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.
(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.
- SOR/2018-11, s. 34
- Date modified: