Research Document 2021/053

Environmental and Indirect Human Health Risk Assessment of the AquAdvantage® Salmon

By McGowan, C., Mimeault, C., Stefanov, I., Leggatt, R., and Beardall, J.

Abstract

Pursuant to the Canadian Environmental Protection Act (CEPA), a notification under the New Substances Notification Regulations (Organisms) (NSNR(O)) was submitted by AquaBounty Canada to Environment Canada (EC) for the commercial manufacture and export of the AquAdvantage™ Salmon (AAS), a transgenic Atlantic Salmon claimed to reach market size in half the time of a domesticated Atlantic Salmon. AquaBounty has indicated its intent to commercially produce all-female triploid, AAS eyed-eggs at their contained, land-based Prince Edward Island facility, for export to a contained, land-based grow-out facility in the highlands of Panama, where AAS will be grown to a commercial weight, and then processed for retail sale in approved markets as food. Fisheries and Oceans Canada (DFO) conducted an environmental and indirect human health risk assessment of AAS to support a regulatory decision by the Minister of the Environment and to underpin recommendations on measures necessary to manage risk.

The risk assessment analyzed potential hazards, likelihood of exposure and associated uncertainties, to reach a conclusion on risk. The exposure assessment was based on a Failure Mode Analysis that focused on the potential for AAS to enter the Canadian environment, with activities in Panama only relevant where they may have resulted in AAS exposure to the Canadian environment. The assessment concludes with reasonable certainty that the likelihood of AAS exposure to the Canadian environment is negligible and that AAS is manufactured at a location where AquaBounty is able to contain AAS in a manner that satisfactorily protects the Canadian environment and human health. The indirect human health hazard assessment characterized the potential for AAS to cause adverse effects to humans in Canada, relative to wild Atlantic Salmon, as a consequence of environmental exposure. Potential human health hazards associated with AAS, including potential toxicity and allergenicity and the capacity of AAS to act as a vector for human pathogens, were considered. The assessment concludes with reasonable certainty that the risk to human health in Canada as a consequence of environmental exposure is low. The environmental hazard assessment characterized the nature and severity of the potential harmful effects that AAS may cause to the Canadian environment. Potential hazards associated with AAS, including the potential to affect wild populations, wild Atlantic Salmon predators, prey, competitors, and habitat, were considered. The assessment concludes with reasonable certainty that the risk to the Canadian environment is low.

Research Document 2021/053 (PDF, 1,611 KB)

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