Canadian Environmental Protection Act, 1999: part 6


Part 6: Animate Products of Biotechnology

Definitions

104. The definitions in this section apply in this Part.

“living organism”
« organisme vivant »

“living organism” means a substance that is an animate product of biotechnology.

“significant new activity”
« nouvelle activité »

“significant new activity” includes, in respect of a living organism, any activity that results or may result in

  1. (a) the entry or release of the living organism into the environment in a quantity or concentration that, in the Ministers’ opinion, is significantly greater than the quantity or concentration of the living organism that previously entered or was released into the environment; or

  2. (b) the entry or release of the living organism into the environment or the exposure or potential exposure of the environment to the living organism in a manner and circumstances that, in the Ministers’ opinion, are significantly different from the manner and circumstances in which the living organism previously entered or was released into the environment or of any previous exposure or potential exposure of the environment to the living organism.

Adding living organisms to Domestic Substances List

105. (1) The Minister shall, for the purposes of sections 74 and 106, add to the Domestic Substances List maintained under section 66 any living organism if the Minister is satisfied that, between January 1, 1984 and December 31, 1986, the living organism

  1. (a) was manufactured in or imported into Canada by any person; and

  2. (b) entered or was released into the environment without being subject to conditions under this or any other Act of Parliament or of the legislature of a province.

Amendment of List

(2) Where the Minister includes a living organism on the Domestic Substances List and subsequently learns that, between January 1, 1984 and December 31, 1986, the requirements set out in paragraphs (1)(a) and (b) were not met, the Minister shall delete the substance from the List.

Publication of List

(3) The Minister shall publish in the Canada Gazette the Domestic Substances List and any amendment to the List.

Designation

(4) The Minister may, by order, designate any person or class of persons to exercise the powers and perform the duties and functions set out in this section.

Manufacture or import of living organisms

106. (1) Where a living organism is not specified on the Domestic Substances List and subsection (2) does not apply, no person shall manufacture or import the living organism unless

  1. (a) the prescribed information with respect to the living organism, accompanied by the prescribed fee, has been provided by that person to the Minister on or before the prescribed date; and

  2. (b) the period for assessing the information under section 108 has expired.

Transitional provision

(2) Where a person has, between January 1, 1987 and June 30, 1994, manufactured or imported a living organism that is not specified on the Domestic Substances List, no person shall manufacture or import the living organism after June 30, 1994 unless, within 180 days after that date or on or before the prescribed date, the prescribed information has been provided to the Minister with respect to the living organism by that person.

Notification of significant new activity in respect of living organism on List

(3) Where a living organism is specified on the Domestic Substances List with an indication that this subsection applies with respect to the living organism, no person shall use, manufacture or import the living organism for a significant new activity that is indicated on the List with respect to the living organism unless

  1. (a) the person has provided the Minister with the prescribed information, on or before the date that is specified by the Minister or prescribed, accompanied by the prescribed fee; and

  2. (b) the period for assessing the information specified by the Minister or provided under section 108 has expired.

Notification of significant new activity in respect of living organism not on List

(4) Where a living organism is not specified on the Domestic Substances List and the Minister publishes a notice in the Canada Gazette indicating that this subsection applies with respect to the living organism, no person shall use the living organism for a significant new activity that is indicated in the notice unless

  1. (a) the person has provided the Minister with the prescribed information, on or before the date that is specified by the Minister or prescribed, accompanied by the prescribed fee; and

  2. (b) the period for assessing the information specified by the Minister or provided under section 108 has expired.

Transfer of rights in respect of substance

(5) Where prescribed information with respect to a substance has been provided under subsection (1), (2), (3) or (4) by a person who subsequently transfers the right or privilege in relation to the substance for which the information was provided, the information is, subject to any conditions that may be prescribed, deemed to have been provided by the transferee of that right or privilege.

Application

(6) Subsections (1) to (4) do not apply to

  1. (a) a living organism that is manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given before the manufacture, import or sale of the living organism and for an assessment of whether it is toxic or capable of becoming toxic;

  2. (b) a living organism that is manufactured, used or imported under the conditions and in the circumstances prescribed as exempt from this section; or

  3. (c) impurities and contaminants related to the preparation of a living organism.

Governor in Council may amend Schedule 4

(7) For the purposes of the administration of this section, the Governor in Council has the exclusive responsibility for determining whether or not the requirements referred to in paragraph (6)(a) are met by or under an Act of Parliament referred to in that paragraph, or regulations made under that Act, and

  1. (a) if the Governor in Council determines that the requirements referred to in paragraph (6)(a) are met by or under an Act of Parliament referred to in that paragraph, or regulations made under that Act, the Governor in Council may by order add to Schedule 4 the name of that Act or those regulations, as the case may be, and the fact that an Act or regulations are listed in Schedule 4 is conclusive proof that the requirements referred to in paragraph (6)(a) are met; and

  2. (b) if the Governor in Council determines that the requirements referred to in paragraph (6)(a) are no longer met by or under an Act of Parliament, or regulations, listed in Schedule 4, the Governor in Council may by order delete from Schedule 4 the name of that Act or those regulations, as the case may be.

Waiver of information requirements

(8) On the request of any person to whom subsection (1), (2), (3) or (4) applies, the Minister may waive any of the requirements to provide information under that subsection if

  1. (a) in the opinion of the Ministers, the information is not needed in order to determine whether the living organism is toxic or capable of becoming toxic;

  2. (b) a living organism is to be used for a prescribed purpose or manufactured at a location where, in the opinion of the Ministers, the person requesting the waiver is able to contain the living organism so as to satisfactorily protect the environment and human health; or

  3. (c) it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information.

Publication of notice of waiver

(9) The Minister shall publish in the Canada Gazette a notice stating the name of any person to whom a waiver is granted and the type of information to which it relates.

Compliance with waiver

(10) Where the Minister waives any of the requirements for information under paragraph (8)(b), the person to whom the waiver is granted shall not use, manufacture or import the living organism unless it is for the purpose prescribed by regulations made under paragraph 114(1)(f) or at the location specified in the request for the waiver, as the case may be.

Correction of information

(11) A person who has provided information under this section, including for the purposes of a request for a waiver under subsection (8), or under section 107 or 109 shall notify the Minister of any corrections to the information as soon as possible after learning of them.

Request for information previously waived

(12) Where the Minister is notified of any corrections to information that was provided for the purposes of a request for a waiver under subsection (8), the Minister may, after consideration by the Ministers of those corrections, require the person to whom the waiver was granted to provide the Minister with the information to which the waiver related within the time specified by the Minister.

Application of section 109

(13) Where the Ministers suspect, after considering

  1. (a) any corrections received under subsection (11), or

  2. (b) the information provided under subsection (12),

that a living organism is toxic or capable of becoming toxic, the Minister may exercise any of the powers referred to in paragraphs 109(1)(a) to (c).

Prohibition of activity

107. (1) Where the Minister has reasonable grounds to believe that a person has used, manufactured or imported a living organism in contravention of subsection 106(1), (3) or (4), the Minister may, in writing, require the person to provide the information referred to in that subsection and prohibit any activity involving the living organism until the expiry of the period for assessing the information under section 108.

Prohibition of activity

(2) Where the Minister has reasonable grounds to believe that a person has manufactured or imported a living organism in contravention of subsection 106(2), the Minister may, in writing, prohibit any activity involving the living organism until the prescribed information is provided to the Minister.

Waiver of information requirements

(3) On the request of any person required under subsection (1) or (2) to provide information, the Minister may waive any of the requirements for prescribed information if one of the conditions specified in paragraphs 106(8)(a) to (c) is met and, in that case, subsections 106(9) to (13) apply with respect to the waiver.

Assessment of information

108. (1) Subject to subsection (4), the Ministers shall, within the prescribed assessment period, assess information provided under subsection 106(1), (3) or (4) or paragraph 109(1)(c) or otherwise available to them in respect of a living organism in order to determine whether it is toxic or capable of becoming toxic.

Assessment of information

(2) Subject to subsections (3) and (4), the Ministers shall assess information provided under subsection 107(1) or otherwise available to them in respect of a living organism in order to determine whether it is toxic or capable of becoming toxic.

Time for assessment

(3) An assessment of information under subsection (2) shall be made following the date on which the information is provided within a period that does not exceed the number of days in the prescribed assessment period.

Extension of assessment period

(4) Where the Ministers are of the opinion that further time is necessary to assess any information, the Minister may, before the expiry of the assessment period referred to in subsection (1) or (3), extend the period for assessing the information, but the extension shall not exceed the number of days in the prescribed assessment period.

Notification of extension

(5) Where the Minister extends the period for assessing information, the Minister shall, before the expiry of the assessment period referred to in subsection (1) or (3), notify the person who provided the information.

Termination of period

(6) The Minister may, before the expiry of the assessment period referred to in subsection (1) or (3), terminate the period for assessing information and, immediately before doing so, shall notify the person who provided the information.

Action to be taken after assessment

109. (1) Where the Ministers have assessed any information under section 108 and they suspect that a living organism is toxic or capable of becoming toxic, the Minister may, before the expiry of the period for assessing the information,

  1. (a) permit any person to manufacture or import the living organism, subject to any conditions that the Ministers may specify;

  2. (b) prohibit any person from manufacturing or importing the living organism; or

  3. (c) request any person to provide any additional information or submit the results of any testing that the Ministers consider necessary for the purpose of assessing whether the living organism is toxic or capable of becoming toxic.

Additional information or testing

(2) Where the Minister requests additional information or test results under paragraph (1)(c), the person to whom the request is directed shall not manufacture or import the living organism unless

  1. (a) the person provides the additional information or submits the test results; and

  2. (b) the period for assessing information under section 108 has expired or a period of 120 days after the additional information or test results were provided has expired, whichever is later.

Variation of conditions and prohibitions

(3) The Minister may vary or rescind a condition or prohibition specified or imposed under paragraph (1)(a) or (b).

Expiry of prohibition

(4) Any prohibition on the manufacture or import of a living organism imposed under paragraph (1)(b) expires two years after it is imposed unless, before the expiry of the two years, the Governor in Council publishes in the Canada Gazette a notice of proposed regulations under section 114 in respect of the living organism, in which case the prohibition expires on the day the regulations come into force.

Publication of conditions and prohibitions

(5) Where the Minister specifies, imposes, varies or rescinds any condition for or prohibition on the manufacture or import of a living organism, the Minister shall publish in the Canada Gazette a notice setting out the condition or prohibition and the living organism in respect of which it applies.

Significant new activity

110. (1) Where the Ministers have assessed any information under section 108 in respect of a living organism that is not on the Domestic Substances List and they suspect that a significant new activity in relation to that living organism may result in the living organism becoming toxic, the Minister may, within 90 days after the expiry of the period for assessing the information, publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice indicating that subsection 106(4) applies with respect to the living organism.

Variation or revocation

(2) The Minister may, by notice published in the Canada Gazette, vary the significant new activities in relation to a living organism in respect of which a notice has been given under subsection (1) or indicate that subsection 106(4) no longer applies with respect to that living organism.

Contents of notice

(3) A notice referred to in subsection (1) or (2) shall indicate, by inclusion or exclusion, the significant new activities in relation to the living organism in respect of which subsection 106(4) is to apply, and where regulations in respect of those significant new activities are not made under paragraphs 114(1)(c), (d) and (g), specify the information to be provided to the Minister under that subsection, the date on or before which it is to be provided and the period within which it is to be assessed under section 108.

Notification of persons required to comply

111. Where a notice is published in the Canada Gazette under subsection 110(1) in respect of a living organism, every person who transfers the physical possession or control of the living organism shall notify all persons to whom the possession or control is transferred of the obligation to comply with subsection 106(4).

Amendment of List

112. (1) The Minister shall add a living organism to the Domestic Substances List within 120 days after the following conditions are met:

  1. (a) the Minister has been provided with information in respect of the living organism under section 106 or 107 and any additional information or test results required under subsection 109(1);

  2. (b) the Ministers are satisfied that the living organism has been manufactured in or imported into Canada by the person who provided the information prescribed for the purpose of this paragraph;

  3. (c) the period for assessing the information under section 108 has expired; and

  4. (d) no conditions specified under paragraph 109(1)(a) in respect of the living organism remain in effect.

Amendment of List

(2) Where the Minister adds a living organism to the Domestic Substances List and subsequently learns that the living organism was not manufactured or imported as described in subsection (1), the Minister shall delete the living organism from the List.

Significant new activity

(3) Where a living organism is on the Domestic Substances List or is to be added to the List under subsection (1), the Minister may amend the List in respect of the living organism to indicate that subsection 106(3) applies with respect to the living organism or that it no longer applies or by varying the significant new activities in relation to the living organism in respect of which subsection 106(3) is to apply.

Contents of amendment

(4) An amendment referred to in subsection (3) shall indicate, by inclusion or exclusion, the significant new activities in relation to the living organism in respect of which subsection 106(3) is to apply, and where regulations in respect of those significant new activities are not made under paragraphs 114(1)(c), (d) and (g), specify the information to be provided to the Minister under that subsection, the date on or before which it is to be provided and the period within which it is to be assessed under section 108.

Publication of masked name

113. Where the publication under this Part of the explicit biological name of a living organism would result in the release of confidential business information in contravention of section 314, the living organism shall be identified by a name determined in the prescribed manner.

Regulations

114. (1) The Governor in Council may, on the recommendation of the Ministers, make regulations

  1. (a) respecting living organisms or establishing groups of living organisms for the purposes of the provision of information under section 106 or 107, including those that are exotic or indigenous, research and development living organisms and living organisms manufactured only for export, and designating ecozones or groups of ecozones;

  2. (b) prescribing conditions and circumstances for the purpose of paragraph 106(6)(b);

  3. (c) respecting the information that shall be provided to the Minister under subsection 106(1), (2), (3) or (4) or section 107 and the form and manner in which it is to be provided;

  4. (d) prescribing dates on or before which information shall be provided under subsection 106(1), (2), (3) or (4);

  5. (e) respecting the maintenance of books and records for the administration of any regulation made under this section;

  6. (f) prescribing the purpose for which a living organism must be used so as to permit the waiver of information requirements under subsection 106(8);

  7. (g) prescribing periods within which the Ministers shall assess information under subsection 108(1);

  8. (h) respecting the conditions, test procedures and laboratory practices to be followed in developing test data on a living organism in order to comply with the information requirements of section 106 or 107 or requests for information under paragraph 109(1)(c);

  9. (i) prescribing information for the purpose of paragraph 112(1)(b);

  10. (j) prescribing the manner of determining a name for a living organism for the purpose of section 113; and

  11. (k) generally for carrying out the purposes and provisions of this Part.

Prescribed assessment period

(2) For the purposes of sections 106 and 108, where no assessment period is prescribed or specified with respect to a living organism, the prescribed assessment period is 120 days after the Minister is provided with the prescribed information.

Prescription of conditions and circumstances

(3) Regulations made under paragraph (1)(b) may prescribe conditions and circumstances in respect of a living organism in terms of

  1. (a) whether or not the living organism is a member of a group of living organisms established by regulations made under paragraph (1)(a); or

  2. (b) the purposes for which the living organism is manufactured or imported.

Prescription of information and assessment periods

(4) Regulations made under paragraph (1)(c), (d) or (g) may prescribe information, dates or periods in respect of a living organism in terms of

  1. (a) whether or not the living organism is a member of a group of living organisms established by regulations made under paragraph (1)(a);

  2. (b) the purposes for which the living organism is manufactured or imported; or

  3. (c) the conditions under which and the circumstances in which the living organism is manufactured or imported.

Other regulations

115. (1) Subject to subsection (2), the Governor in Council may, on the recommendation of the Ministers, make regulations

  1. (a) for the purposes of implementing an international agreement,

    1. respecting living organisms, whether or not they are on the Domestic Substances List, and

    2. respecting the safety of the environment or human health, including, but not limited to, the safe transfer, handling and uses of any living organism that is moved across a boundary; and

  2. (b) respecting the effective and safe use of living organisms in pollution prevention.

Living organisms regulated under other Acts of Parliament

(2) The Governor in Council shall not make a regulation under subsection (1) in respect of any living organism if the regulation regulates an aspect of the living organism that is regulated by or under any other Act of Parliament in a manner that provides, in the opinion of the Governor in Council, sufficient protection to the environment and human health.

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