Canadian Food Inspection Agency Finalizes Guidance on Plants with Novel Traits

On May 3, the Canadian Food Inspection Agency (CFIA) published updated guidance for Part V of the Seed Regulation in reference to plants with novel traits. Part V establishes the process to assess plants with novel traits (PNT), such as plants with biotech traits, for environmental release. The published guidance clarifies when a plant is considered to be a PNT and subject to Part V. Based on the accompanying policy rationale, the guidance reaffirmed CFIA’s product-based approach, and the responsibility of plant breeders to determine if a plant is a PNT. In specific regard to gene editing technology, the guidance states that “gene editing technologies do not present any unique or specifically identifiable environmental or human health safety concerns as compared to other technologies of plant development. For this reason, gene-edited plants are regulated using a product-based approach, like any other product of plant breeding.” With that consideration, the guidance noted that “a plant is to always be a PNT if it expresses a commercially-viable herbicide tolerance trait, and/or if it includes foreign DNA.” This announcement came one year after Health Canada published guidance on the novelty interpretation of products of plant breeding. The policy alignment between CFIA and Health Canada moves Canada towards a more enabling environment for plants developed through plant breeding innovations such as genome editing. Updated guidance from CFIA on novel feed remains to be published.

The press release accompanying the guidance noted that organic certification allows the use of conventional seed by not gene-edited seeds. Further, in support of transparency, the press release announced the establishment of a Government-Industry Steering Committee on Plant Breeding Innovations Transparency, the expansion of the Seeds Canada Canadian Variety Transparency Database, and federal oversight of the database.