New Substances Notification Regulations (Organisms) (SOR/2005-248)

Regulations are current to 2014-12-08

SCHEDULE 2(Subsection 3(4) and paragraph 6(b))INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS MANUFACTURED IN OR IMPORTED TO A CONTAINED FACILITY THAT ARE NOT FOR INTRODUCTION OUTSIDE THE CONTAINED FACILITY OR THAT ARE FOR EXPORT ONLY

  • 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    • (b) its common and superseded names and any synonyms;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.