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

Regulations are current to 2014-09-29

SCOPE

Marginal note:Avoiding regulatory duplication
  •  (1) For greater certainty, these Regulations do not apply in respect of an organism that is manufactured or imported for a use that is regulated under any other Act or regulations listed in Schedule 4 to the Act.

  • Marginal note:Transit

    (2) These Regulations do not apply in respect of an organism that is loaded on a carrier outside Canada and moved through Canada to a location outside Canada, whether or not there is a change of carrier during transit.

  • Marginal note:Research and development organism (micro-organisms)

    (3) These Regulations do not apply in respect of a micro-organism that is a research and development organism not for introduction outside a contained facility, if the containment of the micro-organism is in accordance with either the Laboratory Biosafety Guidelines or Appendix K of the NIH Guidelines and if the micro-organism is

    • (a) imported to a contained facility in a quantity that, at the time of the import, is less than 50 mL or 50 g;

    • (b) subject to paragraphs (c) and (d), manufactured and present at any one time in a contained facility in a quantity of less than 1 000 L, unless the micro-organism requires containment level 2, 3 or 4 as identified in the Laboratory Biosafety Guidelines;

    • (c) manufactured and present at any one time in a contained facility in a quantity of less than 250 L and requires containment level 2 as identified in the Laboratory Biosafety Guidelines; or

    • (d) a human pathogen manufactured and present at any one time in a contained facility in a quantity of less than 250 L and requires containment level 3 or 4 as identified in the Laboratory Biosafety Guidelines, and if an import permit or an approval in writing to transfer has been granted in respect of the micro-organism under the Human Pathogens Importation Regulations.

  • Marginal note:Research and development organism other than a micro-organism

    (4) These Regulations do not apply in respect of an organism, other than a micro-organism, that is a research and development organism and is imported to or manufactured in a facility from which there is no release into the environment of

    • (a) the organism;

    • (b) the genetic material of the organism; or

    • (c) material from the organism involved in toxicity.

MICRO-ORGANISMS

Marginal note:Information: Schedule 1
  •  (1) Subject to subsections (2) to (6), a person who manufactures or imports a micro-organism must provide the information specified in Schedule 1.

  • Marginal note:Exceptions: Information in Schedule 1

    (2) A person who manufactures or imports a micro-organism for introduction

    • (a) into an ecozone where it is not indigenous is not required to provide the information specified in paragraph 5(a) of Schedule 1, but must, in a separate notification for each ecozone, provide the other information specified in that Schedule as well as the identification of the ecozone of intended introduction and the data from tests conducted to determine the effects of the micro-organism on plant, invertebrate and vertebrate species likely to be exposed;

    • (b) in accordance with confinement procedures is not required to provide the information specified in paragraphs 5(a) and 6(c) and (d) of Schedule 1, but must provide the other information specified in that Schedule and a description of those confinement procedures and their effectiveness in restricting the exit or dispersal of the micro-organism from the locations of introduction; or

    • (c) into an ecozone to which the micro-organism is indigenous is not required to provide the information specified in subparagraphs 1(f)(i), (iii) and (iv) and paragraphs 1(i) and 5(a) of Schedule 1, but must, in a separate notification for each ecozone, provide the other information specified in that Schedule as well as the identification of the ecozone of intended introduction and the data that demonstrates that the micro-organism is indigenous to that ecozone.

  • Marginal note:Introduction within 10 km of ecozone boundary

    (3) A person who manufactures or imports a micro-organism for introduction into an ecozone at a point within 10 km of the boundary of an ecozone referred to in paragraph (2)(a) or (c), as the case may be, may elect to have the introduction of the micro-organism considered to be in that ecozone and not into the actual ecozone of introduction, in which case the person must provide a notice in writing of the election and the information required by that paragraph.

  • Marginal note:Information: Schedule 2

    (4) A person who manufactures in a contained facility or imports to a contained facility a micro-organism that is not for introduction outside the contained facility, or is for export only, is not required to provide the information specified in Schedule 1, but must provide the information specified in Schedule 2.

  • 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.

  • Marginal note:Information: Schedule 4

    (6) A person who manufactures a micro-organism at the site from which it was isolated, for introduction into the same site, is not required to provide the information specified in Schedule 1, but must provide the information specified in Schedule 4.