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

Regulations are current to 2021-02-15 and last amended on 2018-02-02. Previous Versions

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.

Organisms Other than Micro-organisms

Marginal note:Information: Schedule 5

 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

 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.

  • SOR/2018-11, s. 36

Information Provision Time Limits

Marginal note:Time limits

 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

 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.

Retention of Information

Marginal note:Five years

 A person who is required to provide information to the Minister under these Regulations must keep a copy of that information and any supporting data at the person’s principal place of business in Canada or at the principal place of business in Canada of a representative of that person. The information and the supporting data must be kept for a period of five years after the year in which the information is provided.

Administrative Requirements

Marginal note:Information and certification

  •  (1) Any information to be provided to the Minister under these Regulations must include

    • (a) the name, civic and postal addresses and telephone number, as well as the fax number and e-mail address, if any, of the manufacturer or importer of the organism;

    • (b) the name, title, civic and postal addresses and telephone number, as well as the fax number and e-mail address, if any, of the person authorized to act on behalf of the manufacturer or importer of the organism, if any;

    • (c) the name, civic and postal addresses and telephone number, as well as the fax number and e-mail address, if any, of the head of the quality assurance unit of every laboratory that developed test data included in the information;

    • (d) an indication of whether the organism will be manufactured in or imported into Canada and the civic address of the site of manufacture in Canada of the organism or, if known, the port of entry into Canada of the organism, as the case may be; and

    • (e) a certification that the information is accurate and complete, dated and signed by the manufacturer or importer if they are resident in Canada or, if not, the person authorized to act on their behalf.

  • Marginal note:Recipient

    (2) Two copies of any information provided under these Regulations must be sent in English or French to the Minister, care of the Substances Management Coordinator, Department of the Environment, Ottawa, Ontario K1A 0H3.

  • Marginal note:Agent

    (3) If a person that provides the information under these Regulations is not resident in Canada, they must identify, under paragraph (1)(b), a person resident in Canada that is authorized to act on their behalf to whom any notice or correspondence may be sent and that is required to keep the information and any supporting data under section 7.

  • SOR/2018-11, s. 37

Coming into Force

Marginal note:Coming into force

Footnote * These Regulations come into force on the day on which the New Substances Notification Regulations (Chemicals and Polymers) come into force.

 
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