Regulating Agricultural Biotechnology in Canada: Environmental Questions

What potential risks are considered when assessing the environmental safety of genetically modified agricultural plants?

Genetically modified agricultural plants (plants with novel traits or "PNTs"), including those modified through modern biotechnology, may have the potential to cause unintended effects on the environment.

Because of this, government evaluators carefully assess potential impacts before these modified plants can be released into the environment. 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

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.

Who is responsible for assessing these products?

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. Plant biosafety evaluators at the CFIA assess PNTs to determine if the new plants are likely to cause harm to the environment. Feed safety evaluators at the CFIA assess PNTs that can be used as livestock feed to determine if they are safe for this purpose.

How are PNTs assessed and regulated?

An important part of the regulation of PNTs is the confined research field trial, which gives plant developers the opportunity to evaluate these plants under highly controlled conditions. These field trials are designed to limit the impact of plants on the environment—and to prevent their introduction into the food and feed systems—until they have been fully evaluated for release by CFIA and Health Canada evaluators.

If a developer wants to market a PNT, it must submit an application to the CFIA for an environmental safety assessment. The application must include:

• detailed information about the novel trait
• the method used to introduce the novel trait into the plant
• the possible effects of releasing the plant into the environment

The information required is described in guidelines that have been developed through consultations with experts and stakeholders in Canada and around the world. Potential risks are identified for each novel product on a case-by-case basis, and information and data addressing these are reviewed.

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, as well as the Submission Example: Data Summary. 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"

What do evaluators look for?

Government evaluators assess all the data and information provided by the applicant—the person or organization seeking government's assessment of a new product. Evaluators may also consult numerous other sources, such as published, peer-reviewed studies, and scientists from academia or other government departments. If necessary, they will ask the applicant to supply them with more or different information than originally provided.

As stated above, 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.

If the PNT is found to pose no potential safety concerns to human, animal, or environmental safety when compared to its traditionally developed counterparts in use in Canada, it is considered safe to be released into the environment.

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. Simplified versions of some of these decision documents are also available.