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Regulating "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 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 "Modern Biotechnology: A Brief Overview"

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.

How are plants with novel traits assessed for their long term safety to the environment by the Canadian Food Inspection Agency (CFIA)?

The most practical approach to assessing their safety to the environment is to compare them to their traditional counterparts in order to determine if they are as safe for release to the environment as these traditional counterparts already in use today.

The Canadian Food Inspection Agency (CFIA) evaluates all PNTs for safety before they can be grown or fed to livestock in Canada. CFIA evaluators begin their assessments of a PNT's new traits by thoroughly examining the plant's molecular characteristics-the new or modified genes in the plant and how they are likely to behave. Environmental safety assessments examine five broad categories of possible impacts of a PNT. These are:

  • the potential of the plant to become a weed or to be invasive of natural habitats
  • the potential for gene flow to wild relatives
  • the potential for a plant to become a plant pest
  • the potential impact of a plant or its gene products on non-target species
  • the potential impact on biodiversity

To see the kind of information that is evaluated in the safety assessments, refer to the Notices of Submission pilot project on the CFIA Web site. You may also refer to the CFIA factsheet, "Data Required for Safety Assessments of Plants With Novel Traits and/or Novel Livestock Feed Derived From Plants"

The CFIA has accumulated a wealth of knowledge about the release of traditionally-derived crops into the environment over a number of decades and this knowledge helps CFIA scientists to determine how plants with novel traits are likely to behave, interact, and grow in the environment.

Each environmental safety assessment examines the five areas of potential impacts a PNT can have on the environment. Depending on the novel trait in the plant, one or more of the five criteria may require more in-depth analysis.

One example of this is the potential for insects to develop resistance to a pesticide as a result of releasing certain plants into the environment. In these cases, the CFIA requires the applicant to submit an insect resistance management plan that farmers are to put in place.

Other potential risks can be managed by imposing conditions that reduce the risk. An example of this would be limiting the area that a plant may be grown in.

Is there just one safety assessment?

No, PNTs undergo several assessments. First, an environmental assessment is required for confined research field trials. Then a second, more detailed environmental assessment is required for the plant's unconfined release into the environment.

If the PNT is to be used as livestock feed, it must be assessed for safety before it can be used for commercial production. If it is also to be used as a human food, it must undergo a separate safety assessment by Health Canada for food safety.

How do people know when a PNT has been evaluated as safe for the environment?

When evaluators have made their decision about the environmental safety of a PNT, they inform the applicant. A summary of the assessment, called a "decision document", is made available to the public.