Unconfined Release of PNTs

Unconfined Release / Environmental Safety

The Plant Biosafety Office of the Canadian Food Inspection Agency is responsible for the regulation of plants with novel traits (PNTs) in Canada in regards to environmental safety. Before a PNT can be authorized for unconfined environmental release, a determination on the risk to the environment, including to human health, is required. Unconfined release involves the release into the environment with limited or no restrictions, generally towards commercialisation.

The following documents define the criteria and information requirements for the environmental safety assessment of a PNT intended for unconfined release:

• Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits (Dir94-08)
• Biology Documents (Companion Documents for Regulatory Directive 94-08)
• CFIA Detection and Identification Method Criteria
• Decision Documents - Determination of Environmental Safety for Unconfined Release
• Fee Submission