Environmental Release of Plants with Novel Traits in Canada: A Product-Based Approach to Regulatory Oversight

Canada’s product-based system for regulating agricultural products of biotechnology has the overall goal of protecting human and animal health, as well as protecting the environment. This product-based framework is not triggered by the methods used in developing a product of biotechnology, but instead employs regulatory triggers that differentiate plants with novel traits (PNTs) and novel plant products from their conventional counterparts. Before they can be authorized for use, novel products are subject to science-based safety assessments and, where applicable, risk management conditions. Since the Canadian system is not focused on the methods used to develop a product of biotechnology, it is well-positioned to adapt to innovations such as gene editing.

In determining whether a plant that is the product of gene editing would be regulated in Canada, it is important to consider whether it is novel. Only products of gene editing that are also novel will trigger the Canadian regulatory system for PNTs. This presentation will focus on Canada’s product-based approach to assessing PNTs for release into the Canadian environment, including the novelty trigger for PNTs, responsibilities of the proponent to identify whether they have created a PNT, our retransformation and remutation policy, and the pre-submission process to meet with regulators to discuss specific products on a case-by-case basis.