New Substances Notification Regulations (Organisms) — 1
Definitions 1 (1) The following definitions apply in these Regulations. Act means the Canadian Environmental Protection Act, 1999 . ( Loi ) Canadian Biosafety Standards and Guidelines means the documents entitled Canadian Biosafety Standard , 2nd Edition, published in 2015, and the Canadian Biosafety Guideline: Containment Level 1: Physical Design and Operational Practices , published in 2017, both developed by the Public Health Agency of Canada and the Canadian Food Inspection Agency, as amended from time to time. ( Normes et lignes directrices canadiennes sur la biosécurité ) confinement procedures means any physical, chemical, biological or operational control, or combination of those controls, to restrict the exit or dispersal of a micro-organism. ( méthodes de confinement ) contained facility means an enclosed building with walls, floor and ceiling, or an area within such a building, where the containment is in accordance with the physical and operational requirements of a level set out in either the Canadian Biosafety Standards and Guidelines or Appendix K of the NIH Guidelines. ( installation étanche ) ecozone means one of the ecozones shown on the map entitled Terrestrial Ecozones and Ecoregions of Canada 1995 , dated May 6, 1999, Catalogue No. cas016e, whose boundaries are more particularly described in the National Soil Data Base (NSDB) of the Canada Soil Information System (CanSIS), developed by the Department of Agriculture and Agri-Food and the Department of the Environment, as amended from time to time. ( écozone ) 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 ) indigenous , in respect of a micro-organism, means occurring naturally in the ecozone into which the micro-organism is intended to be introduced. ( indigène ) Laboratory Biosafety Guidelines [Repealed, SOR/2018-11, s. 33] micro-organism means a microscopic organism that is (a) classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts; (b) a virus, virus-like particle or sub-viral particle; (c) a cultured cell of an organism not referred to in paragraph (a) or (b), other than a cell used to propagate the organism; or (d) any culture other than a pure culture. ( micro-organisme ) NIH Guidelines means the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) June 1994 , published in the Federal Register by the U.S. Department of Health and Human Services, 59 FR 34472 (July 5, 1994), as amended from time to time. ( NIH Guidelines ) organism means a living organism as defined in section 104 of the Act, except in the following provisions: (a) paragraph (c) of the definition micro-organism ; (b) paragraphs 2(4)(b) and (c); (c) paragraph 1(d) and subparagraphs 1(e)(vi) and (viii) of Schedule 5; (d) paragraph 2(d) of Schedule 5; (e) subparagraph 3(d)(iii) and paragraph 3(f) of Schedule 5; and (f) items 5 to 7 in Schedule 5. ( organisme ) research and development organism means an organism that is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, whose primary objective is any of the following: (a) to create or improve a product or process; (b) to determine the technical viability or performance characteristics of a product or process; or (c) to evaluate the organism prior to its commercialization, by pilot plant trials, production trials, including scale-up, or customer plant trials so that technical specifications can be modified in response to the performance requirements of potential customers. ( destiné à la recherche et au développement ) test marketing , in respect of a product, means the expl