108. The following seed is exempt from the operation of this Part:
(a) seed grown in Canada outside of containment before the coming into force of this Part in such a manner that the seed constitutes a distinct, stable population in the Canadian environment;
(b) 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; and
(c) seed that is derived from seed referred to in paragraph (a), or from seed in respect of which an unconfined release has been authorized under paragraph 111(1)(b), 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.
- SOR/97-9, s. 1.
Notification and Authorization
109. (1) Subject to subsections (2) to (4), no person shall undertake either the confined release or unconfined release of seed unless
(a) notification of the proposed release has been provided in writing to the Minister, accompanied by the information set out in section 110; and
(b) the Minister has authorized the release under section 111.
(2) Subsection (1) does not apply in respect of seed of a variety that is registered under Part III.
(3) Subsection (1) does not apply in respect of an unconfined release that was authorized by the Minister before the coming into force of this Part.
(4) Where the accompanying information that is required to be provided to the Minister pursuant to paragraph (1)(a) in respect of a proposed confined release is the same as information that has already been provided to the Minister before the coming into force of this Part, or that is provided on or after the coming into force of this Part in relation to another notification or authorization, the information is not required to be provided again.
- SOR/97-9, s. 1;
- SOR/2001-274, s. 2.
110. (1) Subject to subsection (4), the accompanying information that is required to be provided to the Minister by a person pursuant to paragraph 109(1)(a) is the following:
(a) the name of the person or body responsible for the proposed release and the name of the person who will be in charge of carrying out the release;
(b) the purpose and objectives of the proposed release;
(c) the plants derived from the unmodified host seed;
(d) in the case of seed with a novel trait,
(i) the novel trait expressed by the plants derived from the modified seed and, where the novel trait was introduced from another species, details of the donor organism and of the methods of incorporation of the novel trait into the host seed, where applicable, and
(ii) the plants derived from the modified seed resulting from the introduction of the novel trait, including details relating to expression of the novel trait and the stability of the incorporation of the novel trait into the plants derived from the modified seed, and a comparison of the characteristics of the plants derived from the modified seed with those derived from the unmodified host seed;
(e) all other information and test data in respect of the plants referred to in paragraph (d) that are relevant to identifying the risk to the environment, including the risk to human health, and that are in the person’s possession or to which the person ought reasonably to have access;
(f) other government agencies, either Canadian or foreign, that have been provided with information in respect of the plants referred to in subparagraph (d)(ii), and the purpose for which the information was provided; and
(g) a description of the analytical methodologies followed in generating any submitted data, including quality control and quality assurance procedures.
(2) In addition to the information referred to in subsection (1) and subject to subsection (4), the following accompanying information shall be provided to the Minister with any notification in respect of a proposed confined release:
(a) the proposed starting date, completion date and site of the confined release; and
(b) the proposed confined release protocol, including
(i) any confinement measures intended to mitigate the establishment and spread, in the environment, of the seed or of genetic material from plants derived from the seed, and the interaction of the seed or genetic material with the environment,
(ii) the monitoring plan and procedures to be followed both during and after the confined release,
(iii) the method to be used for the safe disposal of the seed and all progeny and plant material, and
(iv) the contingency plan to minimize any adverse effect of an accidental movement, outside of the confined release site, of the seed or genetic material from plants derived from the seed.
(3) In addition to the information referred to in subsection (1) and subject to subsection (4), data describing potential interactions of the seed, or plants derived from the seed, with other life forms and an evaluation of the potential risk of harm posed to the environment, including the risk of harm posed to human health, as a result of those interactions shall be provided to the Minister with any notification in respect of a proposed unconfined release.
(4) The information required by subparagraph (1)(d)(ii), paragraph (1)(e) or (g) or subsection (2) or (3) or any part of that information may be omitted if the Minister determines, on the basis of a written scientific rationale provided by the person referred to in subsection (1), that the information or part is not relevant or cannot practicably be obtained and is not required for the Minister’s decision under section 111, and notifies the person of that determination.
- SOR/97-9, s. 1.
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