Process in Canada for Regulating Plants with Novel Traits (PNTs) from Field Testing to Commercialization

G.L. Watson

Variety Section, Plant Health and Production Division, Canadian Food Inspection Agency


The regulation of products of biotechnology in Canada operates within a broad federal framework which outlines the guiding philosophies for the regulatory process. Maintain Canada's high standards for the protection of health of workers, the general public and the environment:
- use existing legislation and regulatory institutions to clarify responsibilities and avoid duplication;
- continue to develop clear guidelines for evaluating products of biotechnology which are in harmony with national priorities and international standards;
- provide for a sound scientific database on which to assess risk and evaluate products;
- ensure both the development and enforcement of Canadian biotechnology regulations are open and include consultation; and
- contribute to the prosperity and well-being of Canadians by fostering a favorable climate for investment, development, innovation and adoption of sustainable Canadian biotechnology products and processes.

The Canadian Food Inspection Agency (CFIA) is responsible for assessing biotechnology products in a variety of areas: Plants with Novel Traits (PNTs), fertilizers, animal feeds, veterinary biologics. Health Canada is responsible for assessing the safety of novel foods.

In Canada, PNTs are regulated primarily on the basis of the characteristics of the product, not just the process by which the product was made. The primary trigger of the regulatory process is the novelty of the plant species, its characteristics (traits) and use, in the Canadian context. Therefore, products of traditional breeding or mutagenesis as well as the products of recombinant DNA technology may be considered novel and regulated under the Seeds Act.

The CFIA regulates PNTs at four levels: confined field testing, unconfined environmental release, livestock feed safety, and variety registration for those crops subject to variety registration.

Over 4,000 confined field trials have been conducted in Canada since the first confined field trials were carried out in 1988. The first authorization for unconfined environmental release occurred in 1995 and since then 30 plants with novel traits have been granted unconfined release in Canada.

The first canola varieties with novel herbicide tolerance were commercialized in 1995, the first corn varieties with European Corn Borer Resistance in 1996, the first potato varieties with Colorado Potato Beetle Resistance in 1996, and the first soybeans with novel herbicide tolerance in 1999.