Questions and Answers: New Plant Breeding Techniques
What are New Plant Breeding Techniques (NPBTs)?
New plant breeding techniques is the general term for technologies used to create genetic changes in plants, typically using modern biotechnology techniques. There is no comprehensive list of techniques that are considered new plant breeding techniques. Gene editing methods (for example CRISPR/Cas9) are widely considered to be new plant breeding techniques.
How does Canada oversee the environmental release of products of plant biotechnology?
The CFIA regulates the product, not the process used to make that product. In other words, the CFIA regulates plants with novel traits, whether or not new plant breeding techniques were used to develop them. Plants with novel traits are defined as plants that demonstrate traits that are new to that species in Canada and that may have the potential to affect the Canadian environment.
Plants with novel traits must undergo a thorough science-based pre-market safety assessment before they can be authorized for unconfined environmental release in Canada. A science-based pre-market safety assessment is also performed before a novel product is authorized for use as food or as livestock feed. The CFIA is responsible for environmental release and feed assessments, and Health Canada is responsible for food assessments.
How do I determine whether a plant would be considered a PNT?
The CFIA Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA helps developers who think they may have a plant with a novel trait. We also encourage developers to contact us (firstname.lastname@example.org if they have questions about novelty. A consultation can be arranged to discuss a plant product of interest and to further outline the Canadian regulatory framework.
Will plants with novel traits automatically be considered novel feeds or novel foods?
No. Plants, food and feed are regulated under different legislation. As a result, the regulatory triggers for novel foods, novel feeds and plants with novel traits are somewhat different. Each regulatory trigger is considered separately. Having regulatory triggers specific to novel foods, novel feeds and plants with novel traits is important because it ensures that products are only subject to the appropriate regulatory oversight. Plants with novel traits that are used for food or feed purposes are typically, but not necessarily, also considered to be novel foods or feeds.
Will all products developed using new plant breeding techniques automatically be considered plants with novel traits and require a pre-market safety assessment prior to release into the Canadian environment or use as animal feed or food? Do plants developed using new plant breeding techniques pose particular risks to the Canadian environment?
No, products developed using new plant breeding techniques will not automatically be considered plants with novel traits. If a developer has a plant with a trait that is new to the species in Canada, and has the potential to have an environmental effect, the CFIA evaluates the potential risk of the final plant product, no matter how it was developed. While there may be different factors to consider for different plant breeding techniques, the CFIA makes evidence-based and risk-appropriate decisions on the final product. This approach allows the Canadian regulatory system to focus risk assessments on products with novel traits and efficiently adjust to any new developments in the science of plant breeding. The Government of Canada is committed to protecting the health and safety of its people, food supply and environment, while supporting innovation and sustainable agriculture.
Where do I find information on which plants with novel traits have been authorized in Canada that were developed using new plant breeding techniques?
The CFIA publishes a decision document for each plant with a novel trait that is authorized for livestock feed and environmental release, outlining the information that was assessed, including information on the plant's development method. The CFIA also updates a database of authorized plants with novel traits and publishes a list of stacked plant products (plants with more than one novel trait). In addition, developers can voluntarily publish a notice of submission on our website to give summary information about a plant with a novel trait that was submitted for assessment for unconfined environmental release or use as a livestock feed. When Health Canada approves a novel product for food, it updates its list of novel food decisions.
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