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Canadian Environmental Protection Act, 1999 (S.C. 1999, c. 33)

Act current to 2024-02-06 and last amended on 2023-06-22. Previous Versions

PART 6Animate Products of Biotechnology (continued)

Marginal note:Prohibition of activity

  •  (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.

  • Marginal note:Waiver of information requirements

    (2) On the request of any person required under subsection (1) 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.

  • (3) [Repealed, 2017, c. 26, s. 27]

  • 1999, c. 33, s. 107
  • 2017, c. 26, s. 27

Marginal note:Assessment of information

  •  (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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

Marginal note:Consultation

  •  (1) If the information that the Ministers assess under subsection 108(1) or (2) is in respect of a vertebrate animal or a prescribed living organism or group of living organisms, the Ministers shall consult any interested persons before the expiry of the period for assessing that information.

  • Marginal note:Notice

    (2) Before undertaking consultations, the Minister shall publish a notice of consultation in any manner that the Minister considers appropriate.

Marginal note:Action to be taken after assessment

  •  (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,

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

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

    • (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.

  • Marginal note: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

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

    • (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.

  • Marginal note: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).

  • Marginal note:Expiry of prohibition

    (4) Any prohibition on the manufacture or import of a living organism imposed under paragraph (1)(b) expires two years after the day on which it is imposed unless, before the expiry of the two years, there is published in the Canada Gazette

    • (a) a regulation respecting preventive or control actions, in relation to the living organism, that is proposed to be made under this Act; or

    • (b) a statement, identifying a regulation respecting preventive or control actions in relation to the living organism that is proposed to be made under any other Act of Parliament,

      • (i) made jointly by the Minister and the Minister responsible for the administration of the Act of Parliament under which the regulation is to be made, if the Act is not an Act referred to in subparagraph (ii), or

      • (ii) made by the Minister of Health, if the Act of Parliament is one for whose administration that Minister is responsible.

    If such a proposed regulation — or such a statement identifying a proposed regulation — is so published, the prohibition expires on the day on which the regulation comes into force.

  • Marginal note: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.

Marginal note:Significant new activity

  •  (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.

  • Marginal note:Contents of notice

    (2) A notice referred to in subsection (1)

    • (a) shall indicate, by inclusion or exclusion, the significant new activities in relation to the living organism with respect to which subsection 106(4) is to apply and, if 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; and

    • (b) may specify for the purpose of subsection 111(2) classes of persons who are not required to be notified under subsection 111(1) with respect to the living organism.

  • Marginal note:Classes of persons

    (3) The Minister may, by notice published in the Canada Gazette, specify for the purpose of subsection 111(2) classes of persons who are not required to be notified under subsection 111(1) with respect to a living organism for which a notice was published under subsection (1), if no such class was specified in that notice.

  • Marginal note:Subsequent notice

    (4) The Minister may, by notice published in the Canada Gazette,

    • (a) vary the significant new activities in relation to a living organism for which a notice has been published under subsection (1) or vary the information to be provided to the Minister under subsection 106(4), the date on or before which that information is to be provided or the period within which it is to be assessed under section 108;

    • (b) indicate that subsection 106(4) no longer applies with respect to that living organism;

    • (c) vary the classes of persons, if any, that are specified for the purpose of subsection 111(2) in a notice published under subsection (1) or (3); or

    • (d) indicate that a class of persons is no longer specified for the purpose of subsection 111(2).

Marginal note:Notification of persons required to comply

  •  (1) 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).

  • Marginal note:Exception

    (2) A person who is within a class of persons that is specified in a notice published under subsection 110(1) or (3) — or, if the class is varied by a notice published under subsection 110(4), within the class as varied — is not required to be notified under subsection (1) with respect to the living organism to which the notice relates.

Marginal note:Amendment of List

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

    • (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);

    • (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;

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

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

  • Marginal note: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.

  • Marginal note:Significant new activity

    (3) If a living organism is on the Domestic Substances List or is to be added to the List under subsection (1) or 105.1(1), the Minister may amend the List to indicate that subsection 106(3) applies with respect to the living organism.

  • Marginal note:Contents of amendment

    (4) An amendment referred to in subsection (3)

    • (a) shall indicate, by inclusion or exclusion, the significant new activities in relation to the living organism with respect to which subsection 106(3) is to apply and, if 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; and

    • (b) may specify for the purpose of subsection 112.1(2) classes of persons who are not required to be notified under subsection 112.1(1) with respect to the living organism.

  • Marginal note:Subsequent amendment

    (5) The Minister may amend the Domestic Substances List in respect of a living organism with respect to which subsection 106(3) applies

    • (a) to vary the significant new activities in relation to the living organism or vary the information to be provided to the Minister under subsection 106(3), the date on or before which that information is to be provided or the period within which it is to be assessed under section 108;

    • (b) to indicate that subsection 106(3) no longer applies;

    • (c) to specify classes of persons for the purpose of subsection 112.1(2), if no such classes are specified with respect to the living organism;

    • (d) to vary the classes of persons, if any, that are specified for the purpose of subsection 112.1(2); or

    • (e) to delete any class of persons that is specified for the purpose of subsection 112.1(2).

Marginal note:Notification of persons required to comply

  •  (1) If a living organism is specified on the Domestic Substances List with an indication that subsection 106(3) applies with respect to the 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 that subsection.

  • Marginal note:Exception

    (2) A person is not required to be notified under subsection (1) with respect to a living organism if they are within a class of persons that is specified on the Domestic Substances List in respect of the living organism for the purpose of this subsection.

Marginal note:Publication of masked name

 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.

Marginal note:Regulations

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

    • (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;

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

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

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

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

    • (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);

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

    • (g.1) prescribing a living organism or group of living organisms for the purpose of subsection 108.1(1);

    • (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);

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

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

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

  • Marginal note: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.

  • Marginal note: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

    • (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

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

  • Marginal note: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

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

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

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

 

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