Terms of Reference

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

National Science Response Process - National Capital Region

November 2, 2018
Ottawa, ON

Chairperson: Gilles Olivier

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 26, 2018, AquaBounty Canada Limited submitted a regulatory package to ECCC for the manufacture and production (grow-out) of AquAdvantage® 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 the Schedule 5 of the NSNR(O), data from a test conducted to determine pathogenicity, toxicity or invasiveness, the company has provided information and data from the scientific literature.  This information was assessed by DFO officials to determine if it meets the requirements 5(a).

Objective

The objective of this National Science Response Process is to peer-review the draft DFO assessment of the acceptance of data provided by the company in fulfillment of paragraph 5(a) of the Schedule 5 of the NSNR(O), and to determine whether the data submitted satisfies the information requirement. For clarity, the objective of this process is not to conduct a risk assessment of that information but only to ascertain that it satisfies the requirement.

The Science Response Process will evaluate the conclusions and recommendations of the draft assessment of the acceptance of data, taking account of the weight of scientific evidence, quality of data, identified knowledge gaps and uncertainties associated with the assessment.

Expected Publications

• Science Response

The publication will be subject to third party confidential business information claims by the regulatory proponent, and nondisclosure requirements in accordance with the Access to Information Act and the Canadian Environmental Protection Act, 1999.

Expected Participation

• Fisheries and Oceans Canada (Ecosystems and Oceans Science Sector)
• Environment and Climate Change Canada and Health Canada
• Academia
• Other invited experts