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

Regulations are current to 2016-04-12

SCHEDULE 1(Subsections 3(1) and (2) and paragraph 6(a))Information Required in Respect of Micro-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    • (b) its common and superseded names and any synonyms;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 life cycle,

      • (ii) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity,

      • (iii) its resistance to antibiotics and tolerance to metals and pesticides,

      • (iv) its involvement in biogeochemical cycling,

      • (v) the conditions required for, and conditions that limit, its survival, growth and replication, and

      • (vi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents;

    • (g) a description of the mode of action in relation to the intended use;

    • (h) the identification of any patent or any application for a patent, as the case may be;

    • (i) the dispersal by gene transfer of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, including a description of

      • (i) the genetic basis for pathogenicity to non-human species, toxigenicity and resistance to antibiotics,

      • (ii) the capability to transfer genes, and

      • (iii) the conditions that might select for dispersal of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, and whether the conditions are likely to exist at the locations of introduction or within the range of dispersal of the micro-organism; and

    • (j) a description of the geographic distribution of the micro-organism.

  • 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 physical state of the formulation;

    • (d) the concentration of the micro-organism in the formulation;

    • (e) the identification and concentration of other ingredients and of any contaminants in the formulation;

    • (f) the viability of the micro-organism in the formulation;

    • (g) a description of any recommended storage and disposal procedures;

    • (h) an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be;

    • (i) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures;

    • (j) a description of the location of manufacturing facilities in Canada;

    • (k) a description of the nature of potential releases of the micro-organism from the manufacturing facilities in Canada or from facilities to which the micro-organism will be imported, as the case may be, and the procedures to control releases; and

    • (l) a description of the procedures for the treatment and disposal of wastes containing the micro-organism from the manufacturing facilities in Canada.

  • 3 The following information in respect of the introduction of the micro-organism:

    • (a) the intended and potential uses;

    • (b) the history of use;

    • (c) a comparison of the natural habitat of the micro-organism to the habitat at the potential locations of its introduction, and the nature of the selection that may operate on the micro-organism at the potential locations of introduction;

    • (d) a description of the procedures for the introduction of the micro-organism, including

      • (i) the method of application,

      • (ii) the quantity, frequency and duration of application, and

      • (iii) any activities associated with the introduction;

    • (e) a description of any contingency plans in the event of an accidental release; and

    • (f) a description of any recommended procedures for terminating the introduction of the micro-organism.

  • 4 The following information in respect of the environmental fate of the micro-organism:

    • (a) the identification of the plant and animal species likely to be exposed and, if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified under subparagraph 1(f)(ii), the identification of the receptor species likely to be exposed;

    • (b) a description of habitats where the micro-organism may persist or proliferate;

    • (c) the estimated quantities of the micro-organism in the air, water and soil at the points of introduction, and the estimated population trends; and

    • (d) any other information on the environmental fate of the micro-organism.

  • 5 The following information in respect of the ecological effects of the micro-organism:

    • (a) the data from tests conducted to determine the effects of the micro-organism on

      • (i) aquatic plant, invertebrate and vertebrate species likely to be exposed to it, and

      • (ii) terrestrial plant, invertebrate and vertebrate species likely to be exposed to it;

    • (b) the involvement of the micro-organism in adverse ecological effects; and

    • (c) the potential of the micro-organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity.

  • 6 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;

    • (b) the data from tests of antibiotic susceptibility;

    • (c) the data from tests of pathogenicity that are valid for related micro-organisms that are pathogenic to humans;

    • (d) the potential for adverse immunologic reactions in persons exposed to the micro-organism; and

    • (e) the estimated number of persons who may become exposed and the degree of their exposure to the micro-organism.

  • 7 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.

  • 8 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.

  • 9 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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