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Notice

Vol. 139, No. 19 — September 21, 2005

Registration
SOR/2005-248 August 31, 2005

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).

	NEW SUBSTANCES NOTIFICATION REGULATIONS (ORGANISMS)
	INTERPRETATION
Definitions	1. (1) The following definitions apply in these Regulations.
"Act" « Loi »	"Act" means the Canadian Environmental Protection Act, 1999.
"confinement procedures" « méthodes de confinement »	"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.
"contained facility" « installation étanche »	"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 Laboratory Biosafety Guidelines or Appendix K of the NIH Guidelines.
"ecozone" « écozone »	"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.
"experimental field study" « étude expérimentale sur le terrain »	"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.
"indigenous" « indigène »	"indigenous", in respect of a micro-organism, means occurring naturally in the ecozone into which the micro-organism is intended to be introduced.
"Laboratory Biosafety Guidelines" « Lignes directrices en matière de biosécurité en laboratoire »	"Laboratory Biosafety Guidelines" means the Laboratory Biosafety Guidelines, 3rd Edition, established by the Department of Health, published in 2004, as amended from time to time.
"micro-organism" « micro-organisme »	"micro-organism" means a microscopic organism that is (a) classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts; (b) a virus, virus-like particle or sub-viral particle; (c) a cultured cell of an organism not referred to in paragraph (a) or (b), other than a cell used to propagate the organism; or (d) any culture other than a pure culture.
"NIH Guidelines" « 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.
"organism" « organisme »	"organism" means a living organism as defined in section 104 of the Act, except in the following provisions: (a) paragraph (c) of the definition "micro-organism"; (b) paragraphs 2(4)(b) and (c); (c) paragraph 1(d) and subparagraphs 1(e)(vi) and (viii) of Schedule 5; (d) paragraph 2(d) of Schedule 5; (e) subparagraph 3(d)(iii) and paragraph 3(f) of Schedule 5; and (f) items 5 to 7 in Schedule 5.
"research and development organism" « destiné à la recherche et au développement »	"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: (a) to create or improve a product or process; (b) to determine the technical viability or performance characteristics of a product or process; or (c) 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.
"test marketing" « test de marché »	"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.
Government agencies	(2) The definition of "government" in subsection 3(1) of the Act does not apply to the expression "government agencies" in these Regulations.
	SCOPE
Avoiding regulatory duplication	2. (1) 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	(2) 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 organism (micro-organisms)	(3) 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 either the Laboratory Biosafety Guidelines or Appendix K of the NIH Guidelines and if the micro-organism is (a) imported to a contained facility in a quantity that, at the time of the import, is less than 50 mL or 50 g; (b) subject to paragraphs (c) and (d), manufactured and present at any one time in a contained facility in a quantity of less than 1 000 L, unless the micro-organism requires containment level 2, 3 or 4 as identified in the Laboratory Biosafety Guidelines; (c) manufactured and present at any one time in a contained facility in a quantity of less than 250 L and requires containment level 2 as identified in the Laboratory Biosafety Guidelines; or (d) a human pathogen manufactured and present at any one time in a contained facility in a quantity of less than 250 L and requires containment level 3 or 4 as identified in the Laboratory Biosafety Guidelines, and if an import permit or an approval in writing to transfer has been granted in respect of the micro-organism under the Human Pathogens Importation Regulations.
Research and development organism other than a micro-organism	(4) 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 (a) the organism; (b) the genetic material of the organism; or (c) material from the organism involved in toxicity.
	MICRO-ORGANISMS
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.
	ORGANISMS OTHER THAN MICRO-ORGANISMS
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.
	INFORMATION PROVISION TIME LIMITS
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.
	ASSESSMENT PERIODS
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.
	RETENTION OF INFORMATION
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.
	ADMINISTRATIVE REQUIREMENTS
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 Director, New Substances Branch, 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.
	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.

SCHEDULE 1
(Subsections 3(1) and (2) and paragraph 6(a))

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;

(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;

(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;

(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
(Subsection 3(4) and paragraph 6(b))

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;

(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
(Subsection 3(5) and paragraph 6(c))

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;

(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;

(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;

(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;

(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

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

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
(Subsection 3(6) and paragraph 6(b))

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

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;

(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;

(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
(Section 4 and paragraph 6(d))

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;

(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;

(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;

(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:

better reflect the structure of the Act (see footnote 1);
facilitate the implementation of consensus-based changes to the chemicals and polymers portion of the NSNR; and
simplify the previous NSNR for notifiers, by grouping together regulatory provisions for substances that are of a similar nature and share similar information requirements and notification triggers (i.e. animate, living organisms versus inanimate chemicals and polymers).

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:

Titles and schedule references have been adjusted to harmonize to the extent possible with the New Substances Notification Regulations (Chemicals and Polymers) and to maintain consistency throughout the new regulatory structure for new substances notification.
Some text has been redrafted and/or reorganized to make definitions and provisions clearer and more intuitive for notifiers of living organisms.
References to documents in the definitions have been updated.

Three additional changes in the Regulations are more substantive, but nonetheless have no cost implications for notifiers or the Government of Canada:

Provisions for transitional substances (see footnote 2) in the NSNR have expired, and are therefore not included in the Regulations.
The definition of "research and development substance" has been revised in the Regulations to include an explicit reference to organisms and scale-up trials (see footnote 3). In effect, this amendment formalizes the implicit inclusion of scale-up trials in the definition of "research and development substance" under the previous NSNR.
The Regulations contain a requirement for notifiers to provide a signed certification attesting to the accuracy and completeness of notification information, which formalizes the existing administrative requirement specified in the Guidelines for the Notification and Testing of New Substances: Organisms.

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
New Substances Branch
Risk Assessment Directorate
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: (819) 997-4336
FAX: (819) 953-7155
E-mail: bernard.made@ec.gc.ca

Céline Labossière
Regulatory and Economic Analysis Branch
Economic and Regulatory Affairs Directorate
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: (819) 997-2377
FAX: (819) 997-2769
E-mail: celine.labossiere@ec.gc.ca

Footnote a

S.C. 2004, c. 15, s. 31

Footnote b

S.C. 1999, c. 33

Footnote c

S.C. 1999, c. 33

Footnote 1

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.

Footnote 2

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).

Footnote 3

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.

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.


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Updated: 2005-09-21