Regulating the Environmental Release of Stacked Plant Products in Canada

Before a plant with novel trait (PNT) can be grown in the Canadian environment, its developer must notify the CFIA’s Plant Biosafety Office (PBO) and receive an explicit authorization. A decision to authorize a PNT is based on a rigorous, science-based environmental safety assessment (food safety and feed safety assessments are also required, depending on the plant’s intended use). A database of authorized PNTs is available.

Environmental safety assessments of PNTs require that information be provided to demonstrate that the novel trait is stably inherited and that it has not caused unintended effects on the agronomy or composition of the plant. Another requirement is an analysis of any potential impacts of gene flow, i.e. crossing of the PNT with other plants that may occur once the PNT is released.

Based on the assessment of these and other factors¹, the authorization of a PNT for unconfined environmental release includes a permission to cross the PNT with other plants to develop new varieties. This way, plant breeders are free to introduce a novel trait into different varieties of a crop that are adapted to meet the needs of farmers. Similarly to these new varieties, many stacked products, defined in Canada as plant lines developed by conventional crossing of two or more authorized PNTs, do not require further assessment of their environmental safety. However, as a precaution, the PBO requires notification of all stacked products before they are introduced into the marketplace.

These notifications are required so that regulators may determine if:

• any conditions of authorization placed on the parental PNTs are compatible and appropriate for the stacked plant product
• additional information is required to assess the safety of the stacked plant product

Additional information and further assessment will be required if:

• the conditions of authorization of the parental PNTs would not apply to the stack (for example, a product developer is applying for alterations to stewardship requirements, or the conditions described in the stewardship plans of parental PNTs are no longer effective for the stack)
• the novel traits of the parental PNTs are expressed differently in the stacked plant product (e.g. greater or lower expression)
• the stacked product expresses an additional novel trait

Table² of Stacked Plant Products Authorized for Unconfined Release into the Canadian Environment

Notes:

1. The criteria for the environmental safety assessment of PNTs are described in Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.
2. The information presented in this table may not be complete, as confidential business information (CBI) may be withheld upon written request of the proponent. The dissemination of potential CBI is subject to Access to Information legislation.
3. Living Modified Organism (LMO):  is defined by the Cartegena Protocol on Biosafety to the Convention on biological Diversity as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.
   • "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.
   • "Modern biotechnology" means the application of:
     • In vitro nucleic techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
     • Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.
4. OECD Unique Identifier:  The Organization for Economic Co-operation and Development's (OECD) Working Group on Harmonization of Regulatory Oversight in Biotechnology has developed guidance for a unique identifier for transgenic plants. The purpose is for the use as a "key" to access information in OECD's database of products of modern biotechnology which have been approved for commercial application. (N/A denotes Not-applicable). For more information see: OECD Environmental Directorate, Environment, Health and Safety Division, 2 rue Andre-Pascal, 75775 Paris Cedex 16, France