
• The AC-HPT suggested having notifications for the apps when there are updates to any of the information.
• The AC-HPT noted that the apps could be advertised more.
• The AC-HPT recommended the development of a pathogen safety data sheet for Trypanosoma cruzi.
• The AC-HPT supported the development of an ePATHogen app, and suggested including information of how the RG classification was determined.
• The AC-HPT suggested changing the format of the tables in section 3.5 of the CBS app to have clarifications as drop downs to allow for better view of the table itself.
• The AC-HPT suggested including links to the CBH, ePATHogen and PSDS pages where possible.

Centre for Biosecurity Actions:

CB will send the updated CBS and PSDS apps to the AC-HPT for user acceptability testing. CB to share information related to the use of personal devices in the lab by email communication to stakeholders or as a newsletter article.

Discussion summary

The Centre for Biosecurity, PHAC presented an update on the posting of inspection reports on the Open Government portal. On May 6, CB published the first inspection summaries datasets and will continue to publish this information quarterly. This has been an initiative that CB has been working on for several years and conducted many outreach activities with regulated stakeholders to obtain feedback and address concerns.

Suggestions of the Committee

The AC-HPT congratulated CB on achieving this milestone and is very interested in reviewing the data as it becomes available.

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 3:40 pm EDT.

Discussion summary

The Chair welcomed members to day 2 of the annual meeting and provided a recap of the discussions held on day 1. She also noted some changes made to the agenda and that the meeting will be ending early.

Discussion summary

The Centre for Biosecurity, PHAC presented the newly developed tool for the risk assessment of products of synthetic biology to seek feedback from AC-HPT members before further piloting the tool. The existing risk assessment tools do not direct and guide the assessor to consider and address elements specific to synthetic biological agents and genetically modified microorganisms.

Suggestions of the Committee

• The AC-HPT suggested clarifying who would use this tool, and scenarios when it would be needed.
• The AC-HPT suggested that Mycobank is a better resource for fungal taxonomy than IndexFungorum.
• The AC-HPT noted that the template would be a valuable tool to direct and guide researchers to think about the biosafety and biosecurity aspects of their projects.
• The AC-HPT suggested having this tool available online when the pilot phase is complete.
• The AC-HPT considered/discussed the availability of risk assessments completed by other jurisdictions for a particular biological agent, and the utility of this information in expediting CB's assessment process.
• The AC-HPT suggested including a section on diagnostics in the template.

Centre for Biosecurity Actions:

CB to continue piloting the tool and making improvements.

Discussion summary

During the Sept. 23, 2021 AC-HPT meeting, members brought forward concerns relating to improvements in biosafety oversight in academic and research laboratories. Since the primary focus of the September meeting was Emergomyces, AC-HPT were not able to discuss the concerns. This topic was lead by Dr. Moore, AC-HPT Chair based on questions provided by CB to the AC-HPT in advance of the meeting.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT noted that a plan for administrative oversight (PAO) is a very good tool to use to develop a biorisk management program; however, it should be a living document to establish a strong biosafety program, and not simply filed away.
• The AC-HPT noted that maintaining proper inventory tracking is very important as well as creating a simple system to track incoming samples and transfers.
• The AC-HPT noted that CB's newsletter and webinars are very useful and suggested including an article on "see something, say something". In addition, biosafety training targeted at principal investigators would be very helpful, as well as webinars on focused topics that are more 'bite-sized'. Finally, CB should develop a webinar for biosafety officers detailing roles and responsibilities.
• The AC-HPT suggested sharing real life, practical stories related to laboratory incidents to make it easier for people to understand the risks associated with not following proper procedures.
• The AC-HPT suggested CB could hold meetings with the Biosafety Officer community.

Centre for Biosecurity Actions:

• CB to share information on Transportation of Dangerous Goods (TDG) training.
• CB to circulate the draft Biosafety Program Development Guideline for comments from the AC-HPT members.
• CB to provide the link to the web-based Containment Level requirement checklist.
• CB to initiate discussions with the Canadian Association of Biological Safety (CABS) and the Canadian College of Microbiologists (CCM) regarding BSO training and certification.

Discussion summary

The Centre for Biosecurity, PHAC presented an overview of the Human Pathogens and Toxins Act and Regulations (HPTA/R) evaluation findings, the management response action plan, and the next steps of the regulatory review.

Suggestions of the Committee

• The AC-HPT noted that there is no requirement to report transfers of specimens between labs as a potential gap in the HPTA.
• The AC-HPT requested an update on the regulatory review of the Health of Animals Act/Regulations. CFIA indicated that this initiative was stalled due to the pandemic, but a fulsome review is scheduled for 2024-5.

Centre for Biosecurity Actions:

CB to seek input from the AC-HPT on the HPTA/R review as required.

Discussion summary

The Centre for Biosecurity, PHAC presented a summary of upcoming items that will likely be coming to the AC-HPT for their 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 points included in the workplan.

Centre for Biosecurity Actions:

CB will provide the AC-HPT with updates to the 2022-2023 work plan as required.

Discussion summary

The Centre for Biosecurity, PHAC, provided an overview of the AC-HPT Membership relating to the Committee's Mandate and Terms of Reference and focusing on Member's expertise/experience and terms.

Suggestions of the Committee

• The AC-HPT suggested looking for replacement members with similar expertise to those whose terms are ending.
• The AC-HPT noted maintaining the diversity of lab perspectives (clinical, diagnostic, and academic) is very important.
• The AC-HPT recommended not restricting the number of terms a Member can serve to maintain the expertise of long standing members.
• The AC-HPT did not recommend adding a representative from the DIY biology community but suggested it could be an item for a presentation at a future meeting.

Centre for Biosecurity Action:

• CB to use the information/input provided to enhance the Committee's structure and management.
• CB to invite a representative in the DIY biology community to present at the next AC-HPT annual meeting.
• CB to follow up with non-renewing members for recommendations for replacements.

Discussion summary

The Director General, Centre for Biosecurity thanked all members for their participation in the annual meeting. She also thanked the members who would not be renewing their terms for their many years of contributions to the work of the AC-HPT. She also thanked Ray Clark for his service as A/Director, OSE as he will be retiring soon. She noted that the secretariat will work on the record of discussion and will send it to members for comments in the coming weeks.

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 2:00 pm EDT.