GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
New Substances Notification Regulations (Organisms) — 2.1
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; 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. SOR/2018-11, s. 35
New Substances Notification Regulations (Organisms) — 3
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. 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. 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. 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. 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. 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.
New Substances Notification Regulations (Organisms) — 4
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.
New Substances Notification Regulations (Organisms) — 4.1
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. SOR/2018-11, s. 36
New Substances Notification Regulations (Organisms) — 5
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.
New Substances Notification Regulations (Organisms) — 6
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.
New Substances Notification Regulations (Organisms) — 7
Five years 7 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.
New Substances Notification Regulations (Organisms) — 8
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 (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. 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. 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
New Substances Notification Regulations (Organisms) — Coming into force
Coming into force * 9 These Regulations come into force on the day on which the New Substances Notification Regulations (Chemicals and Polymers) come into force. * [Note: Regulations in force August 31, 2005.]
New Substances Notification Regulations (Organisms) — 1
1 The following information in respect of the micro-organism: (a) its identification and the information substantiating its identification; (b) its common and superseded names and any synonyms; (c) its strain history; (d) a description of any modifications to the micro-organism, including (i) the purpose of the modifications, (ii) the methods and steps taken to make the modifications, (iii) the phenotypic and genotypic changes that resulted from the steps referred to in subparagraph (ii), (iv) the stability of the changes referred to in subparagraph (iii), and (v) the nature, source and function of any inserted genetic material; (e) a description of the methods that can be used to distinguish and detect the micro-organism; (f) a description of the biological and ecological characteristics of the micro-organism, including (i) its life cycle, (ii) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity, (iii) its resistance to antibiotics and tolerance to metals and pesticides, (iv) its involvement in biogeochemical cycling, (v) the conditions required for, and conditions that limit, its survival, growth and replication, and (vi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents; (g) a description of the mode of action in relation to the intended use; (h) the identification of any patent or any application for a patent, as the case may be; (i) the dispersal by gene transfer of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, including a description of (i) the genetic basis for pathogenicity to non-human species, toxigenicity and resistance to antibiotics, (ii) the capability to transfer genes, and (iii) the conditions that might select for dispersal of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, and whether the conditions are likely to exist at the locations of introduction or within the range of dispersal of the micro-organism; and (j) a description of the geographic distribution of the micro-organism.
New Substances Notification Regulations (Organisms) — 2
2 The following information in respect of the manufacture and importation of the micro-organism: (a) the identification of trade names and manufacturers, importers and vendors; (b) the identification of locations of manufacture in Canada; (c) the physical state of the formulation; (d) the concentration of the micro-organism in the formulation; (e) the identification and concentration of other ingredients and of any contaminants in the formulation; (f) the viability of the micro-organism in the formulation; (g) a description of any recommended storage and disposal procedures; (h) an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be; (i) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; (j) a description of the location of manufacturing facilities in Canada; (k) a description of the nature of potential releases of the micro-organism from the manufacturing facilities in Canada or from facilities to which the micro-organism will be imported, as the case may be, and the procedures to control releases; and (l) a description of the procedures for the treatment and disposal of wastes containing the micro-organism from the manufacturing facilities in Canada.
New Substances Notification Regulations (Organisms) — 3
3 The following information in respect of the introduction of the micro-organism: (a) the intended and potential uses; (b) the history of use; (c) a comparison of the natural habitat of the micro-organism to the habitat at the potential locations of its introduction, and the nature of the selection that may operate on the micro-organism at the potential locations of introduction; (d) a description of the procedures for the introduction of the micro-organism, including (i) the method of application, (ii) the quantity, frequency and duration of application, and (iii) any activities associated with the introduction; (e) a description of any contingency plans in the event of an accidental release; and (f) a description of any recommended procedures for terminating the introduction of the micro-organism.
New Substances Notification Regulations (Organisms) — 4
4 The following information in respect of the environmental fate of the micro-organism: (a) the identification of the plant and animal species likely to be exposed and, if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified under subparagraph 1(f)(ii), the identification of the receptor species likely to be exposed; (b) a description of habitats where the micro-organism may persist or proliferate; (c) the estimated quantities of the micro-organism in the air, water and soil at the points of introduction, and the estimated population trends; and (d) any other information on the environmental fate of the micro-organism.
New Substances Notification Regulations (Organisms) — 5
5 The following information in respect of the ecological effects of the micro-organism: (a) the data from tests conducted to determine the effects of the micro-organism on (i) aquatic plant, invertebrate and vertebrate species likely to be exposed to it, and (ii) terrestrial plant, invertebrate and vertebrate species likely to be exposed to it; (b) the involvement of the micro-organism in adverse ecological effects; and (c) the potential of the micro-organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity.
New Substances Notification Regulations (Organisms) — 6
6 The following information in respect of the human health effects of the micro-organism: (a) any documented involvement of the micro-organism in adverse human health effects and a description of the characteristics of the micro-organism that distinguish it from known pathogens; (b) the data from tests of antibiotic susceptibility; (c) the data from tests of pathogenicity that are valid for related micro-organisms that are pathogenic to humans; (d) the potential for adverse immunologic reactions in persons exposed to the micro-organism; and (e) the estimated number of persons who may become exposed and the degree of their exposure to the micro-organism.
New Substances Notification Regulations (Organisms) — 7
7 All other information and test data in respect of the micro-organism that permit the identification of hazards to the environment and human health and that are in the person’s possession or to which the person may reasonably be expected to have access.
New Substances Notification Regulations (Organisms) — 8
8 The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the micro-organism, and the purpose of that notification.
New Substances Notification Regulations (Organisms) — 9
9 A description or specification of the test procedures followed in developing the test data, including the test methods, reference substances and quality control and quality assurance procedures.
New Substances Notification Regulations (Organisms) — 1
1 The following information in respect of the micro-organism: (a) its identification and the information substantiating its identification; (b) its common and superseded names and any synonyms; (c) its strain history; (d) a description of any modifications to the micro-organism, including (i) the purpose of the modifications, (ii) the methods and steps taken to make the modifications, (iii) the phenotypic and genotypic changes that resulted from the steps referred to in subparagraph (ii), (iv) the stability of the changes referred to in subparagraph (iii), and (v) the nature, source and function of any inserted genetic material; (e) a description of the methods that can be used to distinguish and detect the micro-organism; (f) a description of the biological and ecological characteristics of the micro-organism, including (i) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity, and (ii) the conditions required for, and conditions that limit, its survival, growth and replication; (g) a description of the known mode of action in relation to the intended use; and (h) the identification of any patent or any application for a patent, as the case may be.
New Substances Notification Regulations (Organisms) — 2
2 The following information in respect of the manufacture and importation of the micro-organism: (a) the identification of trade names and manufacturers, importers and vendors; (b) the identification of locations of manufacture in Canada; (c) the containment level for each manufacturing facility in Canada or for each facility to which the micro-organism will be imported, as the case may be, determined in accordance with the physical and operational requirements set out in either the Canadian Biosafety Standards and Guidelines or Appendix K of the NIH Guidelines; (d) an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be; (e) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; and (f) a description of any recommended storage procedures.
New Substances Notification Regulations (Organisms) — 3
3 The following information in respect of the introduction of the micro-organism: (a) the intended and potential uses; and (b) the history of its use.
New Substances Notification Regulations (Organisms) — 4
4 The following information in respect of the human health effects of the micro-organism: (a) any documented involvement of the micro-organism in adverse human health effects and a description of the characteristics of the micro-organism that distinguish it from known pathogens; and (b) the data from tests of antibiotic susceptibility.
New Substances Notification Regulations (Organisms) — 5
5 All other information and test data in respect of the micro-organism that permit the identification of hazards to the environment and human health and that are in the person’s possession or to which the person may reasonably be expected to have access.
New Substances Notification Regulations (Organisms) — 6
6 The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the micro-organism, and the purpose of that notification.
New Substances Notification Regulations (Organisms) — 7
7 A description or specification of the test procedures followed in developing the test data, including the test methods, reference substances and quality control and quality assurance procedures.
New Substances Notification Regulations (Organisms) — 1
1 The following information in respect of the micro-organism: (a) its identification and the information substantiating its identification; (b) its common and superseded names and any synonyms; (c) its strain history; (d) a description of any modifications to the micro-organism, including (i) the purpose of the modifications, (ii) the methods and steps taken to make the modifications, (iii) the phenotypic and genotypic changes that resulted from the steps referred to in subparagraph (ii), (iv) the stability of the changes referred to in subparagraph (iii), and (v) the nature, source and function of any inserted genetic material; (e) a description of the methods that can be used to distinguish and detect the micro-organism; (f) a description of the biological and ecological characteristics of the micro-organism, including (i) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity, (ii) the conditions required for, and conditions that limit, its survival, growth and replication, (iii) its life cycle, if the micro-organism is not indigenous, (iv) its resistance to antibiotics and tolerance to metals and pesticides, if the micro-organism is not indigenous, (v) its involvement in biogeochemical cycling, if the micro-organism is not indigenous, and (vi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents; (g) a description of the known mode of action in relation to the objective of the experimental field study; (h) the identification of any patent or any application for a patent, as the case may be; (i) if the micro-organism is not indigenous, the dispersal by gene transfer of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, including a description of (i) the genetic basis for pathogenicity to non-human species, toxigenicity and resistance to antibiotics, (ii) the capability to transfer genes, and (iii) the conditions that might select for dispersal of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, and whether the conditions are likely to exist at the site of the experimental field study or within the range of dispersal of the micro-organism; and (j) a description of the geographic distribution of the micro-organism.