Canada Publishes New CFIA Notification Guidelines
1.1 Purpose
This directive1 is intended to assist breeders, developers and importers of new plant lines (“proponents”) in determining if their plant is regulated under Part V of the Seeds Regulations prior to its environmental release (i.e., whether a developer must notify the Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA) of his or her intent to release a plant into the environment).
1.2 Legal authority for the regulation of environmental releases of plants with novel traits
The Seeds Act, administered by the Plant Health and Biosecurity Directorate, CFIA, provides authority to regulate the quality, testing, inspection and sale of seed in Canada. “Seed” is defined in the Seeds Act as “any part of any species belonging to the plant kingdom, represented, sold or used to grow a plant.”
Part V of the Seeds Regulations, “Release of Seed”, sets out the regulatory requirements for both the confined and unconfined environmental release of seed not substantially equivalent to seed already existing in Canada, such as plants with novel traits (PNTs).
1.2.1 Regulatory Exemptions
Part V of the Seeds Regulations states that the following seed is exempt from regulation:
1. seed grown in Canada outside of containment before the coming into force of this Part (1996) in such a manner that the seed constitutes a distinct, stable population in the Canadian environment; or
2. seed grown in containment in such a manner that there is no release into the environment of any genetic material from the plants derived from the seed; or
3. seed that is derived from seed referred to in paragraph (a), or from seed in respect of which an unconfined release has been authorized by the CFIA and that is substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to seed of the same species, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.
1.3 Scope
This directive applies primarily to plants that were derived through conventional plant breeding techniques. Plants derived through recombinant DNA (rDNA) technology may be subject to requirements in addition to those outlined in this directive, for example, requirements related to posting notification of Canadian regulatory decisions on the Biosafety Clearinghouse.
Developers of rDNA plants are advised to contact the PBO prior to the environmental release of their plant in Canada.
This directive does not address the determination of whether or not a plant is a novel livestock feed or a novel food. Information on determining whether a plant is considered a novel feed or a novel food is available from the following documents:
- Directive 95-03, Guidelines for the Assessment of Novel Feeds: Plant Sources
- Health Canada’s Guidelines for the Safety Assessment of Novel Foods – Volume II
This directive does not specifically address the importation of PNTs. However, if a PNT has not been authorized in Canada for unconfined environmental release, its import may be subject to requirements under the Plant Protection Act. More information is available in Directive D-96-13, Import Requirements for Plants with Novel Traits (Including Transgenic Plants) and Their Products.
To View Full Article Please Follow This Link:
www.inspection.gc.ca/english/plaveg/bio/dir/dir0909e.shtml#a1
Topics: biodiversity, Biosafety, Canada, canadian environment, CFIA, genetic materials, Health Canada's Guidelines, humn health, plant pest, PNTs, safety, Seed Production, Seed Regulation
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