"Novelty" and Plants with Novel Traits

What does "novelty" mean?

In common language, "novelty" refers to something previously unknown. The Canadian Food Inspection Agency (CFIA) uses this meaning when applying the word "novelty" specifically to some of the products it regulates, such as plants, livestock feeds, and plant and soil supplements. This fact sheet focuses on plants with novel traits.

What are plants with novel traits (PNTs)?

The CFIA defines a plant with a novel trait (PNT) as a new variety of a species that has one or more traits that are novel to that species in Canada. A trait is considered to be novel when it has both of these characteristics:

• it is new to stable, cultivated populations of the plant species in Canada, and
• it has the potential to have an environmental effect.

These PNTs are assessed for safety for the environment. For more details see the factsheet "Regulating Agricultural Biotechnology in Canada: Environmental Questions" and the CFIA's Directive 94-08 (Dir94-08) Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits.

Are genetically engineered plants automatically considered to be PNTs?

To date, in Canada, all genetically engineered plants have been considered to contain novel traits and, therefore, have been assessed for safety.

However, the approach used by the CFIA does not mean that all PNTs are developed through genetic engineering. Novel traits can be developed through various techniques. Examples (other than genetic engineering) are mutagenesis, cell fusion, and traditional breeding. For more information, see the factsheet "Biotechnology? Modern Biotechnology? GM? GMO? GE? PNTs? What do these terms mean?"

During extensive consultations, Canadian scientists and other stakeholders recognized that the potential for risk lies with the new trait and not with the process by which the trait was introduced. For example, techniques that are not considered genetic engineering, such as mutagenesis, could lead to a product that is novel from a safety perspective.

When regulating plant products of biotechnology, no other country uses as broad a regulatory scope as Canada does with its "novelty" approach.

Does the concept of "novelty" only apply PNTs?

No, the CFIA regulates other novel agricultural products such as livestock feeds, and plant and soil supplements.

An agricultural product may be considered "novel" if it has:

• a new trait(s) or characteristic(s), or
• a changed trait(s) or characteristic(s), or
• a new use

In the case of livestock feeds and plant and soil supplements, products that have not yet been scheduled or registered in Canada are also considered "novel".

Does the concept of "novelty" apply only to the CFIA?

No, the concept of novelty is very commonly used in regulation. In Canada, the novelty approach is not only used by the CFIA but also by:

• Health Canada in the regulation of novel foods,
• Fisheries and Oceans Canada in the regulation of novel aquatic organisms, and
• Environment Canada in the regulation of new substances.

Also, the Organisation for Economic Co-operation and Development (OECD) endorses this approach. Discussion of it can be found in OECD documents on the Novel Foods and Feeds section of its Web site.