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Vol. 139, No. 19 September 21, 2005 Registration CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999 New Substances Notification Regulations (Organisms) P.C. 2005-1485 August 31, 2005 Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), 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; 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, 1999 (see footnote c), hereby makes the annexed New Substances Notification Regulations (Organisms).
SCHEDULE 1 INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS 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of the micro-organism: (a) its identification and the information substantiating its identification; (b) its common and superseded names and any synonyms; (c) its strain history; (d) a description of any modifications to the micro-organism, including (i) the purpose of the modifications,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. 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. 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. 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. 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. 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. 7. All other information and test data in respect of the micro-organism that are relevant to identifying hazards to the environment and human health and that are in the person's possession or to which the person ought reasonably to have access. 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. 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. SCHEDULE 2 INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS MANUFACTURED IN OR IMPORTED TO A CONTAINED FACILITY THAT ARE NOT FOR INTRODUCTION OUTSIDE THE CONTAINED FACILITY OR THAT ARE FOR EXPORT ONLY 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. 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 Laboratory Biosafety 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. 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. 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. 5. All other information and test data in respect of the micro-organism that are relevant to identifying hazards to the environment and human health and that are in the person's possession or to which the person ought reasonably to have access. 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. 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. SCHEDULE 3 INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS FOR INTRODUCTION IN AN EXPERIMENTAL FIELD STUDY 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. 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 physical state of the formulation; (c) the concentration of the micro-organism in the formulation; (d) the identification and concentration of other ingredients and of any contaminants in the formulation; (e) the viability of the micro-organism in the formulation; (f) a description of any recommended storage and disposal procedures; (g) an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be; (h) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; (i) a description of the location of manufacturing facilities in Canada; (j) 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 (k) a description of the procedures for the treatment and disposal of wastes containing the micro-organism from the manufacturing facilities in Canada. 3. The following information in respect of the site of the experimental field study: (a) its location and a map; (b) its size; (c) the distance to populated areas; (d) the distance to any protected areas; (e) a description of the geological landscape at the site and surrounding the site; (f) a description of the biological diversity found at the site and surrounding the site, including (i) the identification of the endangered or threatened species, and (ii) if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified in subparagraph 1(f)(i), the identification of the receptor species; (g) 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 (h) if the micro-organism is indigenous, data to demonstrate that it is indigenous. 4. The following information in respect of the experimental field study: (a) its objectives; (b) the history of use of the micro-organism; (c) its start date and duration; (d) a description of the procedures for transporting the micro-organism to and from the site of the experimental field study; (e) a description of the procedures and design for the experimental field study, including (i) the method of application of the micro-organism, (ii) the quantity, frequency and duration of application of the micro-organism, and (iii) any activities associated with the experimental field study; (f) 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; (g) a description of the security measures at the site of the experimental field study; (h) a description of any contingency plans in the event of an accidental release; (i) a description of any recommended procedures for terminating the experimental field study; and (j) 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. 5. The following information in respect of the environmental fate of the micro-organism: (a) a description of habitats where the micro-organism may persist or proliferate; (b) the estimated quantities of the micro-organism in the air, water and soil at the points of introduction and the estimated population trends; and (c) any other information on the environmental fate of the micro-organism. 6. The following information in respect of the ecological effects of the micro-organism: (a) the involvement of the micro-organism in adverse ecological effects; and (b) the potential of the micro-organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity. 7. 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; and (c) the estimated number of persons who may become exposed and the degree of their exposure to the micro-organism. 8. All other information and test data in respect of the micro-organism that are relevant to identifying hazards to the environment and human health and that are in the person's possession or to which the person ought reasonably to have access. 9. 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. 10. 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. SCHEDULE 4 INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS MANUFACTURED AT THE SITE FROM WHICH THEY WERE ISOLATED FOR INTRODUCTION INTO THE SAME SITE 1. The following information in respect of the micro-organism: (a) its identification and the information substantiating the identification; (b) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity; and (c) a description of the reasonably expected by-products following introduction. 2. The following information in respect of the manufacture of the micro-organism: (a) data to substantiate that the micro-organism was isolated from the site of introduction; (b) the viability of the micro-organism in the formulation; (c) an estimation of the quantity of the micro-organism that will be manufactured; (d) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures; and (e) a description of the procedures for the treatment and disposal of wastes containing the micro-organism. 3. The location and a map of the site of introduction. 4. The following information in respect of the introduction of the micro-organism: (a) its intended use; (b) the start date and duration; (c) a description of the procedures for its introduction including (i) the method of application, (ii) the quantity, frequency and duration of application, and (iii) any activities associated with the introduction; and (d) a description of any confinement procedures and biosafety conditions for the micro-organism at the site of introduction, and a description of their effectiveness. 5. 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 estimated number of persons who may become exposed and the degree of their exposure to the micro-organism. 6. All other information and test data in respect of the micro-organism that are relevant to identifying hazards to the environment and human health and that are in the person's possession or to which the person ought reasonably to have access. 7. 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. 8. 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. SCHEDULE 5 INFORMATION REQUIRED IN RESPECT OF ORGANISMS OTHER THAN MICRO-ORGANISMS 1. The following information in respect of the organism: (a) the identification, or current taxonomic name to the species or subspecies level, strain, common names, trade name and any synonyms; (b) its strain history; (c) a description of any modifications to the 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 genetic stability of the changes referred to in subparagraph (iii), and (v) the nature, source and function of any introduced genetic material; (d) a description of the methods that can be used to distinguish and detect the organism; (e) a description of the biological and ecological characteristics of the organism, including (i) its life cycle, (ii) its reproductive biology, including species with which the organism could interbreed in Canada, (iii) its involvement in adverse ecological effects, including pathogenicity, toxicity and invasiveness, (iv) a description of the geographic distribution and habitat of the organism, (v) the potential for dispersal of its traits by gene transfer, (vi) the locations and situations where the organism has caused adverse ecological effects, (vii) its involvement in biogeochemical cycling, (viii) its interactions with other organisms in the environment, (ix) the conditions required for its survival, growth, reproduction and overwintering, (x) its capability to act as a vector for agents involved in adverse effects, and (xi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents; and (f) the identification of any patent or other rights, or any application for a patent or other rights, as the case may be. 2. The following information in respect of the manufacture and importation of the organism: (a) the identification of manufacturers, importers and vendors; (b) a description of the locations of manufacture in Canada; (c) a description of the product containing the organism; (d) a description of any recommended procedures for the storage and disposal of the organism; (e) an estimation of the quantity of the organism that will be imported into or manufactured in Canada, as the case may be; and (f) a description of the methods of manufacture and of quality control and quality assurance procedures. 3. The following information in respect of the introduction of the organism: (a) the history of its use; (b) the intended and potential uses of the organism, and the potential locations of introduction; (c) a description of the mode of action in relation to the intended use; and (d) a description of the procedures for the introduction of the organism, including (i) the method and rate of its introduction, (ii) any activities associated with its introduction, (iii) any recommended procedures for the storage and handling of any surplus organism, (iv) any contingency plans in the event of an accidental release and any reproductive isolation measures, and (v) its resistance to control agents; (e) a description of any recommended procedures for terminating the introduction of the organism; and (f) a description of the procedures for the disposal of remaining biomass and residues of the organism. 4. The following information in respect of the environmental fate of the organism: (a) the estimated quantities of the organism in the environment and the estimated population trends; (b) a description of habitats where the organism may persist or proliferate; and (c) 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. 5. The following information in respect of the ecological effects of the organism: (a) the data from a test conducted to determine its pathogenicity, toxicity or invasiveness; (b) the ecological effects of organism residues; and (c) the potential of the organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity. 6. The potential for the organism to be involved in adverse human health effects, and the most likely route of human exposure to the organism. 7. All other information and test data in respect of the organism that are relevant to identifying hazards to the environment and human health and that are in the person's possession or to which the person ought reasonably to have access. 8. 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. 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. REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Description The purpose of the New Substances Notification Regulations (Organisms) (the Regulations) is to implement part of a new regulatory structure for new substances notification under the Canadian Environmental Protection Act, 1999 (the Act). The regulatory structure carves out the provisions related to organisms in the previous New Substances Notification Regulations (NSNR). This new regulatory structure ensures the same level of protection of the environment and human health as the NSNR, and is designed to:
The previous NSNR are being repealed and replaced with these Regulations and the New Substances Notification Regulations (Chemicals and Polymers) pursuant to subsections 89(1) and 114(1) of the Act. These Regulations will come into force on the day on which the New Substances Notification Regulations (Chemicals and Polymers) come into force. Background The New Substances Program (NS Program) ensures that no new substance (chemical, polymer, or living organism) is imported into, or manufactured in, Canada before a formal assessment of its potential risks to the environment and human health has been completed, and any appropriate risk management measures have been taken. Parts I, II and III of the NSNR for chemicals and polymers came into force in 1994, and were amended in 1997 to include both provisions for biochemicals and biopolymers, and Part II.1 for New Substances that are Organisms. These Regulations are part of a new regulatory structure that divides the NSNR into two distinct Regulations: 1. New Substances Notification Regulations (Chemicals and Polymers), which apply to chemicals (including biochemicals) and polymers (including biopolymers) that are for a use not covered under other federal legislation listed in Schedule 2 of the Act; and 2. New Substances Notification Regulations (Organisms), which apply to living organisms that are for a use not covered under other federal legislation listed in Schedule 4 of the Act. Such living organisms include micro-organisms used in bioremediation or micro-organisms used for the production of biochemicals or biopolymers (e.g. enzymes). New Substances Notification Regulations (Organisms) Despite the significant change in the overarching regulatory structure for the notification of new substances, there are only minor amendments to the provisions relating to organisms previously contained in Part II.1 of the NSNR and now contained within these Regulations:
Three additional changes in the Regulations are more substantive, but nonetheless have no cost implications for notifiers or the Government of Canada:
Alternatives No other alternatives were considered because the Regulations are a component of the regulatory structure pursuant to the Act, and are designed to reduce the complexity of the previous NSNR while achieving the same environmental and human health objectives. Benefits and Costs In addition to maintaining the level of protection of the environment and human health provided under the NSNR, the new regulatory structure for new substances notification presents a more logical arrangement that reflects the structure of the Act and the nature of the substances and their notification requirements. This may create qualitative benefits for notifiers in terms of improved clarity and ease of use. The Regulations do not alter the obligations of notifiers of living organisms or the Government of Canada that existed under the previous NSNR. Consequently, the Regulations are not expected to result in any incremental costs to industry or government. Consultation Consultation prior to pre-publication of the proposed Regulations in the Canada Gazette, Part I In 1999, a multistakeholder consultative process was established in fulfillment of an Environment Canada and Health Canada commitment to review the chemicals and polymers portion of the NSNR and the NS Program after the first three years of their implementation. Recognizing the need to limit the scope of the consultations, Environment Canada and Health Canada established certain boundaries at the outset. Specifically, the organisms portion of the NSNR was not considered in these consultations, a decision that received consensus support from the stakeholders involved. While the consultations did not specifically address living organisms, the organisms portion of the NSNR was indirectly affected. One of the recommendations from these consultations was to improve user friendliness of the NSNR and Guidelines by providing a simplified and more intuitive structure. In response, Environment Canada and Health Canada have divided the NSNR into two separate Regulations one for chemicals and polymers, and one for living organisms to reduce the complexity of the new substances notification process for notifiers. Comments received during the comment period following pre-publication in the Canada Gazette, Part I No written comments pertaining to the Regulations were received following their pre-publication in the Canada Gazette, Part I, on October 30, 2004. Compliance and Enforcement The Regulations will be enforced in a manner that is consistent with past enforcement of the organisms portion of the NSNR. Contacts Bernard Madé Céline Labossière S.C. 2004, c. 15, s. 31 S.C. 1999, c. 33 S.C. 1999, c. 33 When the NSNR were amended in 1997 to include organisms, Part II of the Canadian Environmental Protection Act (CEPA) of 1988 provided the authority to regulate new substances whether animate (i.e. living organisms) or inanimate (i.e. chemicals and polymers). Following the first five-year review of CEPA, the authority to regulate new substances was divided between Part 5 and Part 6 of the Act, with Part 6 focusing solely on living organisms, which are called animate products of biotechnology in this part. Transitional substances are those substances that were not listed on the Domestic Substances List and were manufactured or imported during the period before the NSNR came into force (between January 1, 1987 and June 30, 1994). Scale-up trials (or production trials) involve evaluating an increased quantity of a living organism prior to its commercialization so that technical specifications can be modified in response to the performance requirements of potential customers. |
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