Terms of Reference

Environmental and Indirect Human Health Risk Assessment for the Manufacture and Production of Sterile AquAdvantage® Salmon at a Land-Based and Contained Facility near Rollo Bay, PEI

National Peer Review - National Capital Region

December 11-13, 2018
Ottawa, ON

Chairperson: Gilles Olivier

Context

The Canadian Environmental Protection Act, 1999 (CEPA 1999), 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 (Organisms)] under CEPA 1999 prescribe the information that must be provided to ECCC prior to the import to or manufacture in Canada of new living organisms that are animate products of biotechnology, including fish products of biotechnology.

ECCC and HC are responsible for conducting the CEPA risk assessment to evaluate whether the notified fish product of biotechnology is “CEPA toxic” in accordance with Section 64 of CEPA 1999: where a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that:

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

Fisheries and Oceans Canada (DFO), ECCC and HC signed a Memorandum of Understanding respecting the implementation of the NSNR (Organisms) for new living fish products of biotechnology.  DFO assists in implementing the NSNR (Organisms) by providing science advice based on an environmental risk assessment for fish products of biotechnology, and, supports HC, on the indirect human health risk assessment for fish products of biotechnology. In addition, DFO will recommend any necessary measures to manage risks, if required.

Based on the environmental and indirect human health risk assessments, DFO provides science advice to ECCC and HC in support of their CEPA risk assessment and decision making process for products of biotechnology that have been notified under the NSNR (Organisms).

In 2013, AquaBounty Canada submitted a notification to ECCC detailing its intent to commercially produce genetically-modified (GM) Atlantic salmon in Canada in a contained facility. The proposed production scenario consisted of egg production and broodstock maintenance at a land-based and contained facility near Fortune, PEI, and commercial grow-out at a land-based and contained facility in Panama. Under the well-defined containment conditions proposed by AquaBounty, Fisheries and Oceans Canada determined that the AquAdvantage® Salmon poses low risk to the Canadian environment and indirect human health (DFO 2013).

On July 27 of 2018, AquaBounty Canada submitted to ECCC, a notification of its intent to manufacture the AquAdvantage® Salmon at a second facility near Rollo Bay, PEI, under contained conditions. Commercial grow-out of sterilized AquAdvantage® Salmon at the same facility, and under the same conditions of containment, is also proposed.

Objective

The objective of this Science Advisory Process is to peer-review the draft environmental and indirect human health risk assessments for the manufacture and production of sterile AquAdvantage® Salmon at a land-based and contained facility near Rollo Bay, PEI, and provide science advice and recommendations to manage risk taking into account the previous Science advice for the first proposed facility near Fortune, Bay PEI (DFO, 2013).
Working papers to be reviewed will include:

• Environmental Risk Assessment for the Manufacture and Production of Sterile AquAdvantage® Salmon at a Land-Based Facility near Rollo Bay, PEI; and
• Indirect Human Health Risk Assessment Report on AquAdvantage® Salmon.

The DFO environmental risk assessment will include consideration of potential risks to fish, fish habitat and the environment in general.  The HC indirect human health risk assessment will not consider potential risks related to human consumption, but will consider potential risks from environmental exposures to the living organism such as risks from exposure to toxins and allergens and the transmission of zoonotic diseases.

The Science Advisory Process will evaluate the conclusions, rankings, and recommendations of the draft risk assessments, taking account of the weight of scientific evidence, quality of data, identified knowledge gaps and uncertainties associated with the:

• Characterization of the AquAdvantage® Salmon;
• Environmental exposure: characterization and assessment including an assessment of any request for a possible waiver;
• Indirect human health exposure: characterization and assessment;
• Environmental hazard: characterization and assessment;
• Indirect human health hazard: characterization and assessment;
• Environmental risk assessment; and
• Indirect human health risk assessment.

Expected Publications

• Science Advisory Report
• Research Document(s)
• Proceedings

The publications 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; Pacific Region; Central and Arctic Region, Gulf Region, Newfoundland and Labrador Region; Aquaculture Management-Gulf Region)
• Environment and Climate Change Canada and Health Canada
• Province of Prince Edward Island
• Academia
• Other invited experts

References

DFO. 2013. Summary of the Environmental and Indirect Human Health Risk Assessment of AquAdvantage® Salmon. DFO Can. Sci. Advis. Sec. Sci. Resp. 2013/023.