Language selection


Data Required for Safety Assessments of Plants With Novel Traits and/or Novel Livestock Feed Derived From Plants

Before a new agricultural or food product can be produced and marketed, it is thoroughly assessed for safety to protect humans, animals, and the environment. The Canadian Food Inspection Agency (CFIA) is responsible for the regulation of a number of agricultural products derived through biotechnology, including plants and livestock animal feeds. Environmental assessments of biotechnology-derived plants are carried out by the CFIA's Plant Biosafety Office (PBO). If the developers are also applying for approval of plants as livestock animal feeds, they must be assessed and approved by the CFIA's Feed Division. This fact sheet provides an overview of the PBO's Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits and the Feeds Section's Guidelines for the Assessment of Livestock Feed from Plants with Novel Traits. Much of this information is overlapping.

A great deal of information and data is required from applicants to determine the safety of a plant with a novel trait (PNT). Applicants must include the methods used to obtain the information, along with bibliographic references. Below is an overview of the information that must be provided to the CFIA for environmental and livestock feed assessments. For the in-depth details on the assessments, please refer to the assessment criteria and guidelines.

What data does the CFIA use to conduct environmental assessments?

Personnel Involved and Status of the Plant with Novel Trait (PNT) in the Application

Description of the Plant with Novel Trait (PNT) and its modification

Description of the modification

Description of the Novel Traits

Biology and Interactions of the PNT

This information is requested to determine whether the PNT could potentially become a weed of agriculture, become invasive of natural habitats or be otherwise harmful to the environment.

Interactions of the PNT

Agricultural-Silviculture (Forestry Care and Cultivation) Practices

Potential environmental effects resulting from introgression

Where there is potential for gene flow from the PNT into related species, detail the consequences of novel gene introgression into those species and resulting expression. Interactions identified for the original PNT should be considered, as appropriate, for these species.

What data does the CFIA use to conduct livestock feed assessments?

Data required for livestock feeds assessments is similar, in some ways, to what is required for environmental safety assessments. There are some unique items that are required, and some overlap with the assessments done by the PBO.

Development of the Modified Plant

Host and Donor Organisms

Relevant information on the donor and host organisms should be considered. A review of the literature for all information relevant to a feed safety assessment of the host plant and related varieties used in the development of the modified plant should be provided. This information should include a critical assessment of the ability of both donor and host organisms to produce potentially toxic compounds, available toxicology data, history of safe use of livestock feeds from the host plant and related varieties used in the development of the modified plant.

The Novel Trait(s)

Selectable Marker Genes

Nutritional Data

Nutrient Composition

Dietary Exposure

Toxicology Data

Laboratory Animal/Livestock Feeding Trials

Environmental Safety

Date modified: