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

Interpretation

Marginal note:Definitions

• 1 (1) The following definitions apply in these Regulations.

  Act

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

  Canadian Biosafety Standards and Guidelines

  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

  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

  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

  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

  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

  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

  Laboratory Biosafety Guidelines[Repealed, SOR/2018-11, s. 33]

  micro-organism

  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 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

  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

  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 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

• 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.

Marginal note:Agricultural research study — micro-organisms

• 2.1 (1) Despite subsection 3(5), if the following conditions are met, these Regulations do not apply in respect of a micro-organism that is a research and development organism for introduction in an agricultural research study conducted on plants:

  • (a) the study is conducted and supervised by an agronomist, a plant pathologist or a researcher who is trained in conducting agricultural research;

  • (b) the micro-organism

    • (i) is not modified from its natural form and occurs naturally in, and has been isolated from, an ecozone that is the same as the one in which the study is located, and

    • (ii) is identified at a taxonomic level that enables the persons referred to in paragraph (a) to

      • (A) consider its overall characteristics and the potential hazards to the environment and human health that are associated with its release in the study, and

      • (B) ensure that the study is conducted as set out in paragraphs (c) to (e);

  • (c) the manufacture of the micro-organism for the purpose of the study employs laboratory and operation practices to minimize contamination of the formulation and minimize the unintentional release of the micro-organism from the manufacturing facility;

  • (d) the study is conducted in a manner that follows field and sanitation practices to minimize the likelihood of the micro-organism’s dispersal outside the study area where it may be a hazard to the environment and human health; and

  • (e) the manufacturer has operational procedures in place to ensure that physical possession or control of the micro-organism is transferred only to individuals who are made aware of the conditions of this subsection and the manufacturer has reason to believe that they are capable of meeting those conditions when conducting the study;

• Marginal note:Agricultural research study

  (2) For the purposes of subsection (1), agricultural research study means an experimental field study that is conducted

  • (a) on land that is cultivated with annual agricultural crops, such as corn and soybeans;

  • (b) on land that is cultivated with perennials or woody plants that do not have to be replanted for several years such as asparagus, grapevines, fruit trees, Christmas trees, ornamental trees and shrubs destined for nurseries and seedling trees destined for replanting in reforestation, conservation and restoration projects, excluding lands for forestry uses;

  • (c) on land that is used for five or more consecutive years to grow herbaceous forage crops that are either cultivated or growing wild; or

  • (d) inside a greenhouse that is not a contained facility.

Micro-organisms

Marginal note:Information: Schedule 1

• 3 (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.

Organisms Other than Micro-organisms

Marginal note:Information: Schedule 5

4 A person who manufactures or imports an organism other than a micro-organism must provide the information specified in Schedule 5.

Marginal note:Addition to Domestic Substances List — information

4.1 For the purposes of paragraph 112(1)(b) of the Act, a person who provides the information referred to in sections 3 and 4 must also provide — within 30 days after the day on which they manufactured or imported the organism — a notice confirming that manufacture or importation.

Information Provision Time Limits

Marginal note:Time limits

5 The information required under sections 3 and 4 must be provided as follows:

• (a) for the information required under

  • (i) subsection 3(1), at least 120 days before the day on which the person manufactures or imports the micro-organism, and

  • (ii) subsections 3(2) or (3), at least 120 days before the day on which the person manufactures or imports the micro-organism under conditions that trigger the requirement to provide the information;

• (b) for the information required under subsection 3(4) or (6), at least 30 days before the day on which the person manufactures or imports the micro-organism under conditions that trigger the requirement to provide the information;

• (c) for the information required under subsection 3(5), at least 90 days before the day on which the person manufactures or imports the micro-organism under conditions that trigger the requirement to provide the information; and

• (d) for the information required under section 4, at least 120 days before the day on which the person manufactures or imports the organism.

Assessment Periods

Marginal note:Time limits

6 For the purposes of subsection 108(1) of the Act, the periods within which the Ministers must assess the information provided under sections 3 and 4 are as follows:

• (a) 120 days after receiving the information referred to in Schedule 1 or the other information required under subsection 3(2);

• (b) 30 days after receiving the information referred to in Schedule 2 or 4;

• (c) 90 days after receiving the information referred to in Schedule 3; and

• (d) 120 days after receiving the information referred to in Schedule 5.