Regulation of cannabis with novel traits
Notice: Applicants are responsible for ensuring they comply with all applicable acts and regulations, including but not limited to: the Cannabis Act and Regulations, the Seeds Act and Seeds Regulations, and the Plant Protection Act and Plant Protection Regulations.
What is a plant with novel traits?
The Plant Biosafety Office (PBO) defines plants with novel traits (PNTs) as plants into which one or more traits have been intentionally introduced, regardless of method, where:
- the trait is new to cultivated populations of the species in Canada and
- the plant has a potential to have a significant negative environmental effect
These traits can be introduced using biotechnology, mutagenesis or conventional breeding techniques.
How to determine if a cannabis product is a PNT?
To determine whether a product may be a PNT and therefore subject to regulation under Part V of the Seeds Regulations, refer to Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA.
Factors to consider include whether any traits fall outside the historic production range of cannabis (for example, the quantities of THC, CBD or terpenes), or whether the product displays traits or agronomic characteristics not previously seen in cannabis (for example, disease resistance or herbicide tolerance).
For clarification, or if you believe your cannabis product may be a PNT, please contact the Plant Biosafety Office at email@example.com.
Obtaining permission to grow a PNT
To grow a PNT for research purposes in contained conditions (such as in a laboratory or greenhouse), there is no requirement to contact the Plant Biosafety Office. However, you may not grow or permit your PNT to be grown outdoors without authorization from the Plant Biosafety Office.
The environmental release of seed, including PNT cannabis, is regulated under the Seeds Act and Regulations and Plant Protection Act and Regulations:
- confined release allows for testing of PNT material under a specific set of terms and conditions that maintain confinement but allows a PNT to be planted outside in the Canadian environment to mitigate environmental exposure
- For more information about how to apply for confined release, see How to apply for confined or unconfined environmental release of PNTs in Canada and Directive 2000-07: Conducting confined research trials of plants with novel traits in Canada.
- unconfined release is the release of a PNT into the environment that is not isolated either reproductively or physically from managed or natural environments, but may be subject to other restrictions
- For more information about how to apply for unconfined release, see How to apply for confined or unconfined environmental release of PNTs in Canada and Directive 94-08: Assessment criteria for determining environmental safety of plants with novel traits.
Import requirements for PNT cannabis
PNTs (and/or products derived from them) to be imported into Canada may be subject to the Plant Protection Act and Regulations. Import requirements for PNT cannabis are the same as for any other cannabis.
Learn more about PNTs and the Canadian pre-market regulatory process/safety submission process
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