Science Response 2013/023

Summary of the Environmental and Indirect Human Health Risk Assessment of AquAdvantage® Salmon

Context

The Canadian Environmental Protection Act, 1999 (CEPA 1999), administered by Environment Canada (EC) and Health Canada (HC), is the key authority for the Government of Canada to ensure that all new substances, including organisms, are assessed for their potential harm to the environment and human health.  The New Substances Notification Regulations (Organisms) [NSNR (Organisms)] under CEPA 1999 prescribe the information that must be provided to EC prior to the import to or manufacture in Canada of new organisms that are animate products of biotechnology, including fish products of biotechnology.

Fisheries and Oceans Canada (DFO), EC and HC signed a Memorandum of Understanding respecting the implementation of the NSNR (Organisms) for fish.  DFO assists in implementing the NSNR (Organisms) by conducting an environmental and indirect human health risk assessment for fish products of biotechnology and recommending any necessary measures to manage risks.  The risk assessments evaluate whether the notified fish product of biotechnology is “CEPA toxic” in accordance with Section 64 of CEPA 1999: a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that:

1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
2. constitute or may constitute a danger to the environment on which life depends; or
3. constitute or may constitute a danger in Canada to human life or health.

A notification under the NSNR (Organisms) was submitted to EC for AquAdvantage® Salmon by AquaBounty Canada Inc. on April 30, 2013. DFO conducted environmental and indirect human health risk assessments of AquAdvantage® Salmon in order to make recommendations on any necessary risk management measures to EC to support a regulatory decision by the Minister of the Environment on AquAdvantage® Salmon.

This Science Response is the result of the July 17-19, 2013 National Science Response Process on the Environmental and Indirect Human Health Risk Assessment of AquAdvantage® Salmon. The purpose of this meeting was to peer review the conclusions presented in DFO’s preliminary comprehensive Environmental and Indirect Human Health Risk Assessment of AquAdvantage® Salmon.

Complete document (PDF, 279 KB)

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