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Marginal note:Information and certification

• 8 (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

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Marginal note:Information: Schedule 1

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• (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;

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  • (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:Definitions

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

  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)

  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)

  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:

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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:

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  • (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

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

• (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;

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