New Substances Notification Regulations (Organisms)

Marginal note:Avoiding regulatory duplication

• 2 (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 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

  • (a) the containment of the micro-organism is in accordance with the Canadian Biosafety Standards and Guidelines or Appendix K of the NIH Guidelines; and

  • (b) the micro-organism is

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

    • (ii) manufactured in a contained facility under one of the following conditions:

      • (A) the micro-organism does not require containment level 2, 3 or 4 as identified in the Canadian Biosafety Standards and Guidelines and at any given moment there is less than 1 000 L of the micro-organism present at that facility, and

      • (B) the micro-organism requires containment level 2, 3 or 4 as identified in the Canadian Biosafety Standards and Guidelines, its manufacture is a controlled activity authorized under a licence issued under section 18 of the Human Pathogens and Toxins Act whose conditions of licence are complied with and at any given moment there is less than 250 L of the micro-organism present at that facility.

• 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.