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Risk Assessment generated by a regulatory process
(RA)
last updated: 20 Feb 2025
New substances: risk assessment 19702
EN
24 Mar 2019
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Competent National Authority:New Substances Program of Environment and Climate Change Canada and Health Canada ()Place Vincent Massey 351 St Joseph BoulevardGatineau, Quebec
K1A 0H3, CanadaPhone: +1 819 938-3232, 1 800 567-1999 (Toll free within Canada),Fax:Email: substances@ec.gc.ca,Website: https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/biotechnology-living-organisms.html, https://www.canada.ca/fr/environnement-changement-climatique/services/gestion-pollution/evaluation-substances-nouvelles/biotechnologie-organismes-vivants.html,
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AquAdvantage® Salmon| AquaBounty Technologies | Changes in physiology and/or production (Growth rate)
- New substances: risk assessment 19702 [ English ]
- Aquadvantage-salmon-summary (1).pdf [ English ]
- Substances nouvelles : l'évaluation des risques 19702 [ French ]
- Saumon-aquadvantage-resume.pdf [ French ]
Synopsis: The EO-1α salmon was notified for use in a commercial, land-based, aquaculture facility in Rollo Bay, Prince Edward Island. EO-1α salmon are all fish that derive from EO-1♀ and are part of the EO-1α lineage of Atlantic salmon (including AquAdvantage® salmon) that contain the integrated, α-form of the opAFP-GHc2 construct. A detailed description of containment measures was provided by the notifier in 2013 (New Substance Notification 16528) and as additional information submitted for this notification. A waiver of the information requirement for item 5(a) of Schedule 5 of the New Substances Notification Regulations (Organisms) was accepted under paragraph 106(8)(b) of the Canadian Environmental Protection Act, 1999, based on the sufficiency of the proposed containment measures. Despite the negligible to high range of hazard potential for the nine ecological endpoints, the risk to the environment associated with EO-1α does not meet the criteria in paragraphs 64(a) or (b) of the Canadian Environmental Protection Act, 1999 due to the low potential for exposure. A significant new activity notice is recommended to require that containment measures are maintained as described and significant new activities are appropriately reported and assessed. Similarly, assessment of available information does not suggest a risk of adverse human health effects at the exposure levels predicted for the general Canadian population from use in commercial aquaculture and as such EO-1α salmon do not meet the criteria in paragraph 64(c) of the Canadian Environmental Protection Act, 1999.
Yes
No
No
EN