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Substances Notification Regulations ( C-15.31 -- SOR/94-260
) Disclaimer: These documents are not the official versions (more). Source: http://laws.justice.gc.ca/en/C-15.31/SOR-94-260/text.html Updated to August 31, 2004 New Substances Notification Regulations SOR/94-260 CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999 New Substances Notification Regulations His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of National Health and Welfare, pursuant to subsections 32(1) and 87(2) of the Canadian Environmental Protection Act*, is pleased hereby to make the annexed Regulations respecting notification of substances new to Canada, effective July 1, 1994. * R.S., c. 16 (4th Supp.) REGULATIONS RESPECTING NOTIFICATION OF SUBSTANCES NEW TO CANADA 1. These Regulations may be cited as the New Substances Notification Regulations. 2. (1) In these Regulations, "Act" means the Canadian Environmental Protection Act, 1999; (Loi) "anionic polymer" means a polymer that contains one or more monomer units that are covalently bound and bear a net negative charge; (polymère anionique) "biotechnology product" means an inanimate biotechnology product; (produit biotechnologique) "cationic polymer" means a polymer that contains one or more monomer units that are covalently bound and bear a net positive charge; (polymère cationique) "confinement procedures" means any physical, chemical, operational or biological control, or combination thereof, to restrict the exit or dispersal of a micro-organism; (méthodes de confinement) "consumed", in respect of a substance, means destroyed or completely converted to another substance; (consommée) "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 the Laboratory Biosafety Guidelines or Appendix K of the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) June 1994 published by the United States Department of Health and Human Services, in the Federal Register (United States), Vol. 59, No. 127, on July 5, 1994, as amended from time to time; (installation étanche) "DSL" means the Domestic Substances List maintained by the Minister under subsection 66(1) of the Act, as amended from time to time; (LIS) "ecozone" means one of the ecozones which are illustrated on the map entitled Land Ecozones and Ecoregions, Canada, 1994 dated 26 August 1994 and having Catalogue Number CAS005, the boundaries of which 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 substance that is a micro-organism, which study uses the minimum area, up to a maximum of 100 hectares, and the minimum quantity of the substance required to meet the objectives of the study; (étude expérimentale sur le terrain) "indigenous" means, in respect of a micro-organism, occurring naturally in the ecozone into which the micro-organism is intended to be introduced; (indigène) "intermediate substance" means a substance that is consumed in a chemical reaction used for the intentional manufacture of another substance; (substance intermédiaire) "Laboratory Biosafety Guidelines" means the Laboratory Biosafety Guidelines, 2nd edition, established by the Department of Health, published in 1996, as amended from time to time; (Lignes directrices en matière de biosécurit?en laboratoire) "micro-organism" means a microscopic living 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 such an organism, or (d) any culture other than a pure culture; (micro-organisme) "monomer unit" means the reacted form of a monomer in a polymer; (unit?monomère) "NDSL" means the Non-domestic Substances List maintained by the Minister under subsection 66(2) of the Act, as amended from time to time; (LES) "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 29.16(b) and (c), (c) paragraphs 29.19(b) and (c), (d) Schedule XIV, (e) paragraph 1(d) and subparagraphs 1(e)(vi) and (viii) of Schedule XIX, (f) paragraph 2(d) of Schedule XIX, (g) subparagraph 3(d)(iii) and paragraph 3(f) of Schedule XIX, and (h) items 5 to 7 in Schedule XIX; (organisme) "polyester" means a polymer whose molecules contain two or more carboxylic acid ester linkages at least one of which links monomer units; (polyester) "polymer" means a substance that consists of (a) molecules characterized by the sequence of one or more types of monomer units, (b) a simple weight majority of molecules containing three or more monomer units that are covalently bound to one or more other monomer units or reactants, (c) less than a simple weight majority of molecules of the same molecular weight, and (d) molecules distributed over a range of molecular weights where the differences in the molecular weights are primarily attributable to differences in the number of monomer units; (polymère) "product development substance" means a research and development substance that is in the process of being evaluated in a single program of two years or less in duration prior to its full commercialization, which program includes pilot plant trials, production trials or customer trials other than test marketing, in order to modify the technical specifications of the research and development substance in response to the performance requirements of potential customers; (substance destinée au développement de produits) "reactant", in respect of a polymer, means a substance that is used intentionally in the manufacture of the polymer and becomes part of the chemical composition of the polymer; (réactif) "reactive functional group" means an atom or associated groups of atoms in a substance that are intended or may reasonably be expected to undergo facile chemical reaction; (groupe fonctionnel réactif) "research and development substance" means a substance that is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, the primary objective of which is (a) to create or improve a product or process, or (b) to determine the technical viability or performance characteristics of a product or process; (substance utilisée pour la recherche et le développement) "site-limited intermediate substance" means a substance that is manufactured or imported by a person in a quantity that does not exceed an accumulated total of 50 000 kg and is (a) manufactured and consumed at the site of manufacture, (b) manufactured at one site and transported to a second site where it is consumed, or (c) imported and transported directly to the site of consumption where it is consumed, where the combined quantity of the substance in the possession of the person at the sites referred to in paragraphs (a) to (c) and in transport does not, at any one time, exceed 10 000 kg in respect of a substance other than a polymer and 20 000 kg in respect of a polymer; (substance intermédiaire limitée au site) "test marketing" means the exploration of the market capability of a product in a competitive situation where the creation or improvement of the product is not the primary objective; (test de march?/I>) "transitional period" means the period beginning on January 1, 1987 and ending on June 30, 1994; (période transitoire) "whole animal" means an animal or part of an animal, but does not include an animal or part of an animal that exists primarily as a single cell and is without the organization that characterizes tissues or organs; (animal entier) "whole plant" means a plant or part of a plant, but does not include a plant or part of a plant that exists primarily as a single cell and is without the organization that characterizes tissues or organs. (plante entière) (2) In these Regulations, (a) a reference to a calendar year during the transitional period means, in respect of 1994, the period beginning on January 1, 1994 and ending on June 30, 1994; and (b) a reference to a calendar year during the 5-year period beginning on July 1, 1994 and ending on June 30, 1999 means (i) in respect of 1994, the period beginning on July 1, 1994 and ending on December 31, 1994, and (ii) in respect of 1999, the period beginning on January 1, 1999 and ending on June 30, 1999. SOR/97-119, s. 1; SOR/2000-101, s. 1. 3. (1) For greater certainty, these Regulations do not apply in respect of a substance that is manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given prior to the manufacture, import or sale of the substance and for an assessment of whether it is toxic, including, without limiting the generality of the foregoing, the Feeds Act, Fertilizers Act, Health of Animals Act, Pest Control Products Act and Seeds Act. (2) These Regulations do not apply in respect of a substance 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. SOR/97-119, s. 2. 4. For the purposes of paragraph 81(6)(e) of the Act, a substance is exempt from the application of subsections 81(1) and (2) of the Act where it is manufactured or imported in a quantity that does not exceed the quantity that first triggers a requirement to provide information under these Regulations. SOR/2000-101, s. 2. PART I 5. This Part does not apply in respect of polymers or organisms. SOR/97-119, s. 4. Substances Other Than Product Development Substances, Site-limited Intermediate Substances and Substances Manufactured or Imported for Export Only 6. (1) Subject to section 7, where a person manufactures or imports a substance that is not specified on the NDSL and subsections (3) and (4) do not apply, the person shall provide the following information: (a) the information specified in Schedule I, where the substance is not a research and development substance and the quantity of the substance that the person manufactures or imports exceeds 20 kg but does not exceed 1 000 kg in any calendar year; (b) the information specified in Schedule II, except the information specified in paragraphs 2(1)(i) and (j) of that Schedule, where the quantity of the substance that the person manufactures or imports (i) exceeds 1 000 kg but does not exceed 10 000 kg in any calendar year, or (ii) exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 50 000 kg; and (c) the information specified in Schedule III, where the quantity of the substance that the person manufactures or imports (i) exceeds 10 000 kg in any calendar year, or (ii) exceeds an accumulated total of 50 000 kg. (2) Subject to section 7, where a person manufactures or imports a substance that is specified on the NDSL and subsections (3) and (4) do not apply, the person shall provide the following information: (a) the information specified in Schedule I, where the quantity of the substance that the person manufactures or imports (i) exceeds 1 000 kg but does not exceed 5 000 kg in any calendar year, or (ii) exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 25 000 kg; and (b) the information specified in Schedule II, where the quantity of the substance that the person manufactures or imports (i) exceeds 5 000 kg in any calendar year, or (ii) exceeds an accumulated total of 25 000 kg. (3) Subject to subsection (5) and section 7, a person who manufactures or imports a substance that is specified on the NDSL shall, where the person manufactured or imported more than 20 kg of the substance in any calendar year during the transitional period, provide the information specified in Schedule II, where the quantity of the substance that the person manufactures or imports (a) exceeds 5 000 kg in any calendar year; or (b) exceeds an accumulated total of 25 000 kg. (4) Subject to subsection (5) and section 7, a person who manufactures or imports a substance that is not specified on the NDSL shall, where the person manufactured or imported more than 20 kg of the substance in any calendar year during the transitional period, provide the following information: (a) the information specified in Schedule II, where the quantity of the substance that the person manufactures or imports (i) exceeds 5 000 kg in any calendar year during the 5-year period beginning on July 1, 1994 and ending on June 30, 1999, (ii) exceeds, at any time during the 5-year period referred to in subparagraph (i), an accumulated total of 25 000 kg, (iii) exceeds 5 000 kg but does not exceed 10 000 kg during the period beginning on July 1, 1999 and ending on December 31, 1999 or in any calendar year after 1999, or (iv) exceeds, at any time after June 30, 1999, an accumulated total of 25 000 kg but does not exceed an accumulated total of 50 000 kg; and (b) subject to subsection (6), the information specified in Schedule III, where the quantity of the substance that the person manufactures or imports (i) exceeds 10 000 kg during the period beginning on July 1, 1999 and ending on December 31, 1999 or in any calendar year after 1999, or (ii) exceeds, at any time after June 30, 1999, an accumulated total of 50 000 kg. (5) A person to whom subsection (3) or (4) applies is not required to provide the information specified in Schedule II before the day specified in paragraph 11(b) where the person provides that information pursuant to paragraph 13(1)(a) on or before the applicable date set out in section 15. (6) The information specified in Schedule III is not required to be provided by a person to whom subsection (4) applies where that person has, during the 5-year period beginning on July 1, 1994 and ending on June 30, 1999, provided the information specified in Schedule II. 7. Section 6 does not apply in respect of a substance while it is (a) a product development substance; (b) a site-limited intermediate substance; or (c) a substance that is being manufactured or imported by a person for export only, if the quantity of the substance in the person's possession at any one time does not exceed 10 000 kg. Product Development Substances 8. (1) Where a person manufactures or imports a product development substance that is not specified on the NDSL, the person shall provide the following information: (a) the information specified in Schedule II, except the information specified in paragraphs 2(1)(i) and (j) of that Schedule, or the information specified in Schedule IV, where the quantity of the product development substance that the person manufactures or imports (i) exceeds 1 000 kg in any calendar year, or (ii) exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 50 000 kg; and (b) the information specified in Schedule III or IV, where the quantity of the product development substance that the person manufactures or imports exceeds an accumulated total of 50 000 kg. (2) Where a person manufactures or imports a product development substance that is specified on the NDSL, the person shall provide the following information: (a) the information specified in Schedule I or IV, where the quantity of the product development substance that the person manufactures or imports (i) exceeds 1 000 kg in any calendar year, or (ii) exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 25 000 kg; and (b) the information specified in Schedule II or IV, where the quantity of the product development substance that the person manufactures or imports exceeds an accumulated total of 25 000 kg. Site-limited Intermediate Substances or Substances for Export Only 9. Section 10 applies to a person who manufactures or imports a substance for export only, only if the quantity of the substance in the person's possession at any one time does not exceed 10 000 kg. 10. (1) Where a person manufactures or imports a site-limited intermediate substance that is not specified on the NDSL or a substance for export only that is not specified on the NDSL and subsection (3) does not apply, the person shall provide the following information: (a) the information specified in Schedule I, where the quantity of the substance that the person manufactures or imports exceeds 20 kg but does not exceed 1 000 kg in any calendar year; and (b) subject to subsection (4), the information specified in Schedule V, where the quantity of the substance that the person manufactures or imports (i) exceeds 1 000 kg in any calendar year, or (ii) exceeds an accumulated total of 5 000 kg. (2) Where a person manufactures or imports a site-limited intermediate substance that is specified on the NDSL or a substance for export only that is specified on the NDSL and subsection (3) does not apply, the person shall provide the following information: (a) the information specified in Schedule I, where the quantity of the substance that the person manufactures or imports (i) exceeds 1 000 kg but does not exceed 5 000 kg in any calendar year, or (ii) exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 25 000 kg; and (b) subject to subsection (4), the information specified in Schedule V, where the quantity of the substance that the person manufactures or imports (i) exceeds 5 000 kg in any calendar year, or (ii) exceeds an accumulated total of 25 000 kg. (3) Subject to subsection (4), a person who manufactures or imports a site-limited intermediate substance or a substance for export only shall, where the person manufactured or imported more than 20 kg of the substance in any calendar year during the transitional period, provide the information specified in Schedule V, where the quantity of the substance that the person manufactures or imports (a) exceeds 5 000 kg in any calendar year; or (b) exceeds an accumulated total of 25 000 kg. (4) The information specified in items 3 and 4 of Schedule V is not required to be provided in respect of a site-limited intermediate substance that is manufactured and consumed at the site of manufacture. Certain Biotechnology Products 10.1 (1) A person shall, with the information referred to in section 6, 8 or 10, in respect of a biotechnology product that is not derived from whole animals or whole plants, provide the following additional information: (a) where the biotechnology product is subject to the information requirements specified in Schedule I, the information specified in items 1 to 3 of Schedule XIV; (b) subject to subsection (2), where the biotechnology product is subject to the information requirements specified in Schedule II, III or V, (i) the information specified in items 1 to 4 of Schedule XIV, (ii) where the biotechnology product is a nucleic acid, the information specified in items 5 and 6 of Schedule XIV, and (iii) where the biotechnology product possesses enzymatic capability, the information specified in items 7 to 13 of Schedule XIV; and (c) where the biotechnology product is subject to the information requirements specified in Schedule IV, the information specified in items 1 and 2 of Schedule XIV. (2) The information specified in items 3 and 5 to 13 of Schedule XIV is not required to be provided where the biotechnology product is a site-limited intermediate substance that is manufactured and consumed at the site of manufacture. SOR/97-119, s. 5. 11. (1) Information specified in a schedule referred to in sections 6 to 10 shall be provided as follows: (a) for Schedule I, at least 5 days before the day on which a person manufactures or imports a substance in a quantity that triggers the requirement to provide the information specified in Schedule I; (b) for Schedule II, at least 45 days before the day on which a person manufactures or imports a substance in a quantity that triggers the requirement to provide the information specified in Schedule II; (c) for Schedule III, at least 90 days before the day on which a person manufactures or imports a substance in a quantity that triggers the requirement to provide the information specified in Schedule III; and (d) for Schedule IV or V, at least 21 days before the day on which a person manufactures or imports a substance in a quantity that triggers the requirement to provide the information specified in Schedule IV or V, as the case may be. (2) Notwithstanding subsection (1), in the case of a biotechnology product that is not derived from whole animals or whole plants, the information specified in the schedules referred to in sections 6, 8 and 10 shall, where the quantity that triggers the requirement to provide the information was exceeded during the period beginning on July 1, 1994 and ending on August 31, 1997, be provided on or before September 1, 1997. (3) The additional information referred to in paragraph 10.1(1)(a), (b) or (c) shall be provided at the same time as the information specified in Schedule I, II, III, IV or V, as the case may be. SOR/97-119, s. 6. 12. (1) The periods within which the Ministers shall assess the information specified in a schedule referred to in section 6, 8, 10 or 16.1 are as follows: (a) for Schedule I, a period of 5 days following receipt of the information; (b) for Schedule II, a period of 45 days following receipt of the information; (c) for Schedule III, a period of 90 days following receipt of the information; and (d) for Schedules IV and V, a period of 21 days following receipt of the information. (2) The period within which the Ministers shall assess the additional information referred to in paragraph 10.1(1)(a), (b) or (c) is the same period as set out in subsection (1) for the information specified in Schedule I, II, III, IV or V, as the case may be. SOR/97-119, s. 7; SOR/2003-214, s. 1. 13. (1) Subject to subsection (2), a person who manufactured or imported a substance during the transitional period shall provide the following information: (a) the information specified in Schedule I or II, where the quantity of the substance that the person manufactured or imported exceeded 20 kg but did not exceed 5 000 kg in any calendar year during the transitional period; and (b) the information specified in Schedule II, where the quantity of the substance that the person manufactured or imported (i) exceeded 5 000 kg in any calendar year during the transitional period, or (ii) exceeded, at any time during the transitional period, an accumulated total of 25 000 kg. (2) Subsection (1) does not apply in respect of a substance while it is (a) a site-limited intermediate substance; or (b) a substance that is being manufactured or imported by a person for export only, if the quantity of the substance in the person's possession at any one time does not exceed 10 000 kg. 14. (1) Subject to subsection (2), a person who manufactured or imported a site-limited intermediate substance, or a substance for export only, during the transitional period shall provide the following information: (a) the information specified in Schedule I, where the quantity of the substance that the person manufactured or imported exceeded 20 kg but did not exceed 5 000 kg in any calendar year during the transitional period; and (b) subject to subsection (3), the information specified in Schedule V, where the quantity of the substance that the person manufactured or imported (i) exceeded 5 000 kg in any calendar year during the transitional period, or (ii) exceeded, at any time during the transitional period, an accumulated total of 25 000 kg. (2) Subsection (1) applies to a person who manufactured or imported a substance for export only, only if the quantity of the substance in the person's possession at any one time during the transitional period did not exceed 10 000 kg. (3) The information specified in items 3 and 4 of Schedule V is not required to be provided in respect of a site-limited intermediate substance that is manufactured and consumed at the site of manufacture. 14.1 (1) A person shall, with the information referred to in section 13 or 14, in respect of a biotechnology product that is not derived from whole animals or whole plants, provide the following additional information: (a) where the biotechnology product is subject to the information requirements specified in Schedule I, the information specified in items 1 to 3 of Schedule XIV; and (b) subject to subsection (2), where the biotechnology product is subject to the information requirements specified in Schedule II or V, (i) the information specified in items 1 to 4 of Schedule XIV, (ii) where the biotechnology product is a nucleic acid, the information specified in items 5 and 6 of Schedule XIV, and (iii) where the biotechnology product possesses enzymatic capability, the information specified in items 7 to 13 of Schedule XIV. (2) The information specified in items 3 and 5 to 13 of Schedule XIV is not required to be provided where the biotechnology product is a site-limited intermediate substance that is manufactured and consumed at the site of manufacture. SOR/97-119, s. 8. 15. (1) The information that is specified in Schedule I and referred to in sections 13 and 14 shall be provided on or before October 1, 1994. (2) Subject to subsection (3), the information that is specified in Schedule II or V, as the case may be, and referred to in sections 13 and 14 shall, where the quantity that triggers the requirement to provide that information (a) was exceeded in 1987, be provided on or before January 1, 1995; (b) was exceeded in 1988, be provided on or before July 1, 1995; (c) was exceeded in 1989, be provided on or before January 1, 1996; (d) was exceeded in 1990, be provided on or before July 1, 1996; (e) was exceeded in 1991, be provided on or before January 1, 1997; (f) was exceeded in 1992, be provided on or before July 1, 1997; (g) was exceeded in 1993, be provided on or before January 1, 1998; and (h) was exceeded during the period beginning on January 1, 1994 and ending on June 30, 1994, be provided on or before July 1, 1998. (3) Where the information specified in Schedule I is not provided, the information specified in the following items and subitems of Schedule II or V, as the case may be, shall be provided on or before October 1, 1994: (a) subitems 1(1) to (3) and (5), that portion of subitem 2(5) that specifies the information, other than test data, in respect of the substance that is relevant to identifying hazards to human health and the environment and that is in the person's possession, and item 4 of Schedule II; and (b) subitems 1(1) to (4), that portion of subitem 2(1) that specifies the information, other than test data, in respect of the substance that is relevant to identifying hazards to human health and the environment and that is in the person's possession, and item 6 of Schedule V. SOR/94-774, s. 1. 15.1 (1) Notwithstanding subsection 15(1), in the case of a biotechnology product that is not derived from whole animals or whole plants, the information that is specified in Schedule I and referred to in sections 13 and 14 shall be provided on or before December 1, 1997. (2) Notwithstanding subsection 15(2) and subject to subsection (3), in the case of a biotechnology product that is not derived from whole animals or whole plants, the information that is specified in Schedule II or V, as the case may be, and referred to in sections 13 and 14 shall, where the quantity that triggers the requirement to provide that information (a) was exceeded in 1987, be provided on or before March 1, 1998; (b) was exceeded in 1988, be provided on or before September 1, 1998; (c) was exceeded in 1989, be provided on or before March 1, 1999; (d) was exceeded in 1990, be provided on or before September 1, 1999; (e) was exceeded in 1991, be provided on or before March 1, 2000; (f) was exceeded in 1992, be provided on or before September 1, 2000; (g) was exceeded in 1993, be provided on or before March 1, 2001; and (h) was exceeded during the period beginning on January 1, 1994 and ending on June 30, 1994, be provided on or before September 1, 2001. (3) Where the information specified in Schedule I is not provided, the information specified in the following items and subitems of Schedule II or V, as the case may be, shall be provided on or before December 1, 1997: (a) subitems 1(1) to (3) and (5) of Schedule II, that portion of subitem 2(5) of that Schedule that specifies the information, other than test data, in respect of the substance that is relevant to identifying hazards to human health and the environment and that is in the person's possession, that portion of subitem 3(1) of that Schedule that specifies the use of the substance and item 4 of that Schedule; and (b) subitems 1(1) to (4) of Schedule V, that portion of subitem 2(1) of that Schedule that specifies the information, other than test data, in respect of the substance that is relevant to identifying hazards to human health and the environment and that is in the person's possession, that portion of item 5 of that Schedule that specifies the intended uses of the substance and item 6 of that Schedule. (4) The additional information referred to in paragraph 14.1(1)(a) or (b) shall be provided at the same time as the information specified in Schedule I, II or V, as the case may be. SOR/97-119, s. 9. 16. The quantity of a substance prescribed for the purposes of subparagraph 87(1)(b)(iii) of the Act is (a) in the case of a substance that is not specified on the NDSL, where the person did not manufacture or import the substance during the transitional period, a quantity that exceeds 10 000 kg in any calendar year or an accumulated total of 50 000 kg; (b) in the case of a substance that is not specified on the NDSL, where the person manufactured or imported the substance during the transitional period, (i) a quantity that exceeds 5 000 kg in any calendar year during the transitional period or the 5-year period beginning on July 1, 1994 and ending on June 30, 1999, or exceeds at any time during the transitional period or the 5-year period an accumulated total of 25 000 kg, or (ii) a quantity that exceeds 10 000 kg during the period beginning on July 1, 1999 and ending on December 31, 1999 or in any calendar year after 1999, or exceeds at any time after June 30, 1999 an accumulated total of 50 000 kg; and (c) in the case of a substance that is specified on the NDSL, 5 000 kg in any calendar year or an accumulated total of 25 000 kg. SOR/2000-101, s. 3. 16.1 (1) The information that is prescribed with respect to a substance for the purpose of paragraph 87(5)(a) of the Act is the following: (a) a notice from the person who provides the information, stating that the person has manufactured or imported the substance; and (b) the information specified in (i) Schedule II, if the substance is specified on the NDSL or if that information has been provided in accordance with subsection 6(6), or (ii) Schedule III, in any other case. (2) If the substance is a biotechnology product that is not derived from whole animals or whole plants, the person must provide, in addition to the information described in subsection (1), the information described in paragraph 10.1(1)(b). SOR/2003-214, s. 2. PART II 17. (1) This Part does not apply in respect of a polymer that is manufactured by modifying the formulation of a polymer specified on the DSL through the addition of reactants no single one of which constitutes more than 2 per cent by weight of the polymer. SOR/97-119, s. 11. (2) [Repealed, SOR/97-119, s. 11] Polymers Other Than Product Development Substances, Site-limited Intermediate Substances and Substances Manufactured or Imported for Export Only 18. (1) Subject to section 20, where a person manufactures or imports a polymer other than a polymer in respect of which section 19 applies, and subsection (2) does not apply, the person shall provide the following information: (a) where the person manufactures or imports the polymer in a quantity that exceeds 1 000 kg but does not exceed 10 000 kg in any calendar year, or exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 50 000 kg, (i) if the polymer is not a research and development substance, the information specified in Schedule VI, and (ii) if the polymer is a research and development substance, the information specified in Schedule XI; and (b) where the person manufactures or imports the polymer in a quantity that exceeds 10 000 kg in any calendar year or an accumulated total of 50 000 kg, (i) if the polymer is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, and (ii) if the polymer is not specified on the NDSL, (A) in the case of a polymer that is manufactured solely from reactants that are substances specified on the DSL, the information specified in Schedule VII, and (B) in any other case, the information specified in Schedule VIII. (2) Subject to section 20, where a person manufactures or imports a polymer other than a polymer in respect of which section 19 applies, and the person manufactured or imported more than 20 kg of the polymer in any calendar year during the transitional period, the person shall provide the following information: (a) subject to subsection (3), where the person manufactures or imports the polymer in a quantity that exceeds 10 000 kg in any calendar year during the 5-year period beginning on July 1, 1994 and ending on June 30, 1999, or exceeds at any time during the 5-year period an accumulated total of 50 000 kg (i) if the polymer is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, and (ii) if the polymer is not specified on the NDSL, the information specified in Schedule VII; and (b) where the person manufactures or imports the polymer in a quantity that exceeds 10 000 kg during the period beginning on July 1, 1999 and ending on December 31, 1999 or in any calendar year after 1999, or exceeds at any time after June 30, 1999 an accumulated total of 50 000 kg (i) if the polymer is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, and (ii) subject to subsections (3) and (4), if the polymer is not specified on the NDSL, (A) in the case of a polymer that is manufactured solely from reactants that are substances specified on the DSL, the information specified in Schedule VII, and (B) in any other case, the information specified in Schedule VIII. (3) A person to whom paragraph (2)(a) applies is not required to provide the information specified in Schedule VII before the day specified in paragraph 24(a) where the person provides the information pursuant to clause 26(1)(a)(i)(B) on or before the applicable date set out in subsection 28(3). (4) The information specified in Schedule VIII is not required to be provided by a person to whom subsection (2) applies where that person has, during the 5-year period beginning on July 1, 1994 and ending on June 30, 1999, provided the information specified in Schedule VII. 19. (1) This section applies in respect of a polymer that (a) is not one of the types of polymers listed in items 1 to 4 of Schedule IX and has a number average molecular weight greater than 10 000 daltons, less than 2 per cent of its components with molecular weights of less than 500 daltons and less than 5 per cent of its components with molecular weights of less than 1 000 daltons; (b) is not one of the types of polymers listed in Schedule IX and has a number average molecular weight greater than 1 000 daltons, less than 10 per cent of its components with molecular weights of less than 500 daltons and less than 25 per cent of its components with molecular weights of less than 1 000 daltons; or (c) is a polyester manufactured solely from reactants listed in Schedule X, or an anhydrous form of those reactants, other than the reactants or the anhydrous forms of those reactants that include both 1-butanol and 2-butenedioic acid (E). (2) Subject to section 20, where a person manufactures or imports a polymer in respect of which this section applies, and subsection (3) does not apply, the person shall provide the following information: (a) where the person manufactures or imports the polymer in a quantity that exceeds 1 000 kg but does not exceed 10 000 kg in any calendar year, or exceeds an accumulated total of 5 000 kg but does not exceed an accumulated total of 50 000 kg, (i) if the polymer is not a research and development substance, the information specified in Schedule VI, and (ii) if the polymer is a research and development substance, the information specified in Schedule XI; and (b) where the person manufactures or imports the polymer in a quantity that exceeds 10 000 kg in any calendar year or an accumulated total of 50 000 kg, (i) if the polymer is specified on the NDSL, the information specified in Schedule VI, and (ii) if the polymer is not specified on the NDSL, (A) in the case of a polymer that is manufactured solely from reactants that are substances specified on the DSL or the NDSL, the information specified in Schedule VI, and (B) in any other case, the information specified in Schedule VII. (3) Subject to section 20, a person who manufactures or imports a polymer in respect of which this section applies shall, where the polymer is a research and development substance and the person manufactured or imported more than 20 kg of the polymer in any calendar year during the transitional period, provide the information specified in Schedule VI, if the person manufactures or imports the polymer in a quantity that (a) exceeds 10 000 kg in any calendar year; or (b) exceeds an accumulated total of 50 000 kg. 20. Sections 18 and 19 do not apply in respect of a polymer while it is (a) a product development substance; (b) a site-limited intermediate substance; or (c) a polymer that is being manufactured or imported by a person for export only, if the quantity of the polymer in the person's possession at any one time does not exceed 20 000 kg. Product Development Substances 21. Where a person manufactures or imports a polymer that is a product development substance in a quantity that exceeds 10 000 kg in any calendar year or exceeds an accumulated total of 50 000 kg, the person shall provide the following information: (a) the information specified in a schedule referred to in paragraph 18(1)(b) or 19(2)(b), as appropriate; or (b) the information specified in Schedule XII. Site-limited Intermediate Substances or Substances Manufactured or Imported for Export Only 22. Section 23 applies to a person who manufactures or imports a polymer for export only, only if the quantity of the polymer in the person's possession at any one time does not exceed 20 000 kg. 23. (1) Where a person manufactures or imports, in a quantity that exceeds 1 000 kg but does not exceed 10 000 kg in any calendar year, a polymer that is a site-limited intermediate substance or a polymer for export only, the person shall provide the information specified in Schedule VI. (2) Where a person manufactures or imports, in a quantity that exceeds 10 000 kg in any calendar year, a polymer that is a site-limited intermediate substance or a polymer for export only and subsection (3) does not apply, the person shall provide the following information: (a) the information specified in a schedule referred to in paragraph 18(1)(b) or 19(2)(b), as appropriate; or (b) subject to subsection (4), the information specified in Schedule XIII. (3) Subject to subsection (4), a person who manufactures or imports, in a quantity that exceeds 10 000 kg in any calendar year, a polymer that is a site-limited intermediate substance or a polymer for export only shall, where the person manufactured or imported more than 20 kg of the polymer in any calendar year during the transitional period, provide the following information: (a) in the case of a polymer other than a polymer in respect of which section 19 applies, (i) if the polymer is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, or the information specified in Schedule XIII, and (ii) if the polymer is not specified on the NDSL, the information specified in Schedule VII or XIII; and (b) in the case of a polymer in respect of which section 19 applies, the information specified in Schedule VI or XIII. (4) The information specified in paragraphs 2(d) to (f) and item 3 of Schedule XIII is not required to be provided in respect of a site-limited intermediate substance that is manufactured and consumed at the site of the manufacture. SOR/97-119, s. 13. Certain Biotechnology Products 23.1 (1) A person shall, with the information referred to in section 18, 19, 21 or 23, in respect of a biotechnology product that is not derived from whole animals or whole plants, provide the following additional information: (a) where the biotechnology product is subject to the information requirements specified in Schedule VI, the information specified in items 1 to 3 of Schedule XIV; (b) subject to subsection (2), where the biotechnology product is subject to the information requirements specified in Schedule VII, VIII or XIII, (i) the information specified in items 1 to 4 of Schedule XIV, (ii) where the biotechnology product is a nucleic acid, the information specified in items 5 and 6 of Schedule XIV, and (iii) where the biotechnology product possesses enzymatic capability, the information specified in items 7 to 13 of Schedule XIV; and (c) where the biotechnology product is subject to the information requirements specified in Schedule XI or XII, the information specified in items 1 and 2 of Schedule XIV. (2) The information specified in items 3 and 5 to 13 of Schedule XIV is not required to be provided where the biotechnology product is a site-limited intermediate substance that is manufactured and consumed at the site of manufacture. SOR/97-119, s. 12. 24. (1) Information specified in a schedule referred to in sections 18 to 23 shall be provided as follows: (a) for Schedule VI or VII, at least 45 days before the day on which a person manufactures or imports a polymer in a quantity that triggers the requirement to provide the information specified in Schedule VI or VII, as the case may be; (b) for Schedule VIII, at least 90 days before the day on which a person manufactures or imports a polymer in a quantity that triggers the requirement to provide the information specified in Schedule VIII; (c) for Schedule XI, at least 5 days before the day on which a person manufactures or imports a polymer in a quantity that triggers the requirement to provide the information specified in Schedule XI; and (d) for Schedule XII or XIII, at least 21 days before the day on which a person manufactures or imports a polymer in a quantity that triggers the requirement to provide the information specified in Schedule XII or XIII, as the case may be. (2) Notwithstanding subsection (1), in the case of a biotechnology product that is not derived from whole animals or whole plants, the information specified in the schedules referred to in sections 18, 19, 21 and 23 shall, where the quantity that triggers the requirement to provide the information was exceeded during the period beginning on July 1, 1994 and ending on August 31, 1997, be provided on or before September 1, 1997. (3) The additional information referred to in paragraph 23.1(1)(a), (b) or (c) shall be provided at the same time as the information specified in Schedule VI, VII, VIII, XI, XII or XIII, as the case may be. SOR/97-119, s. 14. 25. (1) The periods within which the Ministers shall assess the information specified in a schedule referred to in section 18, 19, 21, 23 or 28.2 are as follows: (a) for Schedules VI and VII, a period of 45 days following receipt of the information; (b) for Schedule VIII, a period of 90 days following receipt of the information; (c) for Schedule XI, a period of 5 days following receipt of the information; and (d) for Schedules XII and XIII, a period of 21 days following receipt of the information. (2) The period within which the Ministers shall assess the additional information referred to in paragraph 23.1(1)(a), (b) or (c) is the same period as set out in subsection (1) for the information specified in Schedule VI, VII, VIII, XI, XII or XIII, as the case may be. SOR/97-119, s. 15; SOR/2003-214, s. 3. 26. (1) Subject to subsection (3), a person who manufactured or imported during the transitional period a polymer other than a polymer in respect of which section 19 applies shall provide the following information: (a) where the person manufactured or imported the polymer in a quantity that exceeded 20 kg but did not exceed 10 000 kg in any calendar year during the transitional period, (i) if the polymer is not a research and development substance (A) the information specified in Schedule VI, or (B) in the case of a polymer that is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, and in the case of a polymer that is not specified on the NDSL, the information specified in Schedule VII, and (ii) if the polymer is a research and development substance, the information specified in Schedule XI; and (b) where the person manufactured or imported the polymer in a quantity that exceeded 10 000 kg in any calendar year during the transitional period, or exceeded, at any time during the transitional period, an accumulated total of 50 000 kg, (i) if the polymer is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, and (ii) if the polymer is not specified on the NDSL, the information specified in Schedule VII. (2) Subject to subsection (3), a person who manufactured or imported during the transitional period a polymer in respect of which section 19 applies shall provide the following information: (a) if the polymer is not a research and development substance and the person manufactured or imported the polymer in a quantity that exceeded 20 kg in any calendar year during the transitional period, the information specified in Schedule VI; and (b) if the polymer is a research and development substance, (i) the information specified in Schedule XI, if the person manufactured or imported the polymer in a quantity that exceeded 20 kg but did not exceed 10 000 kg in any calendar year during the transitional period, and (ii) the information specified in Schedule VI, if the person manufactured or imported the polymer in a quantity that (A) exceeded 10 000 kg in any calendar year during the transitional period, or (B) exceeded, at any time during the transitional period, an accumulated total of 50 000 kg. (3) Subsections (1) and (2) do not apply in respect of a polymer while it is (a) a site-limited intermediate substance; or (b) a polymer that is being manufactured or imported by a person for export only, if the quantity of the polymer in the person's possession at any one time does not exceed 20 000 kg. 27. (1) Subject to subsections (2) and (3), a person who manufactured or imported, in a quantity that exceeded 10 000 kg in any calendar year during the transitional period, a polymer that is a site-limited intermediate substance or a polymer for export only shall provide the following information: (a) in the case of a polymer other than a polymer in respect of which section 19 applies, (i) if the polymer is specified on the NDSL, the information specified in Schedule VII, except the information specified in subitem 2(2) of that Schedule, or the information specified in Schedule XIII, and (ii) if the polymer is not specified on the NDSL, the information specified in Schedule VII or XIII; and (b) in the case of a polymer in respect of which section 19 applies, the information specified in Schedule VI or XIII. (2) Subsection (1) applies to a person who manufactured or imported a polymer for export only, only if the quantity of the polymer in the person's possession at any one time during the transitional period did not exceed 20 000 kg. (3) The information specified in paragraphs 2(d) to (f) and item 3 of Schedule XIII is not required to be provided in respect of a site-limited intermediate substance that is manufactured and consumed at the site of the manufacture. SOR/97-119, s. 16. 27.1 (1) A person shall, with the information referred to in section 26 or 27, in respect of a biotechnology product that is not derived from whole animals or whole plants, provide the following additional information: (a) where the biotechnology product is subject to the information requirements specified in Schedule VI, the information specified in items 1 to 3 of Schedule XIV; (b) subject to subsection (2), where the biotechnology product is subject to the information requirements specified in Schedule VII or XIII, (i) the information specified in items 1 to 4 of Schedule XIV, (ii) where the biotechnology product is a nucleic acid, the information specified in items 5 and 6 of Schedule XIV, and (iii) where the biotechnology product possesses enzymatic capability, the information specified in items 7 to 13 of Schedule XIV; and (c) where the biotechnology product is subject to the information requirements specified in Schedule XI, the information specified in items 1 and 2 of Schedule XIV. (2) The information specified in items 3 and 5 to 13 of Schedule XIV is not required to be provided where the biotechnology product is a site-limited intermediate substance that is manufactured and consumed at the site of manufacture. SOR/97-119, s. 17. 28. (1) Subject to subsection (2), the information specified in Schedule VI or XI, as the case may be, and referred to in sections 26 and 27 shall be provided on or before November 1, 1994. (2) Where the information specified in Schedule XI has been provided in accordance with subparagraph 26(2)(b)(i) in respect of a polymer, Schedule VI is not required to be provided in respect of that polymer until the appropriate date set out in subsection (3). (3) Subject to subsection (4), the information specified in Schedule VI, if appropriate, and in Schedule VII or XIII, as the case may be, and referred to in sections 26 and 27 shall, where the quantity that triggers the requirement to provide that information (a) was exceeded in 1987, be provided on or before January 1, 1995; (b) was exceeded in 1988, be provided on or before July 1, 1995; (c) was exceeded in 1989, be provided on or before January 1, 1996; (d) was exceeded in 1990, be provided on or before July 1, 1996; (e) was exceeded in 1991, be provided on or before January 1, 1997; (f) was exceeded in 1992, be provided on or before July 1, 1997; (g) was exceeded in 1993, be provided on or before January 1, 1998; and (h) was exceeded during the period beginning on January 1, 1994 and ending on June 30, 1994, be provided on or before July 1, 1998. (4) The information specified in the following items, subitems and paragraphs of Schedule VII or XIII, as the case may be, shall be provided on or before November 1, 1994: (a) subitems 1(1) to (7), paragraphs 2(1)(a) to (c), subitems 2(7) and 3(1) and item 4 of Schedule VII; and (b) subitems 1(1) to (7), paragraphs 2(1)(a) to (c) and items 4 to 6 of Schedule XIII. SOR/94-774, s. 2. 28.1 (1) Notwithstanding section 28 and subject to subsection (2), in the case of a biotechnology product that is not derived from whole animals or whole plants, the information specified in Schedule VI or XI, as the case may be, and referred to in sections 26 and 27 shall be provided on or before January 1, 1998. (2) Where the information specified in Schedule XI has been provided in accordance with subparagraph 26(2)(b)(i) in respect of a biotechnology product that is not derived from whole animals or whole plants, the information specified in Schedule VI is not required to be provided in respect of that biotechnology product until the applicable date set out in subsection (3). (3) Subject to subsection (4), in the case of a biotechnology product that is not derived from whole animals or whole plants, the information specified in Schedule VI, if applicable, and in Schedule VII or XIII, as the case may be, and referred to in sections 26 and 27 shall, where the quantity that triggers the requirement to provide that information (a) was exceeded in 1987, be provided on or before March 1, 1998; (b) was exceeded in 1988, be provided on or before September 1, 1998; (c) was exceeded in 1989, be provided on or before March 1, 1999; (d) was exceeded in 1990, be provided on or before September 1, 1999; (e) was exceeded in 1991, be provided on or before March 1, 2000; (f) was exceeded in 1992, be provided on or before September 1, 2000; (g) was exceeded in 1993, be provided on or before March 1, 2001; and (h) was exceeded during the period beginning on January 1, 1994 and ending on June 30, 1994, be provided on or before September 1, 2001. (4) The information specified in the following items, subitems and paragraphs of Schedule VII or XIII, as the case may be, shall be provided on or before January 1, 1998: (a) subitems 1(1) to (7), paragraphs 2(1)(a) to (c), subitems 2(7) and (8), 3(1) and (2) and item 4 of Schedule VII; and (b) subitems 1(1) to (7), paragraphs 2(a) to (c) and items 4 to 6 of Schedule XIII. (5) The additional information referred to in paragraph 27.1(1)(a), (b) or (c) shall be provided at the same time as the information specified in Schedule VI, VII, XI or XIII, as the case may be. SOR/97-119, s. 18. 29. The quantity of a substance prescribed for the purposes of subparagraph 87(1)(b)(iii) of the Act is (a) in the case of a polymer in respect of which section 19 applies that is specified on the NDSL, or that is not specified on the NDSL but is manufactured solely from reactants that are substances specified on the DSL or the NDSL, where the person did not manufacture or import the polymer during the transitional period, a quantity that exceeds 1 000 kg in any calendar year or an accumulated total of 5 000 kg; (a.1) in the case of a polymer in respect of which section 19 applies, where the person manufactured or imported the polymer during the transitional period, (i) a quantity that exceeds 1 000 kg in any calendar year during the transitional period or the 5-year period beginning on July 1, 1994 and ending on June 30, 1999, or exceeds at any time during the transitional period or the 5-year period an accumulated total of 5 000 kg, or (ii) a quantity that exceeds 10 000 kg during the period beginning on July 1, 1999 and ending on December 31, 1999 or in any calendar year after 1999, or exceeds at any time after June 30, 1999 an accumulated total of 50 000 kg; and (b) in the case of any other polymer, a quantity that exceeds 10 000 kg in any calendar year or an accumulated total of 50 000 kg. SOR/97-119, s. 19; SOR/2000-101, s. 4. 29.01 (1) The information that is prescribed with respect to a polymer for the purpose of paragraph 87(5)(a) of the Act is the following: (a) a notice from the person who provides the information, stating that the person has manufactured or imported the polymer; (b) for a polymer, other than a polymer described in subsection 19(1), the information set out in (i) Schedule VII, except the information specified in subitem 2(2) of that Schedule, if the polymer is specified on the NDSL or if that information has been provided in accordance with subsection 18(4), (ii) Schedule VII, if the polymer is not specified on the NDSL and if the polymer is manufactured solely from reactants that are substances specified on the DSL, or if that information has been provided in accordance with subsection 18(4), or (iii) Schedule VIII, in any other case; and (c) for a polymer described in subsection 19(1), the information specified in (i) Schedule VI, if the polymer is specified on the NDSL or is manufactured solely from reactants that are substances specified on the DSL or the NDSL or if that information has been provided in accordance with paragraph 26(2)(a), or (ii) Schedule VII, in any other case. (2) If the polymer is a biotechnology product not derived from whole animals or whole plants, the person must provide, in addition to the information described in subsection (1), the information described in subsection 23.1(1) that is required in respect of that polymer. SOR/2003-214, s. 4. PART II.1 29.1 This Part does not apply in respect of micro-organisms that are research and development substances not for introduction outside a contained facility, where the containment of micro-organisms is in accordance with the Laboratory Biosafety Guidelines or Appendix K of the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) June 1994, published by the United States Department of Health and Human Services, in the Federal Register (United States), Vol. 59, No. 127, on July 5, 1994, as amended from time to time and that are (a) imported to a contained facility in quantities of less than 50 mL or 50 g; (b) subject to paragraphs (c) and (d), manufactured in quantities of less than 1 000 L in a contained facility, unless the micro-organisms require containment level 2, 3 or 4 as identified in the Laboratory Biosafety Guidelines; (c) manufactured in quantities of less than 250 L in a contained facility and that require containment level 2 as identified in the Laboratory Biosafety Guidelines; or (d) human pathogens manufactured in quantities of less than 250 L in a contained facility and that require containment level 3 or 4 as identified in the Laboratory Biosafety Guidelines, where an import permit or an approval in writing to transfer has been granted in respect of the micro-organisms under the Human Pathogens Importation Regulations. SOR/97-119, s. 20. 29.11 (1) A person who manufactures or imports a micro-organism shall provide (a) a notice indicating the date on which the person started to manufacture or import the micro-organism; and (b) subject to subsections (2) to (6), the information specified in Schedule XV. (2) A person who manufactures or imports a micro-organism (a) for introduction into an ecozone where it is not indigenous is not required to provide the information specified in paragraph 5(a) of Schedule XV, but shall provide all other information specified in that Schedule, 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) for introduction in accordance with confinement procedures is not required to provide the information specified in paragraphs 5(a) and 6(c) and (d) of Schedule XV, but shall provide all other information specified in that Schedule and a description of those confinement procedures and their effectiveness in restricting the dispersal of the micro-organism from the locations of introduction; or (c) for introduction into an ecozone where it is indigenous is not required to provide the information in subparagraphs 1(f)(i), (iii) and (iv) and paragraphs 1(i) and 5(a) of Schedule XV, but shall provide all other information specified in that Schedule and the identification of the ecozone of intended introduction and data that demonstrates that the micro-organism is indigenous to that ecozone. (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 shall provide a notice in writing of the election and the information required by that paragraph. (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 XV, but shall provide the information specified in Schedule XVI. (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 XV, but shall provide the information specified in Schedule XVII. (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 XV, but shall provide the information specified in Schedule XVIII. (7) The information referred to in paragraph (2)(a) or (c) shall be provided in a separate notification for each ecozone. SOR/97-119, s. 20; SOR/2003-214, s. 5. 29.12 The information referred to in section 29.11 shall be provided as follows: (a) for information (i) referred to in subsection 29.11(1) (A) no later than 30 days after the start date of the manufacture or importation of the micro-organism, or within 120 days after this subparagraph comes into force, whichever is later, in the case of information referred to in paragraph 29.11(1)(a), or (B) at least 120 days before the day on which the person manufactures or imports the micro-organism, in the case of information referred to in paragraph 29.11(1)(b); (ii) referred to in subsection 29.11(2), 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, or (iii) referred to in subsection 29.11(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 information specified in Schedule XVI or XVIII, 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; and (c) for information specified in Schedule XVII, 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. SOR/97-119, s. 20; SOR/2003-214, s. 6. 29.13 The periods within which the Ministers shall assess the information referred to in section 29.11 are as follows: (a) for information specified in Schedule XV and the other information referred to in subsection 29.11(2), a period of 120 days following receipt of the information; (b) for Schedules XVI and XVIII, a period of 30 days following receipt of the information; and (c) for Schedule XVII, a period of 90 days following receipt of the information. SOR/97-119, s. 20. 29.14 (1) A person who manufactured or imported a micro-organism during the transitional period in any circumstance not described in subsections (2) to (6), and who manufactures or imports it, as the case may be, after that period in any circumstance not described in those subsections, shall provide the information specified in Schedule XV. (2) A person who manufactured or imported a micro-organism during the transitional period (a) for introduction into an ecozone where it is not indigenous and who manufactures or imports it, as the case may be, after that period for introduction into the same ecozone, shall provide the information specified in Schedule XV other than in paragraph 5(a) thereof, and shall provide the identification of the ecozone of 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) for introduction in accordance with confinement procedures and who manufactures or imports it, as the case may be, after that period for introduction in accordance with the same confinement procedures, shall provide the information specified in Schedule XV other than in paragraphs 5(a) and 6(c) and (d) thereof, and shall provide a description of those confinement procedures and their effectiveness in restricting the dispersal of the micro-organism from its locations of introduction; or (c) for introduction into an ecozone where it is indigenous, and who manufactures or imports it, as the case may be, after that period for introduction into the same ecozone, shall provide the information specified in Schedule XV other than in subparagraphs 1(f)(i), (iii) and (iv) and paragraphs 1(i) and 5(a) thereof, and shall provide the identification of the ecozone of introduction and data that demonstrates that the micro-organism is indigenous to that ecozone. (3) A person who, during the transitional period, manufactured or imported a micro-organism for introduction into an ecozone referred to in paragraph (2)(a) or (c) and who manufactures or imports the micro-organism, as the case may be, after that period for introduction into an ecozone at a point within 10 km of the boundary of the ecozone of introduction during the transitional period, may elect to have that introduction of the micro-organism considered to be into the same ecozone of introduction as during the transitional period and not into the actual ecozone of introduction, in which case the person shall provide a notice in writing of the election and the information required by that paragraph. (4) A person who, during the transitional period, manufactured in a contained facility or imported to a contained facility a micro-organism that was not for introduction outside the contained facility or was for export only, and who manufactures the micro-organism in the same contained facility or imports it to the same contained facility, as the case may be, after that period, which micro-organism is not for introduction outside the contained facility or is for export only, shall provide the information specified in Schedule XVI. (5) A person who manufactured or imported a micro-organism for introduction in an experimental field study, during the transitional period, and who manufactures or imports the micro-organism, as the case may be, after that period for introduction in the same experimental field study, shall provide the information specified in Schedule XVII. (6) A person who manufactured a micro-organism at the site from which it was isolated for introduction into the same site, during the transitional period, and who, after that period, manufactures the micro-organism at that site for introduction into that site, shall provide the information specified in Schedule XVIII. (7) The information referred to in paragraph (2)(a) or (c) shall be provided in a separate notification for each ecozone. SOR/97-119, s. 20. 29.15 The information referred to in section 29.14 shall be provided on or before March 1, 1998. SOR/97-119, s. 20. Organisms other than Micro-organisms 29.16 (1) A person who manufactures or imports an organism other than a micro-organism shall provide the information specified in Schedule XIX, unless the organism is a research and development substance 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. (2) The person referred to in subsection (1) must also provide a notice indicating the date on which the person started to manufacture or import the organism. SOR/97-119, s. 20; SOR/2003-214, s. 7. 29.17 (1) The information referred to in subsection 29.16(1) shall be provided at least 120 days before the day on which the person manufactures or imports the organism. (2) The notice referred to in subsection 29.16(2) shall be provided no later than 30 days after the start date of the manufacture or importation of the organism, or within 120 days after this subsection comes into force, whichever is later. SOR/97-119, s. 20; SOR/2003-214, s. 8. 29.18 The period within which the Ministers shall assess the information referred to in section 29.16 is a period of 120 days following receipt of the information. SOR/97-119, s. 20. 29.19 A person who manufactured or imported an organism other than a micro-organism during the transitional period and who manufactures or imports it, as the case may be, after that period shall provide the information specified in Schedule XIX, unless the organism is a research and development substance 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. SOR/97-119, s. 20. 29.2 The information referred to in section 29.19 shall be provided on or before March 1, 1998. SOR/97-119, s. 20. PART III 30. (1) The information that is specified in a schedule to these Regulations and provided to the Minister shall include (a) the name, address and signature of the person manufacturing or importing the substance; (b) the name and address of the head of the quality assurance unit of every laboratory that developed test data included in the information; and (c) an indication of whether the substance will be manufactured in or imported into Canada and the site of manufacture or the port of entry of the substance, if known. (2) The information that is specified in a schedule to these Regulations and provided to the Minister shall be sent to the Chief, New Substances Division, Commercial Chemicals Evaluation Branch, Environment Canada, Ottawa, Ontario, K1A 0H3. (3) Where a person who provides the information specified in a schedule to these Regulations is not resident in Canada, the person shall provide the name and address of an agent resident in Canada to whom any notice or correspondence intended for the person under the Act and these Regulations may be sent. (4) Where information specified in a schedule to these Regulations is provided by an agent referred to in subsection (3), the information shall include the name and address of the agent and be signed by the agent. SOR/97-119, s. 21. 31. (1) The conditions and test procedures to be followed in developing test data in respect of a substance in order to comply with the information requirements of section 81 of the Act or requests for information under paragraph 84(1)(c) of the Act shall be consistent with the conditions and procedures set out in the "OECD Test Guidelines", being Annex 1 of the OECD Guidelines for Testing of Chemicals, adopted by the Organization for Economic Cooperation and Development Council on May 12, 1981, that are current at the time the test data are developed. (2) The laboratory practices to be followed in developing test data referred to in subsection (1) shall be consistent with the practices set out in the "Principles of Good Laboratory Practice", being Annex 2 of the OECD Guidelines for Testing of Chemicals, adopted by the Organization for Economic Cooperation and Development Council on May 12, 1981. SOR/2000-101, s. 5. SCHEDULE I 1. (1) The chemical name of the substance, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the substance and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the substance, if such a number has been assigned. (4) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the substance, if available. 2. All information in respect of the substance that is relevant to identifying hazards to human health and the environment and that is in the person's possession. 3. The intended uses of the substance. 4. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the substance, and the purpose of such notification. SOR/97-119, s. 22. SCHEDULE II 1. (1) The chemical name of the substance, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the substance and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the substance, if such a number can be assigned. (4) The following identification information in respect of the substance: (a) its structural formula; (b) its gram molecular weight; (c) the degree of purity in its technical grade composition, if applicable; (d) any known impurities present and their concentration by weight; and (e) any additives and stabilizers that are essential for the purposes of marketing the substance, and their concentrations by weight. (5) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the substance, if available. 2. (1) The following physical and chemical data in respect of the substance: (a) its melting point or the temperature at which it decomposes (i) expressed in degrees Celsius, where its melting point or the temperature at which it decomposes is -50°C or greater but not greater than 300°C, and (ii) in any other case, expressed as "less than -50°C" or "greater than 300°C", as appropriate; (b) its boiling point or the temperature at which it decomposes (i) expressed in degrees Celsius, where its boiling point or the temperature at which it decomposes is -50°C or greater but not greater than 300°C, and (ii) in any other case, expressed as "less than -50°C" or "greater than 300°C", as appropriate; (c) its density; (d) its vapour pressure, if it has a standard boiling point of 0°C or greater; (e) its water solubility; (f) its octanol-water partition coefficient, if its solubility in water is 10-6 g/L or greater; (g) one of an infra-red, ultra-violet, mass or nuclear magnetic resonance spectrum suitable for characterization of the substance; (h) its dissociation constants; (i) adsorption-desorption screening test data; (j) its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis; (k) if the substance is a solid at room temperature and its water solubility is less than 10-6 g/L, particle size or fibre length distribution data, if applicable; and (l) its fat solubility, if its solubility in water is less than 10-6 g/L. (2) Data from the most appropriate type of acute mammalian toxicity test of the substance, namely oral, dermal or inhalation, selected on the basis of the most significant route of potential human exposure to the substance. (3) For a test referred to in subitem (2), the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the substance is administered and the conditions under which the test is conducted; and (c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle. (4) Mutagenicity data obtained from one in vitro test of the substance, with and without metabolic activation, for chromosomal aberrations or gene mutations or another indicator of mutagenicity that permits an assessment of in vitro mutagenicity. (5) All other information and test data in respect of the substance that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (6) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (7) Notwithstanding subitem (6), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 3. (1) Manufacture, importation, use and disposal information, including an estimate of the quantity of the substance to be manufactured and imported annually, its intended uses, the methods recommended for its destruction or disposal and the expected transportation modes for its distribution. (2) Recommended precautions and emergency measures, including personal protective equipment to be used, engineering controls, leak and spill clean-up procedures, handling procedures, storage requirements and first-aid measures. (3) The anticipated nature and extent of the substance's release into the environment. (4) The estimated number of persons who may become exposed to the substance. 4. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the substance, and the purpose of such notification. SOR/97-119, ss. 23, 24; SOR/2003-214, s. 9. SCHEDULE III 1. (1) The chemical name of the substance, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the substance and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the substance, if such a number can be assigned. (4) The following identification information in respect of the substance: (a) its structural formula; (b) its gram molecular weight; (c) the degree of purity in its technical grade composition, if applicable; (d) known impurities present and their concentration by weight; and (e) any additives and stabilizers that are essential for the purposes of marketing the substance, and their concentrations by weight. (5) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the substance, if available. 2. (1) The following physical and chemical data in respect of the substance: (a) its melting point or the temperature at which it decomposes (i) expressed in degrees Celsius, where its melting point or the temperature at which it decomposes is -50°C or greater but not greater than 300°C, and (ii) in any other case, expressed as "less than -50°C" or "greater than 300°C", as appropriate; (b) its boiling point or the temperature at which it decomposes (i) expressed in degrees Celsius, where its boiling point or the temperature at which it decomposes is -50°C or greater but not greater than 300°C, and (ii) in any other case, expressed as "less than -50°C" or "greater than 300°C", as appropriate; (c) its density; (d) its vapour pressure, if it has a standard boiling point of 0°C or greater; (e) its water solubility; (f) its octanol-water partition coefficient, if its solubility in water is 10-6 g/L or greater; (g) one of an infra-red, ultra-violet, mass or nuclear magnetic resonance spectrum suitable for characterization of the substance; (h) its dissociation constants; (i) adsorption-desorption screening test data; (j) its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis; (k) if the substance is a solid at room temperature and its water solubility is less than 10-6 g/L, particle size or fibre length distribution data, if applicable; and (l) its fat solubility. (2) Data from the two most appropriate types of acute mammalian toxicity tests of the substance, namely, oral, dermal or inhalation, selected on the basis of the two most significant routes of potential human exposure to the substance. (3) Data from one skin irritation test and one skin sensitization test of the substance. (4) Data from one repeated dose mammalian toxicity test of the substance of at least 28 days duration, or of at least 14 days duration where it can be demonstrated that the data were obtained before July 1, 1994, which test is selected on the basis of the most significant route of potential human exposure to the substance. (4.1) Notwithstanding subitem (4), in the case of a biotechnology product that is not derived from whole animals or whole plants, data from one repeated dose mammalian toxicity test of the biotechnology product of at least 28 days duration, or of at least 14 days duration where it can be demonstrated that the data were obtained before September 1, 1997, which test is selected on the basis of the most significant route of potential human exposure to the biotechnology product. (5) For the tests referred to in subitems (2) to (4), the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the substance is administered and the conditions under which the test is conducted; and (c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle. (6) Mutagenicity data obtained from the following tests of the substance: (a) one in vitro test, with and without metabolic activation, for gene mutations; (b) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and (c) one in vivo mammalian test for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with evidence that the tissue investigated was exposed to the substance or its metabolites, permits an assessment of in vivo mutagenicity. (7) Fish and daphnia acute toxicity test data in respect of the substance, including, as appropriate, limit test results or LC50 results. (8) Ready biodegradability test data in respect of the substance and, if known, identification of the products of biodegradation. (9) All other information and test data in respect of the substance that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (10) A description or specification of test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (11) Notwithstanding subitem (10), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 3. (1) Manufacture, importation, use and disposal information, including an estimate of the quantity of the substance to be manufactured and imported annually, its intended uses, the methods recommended for its destruction or disposal and the expected transportation modes for its distribution. (2) Recommended precautions and emergency measures, including personal protective equipment to be used, engineering controls, leak and spill clean-up procedures, handling procedures, storage requirements and first-aid measures. (3) The anticipated nature and extent of the substance's release into the environment. (4) The estimated number of persons who may become exposed to the substance. 4. Full descriptions of or specific reference to analytical test methods that can be used for the detection and determination of concentrations of the substance at or below the limit test results or the LC50 results provided under subitem 2(7). 5. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the substance, and the purpose of such notification. SOR/97-119, ss. 25, 26; SOR/2003-214, s. 10. SCHEDULE IV 1. (1) The chemical name of the product development substance, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The Chemical Abstracts Service registry number of the product development substance, if known. 2. The following identification information in respect of the product development substance: (a) its structural formula; (b) its gram molecular weight; (c) its degree of purity; and (d) any known impurities present and their concentration by weight. 3. All information and test data in respect of the product development substance that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. 4. (1) A description of the plan for product development including the following information in respect of the product development substance: (a) the manufacturing and import activities; (b) its storage; (c) its transport; (d) its intended uses; (e) an assessment of the potential for its release into the environment or for persons to be exposed to it, and any measures that will be taken to protect against such release or exposure; (f) the environmental fate; and (g) analytical test methods that detect the product development substance in the environment and that are in the person's possession or to which the person ought reasonably to have access. (2) A complete description of the plan for disposing of the product development substance outlining (a) all products in which the product development substance will be used; (b) the plan for recalling, recapturing and disposing of the product development substance; and (c) the ultimate mass balance of the product development substance based on the quantity produced and its disposition. SOR/97-119, s. 27. SCHEDULE V 1. (1) The chemical name of the site-limited intermediate substance or substance for export only, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the site-limited intermediate substance or substance for export only and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the site-limited intermediate substance or substance for export only, if such a number has been assigned. (4) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the site-limited intermediate substance or substance for export only, if available. 2. (1) All information and test data in respect of the site-limited intermediate substance or substance for export only that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (2) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (3) Notwithstanding subitem (2), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 3. Data from environmental degradation tests including hydrolysis rate as a function of pH and ready biodegradability and, if known, an identification of the products of the hydrolysis and biodegradation. 4. Data from the most appropriate type of acute mammalian toxicity test, namely, oral, dermal or inhalation, selected on the basis of the most significant route of potential human exposure to the substance. 5. A description of the manufacturing and import activities in respect of the substance, information in respect of its storage, transport and intended uses, the potential for its release into the environment or for persons to be exposed to it, any measures that will be taken to protect against such release or exposure and the environmental fate. 6. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the substance and the purpose of such notification. SOR/97-119, ss. 28, 29. SCHEDULE VI 1. (1) The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the polymer and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the polymer, if such a number can be assigned. (4) The molecular formula of the polymer, if possible. (5) The structural formula of the polymer, if possible, or else a partial structural formula. (6) The composition of the polymer, including constituents such as monomers, other reactants, known impurities expressed in per cent by weight and additives that are essential for the purpose of marketing. (7) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the polymer, if available. 2. (1) The following physical and chemical data in respect of the polymer: (a) its number average molecular weight; (b) the maximum concentration, in per cent, of all constituents with molecular weights of less than 500 daltons and all constituents with molecular weights of less than 1 000 daltons; and (c) its physical state. (2) All other information and test data in respect of the polymer that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (3) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (4) Notwithstanding subitem (3), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 3. (1) Manufacture, importation, use and disposal information, including an estimate of the quantity of the polymer to be manufactured and imported annually, its intended uses, the methods recommended for its destruction or disposal and the expected transportation modes for its distribution. (2) Recommended precautions and emergency measures, including personal protective equipment to be used, engineering controls, leak and spill clean-up procedures, handling procedures, storage requirements and first-aid measures. 4. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the polymer, and the purpose of such notification. SOR/97-119, ss. 30, 31; SOR/2003-214, s. 11. SCHEDULE VII 1. (1) The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the polymer and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the polymer, if such a number can be assigned. (4) The molecular formula of the polymer, if possible. (5) The structural formula of the polymer, if possible, or else a partial structural formula. (6) The composition of the polymer, including constituents such as monomers, other reactants, known impurities expressed in per cent by weight and essential additives for the purpose of marketing. (7) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the polymer, if available. 2. (1) The following physical and chemical data in respect of the polymer: (a) its number average molecular weight; (b) the maximum concentration, in per cent, of all residual constituents with molecular weights of less than 500 daltons and all residual constituents with molecular weights of less than 1 000 daltons; (c) its physical state; (d) whether it is formulated for dispersal in water; (e) its solubility in water at pH 7 (i) expressed in milligrams per litre, where its solubility is 10 mg/L or greater, and (ii) expressed as "less than 10 mg/L", where its solubility is less than 10 mg/L; (f) its solubility in n-octanol or its octanol-water partition coefficient expressed, for solubility in n-octanol, (i) in milligrams per litre, where its solubility is 50 mg/L or greater, and (ii) as "less than 50 mg/L", where its solubility is less than 50 mg/L; and (g) its solubility in water at pH 1 and pH 10, where its solubility is 50 mg/L or greater. (2) Data from one acute lethal toxicity test with one representative species of fish or daphnia for the water-soluble portion of the polymer, where its solubility in water is 10 mg/L or greater. (3) In respect of a cationic polymer or a polymer expected to become cationic in the aquatic environment, data from (a) one aquatic acute lethal toxicity test, other than a test referred to in subitem (2), with one representative species of fish or daphnia; and (b) one ready biodegradability test for the water-soluble portion of the polymer, where its solubility in water is 50 mg/L or greater. (4) In respect of an anionic polymer, data from tests on freshwater green algae. (5) Data from one acute mammalian oral toxicity test of the polymer. (6) For the test referred to in subitem (5), the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. (7) All other information and test data in respect of the polymer that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (8) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (9) Notwithstanding subitem (8), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 3. (1) Manufacture, importation, use and disposal information, including an estimate of the quantity of the polymer to be manufactured and imported annually, its intended uses, the methods recommended for its destruction or disposal and the expected transportation modes for its distribution. (2) Recommended precautions and emergency measures, including personal protective equipment to be used, engineering controls, leak and spill clean-up procedures, handling procedures, storage requirements and first-aid measures. (3) The anticipated nature and extent of the polymer's release into the environment. (4) The estimated number of persons who may become exposed to the polymer. 4. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the polymer, and the purpose of such notification. SOR/97-119, ss. 32, 33; SOR/2003-214, s. 12. SCHEDULE VIII 1. (1) The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the polymer and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the polymer, if such a number can be assigned. (4) The molecular formula of the polymer, if possible. (5) The structural formula of the polymer, if possible, or else a partial structural formula. (6) The composition of the polymer, including constituents such as monomers, other reactants, known impurities expressed in per cent by weight and essential additives for the purpose of marketing. (7) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the polymer, if available. 2. (1) The following physical and chemical data in respect of the polymer: (a) its number average molecular weight; (b) the maximum concentrations, in per cent, of all residual constituents with molecular weights of less than 500 daltons and of all residual constituents with molecular weights of less than 1 000 daltons; (c) its physical state; (d) whether it is formulated for dispersal in water; (e) its solubility in water at pH 7 (i) expressed in milligrams per litre, where its solubility is 10 mg/L or greater, and (ii) expressed as "less than 10 mg/L", where its solubility is less than 10 mg/L; (f) its solubility in n-octanol or the octanol-water partition coefficient expressed, for solubility in n-octanol, (i) in milligrams per litre, where its solubility is 50 mg/L or greater, and (ii) as "less than 50 mg/L", where its solubility is less than 50 mg/L; (g) its solubility in water at pH 1 and pH 10, where its solubility is 50 mg/L or greater; (h) one ultra-violet spectrum; and (i) its hydrolysis rate as a function of pH where its solubility in water is 50 mg/L or greater and, if known, an identification of the products of the hydrolysis. (2) Data from one acute lethal toxicity test with one representative species of fish or daphnia for the water-soluble portion of the polymer, where its solubility in water is 10 mg/L or greater. (3) Data from one ready biodegradability test on the water-soluble portion of the polymer, where its solubility in water is 50 mg/L or greater. (4) In respect of a cationic polymer or a polymer expected to become cationic in the aquatic environment, data from one aquatic acute lethal toxicity test, other than a test referred to in subitem (2), with one representative species of fish or daphnia. (5) In respect of an anionic polymer, data from tests on freshwater green algae. (6) Data from one acute mammalian oral toxicity test of the polymer. (7) Data from one skin irritation test and one skin sensitization test of the polymer. (8) Data from one repeated dose mammalian toxicity test of the polymer of at least 28 days duration, or of at least 14 days duration where it can be demonstrated that the data were obtained before July 1, 1994, which test is selected on the basis of the most significant route of potential human exposure. (8.1) Notwithstanding subitem (8), in the case of a biotechnology product that is not derived from whole animals or whole plants, data from one repeated dose mammalian toxicity test of the biotechnology product of at least 28 days duration, or of at least 14 days duration where it can be demonstrated that the data were obtained before September 1, 1997, which test is selected on the basis of the most significant route of potential human exposure to the biotechnology product. (9) For the tests referred to in subitems (6) to (8), the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the polymer is administered and the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. (10) Mutagenicity data obtained from the following tests of the polymer: (a) one in vitro test, with and without metabolic activation, for gene mutations; (b) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and (c) one in vivo mammalian test for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with evidence that the tissue investigated was exposed to the polymer or its metabolites, permits an assessment of in vivo mutagenicity. (11) All other information and test data in respect of the polymer that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (12) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (13) Notwithstanding subitem (12), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 3. (1) Manufacture, importation, use and disposal information, including an estimate of the quantity of the polymer to be manufactured and imported annually, its intended uses, the methods recommended for its destruction or disposal and the expected transportation modes for its distribution. (2) Recommended precautions and emergency measures, including personal protective equipment to be used, engineering controls, leak and spill clean-up procedures, handling procedures, storage requirements and first-aid measures. (3) The anticipated nature and extent of the polymer's release into the environment. (4) The estimated number of persons who may become exposed to the polymer. 4. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the polymer, and the purpose of such notification. SOR/97-119, ss. 34, 35; SOR/2003-214, s. 13. SCHEDULE IX 1. A cationic polymer or a polymer that is reasonably expected to become cationic in a natural aquatic environment, except (a) a polymer that has a combined equivalent weight for the cationic group in the polymer greater than 5,000; or (b) a polymer that is a solid material, that is not soluble or dispersible in water and that will be used only in the solid phase, such as polymers that can be used as ion exchange beads. 2. A polymer that is designed, or can be expected, to substantially degrade, decompose or depolymerize, including polymers that could substantially decompose after manufacture and use, even though they are not actually intended to do so. Degradation, decomposition or depolymerization mean the types of chemical changes that convert a polymeric substance into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light or microbial action. 3. A polymer that contains as an integral part of its composition only one or none of the following atomic elements: carbon, hydrogen, nitrogen, oxygen, silicon and sulphur. 4. A polymer that contains (a) any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon; (b) any monoatomic counterions other than chlorine ion, bromine ion, iodine ion, sodium ion, divalent magnesium, trivalent aluminum, potassium ion or divalent calcium; and (c) 0.2% or more by weight of any atomic element or combination of the following atomic elements: lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin or zirconium. 5. A polymer (a) that contains reactive functional groups other than carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered "ordinary"*, butenedioic acid groups, blocked isocyanates including ketoxime-blocked isocyanates, thiols, unconjugated nitrile groups, halogens excluding reactive halogen-containing groups such as benzylic or allylic halides, and conjugated olefinic groups contained in naturally occurring fats, oils and carboxylic acids, in combined equivalent weights of less than 5,000; or (b) in which the only reactive functional groups present are part of acid halides, acid anhydrides, aldehydes, hemiacetals, methylol-amides, methylol-amines, methylol-ureas, alkoxysilanes with alkoxy greater than C2-alkoxysilanes, allyl ethers, conjugated olefins, cyanates, epoxides, imines, unsubstituted positions ortho or para to phenolic hydroxyl, in combined equivalent weights of less than 1,000.
SOR/2001-180, s. 1. SCHEDULE X Monobasic Acids and Natural Oils
Dibasic and Tribasic Acids and Esters
SOR/2001-180, s. 1. SCHEDULE XI 1. (1) The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the polymer and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the polymer, if such a number has been assigned. (4) The identification of the reactants and monomers from which the polymer is manufactured. (5) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the polymer, if available. 2. (1) All information in respect of the polymer that is relevant to identifying hazards to human health and the environment and that is in the person's possession. (2) The physical state of the polymer. 3. A description of the intended research and development activity for which the polymer is to be used and the location of the activity. SOR/97-119, s. 36. SCHEDULE XII 1. (1) The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The Chemical Abstracts Service registry number of the polymer, if known. (3) The molecular formula of the polymer, if possible. (4) The structural formula of the polymer, if possible, or else a partial structural formula. (5) The composition of the polymer, including monomers, other reactants, additives and impurities of the polymer. (6) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the polymer, if available. 2. The following physical and chemical data in respect of the polymer: (a) its number average molecular weight; (b) the maximum concentration, in per cent, of all residual constituents with molecular weights of less than 500 daltons and all residual constituents with molecular weights of less than 1 000 daltons; and (c) its physical state. 3. (1) All information and test data in respect of the polymer that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (2) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (3) Notwithstanding subitem (2), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 4. (1) A description of the plan for product development including the following information in respect of the polymer: (a) the manufacturing and import activities; (b) its storage; (c) its transport; (d) its intended uses; (e) an assessment of the potential for its release into the environment or for persons to be exposed to it, and any measures that will be taken to protect against such release or exposure; (f) the environmental fate; and (g) analytical test methods that detect the polymer in the workplace and in the environment and that are in the person's possession or to which the person ought reasonably to have access. (2) A complete description of the plan for disposing of the polymer outlining (a) all products in which the polymer will be used; (b) the plan for recalling, recapturing and disposing of the polymer; and (c) the ultimate mass balance of the polymer based on the quantity produced and its disposition. SOR/97-119, ss. 37, 38. SCHEDULE XIII 1. (1) The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. (2) The trade names of the polymer and the synonyms of its chemical name, if known. (3) The Chemical Abstracts Service registry number of the polymer, if such a number can be assigned. (4) The molecular formula of the polymer, if possible. (5) The structural formula of the polymer, if possible, or else a partial structural formula of the polymer. (6) The composition of the polymer, including constituents such as monomers, other reactants, known impurities expressed in per cent by weight and additives that are essential for the purpose of marketing. (7) A material safety data sheet, as defined in subsection 11(1) of the Hazardous Products Act, in respect of the polymer, if available. 2. The following physical and chemical data in respect of the polymer: (a) its number average molecular weight; (b) the maximum concentrations, in per cent, of all residual constituents with molecular weights of less than 500 daltons and all residual constituents with molecular weights of less than 1 000 daltons; (c) its physical state; (d) its solubility in water at pH 7 (i) expressed in milligrams per litre, where its solubility is 10 mg/L or greater, and (ii) expressed as "less than 10 mg/L", where its solubility is less than 10 mg/L; (e) its solubility in n-octanol or its octanol-water partition coefficient expressed, for solubility in n-octanol, (i) in milligrams per litre, where its solubility is 50 mg/L or greater, and (ii) as "less than 50 mg/L", where its solubility is less than 50 mg/L; and (f) its solubility in water at pH 1 and pH 10, where its solubility is 50 mg/L or greater. 3. (1) Data from at least one acute mammalian oral toxicity test of the polymer. (2) For the test referred to in subitem (1), the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the polymer is administered and the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. 4. (1) All other information and test data in respect of the polymer that are relevant to identifying hazards to human health and the environment and that are in the person's possession or to which the person ought reasonably to have access. (2) A description or specification of the test procedures followed in developing the test data, including, for data developed on or after July 1, 1994 or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. (3) Notwithstanding subitem (2), in the case of a biotechnology product that is not derived from whole animals or whole plants, a description or specification of the test procedures followed in developing the test data, including, for data developed on or after September 1, 1997, or for test procedures that are not prescribed, test methods, reference substances and quality control and quality assurance procedures. 5. A description of the manufacturing and import activities in respect of the polymer, information in respect of its storage, transport and intended uses, the potential for it to be released into the environment or for persons to be exposed to it, any measures that will be taken to protect against such release or exposure and the environmental fate. 6. The identification of other government agencies, either abroad or within Canada, that the person has notified of the manufacture or importation of the polymer, and the purpose of such notification. SOR/97-119, ss. 39, 40. SCHEDULE XIV 1. The identification of the organism and the organ, if applicable, from which the biotechnology product is isolated, including (a) synonyms and common and superseded names, if known; and (b) the source and history. 2. A description of any known adverse human health or environmental effects associated with exposure to the production organism. 3. The concentration of the viable production organism in the final product. 4. A description of the method used to separate the production organism from the biotechnology product. 5. The identification of the encoded products, if known. 6. A description of any known biological activity or adverse human health or environmental effects associated with the nucleic acid or with the encoded products specified pursuant to item 5. 7. A description of all known catalytic functions. 8. The International Union of Biochemistry registry number, if available. 9. The known substrate specificity for each of the catalytic functions specified pursuant to item 7. 10. The optimum pH and temperature for the most appropriate substrates specified pursuant to item 9. 11. The catalytic constants Km and Kcat and the conditions under which they were measured. 12. The known cofactors necessary for enzymatic activity. 13. The activity per unit weight of the final product. SOR/97-119, s. 41. SCHEDULE XV 1. The following information in respect of the micro-organism: (a) the identification and the information substantiating the identification; (b) the synonyms and common and superseded names; (c) the 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) the life cycle, (ii) the infectivity, pathogenicity to non-human species, toxicity and toxigenicity, (iii) the resistance to antibiotics and tolerance to metals and pesticides, (iv) the involvement in biogeochemical cycling, (v) the conditions required for, and conditions that limit, survival, growth and replication, and (vi) the mechanisms of dispersal of the micro-organism and 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 was or will be imported 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 was or 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 introduction of the micro-organism, 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 for 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, where infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified pursuant to 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, and (ii) terrestrial plant, invertebrate and vertebrate species likely to be exposed; (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 that may become exposed and the degree of 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 human health and the environment 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 abroad 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 test methods, reference substances and quality control and quality assurance procedures. SOR/97-119, s. 41. SCHEDULE XVI 1. The following information in respect of the micro-organism: (a) the identification and the information substantiating the identification; (b) the synonyms and common and superseded names; (c) the 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) the infectivity, pathogenicity to non-human species, toxicity and toxigenicity, and (ii) the conditions required for, and conditions that limit, 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 was or will be imported, as the case may be, determined in accordance with the physical and operational requirements set out, as the case may be, in the Laboratory Biosafety Guidelines or Appendix K of the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) June 1994 published by the United States Department of Health and Human Services, in the Federal Register (United States), Vol. 59, No. 127, on July 5, 1994, as amended from time to time; (d) an estimation of the quantity of the micro-organism that was or will be imported 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 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 human health and the environment 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 abroad 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 test methods, reference substances and quality control and quality assurance procedures. SOR/97-119, s. 41. SCHEDULE XVII 1. The following information in respect of the micro-organism: (a) the identification and the information substantiating the identification; (b) the synonyms and common and superseded names; (c) the 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) the infectivity, pathogenicity to non-human species, toxicity and toxigenicity, (ii) the conditions required for, and conditions that limit, survival, growth and replication, (iii) the life cycle, where the micro-organism is not indigenous, (iv) the resistance to antibiotics and tolerance to metals and pesticides, where the micro-organism is not indigenous, (v) the involvement in biogeochemical cycling, where the micro-organism is not indigenous, and (vi) the mechanisms of dispersal of the micro-organism and 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) where 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 was or will be imported 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 was or 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) the location and a map; (b) the 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) where 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) where the micro-organism is indigenous, data to demonstrate that it is indigenous. 4. The following information in respect of the experimental field study: (a) the objectives of the experimental field study; (b) the history of use of the micro-organism; (c) the 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 for 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 that may become exposed and the degree of 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 human health and the environment 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 abroad 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 test methods, reference substances and quality control and quality assurance procedures. SOR/97-119, s. 41. SCHEDULE XVIII 1. The following information in respect of the micro-organism: (a) the identification and the information substantiating the identification; (b) the 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 demonstrate 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 was or will be manufactured, as the case may be; (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) the intended use; (b) the start date and duration; (c) 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; 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 that may become exposed and the degree of 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 human health and the environment 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 abroad 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 test methods, reference substances and quality control and quality assurance procedures. SOR/97-119, s. 41. SCHEDULE XIX 1. The following information in respect of the organism: (a) the identification, or current taxonomic name to species or subspecies level, strain, synonyms, common names and trade name; (b) the 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) the life cycle, (ii) the reproductive biology, including species with which the organism could interbreed in Canada, (iii) the 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 traits by gene transfer, (vi) the locations and situations where the organism has caused adverse ecological effects, (vii) the involvement in biogeochemical cycling, (viii) the interactions with other organisms in the environment, (ix) the conditions required for survival, growth, reproduction and overwintering, (x) the capability of the organism to act as a vector for agents involved in adverse effects, and (xi) the mechanisms of dispersal of the organism and 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 was or will be imported 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 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 introduction, (ii) any activities associated with the introduction, (iii) any recommended procedures for storage and handling of any surplus organism, (iv) any contingency plans for accidental release and any reproductive isolation measures, and (v) the resistance to control agents; (e) a description of any recommended procedures for terminating the introduction of the organism; and (f) a description of procedures for 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 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 the pathogenicity, toxicity or invasiveness of the organism; (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 human health and the environment 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 abroad 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 test methods, reference substances and quality control and quality assurance procedures. SOR/97-119, s. 41. |