2020 Record of decisions: Advisory Committee on Human Pathogens and Toxins

The Advisory Committee on Human Pathogens and Toxins (AC-HPT) met by teleconference on
November 25, 2020.

Members present on call: 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, Dr. Andrew Doxey, Ms. Joy Kearsey

Public Health Agency of Canada present on call: Mr. Rob Ward, Mr. Eméry Gahimbare, Ms. Brigitte Cadieux, Ms. Jennifer Mihowich, Ms. Shannon Chard, Ms. Kirpa Grewal Observers: Ms. Mélanie Coté, Mr. Normand Labée, Mr. Patrick Bigras, Ms. Maria Zafer

Agenda item: Welcome
(Dr. Margo Moore, Chair of AC-HPT)

The Chair welcomed the Members to the meeting and introduced the new Members of the committee, Andrew Doxey and Joy Kearsey.

Agenda item: Updates from Centre of Biosecurity and 2019 workplan update
(Rob Ward, Director of the Office of Stakeholder Engagement and Regulatory Affairs)

Discussion summary

An update was provided to Members on PHAC's work during 2020 related to the COVID-19 pandemic. As the 2020 AC-HPT face to face meeting was cancelled, we plan to hold monthly videoconferences to engage the Committee on specific topics.

PHAC announced that 3 Members as well as the Chair's terms were expiring and announced that all have agreed to renew for another term. PHAC offered thanks to the Members for their contributions to the Committee.

PHAC solicited feedback from Members on a potential face to face meeting in 2021.

The action item tracker from the 2019 face to face meeting was discussed as a number of items were put on hold or delayed due to the COVID-19 pandemic. PHAC highlighted the status of some specific items from the tracker. Members are requested to review the tracker, and provide feedback, if needed or to send any questions to the secretariat.

Suggestions of the Committee

The AC-HPT indicated that while there are benefits to in-person meetings, a face-to-face meeting in 2021 will not be feasible. The preference is to have presentations spread out over several days/weeks.

Centre for Biosecurity actions

The secretariat will work on plan for a virtual format.

Agenda item: Risk group classification of RNA derived from pathogenic single-stranded positive sense RNA viruses
(Brigitte Cadieux, Manager, Biosafety Risk Assessment)

Discussion summary

The risk assessment conducted by PHAC on single stranded positive-sense RNA (ss+RNA) derived from pathogenic viruses was circulated to the AC-HPT for 1) comments on the risk group (RG) classification, and 2) for discussion regarding the impact of regulation of ss+RNA from SARS-CoV-2 under the Health of Animals Regulations (HAR) on diagnostic laboratories.

PHAC will explore several options to alleviate the burden on diagnostic laboratories regarding the regulation of SARS-CoV-2 RNA under the HAR and provide an update to the AC-HPT at the next meeting. In addition, PHAC will explore whether droplets and aerosols are a potential route of infection for ss+RNA.

Suggestions of the Committee

Members supported the RG2 classification of ss+RNA for both humans and animals due to the inherent risk posed by this type of biological material. A member asked whether there was any evidence that transmission occurred via aerosols or droplets.

Members acknowledged that during a pandemic, there should be measures in place to exempt diagnostic laboratories from the HAR regulatory requirements related to the import of SARS-CoV-2 RNA. In addition, members agreed that PHAC should pursue a long-term solution regarding HAR regulations and diagnostic laboratories, i.e., a combination approach done in consultation with CFIA. For example, in the short-term, a temporary HAR exemption could be issued to diagnostic laboratories specifically for the import of SARS-CoV-2 RNA while in the long-term, PHAC and CFIA could pursue an amendment of the HAR to align with the Human Pathogens and Toxins Act (HPTA) with respect to diagnostic activities. Changing the RG classification of SARS-CoV-2 RNA to RG1 based on activities for the duration of the pandemic was also discussed as a potential solution but members did not support this option, mainly due to the inherent risk of ss+RNA.

Centre for Biosecurity action

The Centre for Biosecurity to consider suggestions made by the AC-HPT while pursuing the short-term and long-term solutions regarding HAR regulations for diagnostic activities.

Agenda item: Roundtable and closing
(Dr. Margo Moore, Chair of the AC-HPT)

Members are requested to provide any further thoughts or feedback on the presentation to the secretariat.

Questions were raised by members regarding how synthetic biology and gain of function are handled by the HPTA and regarding the status of the HPTA review.

PHAC thanked all Members for taking the time to participate in the teleconference and for their thorough and engaging comments.

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