2023 Record of decisions: Advisory Committee on Human Pathogens and Toxins

Discussion summary

The Chair welcomed members to the 2023 annual meeting and introduced the Director General (DG), Centre for Biosecurity (CB) and Executive Secretary of the committee, Kimby Barton.

Discussion summary

The DG, CB, PHAC, gave opening remarks and welcomed the new members to the committee. She presented opening remarks on behalf of Jennifer Lutfallah, Vice President (VP), Health Security and Regional Operations Branch (HSROB) who sent her regrets.

The DG acknowledged the contributions of the Committee since the last meeting.

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.

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 a key priority for CB under the Government's biomanufacturing and life sciences strategy and linkages to PHAC's mandate under pillar 5: enabling innovation by ensuring world class regulation. CB will support this pillar and the strategy's objectives by providing advice, guidance and oversight for containment facilities in Canada through consideration of an appropriate legislative and regulatory oversight framework for those facilities.

Discussion summary

The Centre for Biosecurity provided an overview of the Regulatory Life Cycle management process, the Human Pathogens and Toxins Regulations (HPTR) review, and regulatory consultations.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT noted challenges with the biosafety officer (BSO) role in organizations (especially larger organizations) and suggested further guidance on the interpretation of this requirement would be beneficial for compliance.
• The AC-HPT expressed interest in the outcomes of the pending summer 2023 thematic public HPTR consultation.

Centre for Biosecurity actions:

Following the public consultation, the Centre for Biosecurity to consider engaging with the AC-HPT as a sounding board on what was heard, either by teleconference or sharing a report.

Discussion summary

The Centre for Biosecurity, PHAC conducted 2 questionnaires with AC-HPT Members in December 2022 and May 2023 to assess interest in key themes the Government of Canada is exploring to inform potential amendments under the HPTR. A summary was presented of the results of the questionnaires and gave the AC-HPT an opportunity to provide any further comments on the 2 priority themes identified in the December 2022 questionnaire.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT noted the questions are very focused on the institution perspective and suggested revising them to allow responses based on collective or personal experience.
• The AC-HPT noted that guidance for implementation of biosecurity measures will be key for research facilities, and suggested that biosafety/biosecurity measures be included in law (HPTA/R) to promote compliance
• The AC-HPT noted that graduate programs rely heavily on international students; expanded security clearance requirements will impact this group.
• The AC-HPT recommended integrating biosecurity risk evaluations in the pathogen risk assessment process.

Centre for Biosecurity actions:

CB will re-circulate the questionnaire to the new members who were not able to participate in the original response period and to allow current members to provide any additional comments.

Discussion summary

The Toxin Risk Assessment Sub-Committee (TRAS) co-chair presented the toxins to be added or removed from schedule 1 in detail, based on the toxin risk assessments for each toxin. The toxins were grouped into 4 categories:

• Group1 - Listed toxins recommended to remain listed
• Group 2 - Unlisted toxins recommended to be listed
• Group 3 - Listed toxins recommended to be removed
• Group 4 - Unlisted toxins recommended to remain unlisted

The toxins from each group were reviewed, including those that were marked for discussion during the annual meeting. PHAC CB sought concurrence on all the recommendations for inclusion or removal.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT concurred on 82 of 83  recommendations for inclusion or removal of toxins on Schedule 1;  the inclusion of ADP-ribosylating binary toxin was flagged for follow-up. Given there was minimal data available to support toxicity, the AC-HPT recommended contacting the author of the study to clarify experimental details.
• The AC-HPT commended the TRAS and CB for the tremendous amount of work on completing so many very detailed toxins risk assessments, and recommended that the work be published in a scientific journal.
• The AC-HPT noted that toxin nomenclature needs to be reviewed against current standards.
• The AC-HPT recommended using the term repeated exposure instead of chronic exposure.

Centre for Biosecurity actions:

• CB will contact the author of the study on ADP-ribosylating binary toxin for further details and will re-include this toxin when the final group of toxin risk assessments are complete and ready for AC-HPT concurrence.
• CB will verify nomenclature for toxins included in Schedule 1.
• CB will consider publication of toxin risk assessment methodology and outcomes of toxin analysis.
• CB will schedule a virtual meeting with AC-HPT in Fall 2023 to seek concurrence on the remaining group of toxins for inclusion/removal to Schedule 1.
• CB is seeking a new TRAS co-chair among AC-HPT members.

Discussion summary

The Centre for Biosecurity, PHAC presented the considerations around downgrading the risk group classification of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS‑CoV‑2) and sought the AC-HPT's advice.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT concurred with downgrading the classification of SARS-CoV-2 from risk group (RG) 3 to RG2 because contracting SARS-CoV-2 is much more likely to occur within the community than in a laboratory.

Centre for Biosecurity Actions:

CB will complete the risk assessment on SARS-CoV-2 and associated variants. Once the downgrade in RG has been formalized, information will be published online and stakeholders will be notified.

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 3:55 p.m. 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.

Discussion summary

The Centre for Biosecurity, PHAC is considering more formally identifying pathogens with pandemic potential (PPP) in risk assessments. CB sought preliminary opinions from the AC-HPT on what the necessary factors to consider when identifying PPP and where this could fit within the risk assessments (RA) template.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT suggested renaming this work from PPP to pathogens with public health emergency potential.
• The AC-HPT noted the following suggested factors for consideration on this assessment:
  • although they are important features, morbidity and mortality rates can be variable depending on population and therefore should not be the first factors when considering PPP identification.
  • an organism's ability to spread is a defining feature for PPP, which would include the mode and rate of transmission as well as zoonotic and/or vector-borne origin given the potential for pathogens to find new reservoirs or intermediates during geographic range expansion.
  • the origin of the agent is an important factor for consideration as the spread may be more rapid in areas with large populations and in cites with busiest airports with passenger transport.
  • pathogen characteristics such as an RNA genome should be considered since these pathogens have a greater potential for mutation.
  • antibiotic resistance and the level of pre-existing immunity in the community should also be considered.
  • Human behaviour associated with the spread of the pathogens, e.g. MPV.
• The AC-HPT noted that the classification of SARS-CoV-2 as RG3 at the very beginning of the pandemic would likely not have made a difference in slowing or stopping the pandemic.
• The AC-HPT noted that the Canadian Food Inspection Agency (CFIA) has a role to play in the identification of PPP for zoonotic pathogens.
• The AC-HPT strongly suggested that Canada should consider having a federally-managed culture collection to allow Canadian researchers prompt access to pathogens for research and diagnostics development.

Centre for Biosecurity Actions:

• CB to discuss the benefits and risks of renaming this work to pathogens with public health emergency potential (as suggested by the committee) to ensure alignment with other international regulators.
• CB will begin drafting a methodology to identify PPP to present at a future AC-HPT meeting.

Discussion summary

The Centre for Biosecurity, PHAC provided a summary of the annual findings and trends on mandatory laboratory exposure reporting.

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' in the incident reporting module to avoid overlooking the actual cause of the incident. Factors such as failures in the program, standard operating procedures, workload etc. may have impacted the occurrence of the incident.
• The AC-HPT noted that specimen transport can be an issue leading to exposure incidents due to improper categorization of infectious materials. Transport of Dangerous Goods (TDG) training can be lacking in certain sectors or professions, such as physicians and pharmacists.
• The AC-HPT noted that the reporting of inadvertent production is burdensome for diagnostic laboratories.

Centre for Biosecurity Actions:

• CB to consider collecting more details on reported incidents to improve root cause analysis and have targeted questions to dive deeper into the human error root cause.
• CB to engage with AC-HPT on revising root cause questions.
• Consider de-identifying incident reports to make them available for learning opportunities.
• CB to consider working with Transport Canada to provide TDG training specific to infectious agents.

Discussion summary

The Centre for Biosecurity, PHAC provided an update on the Canadian Biosafety Standards 3 (CBS3) implementation, and BSAG general update.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT recommended a training course for BSOs on engineering controls.
• The AC-HPT noted that some institutions prefer more prescriptive requirements to facilitate development of policies and SOPs.

Centre for Biosecurity Actions:

• CB to share the engineering information sheets on puff back and HVAC failure testing and share others as they become available. 
• CB to explore development of an engineering controls webinar or training.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT recommended increasing the awareness of CB resources, such as ePATHogen, mobile apps, and the Biosafety and Biosecurity for Pathogens and Toxins Newsletter.
• The AC-HPT recommended newsletter articles on the use of personal electronic devices in the laboratory, and cybersecurity.
• The AC-HPT noted that the taxonomy of agents listed in ePATHogen should be reviewed and updated (in addition to the Schedule 1 toxin nomenclature).
• The AC-HPT noted that the listing of cell lines in ePATHogen is lacking and should be expanded.

Centre for Biosecurity Actions:

• CB to explore ways to increase promotion of resources.
• CB to share information related to the use of personal devices in the lab by email communication to stakeholders or as a newsletter article.
• CB to publish a newsletter article on risk group classification for pathogens and cells that will point to currently available resources including the Statement of Administrative Intent with respect to cells and cell lines.
• CB to consider adding additional cell lines to ePathogen database.
• CB to continue to review ePATHogen and update as necessary.

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 recommended workplan.

Centre for Biosecurity Actions:

CB will provide the AC-HPT with updates to the 2023-2024 work plan as required.

Discussion summary

The Centre for Biosecurity, PHAC provided an overview of administrative changes to the AC-HPT Terms of Reference (ToR), for approval. CB also presented questions for discussion around considerations for changes to the selection criteria included in the ToR.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT concurred with the administrative changes proposed to the Terms of Reference.
• The AC-HPT suggested adding risk management, biosecurity and biomanufacturing to the list of expertise on the application form.
• The AC-HPT recommended seeking a new member with toxins expertise to replace the departing member with this expertise.
• The AC-HPT suggested new applicants with past Government of Canada (GoC) employment should be held to similar conflict of interest requirements as any other member and should adhere to any GoC retirement rules for re-employment.
• The AC-HPT suggested seeking Indigenous scientist representation, notably for Nunavut.
• The AC-HPT discussed how to evaluate gender, regional and linguistic diversity as part of the selection criteria rather then only a consideration. It was generally recognized that these factors can add different perspectives.

Centre for Biosecurity Actions:

The Centre for Biosecurity to propose further changes as necessary to the membership application, selection criteria and scoring matrix for AC-HPT concurrence.

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 made the following observations and suggestions:

• The AC-HPT suggested seeking presentations from external groups such as DIY biologists, in place of full membership.
• The AC-HPT recommended determining the minimum amount of representation required from each sector to ensure a variety of expertise and then - once the minimum is met – additional members can be selected from any sector.
• The AC-HPT noted area of professional expertise should be the main priority for membership.
• The AC-HPT suggested exploring membership from an engineer working in a facility.
• The AC-HPT suggested exploring ex-officio membership from Agriculture and Agri-food Canada for the plant pathogen perspective.

Centre for Biosecurity Actions:

• CB to use the information/input provided to enhance the Committee's structure and management.
• CB to invite a representative from the DIY biology community to present at the next AC-HPT annual meeting.
• CB to follow up with members for recommendations for replacements.
• CB to consider recruiting an ex-officio member from Agriculture and Agri-food Canada.

Discussion summary

The Director General, Centre for Biosecurity thanked all members for their participation in the annual meeting. She also thanked the one member who would not be renewing his term for his many years of contributions to the work of the AC-HPT.

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 3:02 p.m. EDT.

Discussion summary

The Chair welcomed members to the ad hoc meeting, acknowledged the land on which she was situated, and stated some housekeeping items to ensure the meeting runs smoothly.

The Chair introduced the Director General (DG), Centre for Biosecurity (CB) and Executive Secretary of the AC-HPT, Kimby Barton for her opening remarks.

Discussion summary

The DG of CB acknowledged the land on which she was situated, gave opening remarks and thanked one of the departing members for his contributions to the Committee. She also provided an update on some of CB's key achievements and ongoing work since the last AC-HPT meeting, and thanked the Committee for their contributions to this work.

The DG also welcomed a new member to the AC-HPT Secretariat.

Discussion summary

The Chair welcomed a new member to the AC-HPT and conducted a roundtable of introductions for the new member.

The Chair asked the committee if there were any changes or additions to the Record of Decision (ROD) from the 2023 annual meeting. There were no objections from members. The Chair made a motion to accept 2023 ROD into record, and this was accepted.

Members were asked to declare any affiliations or interests, which would impact the integrity and objectivity of their participation. One member stated that he is an HPTA Licence Holder, which is not considered a conflict of intertest. There were no declarations made by any member. The committee reviewed and approved the meeting agenda.

Discussion summary

Jennifer Whitteker presented the remaining toxins that were assessed for the Schedule 1 update and sought the AC-HPT's concurrence on the recommendations for a toxin to be added to Schedule 1 or remain unlisted based on the toxin risk assessment for each toxin. She provided a brief review of the listing scenarios and the toxins being assessed, consulted with the members, and finished with an overview of next steps.

Of the 48 toxins that were discussed, 9 were recommended to be added to Schedule 1 and the others were recommended to remain unlisted.

Jennifer also provided an update on ADP-ribosylating binary toxin that had been flagged for follow-up at the AC-HPT annual meeting in May 2023. The Biosafety Risk Assessment (BRA) team were unable to reach the authors of the scientific article to obtain more information but after further review of the article and discussion with members of the Toxin Risk Assessment Subcommittee (TRAS), BRA recommended that ADP-ribosylating binary toxin remain unlisted.

CB noted that the toxins are revised every 3-5 years, as applicable.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• The AC-HPT concurred on the recommendations for all 48 remaining toxins.
• The AC-HPT questioned whether there was enough information on human pathogenicity to support listing pinnatoxins but after CB clarified that a thorough literature search was conducted and there was enough data to support listing this toxin (weighted evidence approach, borderline risk assessment decision tree), members concurred with the recommendation presented.
• Members had questions about whether the toxin listing have any standing for the Health of Animals Act (HAA) and if the threshold for toxicity level is also applied to animal models. CB clarified that this exercise is exclusive to the risk to humans under Human Pathogens and Toxins Act and that the toxicity threshold only applied to humans.
• The AC-HPT stated that we should aim to standardize nomenclature and descriptions for toxins and suggested that CB should bring this up with their international collaborators as there is currently no international standard for toxin nomenclature.

Centre for Biosecurity actions:

• CB will begin working with CFIA to discuss how the toxins could or will impact the HAA.
• CB will send out the Schedule 1 nomenclature for consultation with the Committee.
• CB to consider taking the toxin risk assessment methodology to relevant meetings with international stakeholders and collaborators and consider publishing the methodology.
• CB to re-examine toxins, as applicable, based on new information that becomes available.
  • CB to inform AC-HPT (along with other stakeholders) when the Schedule 1 changes are published in the Canada Gazette.

Discussion summary

The presentation provided an update of the Human Pathogens Regulations (HPTR) review, proposed regulatory amendments, high-level summary of the HPTR consultation process, and the next steps of the regulatory review.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• A few members raised concerns that the proposed HPTA security clearance changes will impact facilities negatively and that the term 'distinct' should be revised.
• An AC-HPT member stated that the questions about the financial aspects should have been framed differently, as they are multi-faceted and the survey respondent may not know the answer or may only have context for part of the financial impacts.
• An AC-HPT member stated that the consultation was a great exercise, but it does not provide any 'how to' steps to help stakeholders implement the regulatory amendments to the HPTR ; another member stated that the PHAC training portal is a great resource as it includes tools that may help with the 'how to'.

Centre for Biosecurity actions:

• CB to share the summary report of the HPTR consultation with the AC-HPT.

Discussion summary

CB presented on the proposed changes to the RG3 pathogen definition under the HPTA. She provided a brief review of current RG definition, an overview of issues with the current RG3 definition, proposed a solution for the committee's consideration and provided next steps.

Jennifer stated that the proposed change is considered an administrative modification. The language proposed will lower the legal risk of classifying certain biological agents as RG3, for example those whose risk/impact to public health is greater than "low" but not quite "high". Further, no downstream implications are expected with this change nor are any implications expected on activities and authorities.

CB sought feedback from the AC-HPT on the RG3 definition change.

Suggestions of the Committee

The AC-HPT made the following observations and suggestions:

• One member stated that they like that the definitions are along a risk continuum
• The AC-HPT noted that the World Health Organization is moving away from using the RG definitions and asks if Canada will do the same. CB confirmed that we will continue using RG classification as that is what is written in the HPTA.
• Another member stated that the definitions continue to be outdated based on what we understand, especially in RG3 and RG4 pathogens and toxins. There could be further thought into how they are classified, especially as we understand the human-to-human transmission better.
• The AC-HPT  suggested to broaden the definition of 'community'.

Centre for Biosecurity actions:

• CB will consider the AC-HPT's comments on the proposed RG3 definition changes and will determine if there is a need to revisit the proposed definition in future iterations.
• CB will keep the AC-HPT updated on the progress of the RG3 definition change process.

Discussion summary

The Director of OSERA updated the Committee on upcoming changes to PHAC's External Advisory Body (EAB) Policy and how this will impact the Committee. The Director also provided an update on the AC-HPT annual meeting planning progress, which is well underway. The Director thanked the Committee for their input on the Record of Decision (ROD) from the 2023 AC-HPT annual meeting. Using the ROD, the Secretariat created a tracker of action items which will be shared within CB periodically to ensure follow-up on actions and included as part of the AC-HPT annual meeting materials.

Centre for Biosecurity actions:

• CB will present an updated Terms of Reference for concurrence at the 2024 AC-HPT annual meeting based on any changes required in the new PHAC EAB policy.
• The Secretariat will engage with the AC-HPT throughout the planning of the 2024 annual meeting.

Discussion summary

The Chair thanked all members for taking the time to participate in the meeting and for their engaging comments. The Chair thanked the departing member again for his contributions to the Committee.

The meeting was adjourned at 3:15 p.m. EST.