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  1. New Substances Notification Regulations (Organisms) - SOR/2005-248 (SCHEDULE 3 : Information Required in Respect of Micro-organisms for Introduction in an Experimental Field)

    SCHEDULE 3(Subsection 3(5) and paragraph 6(c))Information Required in Respect of Micro-organisms for Introduction in an Experimental Field Study

    1 The following information in respect of the micro-organism:

    • [...]

    • (g) a description of the known mode of action in relation to the objective of the experimental field study;

    • [...]

    • (i) if the micro-organism is not indigenous, the dispersal by gene transfer of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, including a description of

      • [...]

      • (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 site of the experimental field study or within the range of dispersal of the micro-organism; and

    [...]

    3 The following information in respect of the site of the experimental field study:

    • [...]

    • (g) a comparison of the natural habitat of the micro-organism to the habitat at the site of the experimental field study, and the nature of the selection that may operate on the micro-organism at that site; and

    4 The following information in respect of the experimental field study:

    • [...]

    • (d) a description of the procedures for transporting the micro-organism to and from the site of the experimental field study;

    • (e) a description of the procedures and design for the experimental field study, including

      • [...]

      • (iii) any activities associated with the experimental field study;

    • (f) a description of any procedures for monitoring the micro-organism and its ecological effects at the site of the experimental field study, during and after the experimental field study;

    • (g) a description of the security measures at the site of the experimental field study;

    • [...]

    • (i) a description of any recommended procedures for terminating the experimental field study; and

    • (j) a description of any confinement procedures and biosafety conditions for the micro-organism at the site of the experimental field study, and a description of their effectiveness.

    [...]


  2. New Substances Notification Regulations (Organisms) - SOR/2005-248 (Section 2.1)
    Marginal note:Agricultural research study — micro-organisms

    • 2.1 (1) Despite subsection 3(5), if the following conditions are met, these Regulations do not apply in respect of a micro-organism that is a research and development organism for introduction in an agricultural research study conducted on plants:

      • (a) the study is conducted and supervised by an agronomist, a plant pathologist or a researcher who is trained in conducting agricultural research;

      • (b) the micro-organism

        • (i) is not modified from its natural form and occurs naturally in, and has been isolated from, an ecozone that is the same as the one in which the study is located, and

        • (ii) is identified at a taxonomic level that enables the persons referred to in paragraph (a) to

          • (A) consider its overall characteristics and the potential hazards to the environment and human health that are associated with its release in the study, and

          • (B) ensure that the study is conducted as set out in paragraphs (c) to (e);

      • (c) the manufacture of the micro-organism for the purpose of the study employs laboratory and operation practices to minimize contamination of the formulation and minimize the unintentional release of the micro-organism from the manufacturing facility;

      • (d) the study is conducted in a manner that follows field and sanitation practices to minimize the likelihood of the micro-organism’s dispersal outside the study area where it may be a hazard to the environment and human health; and

      • (e) the manufacturer has operational procedures in place to ensure that physical possession or control of the micro-organism is transferred only to individuals who are made aware of the conditions of this subsection and the manufacturer has reason to believe that they are capable of meeting those conditions when conducting the study;

    • Marginal note:Agricultural research study

      (2) For the purposes of subsection (1), agricultural research study means an experimental field study that is conducted

      [...]

    [...]


  3. New Substances Notification Regulations (Organisms) - SOR/2005-248 (Section 1)
    Marginal note:Definitions

    • 1 (1) The following definitions apply in these Regulations.

      experimental field study

      experimental field study means a study of a research and development organism that is a micro-organism, which study uses the minimum area, consisting of one or more sites whose total area does not exceed one hundred hectares, and the minimum quantity of the micro-organism as are required to meet the objectives of the study. (étude expérimentale sur le terrain)

    [...]


  4. New Substances Notification Regulations (Organisms) - SOR/2005-248 (Section 3)
    Marginal note:Information: Schedule 1

    • [...]

    • Marginal note:Information: Schedule 3

      (5) A person who manufactures or imports a micro-organism for introduction in an experimental field study is not required to provide the information specified in Schedule 1, but must provide the information specified in Schedule 3.


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