New Substances Notification Regulations (Organisms)
SCHEDULE 4(Subsection 3(6) and paragraph 6(b))Information Required in Respect of Micro-organisms Manufactured at the Site from Which They Were Isolated for Introduction into the Same Site
1 The following information in respect of the micro-organism:
(a) its identification and the information substantiating the identification;
(b) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity; and
(c) a description of the reasonably expected by-products following introduction.
2 The following information in respect of the manufacture of the micro-organism:
(a) data to substantiate that the micro-organism was isolated from the site of introduction;
(b) the viability of the micro-organism in the formulation;
(c) an estimation of the quantity of the micro-organism that will be manufactured;
(d) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; and
(e) a description of the procedures for the treatment and disposal of wastes containing the micro-organism.
3 The location and a map of the site of introduction.
4 The following information in respect of the introduction of the micro-organism:
(a) its intended use;
(b) the start date and duration;
(c) a description of the procedures for its introduction including
(i) the method of application,
(ii) the quantity, frequency and duration of application, and
(iii) any activities associated with the introduction; and
(d) a description of any confinement procedures and biosafety conditions for the micro-organism at the site of introduction, and a description of their effectiveness.
5 The following information in respect of the human health effects of the micro-organism:
(a) any documented involvement of the micro-organism in adverse human health effects and a description of the characteristics of the micro-organism that distinguish it from known pathogens; and
(b) the estimated number of persons who may become exposed and the degree of their exposure to the micro-organism.
6 All other information and test data in respect of the micro-organism that permit the identification of hazards to the environment and human health and that are in the person’s possession or to which the person may reasonably be expected to have access.
7 The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the micro-organism, and the purpose of that notification.
8 A description or specification of the test procedures followed in developing the test data, including the test methods, reference substances and quality control and quality assurance procedures.
- SOR/2018-11, s. 43
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