SCHEDULE II
(Paragraphs 6(1)(b) and (2)(b), subsection 6(3), paragraph 6(4)(a), subsections 6(5) and (6), paragraphs 8(1)(a) and (2)(b) and 10.1(1)(b), subsections 11(3), 12(2) and 13(1), paragraph 14.1(1)(b), section 15.1 and subparagraph 16.1(1)(b)(i))
INFORMATION REQUIRED IN RESPECT OF SUBSTANCES OTHER THAN PRODUCT DEVELOPMENT SUBSTANCES, SITE-LIMITED INTERMEDIATE SUBSTANCES AND SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Paragraphs 6(1)(c) and (4)(b), subsection 6(6), paragraphs 8(1)(b) and 10.1(1)(b), subsections 11(3) and 12(2) and subparagraph 16.1(1)(b)(ii))
INFORMATION REQUIRED IN RESPECT OF SUBSTANCES OTHER THAN PRODUCT DEVELOPMENT SUBSTANCES, SITE-LIMITED INTERMEDIATE SUBSTANCES AND SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Section 8, paragraph 10.1(1)(c) and subsections 11(3) and 12(2))
INFORMATION REQUIRED IN RESPECT OF PRODUCT DEVELOPMENT SUBSTANCES

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
(Paragraphs 10(1)(b) and (2)(b), subsections 10(3) and (4), paragraph 10.1(1)(b), subsections 11(3) and 12(2), paragraph 14(1)(b), subsection 14(3), paragraph 14.1(1)(b) and section 15.1)
INFORMATION REQUIRED IN RESPECT OF SITE-LIMITED INTERMEDIATE SUBSTANCES AND SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Subparagraphs 18(1)(a)(i) and 19(2)(a)(i), paragraph 19(2)(b), subsections 19(3) and 23(1), paragraphs 23(3)(b) and 23.1(1)(a), subsections 24(3) and 25(2), clause 26(1)(a)(i)(A), paragraph 26(2)(a), subparagraph 26(2)(b)(ii), paragraphs 27(1)(b) and 27.1(1)(a), section 28.1 and subparagraph 28.2(1)(c)(i))
INFORMATION REQUIRED IN RESPECT OF POLYMERS OTHER THAN PRODUCT DEVELOPMENT SUBSTANCES, SITE-LIMITED INTERMEDIATE SUBSTANCES AND SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Paragraph 18(1)(b), subsections 18(2) and (3), clause 19(2)(b)(ii)(B), paragraphs 23(3)(a) and 23.1(1)(b), subsections 24(3) and 25(2), clause 26(1)(a)(i)(B), paragraphs 26(1)(b), 27(1)(a) and 27.1(1)(b), section 28.1 and subparagraphs 28.2(1)(b)(i) and (ii) and (c)(ii))
INFORMATION REQUIRED IN RESPECT OF POLYMERS OTHER THAN PRODUCT DEVELOPMENT SUBSTANCES, SITE-LIMITED INTERMEDIATE SUBSTANCES AND SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Clauses 18(1)(b)(ii)(B) and (2)(b)(ii)(B), paragraph 23.1(1)(b), subsections 24(3) and 25(2) and subparagraph 28.2(1)(b)(iii))
INFORMATION REQUIRED IN RESPECT OF POLYMERS OTHER THAN PRODUCT DEVELOPMENT SUBSTANCES, SITE-LIMITED INTERMEDIATE SUBSTANCES AND SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Paragraphs 19(1)(a) and (b))
TYPES OF POLYMERS

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
(Paragraph 19(1)(c))
LIST OF REACTANTS AND THEIR CHEMICAL ABSTRACTS SERVICE REGISTRY NUMBER

Monobasic Acids and Natural Oils

Dibasic and Tribasic Acids and Esters

Polyols

Modifiers

SOR/2001-180, s. 1.

SCHEDULE XI
(Subparagraphs 18(1)(a)(ii) and 19(2)(a)(ii), paragraph 23.1(1)(c), subsections 24(3) and 25(2), subparagraphs 26(1)(a)(ii) and (2)(b)(i), paragraph 27.1(1)(c) and section 28.1)
INFORMATION REQUIRED IN RESPECT OF POLYMERS THAT ARE RESEARCH AND DEVELOPMENT SUBSTANCES

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
(Paragraphs 21(b) and 23.1(1)(c) and subsections 24(3) and 25(2))
INFORMATION REQUIRED IN RESPECT OF POLYMERS THAT ARE PRODUCT DEVELOPMENT SUBSTANCES

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
(Paragraph 23(2)(b), subsections 23(3) and (4), paragraph 23.1(1)(b), subsections 24(3), 25(2) and 27(1) and (3), paragraph 27.1(1)(b) and section 28.1)
INFORMATION REQUIRED IN RESPECT OF POLYMERS THAT ARE SITE-LIMITED INTERMEDIATE SUBSTANCES OR MANUFACTURED OR IMPORTED FOR EXPORT ONLY

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
(Sections 10.1, 14.1, 23.1 and 27.1)
INFORMATION REQUIRED IN RESPECT OF BIOTECHNOLOGY PRODUCTS NOT DERIVED FROM WHOLE ANIMALS OR WHOLE PLANTS

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 K_m and K_cat 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
(Section 29.11, paragraphs 29.12(a) and 29.13(a) and subsections 29.14(1) and (2))
INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS

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
(Subsection 29.11(4), paragraphs 29.12(b) and 29.13(b) and subsection 29.14(4))
INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS NOT FOR INTRODUCTION OUTSIDE A CONTAINED FACILITY OR FOR EXPORT ONLY

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
(Subsection 29.11(5), paragraphs 29.12(c) and 29.13(c) and subsection 29.14(5))
INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS FOR INTRODUCTION IN AN EXPERIMENTAL FIELD STUDY

1. The following information in respect of the micro-organism:

(a) 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
(Subsection 29.11(6), paragraphs 29.12(b) and 29.13(b) and subsection 29.14(6))
INFORMATION REQUIRED IN RESPECT OF MICRO-ORGANISMS FOR INTRODUCTION INTO THE SITE FROM WHICH THEY WERE ISOLATED

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.