Terms of Reference

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

Science Response Process – National Capital Region

July 17-19, 2013
Ottawa, Ontario

Co-chairs: Stephen Stephen and Mark Hovorka

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:

• 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.

Based on the scientific risk assessments, DFO would provide science advice to EC to support a regulatory decision by the Minister of the Environment on the fish product of biotechnology that has been notified under the NSNR (Organisms).

Objectives

The objective of this Science Response Process is to peer review the draft Environmental and Indirect Human Health Risk Assessment of the AquAdvantage® Salmon and any recommended measures to manage risks and provide relevant science advice on the assessments and recommendations.

Working papers to be reviewed will include:

• a draft Environmental and Indirect Human Health Risk Assessment of the AquAdvantage® Salmon; and
• a Summary of the Environmental and Indirect Human Health Risk Assessment of the AquAdvantage® Salmon.

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

The Science Response Process will evaluate the conclusions, rankings and recommendations of the draft risk assessment and any recommended measures to manage risks, including the weight of scientific evidence, quality of data, identified gaps and associated uncertainties of the:

• Characterization of AquAdvantage® Salmon;
• 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 Response

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.

Participation

• Fisheries and Oceans Canada (Ecosystems and Oceans Science Sector; Newfoundland and Labrador Region, Gulf Region, Maritimes Region, Central & Arctic Region, Pacific Region)
• Environment Canada and Health Canada
• Provincial Governments
• Academia
• Other invited experts