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 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.