Proceedings 2019/001

Proceedings of the Environmental and Indirect Human Health Risk Assessment of GloFish® Sunburst Orange®, Starfire Red®, Galactic Purple®, Cosmic Blue® and Moonrise Pink® Tetras: Transgenic Ornamental Fish; July 17-18, 2018

Chairperson: Gilles Olivier
Editor: Shauna Baillie

Summary

The purpose of this document is to record the key discussion points that arise at the CSAS national science review process entitled "Environmental and Indirect Human Health Risk Assessment of GloFish® Sunburst Orange®, Starfire Red®, Galactic Purple®, Cosmic Blue® and Moonrise Pink® Tetras: 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. 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 fish products of biotechnology. DFO may also make recommendations regarding any necessary measures to manage risk, if required.

On June 16, 2018, a regulatory submission was made by GloFish LLC under the NSNR(O) for five distinct lines of genetically-engineered Gymnocorymbus ternetzi (Black Tetra): the Sunburst Orange® Tetra, Moonrise Pink® Tetra, Starfire Red® Tetra, Cosmic Blue® Tetra, and Galactic Purple® Tetra, collectively referred to as the GloFish® Tetras. The company's intension is to import GloFish® Tetras to Canada for sale in the ornamental aquarium fish trade.

The CSAS national science review process was used to undertake a peer review of the two risk assessments, and to develop scientific consensus on the risk assessment conclusions and recommendations provided to ECCC and HC. A peer review meeting was held July 17-19, 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 from DFO, ECCC, and HC, and external to government (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.