Science Advisory Report 2019/014

Environmental and Indirect Human Health Risk Assessments for the Manufacture and Grow-out of EO-1α Salmon, including the AquAdvantage® Salmon, at a Land-Based and Contained Facility near Rollo Bay, PEI

Summary

• Pursuant to the Canadian Environmental Protection Act (CEPA), a notification under the New Substances Notification Regulations (Organisms) (NSNR(O)) was submitted by AquaBounty Canada Inc. to Environment and Climate Change Canada (ECCC) for the manufacture and grow-out of a genetically engineered Atlantic Salmon (i.e., the AquAdvantage® EO-1α Salmon) at a new site in PEI, near Rollo Bay.
• 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 toxicity assessment. This risk assessment included consideration of two scenarios:
• Scenario A: the production of non-transgenic fish, for external parties, occurring along-side transgenic fish production under existing and planned procedures; and
• Scenario B: no production of non-transgenic fish, for external parties, at facilities producing transgenic fish.
• In addition to the two scenarios, additional measures were identified that could further reduce exposure and risk of Scenario A (see below in Risk Mitigation section).

Environmental Risk Assessment

• The assessment concluded that environmental exposure attributed to the EO-1α Salmon will be negligible to low in the Canadian environment, recognizing that there are physical, biological and operational measures in place or planned at the Rollo Bay facility that could prevent  unintentional environmental release.
• For Scenario A, where the production of non-transgenic fish for external parties occurs with transgenic fish, the likelihood of exposure of EO-1α Salmon to the Canadian environment is ranked low.
• For Scenario B, where there is no production of non-transgenic fish for external parties, the likelihood of exposure of EO-1α Salmon to the Canadian environment is ranked negligible.
• The uncertainty associated with this environmental exposure estimation is low, given the available information on physical, biological and operational containment of the organism. Production of non-transgenic fish under Scenario A could increase uncertainty in exposure.
• The environmental hazard assessment for EO-1α Salmon ranged from negligible to high depending on the type of interaction considered, such as through environmental toxicity, horizontal gene transfer, as a vector for disease, or effects to biodiversity, biogeochemical cycling, and habitat, with highest ratings through trophic interactions with other organisms and intraspecific hybridization.
• The uncertainty levels associated with the environmental hazard ratings range from moderate to high due to limited data on EO-1α Salmon under a variety of relevant environmental conditions, presence but limited understanding of genotype by environment (GxE) interactions in surrogate models (comparator species, non-transgenic siblings, or domestic strains), and limited understanding of how data from surrogate organisms can be extrapolated to the organism.
• There is negligible to moderate risk of adverse environmental effects at the exposure and hazard levels predicted for the Canadian environment from the use of EO-1α Salmon at the Rollo Bay facility:
• under the proposed use scenario where non-transgenic fish are produced for external parties (Scenario A) the risk is low to moderate; and
• if non-transgenic fish were not sold to external parties (Scenario B), there is negligible to low risk of adverse environmental effects.

Indirect Human Health Risk Assessment

• The indirect human health (IHH) exposure assessment concluded that human exposure potential of the EO-1α Salmon is low, as physical, biological and operational measures are in place or planned at the Rollo Bay facility to prevent unintentional environmental release, thus greatly limiting human exposure to the notified organism. This ranking is not expected to change taking into consideration Scenarios A and B above.
• Uncertainty associated with the IHH exposure assessment is low since adequate information is available regarding exposure scenarios in the Canadian environment given the existing or planned containment measures at the Rollo Bay facility. However, this uncertainty ranking could likely be higher in the event that non-transgenic and transgenic fish are produced alongside each other (Scenario A).
• The IHH hazard assessment concluded that the indirect human hazard potential of EO-1α Salmon 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 organism or Atlantic Salmon in general, 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, under the recognition that information on human health effects are based on reports from suitable surrogate organisms.
• There is a low risk of adverse IHH effects at the exposure levels predicted for the Canadian population from the use of EO-1α Salmon.

Conclusions

• The overall assessment of the manufacture and grow-out of EO-1α Salmon at a land-based facility near Rollo Bay, PEI, is concluded to have:
• a low to moderate risk of adverse environmental effects to the Canadian environment if non-transgenic fish for external parties are produced along-side transgenic fish (Scenario A);
• a negligible to low risk of adverse environmental effects to the Canadian environment if no non-transgenic fish are produced for external parties at facilities producing transgenic fish (Scenario B); and
• a low risk to the indirect human health of Canadians under both Scenario A and Scenario B.
• Additional measures were identified that could further reduce exposure and risk of Scenario A (see below in Risk Mitigation section). There was consensus that the exposure rating could be reduced, but there was not consensus on whether the exposure can be reduced to negligible.
• Any changes to containment or expansion of the manufacture and grow-out facilities could change the outcome of the environmental risk and indirect human health assessments and could require additional information to be provided to ECCC.

This Science Advisory Report is from the December 11-13, 2018 peer-review meeting, Environmental and Indirect Human Health Risk Assessments for the Manufacture and Grow-out of Sterile AquAdvantage® Salmon at a Land-Based Facility near Rollo Bay, PEI. 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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