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Main page on: Canadian Environmental Protection Act, 1999
Disclaimer: These documents are not the official versions (more).
Source: http://laws.justice.gc.ca/en/C-15.31/225821.html
Act current to September 15, 2006

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Regulation of Toxic Substances

90. (1) Subject to subsection (3), the Governor in Council may, if satisfied that a substance is toxic, on the recommendation of the Ministers, make an order adding the substance to the List of Toxic Substances in Schedule 1.

Priority

(1.1) In developing proposed regulations or instruments respecting preventive or control actions in relation to substances specified on the List of Toxic Substances in Schedule 1, the Ministers shall give priority to pollution prevention actions.

Deletion from List

(2) Subject to subsection (3), the Governor in Council may, if satisfied that the inclusion of a substance specified on the List of Toxic Substances in Schedule 1 is no longer necessary, on the recommendation of the Ministers, make an order

(a) deleting the substance from the List and deleting the type of regulations specified in the List as being applicable with respect to the substance; and

(b) repealing the regulations made under section 93 with respect to the substance.

Order subject to conditions

(3) Where a board of review is established under section 333 in relation to a substance, no order may be made under subsection (1) or (2) in relation to the substance until the board’s report is received by the Ministers.

91. (1) Subject to subsections (6) and (7), a proposed regulation or instrument respecting preventive or control actions in relation to a substance shall be published by the Minister in the Canada Gazette within two years after the publication of the Ministers’ statement under paragraph 77(6)(b) indicating that the measure that they propose to take, as confirmed or amended, is a recommendation that the substance be added to the List of Toxic Substances in Schedule 1.

Timeframes in relation to virtual elimination

(2) A proposed regulation or instrument in respect of preventive or control actions in relation to a substance for which a statement has been published under subsection 77(6) indicating that the measure proposed by the Ministers is the implementation of virtual elimination under subsection 65(3) shall specify the dates on which the preventive or control actions are to take effect.

Measurable quantity or concentration

(3) In establishing the quantity or concentration that is measurable in relation to a substance for the purposes of a proposed regulation or instrument referred to in subsection (2), the Ministers shall take into consideration information concerning sensitive and readily available analytical methods and any relevant information contained in plans referred to in subsection 79(2).

Additional measures in relation to virtual elimination

(4) The Minister shall, where applicable, publish in the Canada Gazette a statement accompanying the proposed regulation or instrument for a substance referred to in subsection (2) describing any additional measures that the Ministers intend to recommend with respect to the implementation of virtual elimination under subsection 65(3) and summarizing their reasons for so intending.

Considerations in relation to virtual elimination

(5) In determining the preventive or control actions in relation to a substance and the dates on which those actions are to take effect that are to be set out in a proposed regulation or instrument referred to in subsection (2), and in determining any additional measures described in a statement published under subsection (4), the Ministers shall take into consideration any factor or information that, in the opinion of the Ministers, is relevant, including, but not limited to,

(a) information contained in plans referred to in section 79; and

(b) environmental or health risks identified in the summary published under subsection 77(6) and any other relevant social, economic or technical matters.

Publication of subsequent proposals

(6) Any proposed regulation or instrument respecting preventive or control actions in relation to a substance that is made after the publication of a proposed regulation or instrument published within the period of two years referred to in subsection (1) shall be published in the Canada Gazette.

Suspension of time where board of review

(7) Where a board of review is established under section 333, the period of two years referred to in subsection (1) is suspended from the establishment of the board and does not recommence until the board’s report is received by the Ministers.

92. (1) Subject to subsection (2), any regulation or instrument respecting preventive or control actions in relation to a substance shall be made and published in the Canada Gazette within 18 months after the publication of the proposed regulation or instrument under subsection 91(1) or (6), unless a material substantive change is required to be made to it.

Suspension of time where board of review

(2) Where a board of review is established under section 333 in relation to a substance, the period of 18 months referred to in subsection (1) is suspended from the establishment of the board and does not recommence until the board has submitted its report to the Minister under subsection 340(1).

92.1 For the purposes of subsection 65(3), the Ministers may make regulations prescribing the quantity or concentration of a substance that may be released into the environment either alone or in combination with any other substance from any source or type of source.

93. (1) Subject to subsections (3) and (4), the Governor in Council may, on the recommendation of the Ministers, make regulations with respect to a substance specified on the List of Toxic Substances in Schedule 1, including regulations providing for, or imposing requirements respecting,

(a) the quantity or concentration of the substance that may be released into the environment either alone or in combination with any other substance from any source or type of source;

(b) the places or areas where the substance may be released;

(c) the commercial, manufacturing or processing activity in the course of which the substance may be released;

(d) the manner in which and conditions under which the substance may be released into the environment, either alone or in combination with any other substance;

(e) the quantity of the substance that may be manufactured, processed, used, offered for sale or sold in Canada;

(f) the purposes for which the substance or a product containing it may be imported, manufactured, processed, used, offered for sale or sold;

(g) the manner in which and conditions under which the substance or a product containing it may be imported, manufactured, processed or used;

(h) the quantities or concentrations in which the substance may be used;

(i) the quantities or concentrations of the substance that may be imported;

(j) the countries from or to which the substance may be imported or exported;

(k) the conditions under which, the manner in which and the purposes for which the substance may be imported or exported;

(l) the total, partial or conditional prohibition of the manufacture, use, processing, sale, offering for sale, import or export of the substance or a product containing it;

(m) the total, partial or conditional prohibition of the import or export of a product that is intended to contain the substance;

(n) the quantity or concentration of the substance that may be contained in any product manufactured, imported, exported, offered for sale or sold in Canada;

(o) the manner in which, conditions under which and the purposes for which the substance or a product containing it may be advertised or offered for sale;

(p) the manner in which and conditions under which the substance or a product containing it may be stored, displayed, handled, transported or offered for transport;

(q) the packaging and labelling of the substance or a product containing it;

(r) the manner, conditions, places and method of disposal of the substance or a product containing it, including standards for the construction, maintenance and inspection of disposal sites;

(s) the submission to the Minister, on request or at any prescribed times, of information relating to the substance;

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

(u) the conduct of sampling, analyses, tests, measurements or monitoring of the substance and the submission of the results to the Minister;

(v) the submission of samples of the substance to the Minister;

(w) the conditions, test procedures and laboratory practices to be followed for conducting sampling, analyses, tests, measurements or monitoring of the substance;

(x) the circumstances or conditions under which the Minister may, for the proper administration of this Act, modify

(i) any requirement for sampling, analyses, tests, measurements or monitoring, or

(ii) the conditions, test procedures and laboratory practices for conducting any required sampling, analyses, tests, measurements or monitoring; and

(y) any other matter that by this Part is to be defined or prescribed or that is necessary to carry out the purposes of this Part.

Definition of “sell”

(2) In this section, “sell” includes, in respect of a substance, the transfer of the physical possession or control of the substance.

Advice by Committee

(3) Before a regulation is made under subsection (1), the Minister shall give the Committee an opportunity to advise the Ministers.

Substances regulated under other Acts of Parliament

(4) The Governor in Council shall not make a regulation under subsection (1) in respect of a substance if, in the opinion of the Governor in Council, the regulation regulates an aspect of the substance 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.

Amendment to the List of Toxic Substances in Schedule 1

(5) A regulation made under subsection (1) with respect to a substance may amend the List of Toxic Substances in Schedule 1 so as to specify the type of regulation that applies with respect to the substance.

94. (1) Where

(a) a substance

(i) is not specified on the List of Toxic Substances in Schedule 1 and the Ministers believe that it is toxic or capable of becoming toxic, or

(ii) is specified on that List and the Ministers believe that it is not adequately regulated, and

(b) the Ministers believe that immediate action is required to deal with a significant danger to the environment or to human life or health,

the Minister may make an interim order in respect of the substance and the order may contain any provision that may be contained in a regulation made under subsection 93(1).

Effect of order

(2) Subject to subsection (3), an interim order has effect

(a) from the time it is made; and

(b) as if it were a regulation made under section 93.

Approval of Governor in Council

(3) An interim order ceases to have effect unless it is approved by the Governor in Council within 14 days after it is made.

Consultation

(4) The Governor in Council shall not approve an interim order unless the Minister has

(a) within 24 hours after making the order, offered to consult with all affected governments to determine whether they are prepared to take sufficient action to deal with the significant danger; and

(b) consulted with other ministers of the Crown in right of Canada to determine whether any action can be taken under any other Act of Parliament to deal with the significant danger.

Recommendation of regulations

(5) Where the Governor in Council approves an interim order, the Ministers shall, within 90 days after the approval, publish in the Canada Gazette a statement indicating whether the Ministers intend to recommend to the Governor in Council

(a) that a regulation having the same effect as the order be made under section 93; and

(b) if the order was made in respect of a substance that was not specified on the List of Toxic Substances in Schedule 1, that the substance be added to that List under section 90.

Contravention of unpublished order

(6) No person shall be convicted of an offence consisting of a contravention of an interim order that, at the time of the alleged contravention, had not been published in the Canada Gazette unless it is proved that, at the date of the alleged contravention, that person had been notified of the interim order.

Cessation of effect

(7) Subject to subsection (3), an interim order ceases to have effect on the earliest of

(a) the day it is repealed,

(b) the day a regulation referred to in subsection (5) is made, and

(c) two years after the order is made.

Release of Toxic Substances

95. (1) Where there occurs or is a likelihood of a release into the environment of a substance specified on the List of Toxic Substances in Schedule 1 in contravention of a regulation made under section 92.1 or 93 or an order made under section 94, any person described in subsection (2) shall, as soon as possible in the circumstances,

(a) subject to subsection (4) and any regulations made under paragraph 97(b), notify an enforcement officer or any other person designated pursuant to the regulations and provide a written report on the matter to the enforcement officer or other person;

(b) take all reasonable measures consistent with the protection of the environment and public safety to prevent the release or, if it cannot be prevented, to remedy any dangerous condition or reduce or mitigate any danger to the environment or to human life or health that results from the release of the substance or may reasonably be expected to result if the substance is released; and

(c) make a reasonable effort to notify any member of the public who may be adversely affected by the release or likely release.

Application

(2) Subsection (1) applies to any person who

(a) owns or has the charge, management or control of a substance immediately before its release or its likely release into the environment; or

(b) causes or contributes to the release or increases the likelihood of the release.

Report by property owner

(3) Where there occurs a release of a substance as described in subsection (1), any person, other than a person described in subsection (2), whose property is affected by the release and who knows that it is a substance specified on the List of Toxic Substances in Schedule 1 shall, as soon as possible in the circumstances and subject to subsection (4), report the matter to an enforcement officer or to any person that is designated by regulation.

Report to provincial official

(4) Where there are in force, by or under the laws of a province or an aboriginal government, provisions that the Governor in Council, by regulation, declares to be adequate for dealing with a release described in subsection (1), a report required by paragraph (1)(a) or subsection (3) shall be made to a person designated by those provisions.

Intervention by enforcement officer

(5) Where any person fails to take any measures required under subsection (1), an enforcement officer may take those measures, cause them to be taken or direct any person referred to in subsection (2) to take them.

Limitation on power of direction

(6) A direction of an enforcement officer under subsection (5) that is inconsistent with a requirement imposed by or under any other Act of Parliament is void to the extent of the inconsistency.

Access to property

(7) Any enforcement officer or other person authorized or required to take any measures under subsection (1) or (5) may enter and have access to any place or property and may do any reasonable things that may be necessary in the circumstances.

Personal liability

(8) Any person, other than a person described in subsection (2), who provides assistance or advice in taking the measures required by subsection (1) or who takes any measures authorized under subsection (5) is not personally liable either civilly or criminally in respect of any act or omission in the course of providing assistance or advice or taking any measures under those subsections unless it is established that the person acted in bad faith.

96. (1) Where a person has knowledge of the occurrence or likelihood of a release into the environment of a substance specified on the List of Toxic Substances in Schedule 1, but the person is not required to report the matter under this Act, the person may report any information relating to the release or likely release to an enforcement officer or to any person to whom a report may be made under section 95.

Request for confidentiality

(2) A person making a report under subsection (1) may request that the person’s identity and any information that could reasonably reveal the identity not be released.

Requirement for confidentiality

(3) Where a person makes a request under subsection (2), no person shall release or cause to be released the identity of the person making the request or any information that could reasonably be expected to reveal their identity unless the person making the request authorizes the release in writing.

Employee protection

(4) Despite any other Act of Parliament, no employer shall dismiss, suspend, demote, discipline, harass or otherwise disadvantage an employee, or deny an employee a benefit of employment, by reason that

(a) the employee has made a report under subsection (1);

(b) the employee, acting in good faith and on the basis of reasonable belief, has refused or stated an intention of refusing to do anything that is an offence under this Act; or

(c) the employee, acting in good faith and on the basis of reasonable belief, has done or stated an intention of doing anything that is required to be done by or under this Act.

97. The Governor in Council may make regulations

(a) designating persons for the purposes of paragraph 95(1)(a) and subsection 95(3) and prescribing the form of the report to be made under those provisions and the information to be contained in it;

(b) respecting the notification and reporting of a release;

(c) declaring provisions to be adequate for the purpose of subsection 95(4); and

(d) generally for carrying out the purposes and provisions of sections 95 and 96.

98. (1) Her Majesty in right of Canada may recover the costs and expenses of and incidental to taking any measures under subsection 95(5) from

(a) any person referred to in paragraph 95(2)(a); and

(b) any person referred to in paragraph 95(2)(b) to the extent that that person knowingly or negligently caused or contributed to the release.

Reasonably incurred

(2) The costs and expenses referred to in subsection (1) shall only be recovered to the extent that they can be established to have been reasonably incurred in the circumstances.

Joint and several liability

(3) Subject to subsection (4), the persons referred to in subsection (1) are jointly and severally liable or solidarily liable for the costs and expenses referred to in that subsection.

Limitation

(4) A person referred to in paragraph 95(2)(b) shall not be held liable under subsection (3) to an extent greater than the extent to which the person knowingly or negligently caused or contributed to the release.

Procedure

(5) A claim under this section may be sued for and recovered by Her Majesty in right of Canada with costs in proceedings brought or taken therefor in the name of Her Majesty in right of Canada in any court of competent jurisdiction.

Recourse or indemnity

(6) This section does not limit or restrict any right of recourse or indemnity that a person may have against any other person.

Limitation period

(7) Where events giving rise to a claim under this section occur, no proceedings in respect of the claim may be instituted after five years from the date on which the events occur or become evident to the Minister, whichever is later.

Minister’s certificate

(8) A document purporting to have been issued by the Minister certifying the day on which the events giving rise to a claim under this section came to the knowledge of the Minister shall be received in evidence and, in the absence of any evidence to the contrary, the document shall be considered as proof of that fact without proof of the signature or of the official character of the person appearing to have signed the document and without further proof.

99. Where, in respect of a substance or a product containing a substance, there is a contravention of this Part or any regulation made under this Part, the Minister may, in writing,

(a) direct any manufacturer, processor, importer, retailer or distributor of the substance or product to take any or all of the following measures:

(i) give public notice in a manner directed by the Minister of any danger to the environment or to human life or health posed by the substance or product,

(ii) mail a notice as described in subparagraph (i) to every manufacturer, processor, distributor or retailer of the substance or product, or

(iii) mail a notice as described in subparagraph (i) to every person to whom the substance or product is known to have been delivered or sold; and

(b) direct any manufacturer, processor, distributor, importer or retailer of the substance or product to take any or all of the following measures:

(i) replace the substance or product with one that does not pose a danger to the environment or to human life or health,

(ii) accept the return of the substance or product from the purchaser and refund the purchase price, or

(iii) any other measures for the protection of the environment or of human life or health.

Export of Substances

100. The Ministers may, by order,

(a) add to Part 1 of the Export Control List in Schedule 3 any substance the use of which is prohibited in Canada by or under an Act of Parliament, and delete any substance from that Part;

(b) add to Part 2 of the Export Control List in Schedule 3 any substance that is subject to an international agreement that requires notification or requires the consent of the country of destination before the substance is exported from Canada, and delete any substance from that Part; and

(c) add to Part 3 of the Export Control List in Schedule 3 any substance the use of which is restricted in Canada by or under an Act of Parliament, and delete any substance from that Part.

101. (1) Subject to subsection (4), no person shall export a substance specified in the Export Control List in Schedule 3 unless the person provides prior notice of the proposed export to the Minister in accordance with the regulations made under subsection 102(1).

Restrictions on export

(2) Subject to subsection (4), no person shall export a substance specified in Part 1 of the Export Control List in Schedule 3 unless the export of the substance

(a) is for the purpose of destroying the substance or complying with a direction under subparagraph 99(b)(iii); and

(b) is done in accordance with any regulations made under subsection 102(1).

Restrictions on export

(3) Subject to subsection (4), no person shall export a substance specified in Part 2 or 3 of the Export Control List in Schedule 3 unless the export of the substance is done in accordance with any regulations made under subsection 102(1).

Total prohibition on export

(4) No person shall export a substance specified in the Export Control List in Schedule 3 if the export of the substance is prohibited by a regulation made under subsection 102(2).

102. (1) The Governor in Council may, on the recommendation of the Ministers, make regulations in relation to substances specified in the Export Control List in Schedule 3

(a) respecting the information that must be given to the Minister regarding an export of such a substance, the time when or period within which the information must be given, and the manner in which it must be given;

(b) respecting the information that must accompany an export of such a substance and the manner in which it must accompany the substance;

(c) respecting conditions under which a person may export such a substance;

(d) respecting the information that must be kept by a person who exports such a substance and the manner in which, the period for which and the place where the information must be kept; and

(e) generally for carrying out the purposes of section 101.

Regulations prohibiting exports

(2) The Governor in Council may, on the recommendation of the Ministers, make regulations prohibiting the export of a substance specified in the Export Control List in Schedule 3.

103. If a person exports a substance specified in the Export Control List in Schedule 3, the Minister shall publish in the Environmental Registry the name or specifications of the substance, the name of the exporter and the name of the country of destination.

PART 6

ANIMATE PRODUCTS OF BIOTECHNOLOGY

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

(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

(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.

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

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

(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.

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

(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

(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

(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

(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

(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

(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

(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;

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

(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

(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

(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

(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;

(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

(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

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

(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).

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.

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.

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,

(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.

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.

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.

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.

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).

112. (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.

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.

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.

114. (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), (2), (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), (2), (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);

(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.

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

(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.

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.

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

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

(i) respecting living organisms, whether or not they are on the Domestic Substances List, and

(ii) 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

(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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