Science Response 2019/003

Assessment of the acceptance of data submitted under the Canadian Environmental Protection Act New Substances Notification Regulations (Organisms) to determine invasiveness of the AquAdvantage® salmon

Context

The Canadian Environmental Protection Act, 1999 (CEPA), administered by Environment and Climate Change Canada (ECCC) and Health Canada (HC), is the key authority for the Government of Canada to ensure that all new substances, including living organisms, are assessed for their potential harm to the environment and human health. The New Substances Notification Regulations (Organisms) [NSNR(O)] under CEPA, prescribe the information that must be provided to ECCC prior to the import or manufacture in Canada of new living organisms that are animate products of biotechnology, including fish products of biotechnology. Fisheries and Oceans Canada (DFO), ECCC and HC have signed a Memorandum of Understanding respecting the implementation of the NSNR(O) for new living fish products of biotechnology, whereby DFO provides science advice to ECCC and HC in support of their CEPA risk assessment and decision making process.

On July 27, 2018, AquaBounty Canada Limited submitted a regulatory package to ECCC for the manufacture and production (grow-out) of AquAdvantage® Salmon (EO-1α salmon), a fast-growing, genetically-engineered Atlantic Salmon (Salmo salar), at a land-based aquaculture facility near Rollo Bay, PEI. In addressing paragraph 5(a) of  Schedule 5 of the NSNR(O), data from a test conducted to determine pathogenicity, toxicity or invasiveness, the notifier provided information and data from the scientific literature. This information was assessed by DFO officials to determine if it meets the information requirements of the NSNR(O).

This Science Response Report results from the Science Response Process of November 2, 2018 on the Assessment of the acceptance of data submitted under the Canadian Environmental Protection Act New Substances Notification Regulations (Organisms) to determine invasiveness of the AquAdvantage® salmon.

Complete document (PDF, 257 KB)

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