New Substances Notification Regulations (Organisms)
1 The following information in respect of the micro-organism:
(a) its identification and the information substantiating its identification;
(b) its common and superseded names and any synonyms;
(c) its strain history;
(d) a description of any modifications to the micro-organism, including
(i) the purpose of the modifications,
(ii) the methods and steps taken to make the modifications,
(iii) the phenotypic and genotypic changes that resulted from the steps referred to in subparagraph (ii),
(iv) the stability of the changes referred to in subparagraph (iii), and
(v) the nature, source and function of any inserted genetic material;
(e) a description of the methods that can be used to distinguish and detect the micro-organism;
(f) a description of the biological and ecological characteristics of the micro-organism, including
(i) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity, and
(ii) the conditions required for, and conditions that limit, its survival, growth and replication;
(g) a description of the known mode of action in relation to the intended use; and
(h) the identification of any patent or any application for a patent, as the case may be.
2 The following information in respect of the manufacture and importation of the micro-organism:
(a) the identification of trade names and manufacturers, importers and vendors;
(b) the identification of locations of manufacture in Canada;
(c) the containment level for each manufacturing facility in Canada or for each facility to which the micro-organism will be imported, as the case may be, determined in accordance with the physical and operational requirements set out in either the Laboratory Biosafety Guidelines or Appendix K of the NIH Guidelines;
(d) an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be;
(e) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; and
(f) a description of any recommended storage procedures.
3 The following information in respect of the introduction of the micro-organism:
(a) the intended and potential uses; and
(b) the history of its use.
4 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 data from tests of antibiotic susceptibility.
5 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.
6 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.
7 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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