Environmental Risk Assessment of the GloFish® Electric Green®, Moonrise Pink®, and Sunburst Orange® Bettas : Three Lines of Transgenic Ornamental Fish

Abstract

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 three genetically engineered Betta splendens called the GloFish® Electric Green® Betta (GBS2019), Moonrise Pink® Betta (PiBS2019) and Sunburst Orange® Betta (OBS2019) for commercial sales 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 GBS2019, PiBS2019 and OBS2019 in the Canadian environment, outside of aquaria, is expected to be rare, isolated, and ephemeral due to its 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 line and relevant comparators, and lack of establishment of non-transgenic B. splendens 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 ratings range from negligible to moderate due to data limitations for the notified and surrogate organisms, and some reliance on expert opinion and anecdotal evidence. The use of guide RNA and Cas9 during line creation may have resulted in off-target mutations in the GloFish® Betta 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 GBS2019, PiBS2019 and OBS2019 as ornamental aquarium fish, or other potential uses.