Environmental Risk Assessment of the GloFish® Starfire Red®, Electric Green®, Sunburst Orange®, and Galactic Purple® Barbs (Puntigrus tetrazona) : Transgenic Ornamental Fishes

Pursuant to the Canadian Environmental Protection Act (CEPA), a notification under the New Substances Notification Regulations (Organisms) (NSNR(O)) was submitted by Spectrum Brands to Environment and Climate Change Canada (ECCC) for the import of four genetically engineered lines of Tiger Barb (Puntigrus tetrazona) called the GloFish® Electric Green® Barb (GB2011), Starfire Red® Barb (RB2015), Sunburst Orange® Barb (OB2019), and Galactic Purple® Barb (PB2019), for commercial sale in Canada. The environmental risk assessment analyzed potential hazards, likelihood of exposure, and associated uncertainties to reach a conclusion on risk. The environmental exposure assessment concluded that the occurrence of GB2011, RB2015, OB2019 and PB2019 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 to the Canadian environment is ranked low. Uncertainty associated with the exposure assessment is low, given the available data for temperature tolerance of the notified lines and relevant comparators, and lack of establishment of non-transgenic P. tetrazona in North America despite a long history of use. The environmental hazard assessment concluded that potential hazards linked with environmental toxicity, trophic interactions, hybridization, disease, biodiversity, biogeochemical cycling, and habitat are negligible. There is low hazard (i.e., no anticipated harmful effects) related with horizontal gene transfer. Uncertainty associated with the environmental hazard rankings range from low to moderate due to data limitations for the notified and surrogate organisms, and some reliance on expert opinion and anecdotal evidence. The use of CRISPR during the creation of OB2019 and PB2019 may have resulted in unintended mutations in the GloFish® Barb populations, adding to uncertainty in the hazard assessment, but without altering the overall conclusions on risk. There is low risk of adverse environmental effects at the exposure levels predicted for the Canadian environment from the use of GB2011, RB2015, OB2019, and PB2019 as ornamental aquarium fish, or other potential uses.

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