Description of flow chart - Regulation of plants with novel traits in Canada
Typically, a plant with novel traits (PNT) that has been developed either domestically or in another country (requiring an import permit) and is intended for commercialization follows the full regulatory pathway, which includes contained use, confined environmental release, followed by unconfined environmental release. At all of these stages there are specific regulatory requirements. However, a PNT can enter the regulatory pathway at any stage and one step is not necessarily dependent on the next. Following the authorization of unconfined environmental release, certain crops may be subject to variety registration. Once a product has completed all the required regulatory steps, the developer may decide to sell the product in Canada.
PNT Development – Foreign and – Domestic
PNTs can be either developed domestically or imported into Canada. For those being imported, an import permit is required, which allows the product to be imported into a contained facility. Also, a PNT that is developed domestically must be kept in containment until it is to be taken outside of containment, in which case the proponent must apply for either confined environmental release or unconfined environmental release. If the PNT is to be taken outside of containment, the proponent must apply for either confined environmental release or unconfined environmental release.
Import of a PNT
All importers of PNTs must submit an import permit application that is assessed by the Canadian Food Inspection Agency (CFIA).
For PNTs grown in containment (e.g. in a laboratory or in a greenhouse), developers are recommended to follow Canada's Laboratory Biosafety Guidelines. If the PNT is to be taken outside of containment, the proponent must apply for either confined environmental release or unconfined environmental release.
Confined Environmental Release
The confined research field trial program allows developers to conduct in-field, small-scale testing of a PNT for a variety of purposes, including collecting data for future unconfined environmental release assessment. The CFIA assesses applications for confined release and determines conditions to manage any risks identified. The conditions may include reproductive isolation, harvest and storage requirements and record keeping.
Unconfined Environmental Release
If a developer wants to release their PNT on a large scale with limited or no conditions (e.g. commercialization), the PNT must receive an authorization for unconfined environmental release. The CFIA will conduct an environmental safety assessment of the information submitted following the requirements listed in Directive 94-08, using the crop-specific biology document, as well as other relevant scientific resources. In certain situations, authorizations may be granted with management conditions. Decision documents describing the decisions are posted online.
A PNT being assessed for unconfined environmental release may also require a novel food or novel livestock feed assessment by Health Canada and the Animal Feed Division of CFIA, respectively. The CFIA and Health Canada’s "no-split approval" policy ensures that all required authorizations are granted in order to limit entry of unauthorized products into the food or livestock feed chains.
Furthermore, if a particular pest control product (such as a herbicide or insecticide) is intended to be used with the authorized PNT, this pest control product must be assessed and registered by the Pest Management Regulatory Agency.
Some crop species are subject to variety registration (e.g. canola, sunflower). Once a PNT of such a crop has been authorized for unconfined environmental release, varieties derived from it are subject to variety registration before being sold in Canada. This process is administered by the CFIA.
After all required regulatory steps have been completed, the developer may choose to sell the product in Canada.