Record of Decisions

Meeting of the Advisory Committee on Human Pathogens and Toxins (AC-HPT)
Monday May 13 to Tuesday May 14, 2019
Ottawa, Ontario

Members in attendance: Dr. Margo Moore (Chair), Ms. Ingrid Abbott-Permell, Dr. Maurice Boissinot, Mr. Kevin Cassidy, Dr. Ayush Kumar, Dr. Paul Levett, Dr. Momar Ndao, Dr. John Prescott, Dr. James Scott, Dr. Fiona Smaill, Dr. Manal Tadros

Ex-officio members and Secretariat in attendance: Cindy Evans, Brenda Abbott, Emery Gahimbare, Rob Ward, Marianne Heisz, Brigitte Cadieux, Jennifer Mihowich, Mary Louise Graham (Day 1-only), Basia Schreuders (Day 2-only)

Day 1: Monday, May 13, 2019
Agenda Item Discussion Summary Suggestions of the Committee and Centre for Biosecurity Actions

Welcome and Introductions
(Opening remarks by Sally Thornton, Vice President, Health Security Infrastructure Branch and Cindy Evans, Executive Secretary and Director General, Centre for Biosecurity)
Review of AC-HPT Mandate and Operation
(Dr. Margo Moore, Chair)
Agenda and Terms of Reference (ToR)
(Dr. Margo Moore and Cindy Evans)

The Vice President and the Director General, Centre for Biosecurity, Public Health Agency of Canada (PHAC), gave opening remarks, welcomed all members, and introduced a new member to the AC-HPT. The Chair provided a brief overview of the Human Pathogens and Toxins Act (HPTA) and operations of the committee for orientation of the new member. Members were asked to declare any affiliations or interest which would impact the integrity and objectivity of their participation; no declarations were made by any member. The meeting agenda was reviewed and approved. The updated Terms of Reference of the AC-HPT were reviewed, and unanimously accepted by the AC-HPT. The Director General, Centre for Biosecurity, 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.  

Inspection Planning: Updating the Risk Ranking Process 2019-2020
(Mary Louise Graham, Director, Office of Biosafety and Biocontainment Operations)

The Centre for Biosecurity, PHAC, presented an overview of the risk-based approach for future inspection prioritization. The presentation provided policy background, an analysis of findings from compliance monitoring activities and conclusions, which contributed to the new approach.

The AC-HPT made the following suggestions:

  • AC-HPT members suggested determining if there is causation of combined licence oversight (e.g. Licence Holder = Biological Safety Officer) to the increase of corrective actions;
  • AC-HPT members suggested risk-ranking corrective actions;
  • AC-HPT members suggested monitoring the frequency of access to the Centre for Biosecurity resources as a measure of determining risk of non-compliance.

Centre for Biosecurity Action: The Centre for Biosecurity to share common inspection findings webinar with AC-HPT members.

Toxin Risk Assessment Methodology and Creation of a Toxin Subcommittee
(Brigitte Cadieux, Manager, Biosafety Risk Assessment and Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity, PHAC, presented the revised toxin risk assessment methodology, which was updated based on AC-HPT input and findings from the internal pilot. A toxin subcommittee will be created in order to provide toxin expertise to the Centre for Biosecurity and the AC-HPT, for the purpose of updating HPTA Schedule 1. The subcommittee's role, work objectives, and potential membership were discussed.

The AC-HPT made the following observations and suggestions:

  • AC-HPT members noted that many of the toxins currently listed on HPTA Schedule 1 are not considered high risk, might not even be considered "toxins", and could be removed;
  • AC-HPT members indicated that some of the names of toxins in Schedule 1 may apply to different toxins produced by different microorganisms e.g. alpha toxin, hemolysin;
  • AC-HPT members noted that the quantity of toxin and intended use are important considerations in determination of risk, and that certain toxins should have trigger quantities;
  • AC-HPT members suggested clarifying the objective of the toxin review;
  • AC-HPT members who have not already done so, are asked to submit names of individuals to be considered for participation in and to Co-Chair the toxins subcommittee;
  • AC-HPT members suggested specific changes to the toxin risk assessment template and requested the opportunity to review the changes following input from the toxin subcommittee;
  • AC-HPT members suggested that the toxin subcommittee should conduct some toxin risk assessments to validate the methodology.

Centre for Biosecurity Action: The Centre for Biosecurity will create the toxin subcommittee, appoint an AC-HPT subcommittee co-chair and proceed with implementation of the work plan for the update of HPTA Schedule 1.

Regulatory Openness and Transparency Framework (ROTF)
(Eméry Gahimbare, Manager, Stakeholder Engagement and Lise Murphy, Manager, Inspections, Eastern Region)

The Regulatory Openness and Transparency Framework and plan were presented by the Centre for Biosecurity, PHAC. By end of fiscal 2019/20, PHAC will post information on inspections and incidents online. The presentation highlighted the information on inspections that is being proposed to be posted online.

The AC-HPT made the following observations and suggestions:

  • AC-HPT suggested including an executive summary to provide context and understanding when posting inspection information;
  • AC-HPT observed that without context or compliance ranking (e.g. major or minor non-compliance), members of the institution's own staff or the public may overestimate problems, potentially affecting perception of workplace safety;
  • For the summary of deficiencies posting AC-HPT suggested including the compliance rating next to the status;
  • AC-HPT suggested that published summary statements should reflect severity of the deficiency (e.g. minor documentation deficiency should not be summarized as "documentation inadequate") as well as the nature and timeliness for applying the corrective actions;
  • AC-HPT suggested creating a searchable database, for the posted inspection information.

Centre for Biosecurity Action: The Centre for Biosecurity to consider suggestions made by the AC-HPT for incorporation in published inspection information.
The Centre for Biosecurity to verify the policy on document retention relating to the posting of online compliance history and inspection information.

Review of the Human Pathogens and Toxins Act and Regulations (HPTA/R)
(Natasha Kuran,
Manager, Regulatory Affairs)

The Centre for Biosecurity, PHAC, presented a debrief of the ongoing work related to the review of the Human Pathogens and Toxins Regulatory Framework including the next steps and outcomes related to the external stakeholder engagement portion of the HPTA/R review.

The AC-HPT made the following observations and suggestions:

  • AC-HPT suggested exploring the concept of One Health with respect to human and animal pathogen and toxin regulation;
  • AC-HPT suggested exploring new ways to enhance its engagement of Biological Safety Officers;
  • AC-HPT suggested reviewing the regulations from a diagnostics perspective, as they are currently research-centered.

Centre for Biosecurity Action: The Centre for Biosecurity to consider suggestions made by the AC-HPT for incorporation in the review of the HPTA/R and continue to engage the AC-HPT on proposed changes to the Regulatory Framework.

PHAC's Laboratory Incident Notification Program
(Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity presented a summary of the annual findings and trends from the mandatory Laboratory Incident Notification Program. The analysis highlighted that, although laboratory workers are exposed to pathogens and toxins, mainly through sharps-related incidents, the incidence of laboratory acquired infections in Canada is low. It was also reported that laboratory incidents occurred most frequently in hospital and academic institutions, in Containment Level 2 laboratories, involving Risk Group 2 pathogens. The importance of incident reporting and surveillance was highlighted through the identification of a cluster of exposure incidents that resulted from the misidentification of high risk human pathogens using the MALDI-TOF MS (matrix-assisted laser desorption/ionization time of flight mass spectrometry) identification system.

The AC-HPT made the following observations and suggestions:

  • AC-HPT noted that the MALDI-TOF issue highlights a larger problem of the ever-present possibility of isolating Risk Group 3 organisms in Containment Level 2 diagnostic laboratories, and that increased awareness, robust standard operating procedures (SOPs), and staff training are required to mitigate this risk;
  • AC-HPT suggested the inclusion of guidance regarding working with unknown pathogens in the Canadian Biosafety Guideline for Human Diagnostic Activities;
  • AC-HPT suggested the Centre for Biosecurity develop a root cause analysis template to provide regulated parties with further guidance on incident investigation.

Centre for Biosecurity Actions: The Centre for Biosecurity will circulate the Canadian Biosafety Guideline for Human Diagnostic Activities to the AC-HPT for their input, and continue to develop awareness-raising communications and tools related to laboratory incident reporting, trends, and risks.

Risk Group 3 (RG3) Fungi Directive
(Kyna Caminiti, A/Manager, Biosafety Standards and Guidelines, Brigitte Cadieux, Manager, Biosafety Risk Assessment and Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity presented an overview of the draft Risk Group 3 Fungi Directive, seeking AC-HPT input on the scope of the directive, and the proposed laboratory activities that could be safely performed at containment level 2 with additional biosafety requirements.

The AC-HPT made the following observations and suggestions:

  • AC-HPT suggested the removal of Coccidioides immitis and C. posadasii from the Directive since they are dangerous pathogens and activities with these fungi should always be conducted at containment level 3;
  • AC-HPT indicated that there are several RG3 fungi that under certain circumstances can be safely manipulated at CL2 as long as they are maintained in yeast phase, including: species of Blastomyces (e.g., B. dermatitidis, B. gilchristii, B. silverae), species of Histoplasma, Paracoccidioides (P. Americana, P. brasiliensis, P. venezuelensis), and Emergomyces. The hazard profile of all of these fungi in their yeast phases does not differ from Cryptococcus gattii. AC-HPT indicated that in all circumstances species of Coccidioides should only, be manipulated at CL3;
  • AC-HPT suggested the inclusion of examples of laboratory activities in the Directive to provide further clarity to regulated parties, and to facilitate a local risk assessment;
  • AC-HPT suggested including a statement regarding the instability of fungal taxonomy in the Directive;
  • AC-HPT suggested the creation of a concise information sheet to accompany the Directive that could serve as quick reference tool.

Centre for Biosecurity Actions: The Centre for Biosecurity will circulate the updated draft Risk Group 3 Fungi Directive to the AC-HPT for their input, and consider their comments in finalizing the Directive.

Proposed changes to Fusarium solani risk group
(Brigitte Cadieux, Manager, Biosafety Risk Assessment and Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity presented risk assessment findings of Fusarium solani.

The AC-HPT made the following observations and advice:

  • AC-HPT advised that F. solani should remain classified as Risk Group 2 due to its potential to cause serious disease in humans and terrestrial animals, in particular in immunocompromised individuals;
  • AC-HPT agreed that a precautionary approach should be used when classifying borderline agents;
  • AC-HPT noted that the borderline agent risk assessment decision tree should be reviewed and updated.

Centre for Biosecurity Actions: The Centre for Biosecurity will review and update the borderline agent risk assessment decision tree based on AC-HPT input, and update the F. solani risk assessment. The risk assessments for other fungi, such as Candida auris, will be circulated to the AC-HPT for their input on risk group classification.

Closing Remarks
(Dr. Margo Moore, Chair)

The Chair adjourned the meeting at 4:20 pm.  
Day 2: Tuesday, May 14, 2019
Agenda Item Discussion Summary Actions and Suggestions of the Committee

The Canadian Pathogen Security Interdepartmental Committee and the Intangible Transfer of Technology
(Genevieve Lacroix Manager, Laboratory Biosecurity and Basia Schreuders, Director, Office of Pathogen Security)

The Centre for Biosecurity, PHAC, presented on the concept of the Intangible Transfer of Technology and the Government of Canada's approach to addressing the risks associated with it.

The AC-HPT made the following observations and suggestions:

  • AC-HPT observed that there are safeguards in place in their institutions, that there is low awareness of the issues and/or low perception of risk;
  • AC-HPT observed that risk increases with high lab turnover e.g. student populations and increased use of social media;
  • Some AC-HPT members recommended the Safeguarding Science Workshop as an effective tool to raise awareness;
  • AC-HPT suggested providing clarity on where efforts should be focused to best protect Canadians and their intellectual property e.g. the use of international servers;
  • AC-HPT suggested the creation of tools or well-timed general training to raise issue awareness, across all levels of stakeholders;
  • AC-HPT suggested engagement efforts involving all levels of stakeholders; researchers, institutions, publishers, funders etc.;
  • AC-HPT suggested partnering with continuing education institutions to create recognized certification or training programs;
  • AC-HPT noted that some training courses provided in the Centre for Biosecurity's training portal should be reviewed for information and translation accuracy.

Centre for Biosecurity Action: The Centre for Biosecurity to inform members of Dual-Use course, upcoming Safeguarding Science workshops and to list future Safeguarding Science workshops in newsletter.
The Centre for Biosecurity to address errors in training module on microbiology, review all online courses and validate new courses before release.
The Centre for Biosecurity to share Safeguarding Science contact information and link to the Centre for Biosecurity's training portal.
The Centre for Biosecurity to share Dual-Use guidelines with AC-HPT members for information.

Approach for reviewing Canadian Biosafety Standard (CBS) Requirements
(Kyna Caminiti, A/Manager, Biosafety Standards and Guidelines and Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity presented the approach for the review of the Canadian Biosafety Standard requirements in preparation of the release of the CBS 3rd edition, which is anticipated in 2021. Particular focus was placed on the root cause analysis methodology employed in the preliminary review, as well as domestic and international considerations.

The AC-HPT made the following observations and suggestions:

  • AC-HPT noted that the CBS review methodology includes only the qualitative level of risk, and that the quantitative (severity) level of risk should be included in the analysis to help clarify the significance of deficiencies;
  • AC-HPT agreed that the prioritization of CBS requirements is a good approach that will strengthen the CBS, improve compliance, and provide context to non-compliance ratings;
  • AC-HPT suggested linking non-compliances to impact and frequency e.g. high impact vs. low impact that occurs frequently;
  • AC-HPT suggested including an executive summary in the CBS about risk groups and containment levels;
  • AC-HPT acknowledged that the CBS is aligned with the new World Health Organization (WHO) approach that will be released in the Laboratory Biosafety Manual 4th Ed. e.g. the foundational role of risk assessment, increasing mitigation as risk increases. The AC-HPT suggested that the CBS should state how it aligns with international biosafety trends; however, Canada should not follow WHO's new containment requirements format, as this would be confusing to users;
  • AC-HPT indicated that the CBS is working well and suggested the Centre for Biosecurity avoid making major changes to the CBS requirements;
  • AC-HPT suggested outreach to Biological Safety Officers for their input on the review of the CBS requirements;
  • AC-HPT suggested increasing internal accountability for compliance by formalizing the internal and third party inspection processes.

Centre for Biosecurity Actions: The Centre for Biosecurity will continue with the review of the CSB requirements, addressing AC-HPT suggestions and seek further input from the committee, as required.

Advisory Committee Work Plan for 2019-2020
(Brigitte Cadieux, Manager, Biosafety Risk Assessment and Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity, PHAC, presented the 2019-2020 AC-HPT work plan. The work plan includes providing input on Directives and Guidelines and establishing a Toxins Subcommittee to review and report back to AC-HPT on the proposed additions to and deletions from Schedule 1.

Centre for Biosecurity Actions: The Centre for Biosecurity will provide the AC-HPT with updates to the 2019-2020 work plan as required.

Policy on the Interpretation of Producing Human Pathogens and Toxins
(Cody Anderson Manager, Emerging Technologies and Marianne Heisz, Director, Office of Biosafety Programs and Planning)

The Centre for Biosecurity presented the draft policy approach to provide clarification on the interpretation of "production", a controlled activity under the HPTA.

The AC-HPT made the following observations and suggestions:
-AC-HPT expressed concerns regarding the current scope and implications of the proposed policy, and suggested that PHAC avoid unintentionally capturing diagnostic production;
- AC-HPT agreed with the proposed policy approach, with refinement to language and examples for improved clarity;
-AC-HPT stressed that the policy must not conflict with the exemption from the HPTA licence requirement for production done using a sealed container (paragraph 27. 1.b of the HPTR).

Centre for Biosecurity Actions: The Centre for Biosecurity will consult with the AC-HPT as it develops the policy on interpretation of production.

Advisory Committee Membership
(Rob Ward, Director, Office of Stakeholder Engagement and Regulatory Affairs)

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.

The AC-HPT made the following observations and suggestions:

  • AC-HPT suggested increasing the amount of technical and interactive discussions;
  • AC-HPT suggested increasing representation from Atlantic Canada and Biological Safety Officers;
  • AC-HPT suggested enhancing the Committees expertise in the fields of toxinology, mycology and neurology/prion science;
  • AC-HPT suggested an official from Canadian Food Inspection Agency should attend future meetings.

Centre for Biosecurity Action: The Centre for Biosecurity to use the information/input provided to enhance the Committee's structure and management.
The Centre for Biosecurity to invite a representative of the AC-HPT to participate in the DIY bio summit.
The Centre for Biosecurity to schedule an AC-HPT teleconference in October to validate membership renewal plans.

Closing Remarks

The Chair and the Director General, Centre for Biosecurity, PHAC, gave closing remarks. The Chair thanked the AC-HPT for their active participation in the meeting, as well as the Centre for Biosecurity for organizing a productive meeting. The Director General, PHAC, thanked the Chair for her role in the meeting. The meeting was adjourned by the Chair at 2:45 p.m.  
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