Science Advisory Report 2021/046

Environmental and Indirect Human Health Risk Assessment of the GloFish® Bettas: three lines of transgenic ornamental fish

Summary

• Pursuant to the Canadian Environmental Protection Act (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 Betta splendens (GloFish® Electric Green® Betta (GBS2019), GloFish® Moonrise Pink® Betta (PiBS2019) and GloFish® Sunburst Orange® Betta (OBS2019).
• 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® Danio and Tetra lines.

Environmental Risk Assessment

• 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 their inability to survive typical low winter temperatures in Canada’s freshwater environments. Consequently, the likelihood of exposure of GBS2019, PiBS2019 and OBS2019 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 Betta splendens in North America.
• The environmental hazard assessment concluded that the hazards of GBS2019, PiBS2019 and OBS2019 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 negligible 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 GBS2019, PiBS2019 and OBS2019 as an ornamental aquarium fish or other potential uses.

Human Health Risk Assessment

• The indirect human health (IHH) exposure assessment concluded that human exposure potential of GBS2019, PiBS2019 and OBS2019 is low to medium as their intended use is as an ornamental aquarium fish, thus largely limiting public exposure to those individuals who possess them for use in home aquaria, primarily through tank maintenance, and would include potentially vulnerable individuals (e.g., immunocompromised, children, those with medical conditions).
• Uncertainty associated with the IHH exposure assessment is moderate due to limited information on future import quantities and market uptake, and regarding exposure scenarios in Canada.
• The IHH hazard assessment concluded that the indirect human hazard potential of GBS2019, PiBS2019 and OBS2019 is low as there are no reported cases of zoonotic infections associated with the other commercially available GloFish® lines and only one report for the non-transgenic Betta splendens 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 B. splendens and other ornamental aquarium fishes, and the lack of adverse effects supported by the history of safe use of all commercially available GloFish® lines including GBS2019 and the non-transgenic B. splendens in Canada and other countries.
• There is a low risk of adverse indirect human health effects at the exposure levels predicted for the Canadian population from the use of GBS2019, PiBS2019 and OBS2019 as ornamental aquarium fish or other potential uses.

Conclusion and Summary

• The overall assessment of the use of GBS2019, PiBS2019 and OBS2019 in the ornamental aquarium trade or other potential uses in Canada is a low risk to the indirect human health of Canadians and to the Canadian environment. Although there was moderate uncertainty associated with a few of the assessment components, these do not affect confidence in the overall risk ratings. Assessment conclusions were consistent with those for the GloFish® Danios and GloFish® Tetras.
• The use of guide RNA and Cas9 during line creation may have resulted in off-target mutations in the GloFish® Betta populations, and this adds to the uncertainty in both hazard assessments, but there is no information to suggest that this would alter overall conclusions on risk.

This Science Advisory Report is from the April 22-23, 2021 Canadian Science Advisory Secretariat (CSAS) national advisory meeting on Environmental and Indirect Human Health Risk Assessment of GloFish® Moonrise Pink®, Sunburst Orange®, and Electric Green® Bettas: Transgenic Ornamental Fishes. Additional publications from this meeting will be posted on the Fisheries and Oceans Canada (DFO) Science Advisory Schedule as they become available.

Science Advisory Report 2021/046 (PDF, 459 KB)

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