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, that is crossing of the PNT with other plants that may occur once the PNT is released.

Based on the assessment of these and other factors ^Footnote 1, 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 (for example greater or lower expression)
• the stacked product expresses an additional novel trait

Table ^Footnote 2 of Stacked Plant Products Authorized for Unconfined Release into the Canadian Environment