Science Advisory Report 2019/002

Environmental and Indirect Human Health Risk Assessment of the GloFish® Tetras (Gymnocorymbus ternetzi): Five Lines of Transgenic Ornamental Fish

Summary

• Pursuant to the Canadian Environmental Protection Act (CEPA), five notifications of living organisms under the New Substances Notification Regulations (Organisms) (NSNR(O)) were submitted by GloFish LLC to Environment and Climate Change Canada (ECCC) for five distinct lines of genetically-engineered Gymnocorymbus ternetzi (Black Tetra): the Sunburst Orange® Tetra, Moonrise Pink® Tetra, Starfire Red® Tetra, Cosmic Blue® Tetra, and Galactic Purple® Tetra. Here, they are collectively referred to as the GloFish® Tetras.
• Environmental and indirect human health risk assessments were conducted that included an analysis of potential hazards, likelihood 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 the GloFish® Tetras 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.
• Uncertainty associated with the IHH exposure assessment is moderate due to limited information regarding exposure scenarios (i.e., information on number of people purchasing fish and how they will handle them) in the Canadian market.
• The IHH hazard assessment concluded that the indirect human hazard potential of the GloFish® Tetras is low as the inserted genetic materials are not known to be toxic or pathogenic to humans, there are no reported cases of zoonotic infections associated with GloFish® Tetras or the wild type (i.e., non-genetically modified Black Tetra), there is safe history of use of the notified lines in the US, and based on the sequence identity and the structure of the inserted transgenes, the production of allergens or toxins is not anticipated.
• Uncertainty associated with the IHH hazard assessment is low based on reliance on information from other ornamental aquarium fish and lack of direct studies investigating human health effects of fluorescent transgenic ornamental fish.
• Therefore, there is a low risk of adverse indirect human health effects at the exposure levels predicted for the Canadian population from the use of GloFish® Tetras as an ornamental aquarium fish or other potential uses.

Environmental Risk Assessment

• The environmental exposure assessment concluded that the exposure of GloFish® Tetras to the Canadian environment is low. The occurrence outside of aquaria is possible, but it is expected to be rare, isolated and ephemeral due to their inability to survive typical low winter temperatures in Canada's freshwater environments.
• The uncertainty associated with this environmental exposure estimation is low, given the available data for temperature tolerance of the five GloFish® Tetras and wild type tetras.
• The environmental hazard assessment concluded negligible hazards of the GloFish® Tetras to the Canadian environment with respect to: environmental toxicity, interactions with other organisms, hybridization or as a vector for disease, as well as to biodiversity, biogeochemical cycling, and habitat. There is a low hazard rating of GloFish® Tetras with respect to horizontal gene transfer (i.e., no anticipated harmful effects).
• The uncertainty levels, associated with the environmental hazard ratings, range from negligible to moderate due to the limited data specific to the GloFish® Tetras, the inconsistent results from studies on other fluorescent transgenic organisms, and the reliance on expert opinion.
• Therefore, there is low risk of adverse environmental effects at the exposure levels predicted for the Canadian environment from the use of GloFish® Tetras as an ornamental aquarium fish or other potential uses.

Conclusions

• The overall assessment of the use of GloFish® Tetras 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 moderate level of uncertainty in some individual assessment components, there is no current evidence to suggest overall risk ratings of GloFish® Tetras used for the ornamental aquarium trade in Canada may be higher than the assessed low rating risk to Canadians and to the Canadian environment.

This Science Advisory Report is from the July 17 -18, 2018 peer-review meeting, Environmental and Indirect Human Health Risk Assessment of GloFish® Sunburst Orange®, Starfire Red®, Galactic Purple®, Cosmic Blue® and Moonrise Pink® Tetras: 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.

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