Proceedings 2020/028

Proceedings of the National Peer Review on Environmental and Indirect Human Health Risk Assessment for the Manufacture and Production of Sterile AquAdvantage® Salmon at a Land-Based and Contained Facility near Rollo Bay, PEI; December 11-13, 2018

Chairperson: Gilles Olivier

Editor: Lily Weber

Summary

The Canadian Environmental Protection Act (CEPA), administered by Environment and Climate Change Canada (ECCC) and Health Canada (HC), is the key authority for the Government of Canada to ensure that all new substances, including living organisms, are assessed for their potential harm to the environment and human health prior to their manufacture or import into Canada. In accordance with a Memorandum of Understanding (MOU) between Fisheries and Oceans Canada (DFO), ECCC, and HC, DFO assists in implementing the New Substances Notification Regulations (Organisms) [NSNR(O)] by providing science advice that is based on an environmental risk assessment for fish products of biotechnology, and, along with HC, on the indirect human health risk assessment for fish products of biotechnology. DFO may also make recommendations regarding any necessary measures to manage risks, if required.

On July 27, 2018, AquaBounty Canada Inc. submitted a regulatory package to ECCC under the NSNR(O) of the Canadian Environmental Protection Act (CEPA) for the manufacture and production of EO-1α Salmon, a fast growing, genetically engineered Atlantic Salmon (Salmo salar), at a new land-based aquaculture facility, near Rollo Bay, PEI. AquaBounty Canada submitted a similar notification in 2013, detailing its intent to commercially manufacture the EO-1α Salmon, in a land-based contained facility near Fortune Bay, PEI. For the current assessment, DFO and HC collaborated to conduct the environmental and indirect human health risk assessments, respectively, and to develop recommendations, taking into account the previous Science Advice for the previous notification to support a regulatory decision by the Ministers of ECCC and HC.

The CSAS national science advisory process was used to peer review the two risk assessments and to develop scientific consensus on the risk assessment outcomes and recommendations provided to ECCC and HC. A peer review meeting was held on December 11-13, 2018 in Ottawa, Ontario. The terms of reference and agenda for this process are found in Appendix 1 and 2, respectively. Meeting participants included experts and scientists from DFO, ECCC and HC, the government of PEI, academia, the Atlantic Salmon Federation and the US National Oceanographic and Atmospheric Administration (Appendix 3). The conclusions and advice resulting from this meeting are provided in the form of a Science Advisory Report, as well as two  research documents containing the details of the risk assessments and will be publically available on the CSAS website. The purpose of this document is to summarize the key discussions points and conclusions from the peer-review meeting.