Science Advisory Report 2020/015

Environmental and Indirect Human Health Risk Assessment of the Glofish® Sunburst Orange® Danio (Danio rerio): A Transgenic Ornamental Fish

Summary

• Pursuant to the Canadian Environmental Protection Act (CEPA), a notification under the New Substances Notification Regulations (Organisms) (NSNR(O)) was submitted by GloFish LLC to Environment and Climate Change Canada (ECCC) for a genetically engineered Danio rerio (GloFish® Sunburst Orange® Danio (YZ2018)).
• 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. Indirect Human Health Risk Assessment
• The indirect human health (IHH) exposure assessment concluded that human exposure potential of YZ2018 is low to medium as its 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 YZ2018 is low as there are no reported cases of zoonotic infections associated with the YZ2018 or the non-transgenic Danio rerio. Although one of the source organisms from which the inserted genetic material was derived appears to produce toxins, there is no indication that either the inserted genetic material or the fluorescent protein is associated with any toxicity or pathogenicity in humans.
• Uncertainty associated with the IHH hazard assessment is low based on available data on the organism, information from the literature on the non-transgenic D. rerio and other ornamental aquarium fishes, and the lack of adverse effects supported by the history of safe use of YZ2018 in the United States and the use of the non-transgenic D. rerio 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 YZ2018 as an ornamental aquarium fish or other potential uses. Environmental Risk Assessment
• The environmental exposure assessment concluded that the occurrence of YZ2018 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 YZ2018 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 YZ2018 and relevant comparators and the lack of establishment through the long history of use of Danio rerio in North America.
• The environmental hazard assessment concluded that the hazards of YZ2018 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 low to moderate due to the limited data specific to YZ2018, the inconsistent results from studies on other fluorescent transgenic Zebrafish, and some reliance on expert opinion.
• There is low risk of adverse environmental effects at the exposure levels predicted for the Canadian environment from the use of YZ2018 as an ornamental aquarium fish or other potential uses. Conclusions
• The overall assessment of the use of YZ2018 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. Despite the moderate level of uncertainty in some individual assessment components, there is no current evidence to suggest that the overall risk rating may be higher than assessed.

This Science Advisory Report is from the May 8-9, 2019 peer-review meeting, Environmental and Indirect Human Health Risk Assessment of the Glofish® Sunburst Orange® Danio: Transgenic Ornamental Fish. 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 2020/015 (PDF, 869 KB)

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