Record of Decisions

Welcome and Introductions

The Director General, Centre for Biosecurity, Public Health Agency of Canada (PHAC), gave opening remarks, welcomed all members, and introduced the Chair of 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 new members. The meeting agenda was reviewed and approved, and there were no declarations of conflict of interest by any members. The 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.

-

PHAC's internal review of the Human Pathogens and Toxins Regulations

The Centre for Biosecurity, PHAC, presented on the Human Pathogens and Toxins Act/Regulations (HPTA/R) program evaluation. Driving factors, timelines and work activities were discussed. AC-HPT members were asked to provide comments regarding challenges with the current HPTA/R requirements, and identify any gaps within the current regulatory regime.

The Centre for Biosecurity will proceed with the HPTA/R program evaluation and include AC-HPT recommendations.

The Centre for Biosecurity will develop a Biosafety Newsletter item to help clarify the requirements for shipping materials internationally.

PHAC's Risk Group Database: ePATHogen

The Centre for Biosecurity, PHAC, presented on ePATHogen, PHAC's soon to be released public facing biological agent search tool. This search tool will allow greater access to the risk group database, and has improved search functionality compared to what is currently available through the Biosecurity Portal. The ePATHogen risk group database was demonstrated to the AC-HPT. Committee members noted a few improvements for increased ease of use and clarity.

The Centre for Biosecurity will incorporate comments from the AC-HPT into ePATHogen, and proceed with the launch of the tool.

Update on International Activities

The Centre for Biosecurity, PHAC, presented an overview of international activities carried out by the Centre. Particular focus was placed on designation as a WHO Collaborating Centre for Biosafety and Biosecurity, as well as activities associated with the International Health Regulations Joint External Evaluation, the Global Polio Eradication Initiative, the Global Health Security Agency, the Biological Weapons Convention, and the International Experts Group of Biosafety and Biosecurity Regulators. The AC-HPT agreed to promote the international activities of the Centre and offered their expertise, as needed.

The AC-HPT noted that there is a push in academic institutions to increase science awareness in the community by hosting hands-on activities. Guidance materials for students working in the laboratory would be helpful.

The Centre for Biosecurity will consult with the AC-HPT, as required, in their international activities related to biosafety and biosecurity.

The Centre for Biosecurity will send the first draft of the Analytical Approach to the AC-HPT.

The AC-HPT will share any student guidance material that has already been developed to support the creation of training materials for students.

Toxin Risk Assessment Methodology

In preparation for the review and update of Schedule 1 to the HPTA, the Centre for Biosecurity, PHAC, presented a draft toxin risk assessment methodology, as well as a decision tree for identification of toxins for potential addition to Schedule 1.  

The Centre for Biosecurity will establish small working groups in consultation with the
AC-HPT, to review and provide recommendations on the draft toxin risk assessment methodology and decision tree.

AC-HPT members will submit names of individuals to be considered for participation in toxins working group.

Dual-Use Awareness/Education

The Centre for Biosecurity, PHAC presented on dual-use awareness and education activities, including the decision tree for identification of research with potential for dual-use, what the Centre has learnt through the Plan for Administrative Oversight, and the results from a small dual-use survey conducted among Canadian academic institutions. A discussion ensued regarding the generalized lack of understanding regarding the concept of dual-use amongst stakeholders and the biosafety community, and the reluctance of researchers to identify work with dual-use potential due to fear of negative implications on their work. The committee suggested that additional training material and tools would be beneficial to address these issues.

The Centre for Biosecurity will review its awareness and education activities related to dual-use, and in consultation with the AC-HPT, modify/develop training materials to help stakeholders understand, identify, and mitigate research with dual-use potential.

The AC-HPT will review and provide feedback on the draft dual-use guideline.

Regulatory Openness and Transparency Framework

The Regulatory Openness and Transparency Framework and the implementation plan was presented by the Centre for Biosecurity, PHAC. By end of fiscal 2019/20, PHAC will be required to post information on inspection reports and incident reports on the Canada.ca website. The AC-HPT voiced some concerns over the release of this information, in particular, the reputational risk to an institution, the indirect identification of an institution/individual involved in an incident, and biosecurity risk.

The Centre for Biosecurity will continue to consult the AC-HPT, leading up to implementation of the Regulatory Openness and Transparency Framework.

Closing Remarks

The Chair adjourned the meeting at 4:15 pm.

-

Innovation Needs and Opportunities for PHAC

The Office of the Chief Science Officer, PHAC, presented on how innovation has been used at PHAC, and what innovation opportunities are available through the Built in Canada Innovation Program (BCIP) offered by Innovative Solutions CDay 1: Monday May 14^th, 2018anada. Key areas of interest for PHAC are novel technologies and tools to handle computational demands for disease risk assessment, as well as tools to improve the provision of evidence-based advice to Canadians on how to maintain and improve their health.

-

Innovation and Data Intensive Science

AC-HPT members were given the opportunity to present on innovative projects ongoing at their institutions.
Dr. Fiona Smail presented on pre-clinical drug development work at McMaster University, including a drug to halt antimicrobial resistance, a universal influenza vaccine, and a vaccination strategy for tuberculosis.
Dr. Maurice Boissinot presented work on big data analytics for microorganisms that is ongoing at University of Laval. This type of data analysis has led to the discovery of new bacterial species, the analysis of the metagenome, machine learning and artificial intelligence, study of the evolution of prokaryotes, antibiotic resistance in clinical isolates, large scale comparison of species, and microbiome comparisons.

-

Risk Group Classification Methodology for Borderline Agents

The Centre for Biosecurity, PHAC, presented on the draft risk assessment triage for borderline Risk Group 1 and Risk Group 2 biological agents. The AC-HPT provided feedback on the triage tool, and suggested the incorporation of confidence levels into the template.

The Centre for Biosecurity will incorporate suggestions made the AC-HTA into the triage tool, and finalize it.

PHAC's Inspection Program

The Centre for Biosecurity, PHAC presented on the Laboratory Inspection Program. The risk-based system used to prioritize inspections was presented, along with the most common deficiencies observed during inspections. The AC-HPT noted that there are gaps in the local risk assessment guideline with respect to how to conduct a local risk assessment. In particular, an expansion of the expectations of the outcome of the local risk assessment, and the implications for licencing are required.

The Centre for Biosecurity will seek detailed comments from the AC-HPT on the local risk assessment guideline.

PHAC's Laboratory Incident Notification Program

The Centre for Biosecurity, PHAC presented an overview of the Laboratory Incident Notification Program and highlighted the findings from the first annual report. The AC-HPT noted that the highest number of reported exposure incidents is sharps-related. Through analysis of incident notification data, PHAC was able to identify a trend in exposure events related to the use of MALDI-TOF MS (matrix-assisted laser desorption/ionization time of flight mass spectrometry) in Canada.

The Centre for Biosecurity will prepare a Biosafety and Biosecurity Newsletter item to increase awareness of the risks associated with the use of sharps, and MALDI – TOF MS.

WHO Polio Eradication

The Centre for Biosecurity, PHAC, presented on Canada's contributions to the WHO's global polio eradication strategy. PHAC solicited input from the AC-HPT on specific Canadian groups that should be surveyed for the identification of potentially infectious poliovirus material (PIM). This information will be included in the Poliovirus National Report requested by the Pan American Health Organization. The AC-HPT noted the tight timeline (Aug 2018) for the identification of PIM.

-

Advisory Committee Work Plan for 2018-2019

The Centre for Biosecurity, PHAC, presented the 2018-2019 workplan to the AC-HPT.

The Centre for Biosecurity, PHAC, requested input from the AC-HPT on the identification of laboratory activities with Cryptococcus gattii that pose a higher risk, to be included in a directive for working with RG3 fungi in a CL 2 laboratory. The AC-HPT noted that the mold form of C. gattii is more risky than the yeast form, and hence research projects that involve mating experiments, habitat surveys, large scale growth, and evolution of drug resistance would be considered higher risk activities. The yeast form of C. gattii would be the most likely form encountered in a clinical lab, and this form is not particularly pathogenic.

The Centre for Biosecurity will consult with the AC-HPT, as required, throughout the next year, for completion of the items listed on the 2018-2019 workplan.

The AC-HPT Secretariat will launch a process to recruit a Toxinologist and Parasitologist in the coming calendar year.

Meeting Evaluation / Travel Claims

The Centre for Biosecurity, PHAC, gave guidance to AC-HPT members on how to fill their travel claims and complete the meeting evaluation.

AC-HPT members to complete meeting evaluation forms and to submit travel claims.

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 3:00 p.m.

-