New Substances Notification Regulations (Organisms)

New Substances Notification Regulations (Organisms) Whereas, pursuant to subsection 332(1)a of the Canadian Environmental Protection Act, 1999b, 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; S.C. 2004, c. 15, s. 31 S.C. 1999, c. 33 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). Definitions The following definitions apply in these Regulations. Act means the Canadian Environmental Protection Act, 1999. (Loi) 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 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 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 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 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, 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[Repealed, SOR/2018-11, s. 33] micro-organism means a microscopic organism that is classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts; a virus, virus-like particle or sub-viral particle; a cultured cell of an organism not referred to in paragraph (a) or (b), other than a cell used to propagate the organism; or any culture other than a pure culture. (micro-organisme) 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 means a living organism as defined in section 104 of the Act, except in the following provisions: paragraph (c) of the definition micro-organism; paragraphs 2(4)(b) and (c); paragraph 1(d) and subparagraphs 1(e)(vi) and (viii) of Schedule 5; paragraph 2(d) of Schedule 5; subparagraph 3(d)(iii) and paragraph 3(f) of Schedule 5; and items 5 to 7 in Schedule 5. (organisme) 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: to create or improve a product or process; to determine the technical viability or performance characteristics of a product or process; or 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, 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) Government agencies The definition of government in subsection 3(1) of the Act does not apply to the expression “government agencies” in these Regulations. Avoiding regulatory duplication 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. Transit 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. Research and development micro-organisms 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 the Canadian Biosafety Standards and Guidelines or Appendix K of the NIH Guidelines; and the micro-organism is imported to a contained facility in a quantity that, at the time of the import, is less than 50 mL or 50 g, or manufactured in a contained facility under one of the following conditions: 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 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. Research and development organism other than a micro-organism 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 the organism; the genetic material of the organism; or material from the organism involved in toxicity. Agricultural research study — micro-organisms 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: the study is conducted and supervised by an agronomist, a plant pathologist or a researcher who is trained in conducting agricultural research; the micro-organism 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 is identified at a taxonomic level that enables the persons referred to in paragraph (a) to consider its overall characteristics and the potential hazards to the environment and human health that are associated with its release in the study, and ensure that the study is conducted as set out in paragraphs (c) to (e); 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; 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 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 For the purposes of subsection (1), agricultural research study means an experimental field study that is conducted on land that is cultivated with annual agricultural crops, such as corn and soybeans; 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; on land that is used for five or more consecutive years to grow herbaceous forage crops that are either cultivated or growing wild; or inside a greenhouse that is not a contained facility. Information: Schedule 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 A person who manufactures or imports a micro-organism for introduction 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; 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 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 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 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 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 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. Information: Schedule 5 A person who manufactures or imports an organism other than a micro-organism must provide the information specified in Schedule 5. 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. Time limits The information required under sections 3 and 4 must be provided as follows: for the information required under subsection 3(1), at least 120 days before the day on which the person manufactures or imports the micro-organism, and 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; 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; 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 for the information required under section 4, at least 120 days before the day on which the person manufactures or imports the organism. 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: 120 days after receiving the information referred to in Schedule 1 or the other information required under subsection 3(2); 30 days after receiving the information referred to in Schedule 2 or 4; 90 days after receiving the information referred to in Schedule 3; and 120 days after receiving the information referred to in Schedule 5. 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. Information and certification Any information to be provided to the Minister under these Regulations must include 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; 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; 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; 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 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 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 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. Coming into force 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.] The following information in respect of the micro-organism: its identification and the information substantiating its identification; its common and superseded names and any synonyms; its strain history; a description of any modifications to the micro-organism, including the purpose of the modifications, the methods and steps taken to make the modifications, the phenotypic and genotypic changes that resulted from the steps referred to in subparagraph (ii), the stability of the changes referred to in subparagraph (iii), and the nature, source and function of any inserted genetic material; a description of the methods that can be used to distinguish and detect the micro-organism; a description of the biological and ecological characteristics of the micro-organism, including its life cycle, its infectivity, pathogenicity to non-human species, toxicity and toxigenicity, its resistance to antibiotics and tolerance to metals and pesticides, its involvement in biogeochemical cycling, the conditions required for, and conditions that limit, its survival, growth and replication, and the mechanisms of its dispersal and the modes of interaction with any dispersal agents; a description of the mode of action in relation to the intended use; the identification of any patent or any application for a patent, as the case may be; the dispersal by gene transfer of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, including a description of the genetic basis for pathogenicity to non-human species, toxigenicity and resistance to antibiotics, the capability to transfer genes, and 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 a description of the geographic distribution of the micro-organism. The following information in respect of the manufacture and importation of the micro-organism: the identification of trade names and manufacturers, importers and vendors; the identification of locations of manufacture in Canada; the physical state of the formulation; the concentration of the micro-organism in the formulation; the identification and concentration of other ingredients and of any contaminants in the formulation; the viability of the micro-organism in the formulation; a description of any recommended storage and disposal procedures; an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be; a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; a description of the location of manufacturing facilities in Canada; 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 a description of the procedures for the treatment and disposal of wastes containing the micro-organism from the manufacturing facilities in Canada. The following information in respect of the introduction of the micro-organism: the intended and potential uses; the history of use; 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; a description of the procedures for the introduction of the micro-organism, including the method of application, the quantity, frequency and duration of application, and any activities associated with the introduction; a description of any contingency plans in the event of an accidental release; and a description of any recommended procedures for terminating the introduction of the micro-organism. The following information in respect of the environmental fate of the micro-organism: 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; a description of habitats where the micro-organism may persist or proliferate; the estimated quantities of the micro-organism in the air, water and soil at the points of introduction, and the estimated population trends; and any other information on the environmental fate of the micro-organism. The following information in respect of the ecological effects of the micro-organism: the data from tests conducted to determine the effects of the micro-organism on aquatic plant, invertebrate and vertebrate species likely to be exposed to it, and terrestrial plant, invertebrate and vertebrate species likely to be exposed to it; the involvement of the micro-organism in adverse ecological effects; and the potential of the micro-organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity. The following information in respect of the human health effects of the micro-organism: 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; the data from tests of antibiotic susceptibility; the data from tests of pathogenicity that are valid for related micro-organisms that are pathogenic to humans; the potential for adverse immunologic reactions in persons exposed to the micro-organism; and the estimated number of persons who may become exposed and the degree of their exposure to the micro-organism. 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. 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. 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. its infectivity, pathogenicity to non-human species, toxicity and toxigenicity, and the conditions required for, and conditions that limit, its survival, growth and replication; a description of the known mode of action in relation to the intended use; and the identification of any patent or any application for a patent, as the case may be. 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; a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; and a description of any recommended storage procedures. the intended and potential uses; and the history of its use. 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 the data from tests of antibiotic susceptibility. the conditions required for, and conditions that limit, its survival, growth and replication, its life cycle, if the micro-organism is not indigenous, its resistance to antibiotics and tolerance to metals and pesticides, if the micro-organism is not indigenous, its involvement in biogeochemical cycling, if the micro-organism is not indigenous, and a description of the known mode of action in relation to the objective of the experimental field study; 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 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 a description of the nature of potential releases of the micro-organism from the manufacturing facilities in Canada or from the facilities to which the micro-organism will be imported, as the case may be, and the procedures to control releases; and The following information in respect of the site of the experimental field study: its location and a map; its size; the distance to populated areas; the names of any national, provincial or territorial parks, wildlife reserves or migratory bird sanctuaries that have been established by federal or provincial law and are located within 100 km from the site; a description of the geological landscape at the site and surrounding the site; a description of the biological diversity found at the site and surrounding the site, including the identification of the endangered or threatened species, and if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified in subparagraph 1(f)(i), the identification of the receptor species; a comparison of the natural habitat of the micro-organism to the habitat at the site of the experimental field study, and the nature of the selection that may operate on the micro-organism at that site; and if the micro-organism is indigenous, data to demonstrate that it is indigenous. The following information in respect of the experimental field study: its objectives; the history of use of the micro-organism; its start date and duration; a description of the procedures for transporting the micro-organism to and from the site of the experimental field study; a description of the procedures and design for the experimental field study, including the method of application of the micro-organism, the quantity, frequency and duration of application of the micro-organism, and any activities associated with the experimental field study; a description of any procedures for monitoring the micro-organism and its ecological effects at the site of the experimental field study, during and after the experimental field study; a description of the security measures at the site of the experimental field study; a description of any contingency plans in the event of an accidental release; a description of any recommended procedures for terminating the experimental field study; and a description of any confinement procedures and biosafety conditions for the micro-organism at the site of the experimental field study, and a description of their effectiveness. the estimated quantities of the micro-organism in the air, water and soil at the points of introduction and the estimated population trends; and the data from tests of antibiotic susceptibility; and its identification and the information substantiating the identification; its infectivity, pathogenicity to non-human species, toxicity and toxigenicity; and a description of the reasonably expected by-products following introduction. The following information in respect of the manufacture of the micro-organism: data to substantiate that the micro-organism was isolated from the site of introduction; an estimation of the quantity of the micro-organism that will be manufactured; a description of the procedures for the treatment and disposal of wastes containing the micro-organism. The location and a map of the site of introduction. its intended use; the start date and duration; a description of the procedures for its introduction including any activities associated with the introduction; and a description of any confinement procedures and biosafety conditions for the micro-organism at the site of introduction, and a description of their effectiveness. The following information in respect of the organism: the identification, or current taxonomic name to the species or subspecies level, strain, common names, trade name and any synonyms; a description of any modifications to the organism, including the genetic stability of the changes referred to in subparagraph (iii), and the nature, source and function of any introduced genetic material; a description of the methods that can be used to distinguish and detect the organism; a description of the biological and ecological characteristics of the organism, including its reproductive biology, including species with which the organism could interbreed in Canada, its involvement in adverse ecological effects, including pathogenicity, toxicity and invasiveness, a description of the geographic distribution and habitat of the organism, the potential for dispersal of its traits by gene transfer, the locations and situations where the organism has caused adverse ecological effects, its interactions with other organisms in the environment, the conditions required for its survival, growth, reproduction and overwintering, its capability to act as a vector for agents involved in adverse effects, and the mechanisms of its dispersal and the modes of interaction with any dispersal agents; and the identification of any patent or other rights, or any application for a patent or other rights, as the case may be. The following information in respect of the manufacture and importation of the organism: the identification of manufacturers, importers and vendors; a description of the locations of manufacture in Canada; a description of the product containing the organism; a description of any recommended procedures for the storage and disposal of the organism; an estimation of the quantity of the organism that will be imported into or manufactured in Canada, as the case may be; and a description of the methods of manufacture and of quality control and quality assurance procedures. The following information in respect of the introduction of the organism: the history of its use; the intended and potential uses of the organism, and the potential locations of introduction; a description of the mode of action in relation to the intended use; and a description of the procedures for the introduction of the organism, including the method and rate of its introduction, any activities associated with its introduction, any recommended procedures for the storage and handling of any surplus organism, any contingency plans in the event of an accidental release and any reproductive isolation measures, and its resistance to control agents; a description of any recommended procedures for terminating the introduction of the organism; and a description of the procedures for the disposal of remaining biomass and residues of the organism. The following information in respect of the environmental fate of the organism: the estimated quantities of the organism in the environment and the estimated population trends; a description of habitats where the organism may persist or proliferate; and the identification of the species that are likely to be exposed to the organism and other species that are likely to be affected by it. The following information in respect of the ecological effects of the organism: the data from a test conducted to determine its pathogenicity, toxicity or invasiveness; the ecological effects of organism residues; and the potential of the organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity. The potential for the organism to be involved in adverse human health effects, and the most likely route of human exposure to the organism. All other information and test data in respect of the 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. The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the organism, and the purpose of that notification.