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Proceedings 2020/004

Proceedings of the Environmental and Indirect Human Health Risk Assessment of GloFish® Sunburst Orange® Danio (Danio rerio): A Transgenic Ornamental Fish; May 8-9, 2019

Chairperson: Gilles Olivier

Editor: Melissa Gagné

Summary

The purpose of this document is to record the key discussion points from the CSAS national science review process entitled "Environmental and Indirect Human Health Risk Assessment of GloFish® Sunburst Orange® Danio (Danio rerio): A Transgenic Ornamental Fish".

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 to harm the environment and human health prior to their import to or manufacture in Canada. In accordance with a Memorandum of Understanding 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 based on an environmental risk assessment, and, in collaboration with HC, on the indirect human health risk assessment for living fish that are products of biotechnology. DFO may also make recommendations regarding any necessary measures to manage risk, if required.

On March 4, 2019, a regulatory submission was made by GloFish LLC under the NSNR(O) for a genetically-engineered Danio rerio (Zebrafish): the Sunburst Orange® Danio. The company's intention is to import GloFish® Sunburst Orange® Danio to Canada for sale in the ornamental aquarium fish trade. The CSAS national science advisory process was used to undertake a peer review of the two risk assessments (environmental and indirect human health), and to develop scientific consensus on the risk assessment conclusions and recommendations provided to ECCC and HC to inform the CEPA risk assessment and decision.

A peer review meeting was held May 8-9, 2019 in Ottawa, Ontario. The terms of reference and agenda for this process are found in Appendix 1 and 2, respectively. Meeting participants included experts from DFO, ECCC, HC, and academia (Appendix 3). The conclusions and advice resulting from this meeting are provided in the form of a Science Advisory Report, as well as two peer-reviewed risk assessment documents that are made publically available on the CSAS website.

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