Science Advisory Report 2023/043

*This advice was developed in a peer review meeting in 2022 and should be interpreted within the context of the situation at that time.

Environmental and Indirect Human Health Risk Assessment of GloFish® Starfire Red®, Electric Green®, Sunburst Orange®, and Galactic Purple® Barbs (PuntiGrus tetrazona): Transgenic Ornamental Fish

Summary

• Pursuant to the Canadian Environmental Protection Act (CEPA), four notifications were submitted under the New Substances Notification Regulations (Organisms) (NSNR[O]) by Spectrum Brands to Environment and Climate Change Canada (ECCC) for genetically engineered PuntiGrus tetrazona: GloFish® Electric Green® Barb (GB2011), GloFish® Starfire Red® Barb (RB2015), GloFish® Sunburst Orange® Barb (OB2019), and GloFish® Galactic Purple® Barb (PB2019).
• 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® Tetra, Danio, and Betta lines.

Environmental Risk Assessment

• The environmental exposure assessment concluded that the occurrence of GB2011, RB2015, OB2019, and PB2019 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 GB2011, RB2015, OB2019, and PB2019 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 P. tetrazona in North America.
• The environmental hazard assessment concluded that the hazards of GB2011, RB2015, OB2019, and PB2019 associated with environmental toxicity, trophic interactions, hybridization, disease transmission, biodiversity, biogeochemical cycling, and habitat are negligible. There is low hazard associated with horizontal gene transfer.
• The uncertainty levels associated with the environmental hazard ratings range from low to moderate due to data limitations for the notified and surrogate organisms, and 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 GB2011, RB2015, OB2019, and PB2019 as ornamental aquarium fish or other potential uses.

Indirect Human Health Risk Assessment

• The indirect human health (IHH) exposure assessment concluded that human exposure potential of GB2011, RB2015, OB2019, and PB2019 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 (e.g., exposure through tank maintenance), potentially including vulnerable individuals (e.g., immunocompromised, children, those with medical conditions).
• Uncertainty associated with the IHH exposure assessment is moderate due to limited information regarding future import quantities, market uptake, and exposure scenarios in Canada.
• The IHH hazard assessment concluded that the indirect human hazard potential of GB2011, RB2015, OB2019, and PB2019 is low as there are no reported cases of zoonotic infections associated with the other commercially available GloFish® lines or wild-type P. tetrazona arising from aquarium use. Although the inserted genetic material was derived from some source organisms that 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 P. tetrazona and other ornamental aquarium fishes, and the lack of adverse effects supported by the history of safe use of all commercially available GloFish® lines and non-transgenic P. tetrazona 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 GB2011, RB2015, OB2019, and PB2019 as ornamental aquarium fish or other potential uses.

Conclusion and Summary

• Overall, GB2011, RB2015, OB2019, and PB2019 imported for aquarium use pose a low risk to the Canadian environment and the indirect human health of Canadians. Although there was moderate uncertainty associated with some of the assessment components, these do not affect confidence in the overall risk ratings. Assessment conclusions were consistent with those for the GloFish® Tetras, Danios, and Bettas

This Science Advisory Report is from the April 13-14, 2022 National Advisory Meeting on the Environmental and Indirect Human Health Risk Assessment of the Glofish® Electric Green®, Starfire Red®, Sunburst Orange®, And Galactic Purple® Barbs (PuntiGrus tetrazona): 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 2023/043 (PDF, 577 KB)

Accessibility Notice

This document is available in PDF format. If the document is not accessible to you, please contact the Secretariat to obtain another appropriate format, such as regular print, large print, Braille or audio version.