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

Regulations are current to 2017-11-06

New Substances Notification Regulations (Organisms)

SOR/2005-248

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Registration 2005-08-31

New Substances Notification Regulations (Organisms)

P.C. 2005-1485 2005-08-31

Whereas, pursuant to subsection 332(1)Footnote a of the Canadian Environmental Protection Act, 1999Footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on October 30, 2004, a copy of the proposed New Substances Notification Regulations (Organisms), substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 114(1) of the Canadian Environmental Protection Act, 1999b, hereby makes the annexed New Substances Notification Regulations (Organisms).

Interpretation

Marginal note:Definitions
  •  (1) The following definitions apply in these Regulations.

    Act

    Loi

    Act means the Canadian Environmental Protection Act, 1999. (Loi)

    confinement procedures

    méthodes de confinement

    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

    installation étanche

    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 Laboratory Biosafety Guidelines or Appendix K of the NIH Guidelines. (installation étanche)

    ecozone

    écozone

    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

    étude expérimentale sur le terrain

    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

    indigène

    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

    Lignes directrices en matière de biosécurité en laboratoire

    Laboratory Biosafety Guidelines means the Laboratory Biosafety Guidelines, 3rd Edition, established by the Department of Health, published in 2004, as amended from time to time. (Lignes directrices en matière de biosécurité en laboratoire)

    micro-organism

    micro-organisme

    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

    NIH Guidelines

    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

    organisme

    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

    destiné à la recherche et au développement

    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

    test de marché

    test marketing, in respect of a product, means the exploration of its market capability in a competitive situation in which the creation or improvement of the product is not the primary objective. (test de marché)

  • Marginal note:Government agencies

    (2) The definition of government in subsection 3(1) of the Act does not apply to the expression government agencies in these Regulations.

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.

 
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