Record of Decisions

Meeting of the Advisory Committee on Human Pathogens and Toxins (AC-HPT)
Thursday, February 9th to Friday, February 10th, 2017
Ottawa, Ontario

Members in attendance: Jack Kitts, Maurice Boissinot, Kevin Cassidy, David Evans, Paul Levett, Margo Moore, James Scott, Fiona Smaill, Cecile Tremblay

Regrets: Georgia Perona-Wright, Rodney Russell

Ex-officio members and Secretariat in attendance: Élaine Chatigny, Cindy Evans, Marianne Heisz, Rob Ward, Stacey Mantha, Kirsten Jacobsen, Morgan Kafenzakis, Mylene Malette, Nisrine Haddad, Kathrina Yambao, Adam St. John (Public Safety Canada)

Day 1: Thursday, February 9th, 2017
Agenda Item Discussion Summary Action Required

Welcome and Introductions

The A/Assistant Deputy Minister, Health Security Infrastructure Branch, Public Health Agency of Canada, welcomed the committee and gave opening remarks. The Director General of the Centre for Biosecurity, Public Health Agency of Canada, gave a brief overview of the Centre's milestones over the last year, as well as the work completed by the committee since the last meeting. The Chair of the AC-HPT facilitated the committee's approval of the 2016 Records of Decisions and the 2017 meeting agenda.

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Amendments to Schedules 2-4 of the Human Pathogens and Toxins Act

The Centre for Biosecurity, Public Health Agency of Canada, presented on amendments to Schedules 2-4 of the Human Pathogens and Toxins Act, based on the committee's 2016 recommendations. Finalizations to the amendments for Schedules 2 and 3 were discussed. Agent-specific discussions took place; the value of having higher level taxonomic entries was considered (e.g., including a species level entry on Schedule 2 when multiple strains may be classified as Risk Group 1). Final recommendations on several agents were provided by the committee, including Salmonella, Escherichia coli, and Brucella. A summary of the work completed by Working Group 2 (Viruses) regarding recommendations for Schedule 4 was also presented for discussion. Finally, the regulatory amendment processes and timelines were presented and discussed.

The Centre for Biosecurity to proceed with the HPTA regulatory amendment processes based on final Committee recommendations.

Public Health Agency of Canada's Biological Agent Database

The Centre for Biosecurity, Public Health Agency of Canada, presented on its Biological Agent Database. Background on the database, its composition, and the methodology used to classify agents was presented. The biological agent database was demonstrated to the committee. Challenges with the database were presented and discussed, including current errors/gaps raised by committee members. A proposed approach for the AC-HPT to review the database was presented and accepted by members. The approach will include the following:

  • The AC-HPT will undertake a systematic review of the biological agent database, focussing first on the classification of Risk Group 3 agents, and then reviewing for any errors in their respective areas of expertise.
  • The AC-HPT requested a timeline of approximately 3.5 months to review the biological agent database.

The Centre for Biosecurity to provide the AC-HPT with the Biological Agent Database (timeline for completion May 31, 2017).

Update on International Activities

The Centre for Biosecurity, Public Health Agency of Canada, presented an overview of its international activities and initiatives, noting its alignment with the Health Portfolio's International Strategic Framework and summarizing the assessment criteria used for international engagement. The presentation and discussion focussed on the Centre's current international efforts including its designation as a World Health Organization Collaborating Centre for Biosafety and Biosecurity, its contribution to the Global Health Security Agenda, its support of the Global Polio Eradication Initiative, and its participation in the Biological and Toxins Weapon Convention, the Australia Group, and the International Expert Group on Biosafety and Biosecurity Regulations. A discussion ensued on additional international activities with a linkage to biosafety and biosecurity. The AC-HPT gave its full support and indicated its willingness to collaborate to advance the Centre's current international commitments.

The Centre for Biosecurity will engage with the committee, as needed, to advance its international commitments.

The HPTA and Toxin Oversight

The Centre for Biosecurity, Public Health Agency of Canada, presented on toxin oversight in Canada. The legislative oversight of microbial toxins was presented including the authority under the HPTA to add toxins to Schedule 1. A preliminary analysis of toxins and toxin classes that could potentially be considered for inclusion in Schedule 1 was also presented. A discussion on the AC-HPT's approach to the review of Schedule 1 took place, including the creation of a working group to support the committee. The committee supported the establishment of a toxin working group, and agreed to reach out within their organization and solicit toxin expertise.

The Centre for Biosecurity to share preliminary toxin analysis and draft invitation to toxin experts for AC-HPT to circulate within organizations.

Risk Group Classification of Borderline Pathogens

The Centre for Biosecurity, Public Health Agency of Canada, presented on the risk group classification of borderline agents. The issue of biological agents lying on the boundary of the Risk Group 1 and Risk Group 2 definition was presented and discussed. A preliminary review of fungal agents was provided to the committee outlining the critical factors used to determine whether or not an agent would be classified as Risk Group 1 or Risk Group 2, including evidence of human exposure and cases in both immunocompromised and immunocompetent individuals. Break out groups evaluated and deliberated upon the data and supporting documentation provided. The committee provided suggestions for criteria to be considered when evaluating borderline agents. In addition, the committee provided recommendations for the risk group classification of several borderline agents.

The Centre for Biosecurity to integrate criteria for classification of borderline agents into pathogen risk assessment methodology.

Emerging Technologies

The Centre for Biosecurity, Public Health Agency of Canada, presented on Emerging Life Science Technologies in Canada. Examples of emerging life science technologies, including gene drives and CRISPR/CAS9, were presented and discussed, as well as the biosafety/biosecurity concerns that arise from this type of work. In addition, the Centre's ongoing outreach to the Do-It-Yourself Biology community was presented. The committee provided feedback on the aspects of emerging life sciences that are important in the context of biosafety and biosecurity. The committee also provided suggestions for engaging the appropriate groups (e.g., high school students outside of the traditional sciences) to ensure that biosafety awareness is championed in this growing sector.

The Centre for Biosecurity to integrate the AC-HPT's feedback into its Emerging Technology initiatives.

Closing Remarks

The Chair adjourned the meeting at 4:00p.m.

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Day 2: Friday, February 10th, 2017
Agenda Item Discussion Summary Action Required

PHAC's Biosafety Guideline Series

The Centre for Biosecurity, Public Health Agency of Canada, presented on the Biosafety Standards and Guidelines Program and its upcoming deliverables. The Centre presented on its 5-tiered Document Hierarchy, published standards and guidelines (i.e., the Canadian Biosafety Standard and Handbook) and future plans for Biosafety Directive publications (e.g., New and Emerging Influenza A Viruses and Lentiviral Vectors). The committee provided feedback on mechanisms to disseminate this information to those who are not stakeholders and provided feedback on some directives they were recently asked to review. In addition, the committee provided feedback on the implementation of biosecurity requirements in the Canadian Biosafety Standard and the Developing a Comprehensive Biosecurity Plan guideline (with respect to dual use life sciences). The recommendation to include a purpose statement within each guideline or directive was put forward by the committee.

The Centre for Biosecurity to evaluate options for including a statement of intent (purpose statement) in current/future guidelines and directives.

Process for AC-HPT feedback on work plan items

The process for the AC-HPT review of documents and/or completion of work plan items was discussed. The committee recommended being provided one month to review guidelines/directives, and also indicated their preference to comment on documents in a tracked change format.

The Centre for Biosecurity to apply AC-HPT's recommendations when tasking work-plan items.

Policy Clarifying the Definition of Scientific Research

The Centre for Biosecurity, Public Health Agency of Canada, presented a summary of the Plan for Administrative Oversight (PAO), a requirement for facilities conducting scientific research. The elements of the PAO were presented, along with statistics and trends of PAO submissions received by the Centre to date. The unique risks associated with facilities conducting scientific research were discussed and the definition of "Experimental Development" as defined in the Human Pathogens and Toxins Regulations was explored. The committee provided recommendations on what would fall within the definition of experimental development, and provided specific examples of what would not be considered experimental development.

The Centre for Biosecurity to integrate AC-HPT's feedback into its policy clarifying the definition of scientific research.

HPTA Federal Oversight Analysis

The Centre for Biosecurity, Public Health Agency of Canada, presented an overview of its ongoing work to analyse all federal legislative oversight of pathogens and toxins in Canada. Existing legislative frameworks that oversee pathogens and toxins in Canada were presented and discussed; members provided suggestions on other potential areas of overlap for consideration by the Centre. The process and next steps for the Centre's report on federal overlap were discussed, including the validation by subject matter experts by appropriate federal departments, and the finalization and publication of the report.

The Centre for Biosecurity to integrate AC-HPT's feedback into its analysis of Federal pathogen and toxin oversight.

Advisory Committee Work Plan for 2017-2018

The Centre for Biosecurity, Public Health Agency of Canada, presented the AC-HPT's work plan for the upcoming fiscal year, 2017-2018. The work plan included many of the action items stemming from the 2017 meeting (e.g., review of biological agent list, toxin oversight in Canada) as well as few new and adhoc items. The commitment and workload for the 2017-2018 year was predicted to be similar to the previous year. Should the workload be in excess of what the AC-HPT can manage, working groups may be established, as per the committee's Terms of Reference. The committee was in agreement with the proposed 2017-2018 work-plan.

The AC-HPT to contribute to the specific deliverables in the 2017-2018 work plan.

Regulatory Openness and Transparency Framework

The Centre for Biosecurity, Public Health Agency of Canada, presented on Regulatory Openness and Transparency Framework and its draft implementation plan. A summary of the Public Health Agency of Canada's regulatory responsibilities was provided, including the three pillars of the regulatory openness and transparency framework (Inform and Engage, Enable, and Enforce). The draft implementation plan, including timelines, was presented and discussed. The committee was asked to provide preliminary feedback on the draft implementation plan, including whether or not they viewed any of the aspects of the plan to be problematic for stakeholders. Discussions regarding the confidentiality of information contained within incident and inspection reports took place; the publication of reports in the context of biosecurity was raised and discussed. In addition, the committee recommended consistency in how information is communicated, and that the context/background of published reports be included in public documents.

The Centre for Biosecurity to integrate the feedback provided by the committee into its draft implementation plan.

Safeguarding Science

Public Safety Canada presented an overview of the Safeguarding Science initiative, a program designed to reduce the risks of misuse of chemical, biological, and radiological/nuclear substances. The formatted and targeted approach of the program was presented to the committee, noting the opportunity for Public Safety to assist in conducting dual-use risk assessments, broaden the understanding of dual-use scenarios applicable to academia, and provide mitigation strategies to manage dual-use risks. Discussions regarding the financial implications of implementing mitigation strategies took place; the committee recommended highlighting resources available to academia to support these projects. In addition, the committee commented that it would be valuable to incorporate some the information presented into existing institutional values and ethics training.

The Centre for Biosecurity to circulate electronic version of presentation. Public Safety Canada to provide the AC-HPT with their risk management tool kit.

Advisory Committee Membership Renewal

The Centre for Biosecurity, Public Health Agency of Canada, provided an overview of the reappointment and replacement process for the AC-HPT. Based on the Terms of Reference of the committee, this overview included each member's terms of membership and the specific processes (including documentation) required to seek reappointment. In addition, the selection process for the committee chair was presented and discussed. Proposed subject matter expertise was discussed for incoming members including BSOs and do-it-yourself biologists. Given that the terms of several committee members (including the chair) were coming to an end, members were asked to complete a self-assessment to provide feedback on the first two years of the AC-HPT's proceedings. In addition, members were asked to complete a meeting evaluation to provide feedback on the present meeting in particular. Both evaluations will be used to assist the Secretariat in improving the Committees' structure and management.

The Centre for Biosecurity to circulate electronic versions of the member self-assessment for completion by AC-HPT members.

Closing Remarks

The Chair and the Director General of the Centre for Biosecurity, Public Health Agency of Canada gave closing remarks. The Chair thanked the committee for their active engagement and positive dynamic, noting the depth of their scientific skills and expertise. The Chair also thanked the Centre for their instrumental role in the management and advancement of work objectives of the committee. The Director General thanked the Chair for his service to the Committee. The Chair adjourned the meeting at 3:00p.m.

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