New substances: risk assessment 19702

Substance designation: EO-1α Salmon including the triploid, hemizygous, all-female line; Trade name: AquAdvantage® Salmon refers only to the triploid, hemizygous, all-female line

Summary:

The EO-1α Salmon was notified for use in a commercial, land-based, aquaculture facility in Rollo Bay, PEI. 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 Substances Notification 16528) and as additional information submitted for this notification. A waiver of the information requirement for paragraph 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 (CEPA), 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 CEPA 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 notified 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 CEPA.

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