Environmental and Indirect Human Health Risk Assessment of the GloFish® Electric Green®, Sunburst Orange® and Moonrise Pink® Corydoras (Corydoras aeneus) : Three Lines of Transgenic Ornamental Fish

Abstract

Pursuant to the Canadian Environmental Protection Act, 1999 (CEPA), three notifications under the New Substances Notification Regulations (Organisms) (NSNR(O)) were submitted by Spectrum Brands to Environment and Climate Change Canada (ECCC) for genetically engineered Corydoras aeneus GloFish® Electric Green® Cory (GCA2021), GloFish® Sunburst Orange® Cory (OCA2020), and GloFish® Moonrise Pink® Cory (PiCA2020). Environmental and indirect human health risk assessments were conducted that included analyses of potential hazards, likelihoods of exposure, and associated uncertainties to reach conclusions on risk and to provide science advice to ECCC and Health Canada (HC) to inform their CEPA risk assessment. Environmental Risk Assessment The environmental exposure assessment concluded that the occurrence of GCA2021, OCA2020, and PiCA2020 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 GCA2021, OCA2020, and PiCA2020 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 in Canada through the long history of use of non-transgenic C. aeneus in North America. The environmental hazard assessment concluded that the hazards of GCA2021, OCA2020, and PiCA2020 associated with environmental toxicity, trophic interactions, hybridization, vector for disease, biogeochemical cycling, habitat, and biodiversity 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 negligible to moderate, depending on availability and quality of data for the notified and surrogate organisms, and 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 GCA2021, OCA2020, and PiCA2020 as an ornamental aquarium fish or other potential uses. Indirect Human Health Risk Assessment The indirect human health (IHH) exposure assessment concluded that human exposure potential of GCA2021, OCA2020, and PiCA2020 is low to medium given their intended use as an ornamental aquarium fish. Exposure is limited to those who possess them for use in home aquaria, primarily through tank maintenance, and would include potentially vulnerable individuals (e.g., immunocompromised, children, those with underlying medical conditions). Uncertainty associated with the IHH exposure assessment is moderate due to limited information on future import quantities, market uptake, and exposure scenarios in Canada. The IHH hazard assessment concluded that the indirect human hazard potential of GCA2021, OCA2020, and PiCA2020 is low as there are no reported cases of zoonotic infections associated with the GloFish® Corydoras, wild-type C. aeneus, and other commercially available GloFish® lines, arising from aquarium use. Although some of the source organisms from which the inserted genetic material were derived produce toxins, there is no indication that the inserted genetic material is associated with any toxicity, allergenicity, or pathogenicity in humans. Uncertainty associated with the IHH hazard assessment is low, based on available data on the organisms, information from the literature on the non-transgenic C. aeneus and other ornamental aquarium fishes, and the lack of adverse effects supported by the history of safe use of all commercially available GloFish® lines. There is a low risk of adverse indirect human health effects at the exposure levels predicted for the Canadian population from the use of GCA2021, OCA2020, and PiCA2020 as ornamental aquarium fish or other potential uses. Conclusion and Summary The overall assessment of the intended use of GCA2021, OCA2020, and PiCA2020 in the ornamental aquarium trade, or other potential uses, in Canada is low risk to the Canadian environment and to the indirect human health of Canadians. Although there was moderate uncertainty associated with some of the assessment components, these did not affect the overall risk ratings. The use of guide RNA and Cas9 during line creation may have resulted in off-target mutations in the GloFish® Corydoras populations, and this contributed to the uncertainty in both hazard assessments, but did not alter the overall conclusions on risk. Notification of the GloFish® Corydoras under CEPA follows similar previous GloFish® notifications for six lines of GloFish® Tetra (DFO 2018, 2019), three lines of GloFish® Danio (DFO 2020a, 2020b), three lines of GloFish® Betta (DFO 2021), four lines of GloFish® Barb (DFO 2023), four lines of GloFish® Pristella (DFO 2024), and four lines of GloFish® Rainbow Shark (DFO in press).