Terms of Reference

Environmental and Indirect Human Health Risk Assessment of GloFish® Sunburst Orange® Danio: Transgenic Ornamental Fish

National Peer Review – National Capital Region

May 8-9, 2019
Ottawa, Ontario

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 (a Science Advisory Report) based on an environmental risk assessment for fish products of biotechnology, and, with the support of 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 (working papers), 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).

Objective

The objective of this Science Advisory Process is to peer review the draft Environmental and Indirect Human Health Risk Assessment of the GloFish® Sunburst Orange® Danio and recommended measures to manage risks, if required and provide relevant science advice on the assessments and recommendations.

Working papers to be reviewed will include:

• the Environmental Risk Assessment of the GloFish® Sunburst Orange® Danio; and
• the Indirect Human Health Risk Assessment of the GloFish® Sunburst Orange® Danio.

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 Advisory 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 GloFish® Sunburst Orange® Danio
• 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 & Arctic Region)
• Environment and Climate Change Canada
• Health Canada
• Academia
• Other invited experts