Proceedings 2018/005
Proceedings of the national peer review on Environmental and Indirect Human Health Risk Assessments of the GloFish® Electric Green® Tetra and GloFish® Long-Fin Electric Green® Tetra; September 12-14, 2017
Chairperson : Gilles Olivier
Editor : Shauna Baillie
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. ECCC and HC are responsible for conducting a CEPA risk assessment to evaluate whether an organism product of biotechnology is “CEPA toxic” in accordance with Section 64 of CEPA.
In accordance with a Memorandum of Understanding between Fisheries and Oceans Canada (DFO), Environment and Climate Change Canada (ECCC), and Health Canada (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, with the support of 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. DFO provides the advice as a Science Advisory Report through the Canadian Science Advisory Secretariat (CSAS) National Review Process.
On July 5, 2017, a regulatory notification was submitted to ECCC for the GloFish® Electric Green® Tetra and the GloFish® Long-Fin Electric Green® Tetra (CGT2016), a genetically engineered tropical fish species (Black Tetra Gymnocorymbus ternetzi) notified by GloFish LLC under the NSNR(O). The notifier intends to import CGT2016 to Canada for sale as an ornamental aquarium fish. DFO and HC collaborated to conduct the environmental and indirect human health risk assessments, respectively, and to develop recommendations to support a regulatory decision by the Minister of Environment and Climate Change. The purpose of the CSAS Science National Review Process was to undertake a national peer review of the risk assessment and to develop scientific consensus on the risk assessment outcomes and recommendations provided to ECCC, which, in collaboration with HC, is responsible for the final CEPA Risk Assessment. The peer review meeting was held on September 12-14, 2017 in Ottawa, Ontario. The terms of reference and agenda for this process are found in Appendix 1 and 2, respectively. Meeting participants included experts, science advisors, and research scientists from ECCC and HC, various sectors and regions of DFO, and from the University of Ottawa, University of New Brunswick, and St Michael’s Hospital (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 will be publically available on the CSAS website.
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