Science Advisory Report 2020/016

Environmental and Indirect Human Health Risk Assessment of GloFish^® Cosmic Blue^® and Galactic Purple^® Danios (Danio rerio): Transgenic Ornamental Fish

Summary

• Pursuant to the Canadian Environmental Protection Act (CEPA), two notifications under the New Substances Notification Regulations (Organisms) (NSNR(O)) were submitted by GloFish LLC to Environment and Climate Change Canada (ECCC) for genetically engineered Danio rerio (GloFish^® Cosmic Blue^® Danio (BZ2019) and GloFish^® Galactic Purple^® Danio (PZ2019)).
• 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 previously notified GloFish^® Sunburst Orange^® Danio (YZ2018).

Indirect Human Health Risk Assessment

• The indirect human health (IHH) exposure assessment concluded that human exposure potential of BZ2019 and PZ2019 is low to medium as their intended use is as 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 BZ2019 and PZ2019 is low as there are no reported cases of zoonotic infections associated with the notified lines or the non-transgenic Danio rerio 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 either the inserted genetic material or the pigment proteins are 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 D. rerio and other ornamental aquarium fishes, and the lack of adverse effects supported by the history of safe use of BZ2019 and PZ2019 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 BZ2019 and PZ2019 as ornamental aquarium fish or other potential uses.

Environmental Risk Assessment

• The environmental exposure assessment concluded that the occurrence of BZ2019 and PZ2019 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 BZ2019 and PZ2019 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 Danio rerio in North America.
• The environmental hazard assessment concluded that the hazards of BZ2019 and PZ2019 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 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 BZ2019 and PZ2019 as an ornamental aquarium fish or other potential uses.

Conclusions

• The overall assessment of the use of BZ2019 and PZ2019 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^® Sunburst Orange^® Danio.

This Science Advisory Report is from the July 4, 2019 Environmental and Indirect Human Health Risk Assessments of GloFish^® Cosmic Blue^® and Galactic Purple^® Danios: 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 2020/016 (PDF, 987 KB)

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