Research Document 2021/005

Environmental Risk Assessment of the GloFish^® Galactic Purple^® and Cosmic Blue^® Danios: Transgenic Ornamental Fish

By McGowan, C., and Leggatt, R.

Abstract

Pursuant to the Canadian Environmental Protection Act (CEPA), two notifications under the New Substances Notification Regulations (Organisms) (NSNR(O)) were submitted by GloFish LLC to Environment and Climate Change Canada (ECCC) for genetically engineered Danio rerio (GloFish^® Cosmic Blue^® Danio (BZ2019) and GloFish^® Galactic Purple^® Danio (PZ2019)). The environmental risk assessment was conducted that included an analysis of potential hazards, likelihoods of exposure, and associated uncertainties to reach conclusions on risk. Assessments were compared with previously notified GloFish^® Sunburst Orange^® Danio (YZ2018). The environmental exposure assessment concluded that the occurrence of BZ2019 and PZ2019 in the Canadian environment, outside of aquaria, is expected to be rare, isolated, and ephemeral due to their inability to survive typical low winter temperatures in Canada’s freshwater environments. Consequently, the likelihood of exposure of BZ2019 and PZ2019 to the Canadian environment is ranked low. The uncertainty associated with this environmental exposure estimation is low, given the available data for temperature tolerance of the notified lines and relevant comparators and the lack of establishment through the long history of use of non-transgenic Danio rerio in North America. The environmental hazard assessment concluded that the hazards of BZ2019 and PZ2019 associated with environmental toxicity, trophic interactions, hybridization, vector for disease, biodiversity, biogeochemical cycling, and habitat are negligible. There is low hazard (i.e., no anticipated harmful effects) associated with horizontal gene transfer. The uncertainty levels, associated with the environmental hazard ratings, range from low to moderate due to data limitations and quality for the notified and surrogate organisms, or some reliance on expert opinion and anecdotal evidence. There is low risk of adverse environmental effects at the exposure levels predicted for the Canadian environment from the use of BZ2019 and PZ2019 as an ornamental aquarium fish or other potential uses.

Research Document 2021/005 (PDF, 820 KB)

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