The Canadian Food Inspection Agency (CFIA) is responsible for regulating the field testing of plants with novel traits (PNTs) in Canada. PNTs are defined as a plant variety/genotype possessing characteristics that demonstrate neither familiarity nor substantial equivalence to those present in a distinct, stable population of a cultivated species of seed in Canada and that have been intentionally selected, created or introduced into a population of that species through a specific genetic change. Familiarity is defined as the knowledge of the characteristics of a plant species and experience with the use of that plant species in Canada. Substantial equivalence is defined as the equivalence of a novel trait within a particular plant species, in terms of its specific use and safety to the environment and human health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.
PNTs may be developed using traditional plant breeding techniques or other methodologies such as recombinant DNA technologies. Regulated field testing is necessary when PNTs are: 1) considered unfamiliar when compared with products already on the market; 2) not considered substantially equivalent to similar, familiar plant types already in use and regarded as safe.
Before PNTs may be authorized for unconfined release, they must be assessed for environmental safety. Regulatory Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits describes the criteria and information requirements that must be considered in the environmental assessment of PNTs to ensure environmental safety in the absence of confined conditions.