Canadian Food Inspection Agency
Science Branch
Office of Biotechnology

"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 possesses one or more traits new to that species in Canada. A trait is considered to be novel when one of the following two options is true:

• the new trait is not present in stable, cultivated populations of the plant species in Canada, or
• the trait in the plant species is present at a level significantly outside the range of that trait in stable, cultivated populations of that plant species in Canada.

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?"

There are two reasons why the CFIA uses this approach.

First, techniques that are not considered genetic engineering could lead to a product that is novel (previously unknown) from a safety perspective. For example, some plants created by means of mutagenesis have been considered to be PNTs and as such, have been assessed for environmental safety. This could also be the case with yet-to-be invented techniques.

Second, a plant that has been developed using some other technique of biotechnology could have traits that are very well understood (previously known) from a safety perspective.

When regulating new, or novel, plant traits, no other country uses as broad an interpretation of the word "novel" as Canada does.

Are the reasons for considering a crop "novel" the same for all classes of plants that the CFIA regulates?

No, the criteria for novelty are specific to the species (canola, corn, soy, and so on) and are defined in the appropriate directives, regulations or guidelines. However, the basic logic—focussing safety assessments on products with previously unknown traits—remains the same.

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. The Organisation for Economic Co-operation and Development (OECD) endorses this approach and discussion of it can be found in OECD documents on the Novel Foods and Feeds section of its Web site. In Canada, the novelty approach is not only used by the CFIA but also by Health Canada, for food safety.