Research Document 2020/076
Environmental Risk Assessment for the Manufacture and Grow-out of EO-1α Salmon, Including the Sterile AquAdvantage® Salmon, at a Land-Based and Contained Facility near Rollo Bay, PEI
By McGowan, C. and Leggatt, R.
Abstract
On July 27, 2018, AquaBounty Canada Limited submitted a regulatory package to Environment and Climate Change Canada (ECCC) under the New Substances Notification Regulations (Organisms) of the Canadian Environmental Protection Act, for the manufacture of EO-1α Salmon (also known as the AquAdvantage® Salmon), a fast growing genetically engineered Atlantic Salmon (Salmo salar), at a land-based aquaculture facility near Rollo Bay, Prince Edward Island. Under a Memorandum of Understanding between the Department of Fisheries and Oceans (DFO), ECCC, and Health Canada, DFO conducted an environmental risk assessment of the notified organism and its proposed use.
The environmental risk assessment was conducted using the paradigm where risk is directly related to the exposure and hazard of the organism, and considers level of uncertainty for both exposure and hazard determinations. The exposure assessment considers the likelihood and magnitude of release into, and survival, reproduction, establishment, and spread of the organism, in the Canadian environment. The hazard assessment is focused on the potential for the organism to impact through hazard pathways, specifically: through environmental toxicity, horizontal gene transfer, trophic interactions, hybridization and as a vector of disease; and to impact environmental components, specifically: biogeochemical cycling, habitat, and biodiversity. The risk assessment included consideration of two scenarios, Scenario A where the company would include the production of non-transgenic fish for external parties at the same facility as EO-1α Salmon production, or Scenario B, where there is no production of non-transgenic fish for external parties.
EO-1α Salmon were determined to have the capacity to survive in Canadian environments, and hazard assessments to Canadian environments ranged from negligible (e.g. through environmental toxicity) to high (i.e. through trophic interactions or intraspecific hybridization). However, extensive and redundant physical containment of EO-1α Salmon at the proposed land-based facility, as well as >98% sterility (via triploidy) of the production form of EO-1α Salmon, resulted in a negligible environmental exposure ranking for the notified organism under Scenario B, and negligible to low risk. Under Scenario A, the potential for human error in shipping eggs increases potential exposure, resulting in low to moderate risk. Mitigation procedures were proposed to decrease exposure and hence environmental risk under use Scenario A, although it is not clear if they would decrease final risk conclusion to low. Notified containment measures are essential to minimizing risk of the EO-1α Salmon to the Canadian environment, and any changes to containment or expansion of the manufacture and production facilities could change the outcome of the environmental risk assessment.
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.
- Date modified: