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 are relevant to identifying hazards to the environment and human health and that are in the person’s possession or to which the person ought reasonably 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.
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