23.2 (1) Subject to subsection (2), the accompanying information that is required to be provided by a person to the Minister pursuant to paragraph 23.1(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 proposed starting date, time period and site of the release;
(d) the proposed release protocol, including
(i) any confinement measures intended to mitigate the establishment and spread, in the environment, of the novel supplement and the interaction of the novel supplement with the environment,
(ii) the monitoring plan and procedures to be followed both during and after the release,
(iii) the method to be used for the safe disposal of the novel supplement and all crops produced on the land or growing medium to which the novel supplement is applied, and
(iv) the contingency plan to be followed to mitigate any adverse effect of an accidental release of the novel supplement on the environment, including any adverse effect on human health;
(e) the identification and characterization of the novel supplement, including, in the case of a novel supplement that is derived through biotechnology and has a novel trait
(i) the identification and characterization of the novel trait expressed by the novel supplement and, where the novel trait is introduced from another species, details of the host and donor organism and of the methods of incorporation of the novel trait into the novel supplement, where applicable, and
(ii) the identification and characterization of the novel supplement 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 novel supplement, and a comparison of the characteristics of the novel supplement with those of the unmodified supplement;
(f) all other information and test data in respect of the novel supplement 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;
(g) other government agencies, either Canadian or foreign, that have been provided with information in respect of the novel supplement, and the purpose for which the information was provided; and
(h) a description of the analytical methodologies followed in generating any submitted data, including quality control and quality assurance procedures.
(2) The information required by subparagraph (1)(e)(ii) or paragraph (1)(f) or (h) 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 23.3, and notifies the person of that determination.
- SOR/97-7, s. 4.
DECISION OF THE MINISTER
23.3 (1) On receiving the notification provided pursuant to paragraph 23.1(1)(a), the Minister shall, after considering all relevant matters, including the information provided pursuant to that paragraph, and after evaluating the potential impact on and risk to the environment, including the potential impact on and risk to human health, posed by the proposed release
(a) authorize the release where there is minimal risk to the environment, and may, where necessary in order to minimize the risk, impose conditions for the management of the risk; or
(b) refuse to authorize the release where the proposed release poses an unacceptable risk to the environment.
(2) In evaluating the risk to the environment for the purposes of subsection (1), the Minister shall
(a) consider such matters as
(i) the effects of the proposed release on the environment, and
(ii) the magnitude of the exposure to the environment of the novel supplement involved in the proposed release; and
(b) assess whether the novel supplement is toxic.
- SOR/97-7, s. 4.
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