PRACTICING PRECAUTION and ADAPTIVE MANAGEMENT ...

As a result, a new plant is exempt from regulation under Part V where the new plant is (1)derived from a plant that was already being grown as a distinct and stable population in Canadabefore Part V of the Seeds Regulations came into effect, or from a plant whose unconfinedrelease was already authorized, and (2) the new plant is substantially equivalent in terms of itsuse and safety. Further exemptions to the notification and authorization requirements in s.109are provided in s.109(2)-(4). 7A question arises as to who is responsible for determining whether or not the new plant is“substantially equivalent, in terms of its specific use and safety” to seed of the same species. Itappears that, in some cases at least, the applicant might conclude on its own that its new plant issubstantially equivalent in terms of specific use and safety for the environment to its counterpartplant, and thus is exempt from all notification and authorization requirements by virtue of theexemption available under s.108. In such cases, the threshold decision about whether theregulator’s jurisdiction is engaged appears to be confounded with the very safety assessment thatthe regulator (rather than the applicant) ought to conduct.Directive 94-08 “Assessment Criteria for Determining Environmental Safety of Plantswith Novel Traits” is published by the Plant Biosafety Office in order to “provide guidanceregarding the submission of an application for the authorization of the unconfined release of aplant with a novel trait (PNT) in Canada, as may be required under Part V of the SeedRegulations.” 8 Directive 94-08 states that “a new variety of a species is subject to thenotification and authorization requirements of the Seeds Regulations when it possesses trait(s)novel to that species in Canada, i.e., (i) the new trait is not present in stable, cultivatedpopulations of the plant species in Canada, or (ii) the trait in the plant species is present at a levelsignificantly outside the range of that trait in stable, cultivated populations of that plant species inCanada.” 9 On its surface, this would appear to solve the problem that an applicant might, insome cases, conclude that its new plant is “substantially equivalent” to its counterpart alreadygrowing in the Canadian environment, and thus be exempt from notification and authorizationrequirements. However, Directive 94-08 also notes that “a plant that is substantially equivalentto its counterpart and is derived from seed authorized for unconfined release may be exemptedfrom the notification and authorization requirements under the Seeds Regulations.” 10 Directive94-08 emphasizes that “[a]ll PNTs are subject to an environmental safety assessment,” 11 but it isnot clear that the PBO will be conducting or reviewing the assessment in these cases if the plantis exempted from notification and authorization requirements.In any event, where the exemptions do not apply, section 109 of the Seeds Regulationsprovides that no person may release seed without first filing a notification under s.110 andreceiving authorization for the release under s.111. The information that an applicant mustprovide in its notification and request for authorization for unconfined release of its plant is setout in s.110 of the Seeds Regulations. Certain information is required for the release of any nonexemptedseed, while additional information is required of seeds “with a novel trait.” 12 Theapplicant seeking authorization for the unconfined release of a seed with a novel trait mustprovide: 13 a) The name of the person or body responsible for the proposed release(s.110(1)(a)).b) The name of the person who will be in charge of carrying out therelease (s.110(1)(a)).Jennifer A. Chandler - The Regulation of Genetically Modified Plants: D-40Authorization of Unconfined Environmental Release