Science Advisory Report 2018/027

Environmental and Indirect Human Health Risk Assessment of the Glofish® Electric Green® Tetra and the Glofish® Long-Fin Electric Green® Tetra (Gymnocorymbus ternetzi): 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 Gymnocorymbus ternetzi (GloFish® Electric Green® Tetra (CGT2016)).
  • 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 CGT2016 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.
  • Uncertainty associated with the IHH exposure assessment is moderate due to limited information regarding exposure scenarios in the Canadian market.
  • The IHH hazard assessment concluded that the indirect human hazard potential of CGT2016 is low as the source organisms for the inserted genetic materials are not pathogenic, there are no reported cases of zoonotic infections associated with the CGT2016 or the wild type, 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 available data on the organism, information from the literature on the unmodified G. ternetzi and other ornamental aquarium fishes, and the lack of adverse effects supported by the history of safe use of CGT2016 in the United States and the use of unmodified G. ternetzi 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 CGT2016 as an ornamental aquarium fish or other potential uses.
  • Environmental Risk Assessment
  • The environmental exposure assessment concluded that the occurrence of CGT2016 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 CGT2016 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 CGT2016 and wild type tetras.
  • The environmental hazard assessment concluded negligible hazards of CGT2016 through environmental toxicity, interactions with other organisms, hybridization or as a vector for disease, as well as to biodiversity, biogeochemical cycling, and habitat. There is low hazard of CGT2016 through 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 CGT2016, the inconsistent results from studies on other fluorescent transgenic organisms, and the 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 CGT2016 as an ornamental aquarium fish or other potential uses.
  • Conclusions
  • The overall assessment of the use of CGT2016 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.

This Science Advisory Report is from the September 12-14, 2017 peer-review meeting, Environmental and Indirect Human Health Risk Assessment of the Glofish® Electric Green® Tetra and the Glofish® Long-Fin Electric Green® Tetra (Gymnocorymbus ternetzi): A 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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