Environmental and indirect human health risk assessment of GloFish® Pristella Tetras : transgenic ornamental fishes

Pursuant to the Canadian Environmental Protection Act (CEPA), four notifications were submitted under the New Substances Notification Regulations (Organisms) (NSNR[O]) by Spectrum Brands to Environment and Climate Change Canada (ECCC) for genetically engineered Pristella Tetras: GloFish® Electric Green® (GPM2021), Starfire Red® (RPM2022), Sunburst Orange® (OPM2021), and Galactic Purple® (PPM2021) Pristella Tetra. Environmental and indirect human health risk assessments were conducted that included an analysis 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. Assessments were compared with the assessments of previously notified GloFish® Tetra, Danio, Betta, and Barb lines. Environmental Risk Assessment The environmental exposure assessment concluded that the occurrence of GPM2021, RPM2022, OPM2021, and PPM2021 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 and brackish environments. Consequently, the likelihood of exposure of GPM2021, RPM2022, OPM2021, and PPM2021 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 P. maxillaris in North America. The environmental hazard assessment concluded that the hazards of GPM2021, RPM2022, OPM2021, and PPM2021 associated with environmental toxicity, trophic interactions, hybridization, disease transmission, biodiversity, biogeochemical cycling, and habitat are negligible. There is low hazard associated with horizontal gene transfer. The uncertainty levels 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. There is low risk of adverse environmental effects at the exposure levels predicted for the Canadian environment from the use of GPM2021, RPM2022, OPM2021, and PPM2021 for use as 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 GPM2021, RPM2022, OPM2021, and PPM2021 is low to medium. Their intended use is in the ornamental aquarium trade, thus largely limiting public exposure to those individuals who possess them for use in home aquaria, potentially including vulnerable individuals. Uncertainty associated with the IHH exposure assessment is moderate due to limited information regarding future import quantities, market uptake, and exposure scenarios in Canada. The IHH hazard assessment concluded that the indirect human hazard potential of GPM2021, RPM2022, OPM2021, and PPM2021 is low. There are no reported cases of zoonotic infections associated with the other commercially available GloFish® lines or wild-type P. maxillaris arising from aquarium use. 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. This is based on available data about the organisms, and information from the literature about non-transgenic P. maxillaris and other ornamental aquarium fishes. The history of use of all commercially available GloFish® lines and non-transgenic P. maxillaris in Canada and other countries further supports this assessment. There is a low risk of adverse indirect human health effects at the exposure levels predicted for the Canadian population from the use of GPM2021, RPM2022, OPM2021, and PPM2021 as ornamental aquarium fish or other potential uses. Conclusion and Summary Overall, GPM2021, RPM2022, OPM2021, and PPM2021 imported for aquarium use pose a 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 do not affect confidence in the overall risk ratings. Assessment conclusions of the notified lines of GloFish® Pristella Tetra were consistent with those for the GloFish® Tetras, Danios, Bettas, and Barbs.

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