This enactment amends the Canadian Environmental Protection Act, 1999 to, among other things,

The enactment also makes related amendments to the Food and Drugs Act to enable the assessment and management of risks to the environment associated with foods, drugs, cosmetics and devices by, among other things,

Finally, the enactment repeals the Perfluorooctane Sulfonate Virtual Elimination Act.

Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

• (a) exercise its powers in a manner that

  • Insertion start (i) Insertion end  protects the environment and human health, Insertion start including the health of vulnerable populations Insertion end ,

  • Insertion start (ii) Insertion end  applies the precautionary principle, Insertion start which provides Insertion end that Insertion start the Insertion end lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation Insertion start if Insertion end there are threats of serious or irreversible damage, and

  • Insertion start (iii) Insertion end  promotes and reinforces enforceable pollution prevention approaches;

• Start of inserted block

  (a.‍2) protect the right of every individual in Canada to a healthy environment as provided under this Act, which right may be balanced with relevant factors, including social, economic, health and scientific factors;

  End of inserted block

and, except for the purposes of sections 66 Insertion start to 66.‍2 Insertion end , 80 to 89 and 104 to 115, includes

vulnerable population means a group of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be at an increased risk of experiencing adverse health effects from exposure to substances. (population vulnérable)

Implementation of Right to a Healthy Environment

Implementation framework

5.‍1 (1) For the purposes of paragraph 2(1)‍(a.‍2), the Ministers shall, within two years after the day on which this section comes into force, develop an implementation framework to set out how the right to a healthy environment will be considered in the administration of this Act.

Content

(2) The implementation framework shall, among other things, elaborate on

• (a) the principles to be considered in the administration of this Act, such as principles of environmental justice — including the avoidance of adverse effects that disproportionately affect vulnerable populations — and the principle of non-regression;

• (b) research, studies or monitoring activities to support the protection of the right to a healthy environment referred to in paragraph 2(1)‍(a.‍2); and

• (c) the balancing of that right with relevant factors, including social, economic, health and scientific factors.

  End of inserted block

Consultation

(3) In developing the implementation framework, the Ministers shall consult any interested persons.

Publication

(4) The Minister shall publish the implementation framework in the manner that the Minister considers appropriate.

Report

(5) The Minister shall include in the annual report required by section 342 a report on the implementation of the framework.

Additional rights

15 The rights conferred by this Part are in addition to the right to request, Insertion start under section 76, that Insertion end a substance Insertion start be assessed Insertion end , the right to file a notice of objection under Parts 1, 7 and 11 and the right to request under Parts 7 and 11 that a board of review be established under section 333.

Protection of right to healthy environment

(3.‍1) The Ministers shall conduct research, studies or monitoring activities to support the Government of Canada in protecting the right to a healthy environment referred to in paragraph 2(1)‍(a.‍2).

• (a) conduct research and studies, Insertion start including biomonitoring surveys Insertion end , relating to the role of substances in illnesses or in health problems;

Vulnerable populations

(2) For greater certainty, the research and studies referred to in paragraph (1)‍(a) may relate to vulnerable populations.

• (a) substances Insertion start specified in Insertion end the Insertion start plan developed under section 73 Insertion end ;

• Start of inserted block

  (e.‍1) products that contain a substance that is toxic under section 64 or that may become toxic, or products that may release such a substance into the environment;

  End of inserted block

• Start of inserted block

  (k.‍1) activities that may contribute to pollution;

  End of inserted block

Requirement for pollution prevention plans

56 (1) The Minister may, at any time, publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice requiring any person or class of persons described in the notice to prepare and implement a pollution prevention plan in respect of

• Insertion start (a) Insertion end  a substance or group of substances specified on the list of toxic substances in Schedule 1;

• Insertion start (b) Insertion end Insertion start   Insertion end Insertion start a substance or group of substances with respect Insertion end to which subsection 166(1) or 176(1) applies; or

• Start of inserted block

  (c) a product that contains a substance specified on the list of toxic substances in Schedule 1 or that may release such a substance into the environment.

  End of inserted block

• (a) the substance, group of substances or Insertion start product Insertion end in relation to which the plan is to be prepared;

Requirement to submit certain plans

60 (1) The Minister may publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice requiring any person or class of persons described in the notice who are required to prepare and implement a pollution prevention plan under section 56 to submit, within the period specified by the Minister, the plan or any part of the plan for the purpose of determining and assessing preventive or control actions in respect of a substance, group of substances or Insertion start product Insertion end .

Domestic Substances List

66 (1) The Minister shall, for the Insertion start purpose Insertion end of Insertion start section Insertion end 81, maintain a list to be known as the Domestic Substances List and, Insertion start subject to subsection 66.‍2(1) Insertion end , the List shall specify all substances that the Minister is satisfied were, between January 1, 1984 and December 31, 1986,

• (a) the substances referred to in subsection (1), Insertion start unless the substance has been deleted from the Domestic Substances List under subsection 66.‍2(1) Insertion end ; and

Domestic Substances List — Food and Drugs Act

66.‍1 (1) The Minister may, for the purpose of section 81, add to the Domestic Substances List any substance if the Minister is satisfied that, between January 1, 1987 and September 13, 2001, the substance

• (a) was in Canadian commerce as a product to which the Food and Drugs Act applied; or

• (b) was in Canadian commerce as a substance that was in or on such a product.

If the substance appears on the Non-domestic Substances List, the Minister shall delete it from that List.

Amendment of Lists

(2) If the Minister includes a substance on the Domestic Substances List and subsequently learns that, between January 1, 1987 and September 13, 2001, the requirements set out in paragraph (1)‍(a) or (b) were not met in respect of the substance, the Minister shall delete the substance from the List and may add it to the Non-domestic Substances List.

Designation

(3) 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.

Amendment of Lists

66.‍2 (1) If the Minister is satisfied that a substance referred to in subsection 66(1) that is specified on the Domestic Substances List — or a substance added to the List under subsection 66.‍1(1) or 87(1) or (5) — is not being manufactured in Canada, imported into Canada, in Canadian commerce or used for commercial manufacturing purposes in Canada, the Minister may delete the substance from the List and may add it to the Non-domestic Substances List.

Publication — notice of intent

(2) Before deleting a substance from the Domestic Substances List under subsection (1), the Minister shall publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice indicating the Minister’s intention to delete it from the List.

Comments

(3) Within 60 days after the publication of the notice, any person may file written comments with the Minister.

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.

• (a) respecting a property or characteristic of a substance, including persistence, bioaccumulation, Insertion start carcinogenicity, mutagenicity and reproductive toxicity Insertion end ;

• Start of inserted block

  (e) respecting, for the purpose of subsection 77(3), the classification of a substance as a substance that poses the highest risk.

  End of inserted block

Research, investigation and evaluation

68 For the purpose of assessing whether a substance is toxic or is capable of becoming toxic — or for the purpose of assessing whether to control, or the manner in which to control, a substance, Insertion start a product that contains a substance or a product that may release a substance into the environment Insertion end — including a substance specified on the list of toxic substances in Schedule 1, either Minister may

• (a) collect or generate data and conduct investigations respecting any matter in relation to Insertion start the Insertion end substance Insertion start or product Insertion end including

• Start of inserted block

  (iii.‍1) whether exposure to the substance in combination with exposure to other substances has the potential to cause cumulative effects,

• (iii.‍2) whether there is a vulnerable population in relation to the substance,

  End of inserted block

• (v) the ability of the substance to cause delayed or latent effects over the lifetime of an organism, Insertion start including carcinogenic, mutagenic or neurotoxic effects Insertion end ,

• (vi) the ability of the substance to cause survival impairment of an organism,

• Start of inserted block

  (vi.‍1) the ability of the substance to disrupt the reproductive system or endocrine system of an organism,

  End of inserted block

• (xii) the Insertion start existence Insertion end , development and use of Insertion start safer or more sustainable Insertion end alternatives to the substance Insertion start or product Insertion end ,

• Start of inserted block

  (xv) the manner in which the public may be provided with information regarding the substance or product, including, in the case of a product, by labelling it;

  End of inserted block

• (c) provide information and make recommendations respecting any matter in relation to Insertion start the Insertion end substance Insertion start or product Insertion end , including measures to control the presence of the substance Insertion start or product Insertion end in the environment.

Saving

(2.‍1) Nothing in subsection (2) shall prevent Insertion start either Insertion end Minister Insertion start or both Ministers Insertion end from exercising the powers under subsection (1) at any time after the 60th day following the day Insertion start on which Insertion end an offer is made under subsection (2).

Guidelines public

(3) Guidelines issued under this section shall be made available to the public, and the Minister who issued the guidelines shall give notice of them in the Canada Gazette and in any other manner that Insertion start that Insertion end Minister considers appropriate.

Notice requiring information, samples or testing

71 (1) The Minister may, for the purpose of assessing whether a substance is toxic or is capable of becoming toxic — or for the purpose of assessing whether to control, or the manner in which to control, a substance, Insertion start a product that contains a substance or a product that may release a substance into the environment Insertion end — including a substance specified on the list of toxic substances in Schedule 1,

• (a) publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice requiring any person who is described in the notice and who is or was within the period specified in the notice engaged in any activity involving the substance Insertion start or product, as the case may be, Insertion end to notify the Minister that the person is or was during that period engaged in that activity;

• (c) subject to section 72, send a written notice to any person who is described in the notice and who is or was within the period specified in the notice engaged in any activity involving the importation or manufacturing of the substance or product, Insertion start as the case may be, Insertion end requiring the person to conduct toxicological Insertion start or Insertion end other tests that the Minister may specify in the notice and submit the results of the tests to the Minister.

Contents of notice under paragraph (1)‍(b)

(2) A notice Insertion start published Insertion end under paragraph (1)‍(b) may require any information and samples, including

• (a) in respect of a substance, available toxicological information, available monitoring information, samples of the substance and information on the quantities, composition, uses and distribution of the substance;

• Start of inserted block

  (a.‍1) in respect of a product that contains a substance or that may release a substance into the environment, information on the quantities, composition, manufacturing, processing, packaging, labelling, uses and distribution of the product;

  End of inserted block

• Start of inserted block

  (c) information on the method used to quantify any information that is provided.

  End of inserted block

Method and manner — notice under paragraph (1)‍(b)

(2.‍1) A notice published under paragraph (1)‍(b) may specify the method to be used to quantify any information that is to be provided and the manner in which that information and any sample is to be provided.

Contents of notice under paragraph (1)‍(c)

(2.‍2) A notice sent under paragraph (1)‍(c) may, among other things, require the person to provide any information and samples, including

• (a) in respect of a substance or of a product that contains a substance or that may release a substance into the environment, toxicological information, monitoring information, test samples and information on the quantities, composition, uses and distribution of the substance or product; and

• (b) information on the methods, test procedures and laboratory practices followed for performing any required test and on the conditions under which those tests are conducted.

  End of inserted block

Method and manner — notice under paragraph (1)‍(c)

(2.‍3) The notice sent under paragraph (1)‍(c) may, among other things, specify

• (a) the conditions, methods, test procedures and laboratory practices to be followed for conducting sampling, analyses, measurements, quantification or monitoring as part of any required test;

• (b) the manner in which the test results are to be submitted;

• (c) the method to be used to quantify any information that is to be provided; and

• (d) the manner in which that information and any sample is to be provided.

  End of inserted block

Extension of time

(4) Despite subsection (3), the Minister may, on request in writing from any person to whom a notice referred to in Insertion start any of paragraphs Insertion end (1)‍(a) Insertion start to Insertion end (c) Insertion start is directed or Insertion end sent, extend the time or times within which the person shall comply with the notice.

Exercise of power under paragraph 71(1)‍(c)

72 The Minister may not exercise the power under paragraph 71(1)‍(c) in relation to a substance, Insertion start a product that contains a substance or a product that may release a substance into the environment Insertion end unless the Ministers have reason to suspect that the substance is toxic or capable of becoming toxic or it has been determined under this Act that the substance is toxic or capable of becoming toxic.

Substances and Insertion start Assessments of Insertion end Substances

Plan — priorities

73 (1) The Ministers shall, within two years after the day on which this section receives royal assent, develop and publish a plan

• (a) that specifies the substances to which the Ministers are satisfied priority should be given in assessing whether they are toxic or capable of becoming toxic; and

• (b) that may specify the activities or initiatives in relation to assessing, controlling or otherwise managing the risks to the environment or to human health posed by substances that are or will be undertaken under an Act of Parliament for whose administration either Minister is responsible and which the Ministers are of the opinion should be prioritized.

  End of inserted block

Review

(2) The plan shall also include the period after which the Ministers will review the plan.

Consultation and considerations

(3) In developing a proposed plan, and in implementing the plan, the Ministers

• (a) may consult with the Committee, a government department or agency, aboriginal people, representatives of industry and labour and municipal authorities or with persons interested in the quality of the environment or the preservation and improvement of public health;

• (b) shall consider whether assessing substances by class is more advantageous than assessing them individually; and

• (c) shall take into account the matters referred to in paragraph 68(a).

  End of inserted block

Publication of proposed plan

(4) The Minister shall publish the proposed plan in the Environmental Registry and shall give notice in the Canada Gazette and in any other manner that the Minister considers appropriate of the proposed plan’s availability.

Comments

(5) Within 60 days after the publication of the notice, any person may file with the Minister written comments on the proposed plan.

Consideration of comments

(6) The Ministers shall take into account the comments and may amend the proposed plan in any manner they consider appropriate based on those comments.

Publication of plan

(7) The Minister shall publish the plan in the Canada Gazette and in any other manner that the Minister considers appropriate.

Application

(8) If after reviewing the plan the Ministers propose to amend it, subsections (2) to (7) apply to the proposed amended plan.

Report to Parliament

74 The Ministers shall include in the annual report required by section 342 a report on the progress made in assessing the substances specified in the plan developed under section 73 and in respect of any activities or initiatives specified in the plan.

List of substances capable of becoming toxic

75.‍1 (1) The Minister shall compile and may amend from time to time a list that specifies substances that the Ministers have reason to suspect are capable of becoming toxic or that have been determined to be capable of becoming toxic.

Additional information

(2) The List may include information regarding a substance specified on the List, including an indication that

• (a) the substance is specified on the Domestic Substances List with an indication that subsection 81(3) or 106(3) applies with respect to the substance; or

• (b) the Minister has published a notice in the Canada Gazette indicating that subsection 81(4) or 106(4) applies with respect to the substance.

  End of inserted block

Publication

(3) The Minister shall publish the List and any amendments to it in the Environmental Registry and in any other manner that the Minister considers appropriate.

Statutory Instruments Act

(4) The List is not a statutory instrument as defined in subsection 2(1) of the Statutory Instruments Act.

Request to assess substance

76 (1) Any person may file in writing with the Minister a request that the Ministers assess a substance to determine whether it is toxic or capable of becoming toxic.

Consideration of request

(2) The Ministers shall consider the request and, within 90 days after the day on which the request is filed, the Minister shall inform the person who filed the request of how the Ministers intend to deal with it and the reasons for dealing with it in that manner.

Form and manner

(3) A request shall be filed in the form and manner and shall contain the information specified by the Minister.

Weight of evidence and precautionary principle

76.‍1  Insertion start (1) Insertion end  The Ministers shall apply a weight of evidence approach and the precautionary principle when Insertion start they Insertion end are conducting and interpreting the results of

• (a) an assessment Insertion start conducted under this Part, other than under section 83, in order to determine Insertion end whether a substance is toxic or capable of becoming toxic; or

• (b) a review of a decision of another jurisdiction under subsection 75(3) that, in their opinion, is based on scientific considerations and is relevant to Canada.

Vulnerable population and cumulative effects

(2) When the Ministers are conducting and interpreting the results of an assessment or review referred to in subsection (1), they shall consider available information on any vulnerable population in relation to the substance and on the cumulative effects that may result from exposure to the substance in combination with exposure to other substances.

Publication after assessment or review

77 (1)  Insertion start If Insertion end the Ministers have conducted Insertion start an Insertion end assessment Insertion start under this Part, other than under section 83, to determine whether a substance is toxic or capable of becoming toxic Insertion end or a review of a decision of another jurisdiction under subsection 75(3) that, in their opinion, is based on scientific considerations and is relevant to Canada, the Ministers shall publish in the Canada Gazette, and either Minister may publish in any other manner that that Minister considers appropriate,

• (a) a statement indicating one of the measures referred to in subsection (2) that the Ministers propose to take and a summary of the scientific considerations on the basis of which the measure is proposed; and

• (b)  Insertion start if the measure is one referred to in paragraph (2)‍(c) or (d) and the Ministers are of the opinion that the substance is regulated by any other Act of Parliament, or a regulation or instrument made under that Act, in a manner that provides sufficient protection to the environment and human health, a statement made jointly by the Minister and the Minister responsible for the administration of that Act identifying the Act, regulation or instrument and indicating the manner in which the substance is regulated by it. Insertion end

Proposed measures

(2) Subject to subsection (3), for the purposes of subsection (1), the Ministers shall propose one of the following measures:

• (a) taking no further action in respect of the substance;

• (b) unless the substance is already on the List Insertion start referred to in section 75.‍1 Insertion end , adding the substance to Insertion start that Insertion end List;

• (c) recommending that the substance be added to Insertion start Part 1 of the list of toxic substances in Insertion end Schedule 1; or

• Start of inserted block

  (d) recommending that the substance be added to Part 2 of the list of toxic substances in Schedule 1.

  End of inserted block

Mandatory proposal

(3) The Ministers shall propose to take the measure referred to in paragraph (2)‍(c) Insertion start if Insertion end the substance is determined to be toxic and the Ministers are satisfied that

• (a) the substance may have a long-term harmful effect on the environment and

  • (i) is persistent and bioaccumulative in accordance with the regulations,

  • (ii) is Insertion start present Insertion end in the environment primarily Insertion start as a result of Insertion end human activity, and

  • Start of inserted block

    (iii) is not a naturally occurring radionuclide or a naturally occurring inorganic substance; or

    End of inserted block
• Start of inserted block

  (b) the substance

  End of inserted block

  • Insertion start (i) Insertion end  is inherently toxic to human beings or non-human organisms, as determined by laboratory or other studies, Insertion start and Insertion end

  • Start of inserted block

    (ii) is, in accordance with the regulations, a substance that poses the highest risk.

    End of inserted block

Publication of final decision

(6) After taking into consideration in an expeditious manner the comments filed under subsection (5), the Ministers shall publish in the Canada Gazette

• (a) a summary of the assessment or of the review, as the case may be, Insertion start referred to in subsection (1) Insertion end ;

• (b) a statement indicating the measure that the Ministers propose to take; and

• (c)  Insertion start if Insertion end the measure is Insertion start one Insertion end referred to in paragraph (2)‍(c) Insertion start or (d), Insertion end

  • Insertion start (i) Insertion end  a statement indicating the manner in which a proposed regulation or instrument respecting preventive or control actions in relation to the substance Insertion start is to be developed under this or any other Act of Parliament, or Insertion end

  • Start of inserted block

    (ii) if the Ministers are of the opinion that the substance is regulated by any other Act of Parliament, or a regulation or instrument made under that Act, in a manner that provides sufficient protection to the environment and human health, a statement made jointly by the Minister and the Minister responsible for the administration of that Act identifying the Act, regulation or instrument and indicating the manner in which the substance is regulated by it.

    End of inserted block

Exemption

(7) If the Ministers publish a statement under paragraph (6)‍(b) in respect of a substance already specified on the list of toxic substances in Schedule 1, paragraph (6)‍(c) does not apply.

Recommendation to Governor in Council

(9) When the Ministers Insertion start publish Insertion end a statement under paragraph (6)‍(b) indicating that the measure that they propose to take is a recommendation that the substance be added to Insertion start Part 1 or 2 of Insertion end the list of toxic substances in Schedule 1, Insertion start the Ministers Insertion end shall make a recommendation for an order under subsection 90(1), and, if Insertion start the substance is already specified in the other Part, the Ministers shall make a recommendation for an order under subsection 90(2) Insertion end .

Subsequent regulations or instruments

78 (1) If the Ministers publish a statement under subparagraph 77(6)‍(c)‍(i) indicating that more than one proposed regulation or instrument respecting preventive or control actions in relation to a substance is to be developed, the Minister shall, when the first regulation or instrument respecting preventive or control actions in relation to the substance is published under paragraph 92(1)‍(a) or a statement identifying the first such regulation or instrument is published under paragraph 92(1)‍(b) or (c), as the case may be, publish in the Environmental Registry and in any other manner that the Minister considers appropriate a statement respecting the development of the subsequent proposed regulations or instruments that specifies, to the extent possible, an estimated time frame within which those proposed regulations or instruments are to be developed.

Amendments to statement

(2) If the Ministers amend the statement respecting the development of the subsequent proposed regulations or instruments, the Minister shall publish that statement as amended in the Environmental Registry and in any other manner that the Minister considers appropriate.

Expiry of prohibition

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

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

• Start of inserted block

  (b) a statement, identifying a regulation respecting preventive or control actions in relation to the substance 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.

    End of inserted block

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

Contents of notice

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

• Insertion start (a) Insertion end  shall indicate, by inclusion or exclusion, the significant new activities in relation to the substance Insertion start with Insertion end respect Insertion start to Insertion end which subsection 81(4) is to apply and, if regulations in respect of those significant new activities are not made under paragraphs 89(1)‍(c), (d) and (g), specify the information to be provided to the Minister under that subsection, the date Insertion start on or before Insertion end which it is to be provided and the period within which it is to be assessed under section 83; Insertion start and Insertion end

• Start of inserted block

  (b) may specify for the purpose of subsection 86(2) classes of persons who are not required to be notified under subsection 86(1) with respect to the substance.

  End of inserted block

Classes of persons

(3) The Minister may, by notice published in the Canada Gazette, specify for the purpose of subsection 86(2) classes of persons who are not required to be notified under subsection 86(1) with respect to a substance for which a notice was published under subsection (1), if no such class was specified in that notice.

Subsequent notice

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

• Insertion start (a) Insertion end  vary the significant new activities in relation to a substance for which a notice has been Insertion start published Insertion end under subsection (1) Insertion start or vary Insertion end the information to be provided to the Minister under subsection Insertion start 81(4) Insertion end , the date Insertion start on or before Insertion end which Insertion start that information Insertion end is to be provided Insertion start or Insertion end the period within which it is to be assessed under section 83;

• Insertion start (b) Insertion end  indicate that subsection 81(4) no longer applies with respect to the substance;

• Start of inserted block

  (c) vary the classes of persons, if any, that are specified for the purpose of subsection 86(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 86(2).

  End of inserted block

Exception

(2) A person who is within a class of persons that is specified in a notice published under subsection 85(1) or (3) — or, if the class is varied by a notice published under subsection 85(4), within the class as varied — is not required to be notified under subsection (1) with respect to the substance to which the notice relates.

Significant new activity

(3)  Insertion start If Insertion end a substance is on the Domestic Substances List or is to be added to the List under subsection (1) Insertion start or 66.‍1(1) Insertion end , the Minister may amend the List to indicate that subsection 81(3) applies with respect to the substance.

Contents of amendment

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

• Insertion start (a) Insertion end  shall indicate, by inclusion or exclusion, the significant new activities in relation to the substance Insertion start with Insertion end respect Insertion start to Insertion end which subsection 81(3) is to apply and, if regulations in respect of those significant new activities are not made under paragraphs 89(1)‍(c), (d) and (g), specify the information to be provided to the Minister under that subsection, the date Insertion start on or before Insertion end which it is to be provided and the period within which it is to be assessed under section 83; Insertion start and Insertion end

• Start of inserted block

  (b) may specify for the purpose of subsection 87.‍1(2) classes of persons who are not required to be notified under subsection 87.‍1(1) with respect to the substance.

  End of inserted block

Subsequent amendment

Insertion start (4.‍1) Insertion end Insertion start   Insertion end Insertion start The Minister may Insertion end amend the Insertion start Domestic Substances Insertion end List in respect of Insertion start a Insertion end substance Insertion start with respect to which subsection 81(3) applies Insertion end

• Insertion start (a) Insertion end Insertion start   Insertion end Insertion start to vary Insertion end the significant new activities in relation to the substance Insertion start or vary Insertion end the information to be provided to the Minister under subsection Insertion start 81(3) Insertion end , the date Insertion start on or before Insertion end which Insertion start that information Insertion end is to be provided Insertion start or Insertion end the period within which it is to be assessed under section 83;

• Insertion start (b) Insertion end  to indicate that subsection 81(3) no longer applies;

• Start of inserted block

  (c) to specify classes of persons for the purpose of subsection 87.‍1(2), if no such classes are specified with respect to the substance;

• (d) to vary the classes of persons, if any, that are specified for the purpose of subsection 87.‍1(2); or

• (e) to delete any class of persons that is specified for the purpose of subsection 87.‍1(2).

  End of inserted block

Notification of persons required to comply

87.‍1 (1) If a substance is specified on the Domestic Substances List with an indication that subsection 81(3) applies with respect to the substance, every person who transfers the physical possession or control of the substance shall notify all persons to whom the possession or control is transferred of the obligation to comply with that subsection.

Exception

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

• (k) generally for carrying out the purposes and provisions of sections 66 Insertion start to 66.‍2 Insertion end and 80 to 88.

Addition to list 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 Insertion start Part 1 or 2 of Insertion end the list of toxic substances in Schedule 1.

Priorities

(1.‍1) In developing Insertion start a Insertion end proposed Insertion start regulation Insertion end or Insertion start instrument Insertion end respecting preventive or control actions in relation to Insertion start a substance Insertion end specified on the list of toxic substances in Schedule 1, the Ministers shall give priority to,

• Start of inserted block

  (a) in the case of a substance specified in Part 1 of the list of toxic substances in that Schedule, the total, partial or conditional prohibition of activities in relation to the substance or of releases of the substance into the environment; or

• (b) in the case of a substance specified in Part 2 of the list of toxic substances in that Schedule, pollution prevention actions.

  End of inserted block

Consideration of factors

(1.‍2) For the purposes of paragraph (1.‍1)‍(a), the Ministers may consider any factor that they consider appropriate, including whether the activity or release can be undertaken in a manner that minimizes or eliminates any harmful effect on the environment or human health and whether there are feasible alternatives to the substance.

Deletion from the list of toxic substances

(2) Subject to subsection (3), the Governor in Council may, if satisfied that the inclusion of a substance specified Insertion start in Part 1 or 2 of Insertion end the list of toxic substances in Schedule 1 is no longer necessary, on the recommendation of the Ministers, make an order deleting the substance from Insertion start that Part Insertion end and repealing the regulations made under section 93 with respect to the substance.

Publication of proposed preventive or control actions

91 (1) Subject to subsections Insertion start (2) Insertion end , (6) and (7), 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, Insertion start in respect of a substance Insertion end is a recommendation that the substance be added to Insertion start Part 1 or 2 Insertion end of the list of toxic substances in Schedule 1,

• Insertion start (a) Insertion end  the Minister shall Insertion start publish Insertion end in the Canada Gazette

  • Insertion start (i) Insertion end Insertion start   Insertion end Insertion start a Insertion end regulation or instrument respecting preventive or control actions, in relation to Insertion start the Insertion end substance, Insertion start that is proposed to be made under this Act, other than an instrument that may be made only by the Minister of Health, or Insertion end

  • Start of inserted block

    (ii) a statement — identifying a regulation or instrument respecting preventive or control actions, in relation to the substance, that is proposed to be made under any other Act of Parliament other than an Act for whose administration the Minister of Health is responsible — made jointly by the Minister and the Minister responsible for the administration of the Act under which the regulation or instrument is to be made; or

    End of inserted block
• Start of inserted block

  (b) the Minister of Health shall publish in the Canada Gazette

  End of inserted block

  • Start of inserted block

    (i) an instrument respecting preventive or control actions, in relation to the substance, that is proposed to be made by that Minister under this Act, or

  • (ii) a statement identifying a regulation or instrument respecting preventive or control actions in relation to the substance that is proposed to be made under any other Act of Parliament for whose administration that Minister is responsible.

    End of inserted block

Exceptions

(2) Subsection (1) does not apply in respect of

• (a) a substance specified in Part 1 or 2 of the list of toxic substances in Schedule 1 in relation to which the measure the Ministers propose to take, as confirmed or amended, is a recommendation that the substance be added to the other Part; or

• (b) a substance in relation to which a statement has been published under subparagraph 77(6)‍(c)‍(ii).

  End of inserted block

Publication of preventive or control actions

92 (1) Subject to subsection (2), within 18 months after the Insertion start day on which a Insertion end proposed regulation or instrument Insertion start is published Insertion end under Insertion start subparagraph Insertion end 91(1) Insertion start (a)‍(i) or (b)‍(i) Insertion end or subsection Insertion start 91 Insertion end (6) Insertion start or a statement identifying a proposed regulation or instrument is published under subparagraph 91(1)‍(a)‍(ii) or (b)‍(ii) Insertion end , unless a material substantive change is required to be made to Insertion start that proposed regulation or instrument Insertion end ,

• Insertion start (a) Insertion end Insertion start   Insertion end Insertion start a Insertion end regulation or instrument respecting preventive or control actions in relation to a substance shall be made Insertion start under this Act Insertion end and published in the Canada Gazette;

• Start of inserted block

  (b) the Minister shall publish in the Canada Gazette a statement — identifying a regulation or instrument respecting preventive or control actions in relation to a substance that was made under any other Act of Parliament — made jointly by the Minister and the Minister responsible for the administration of the Act under which the regulation or instrument is made; or

• (c) the Minister of Health shall publish in the Canada Gazette a statement identifying a regulation or instrument respecting preventive or control actions in relation to a substance that was made under any other Act of Parliament for whose administration that Minister is responsible.

  End of inserted block

Regulations

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,

• (f) the purposes for which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be imported, Insertion start exported Insertion end , manufactured, processed, used, offered for sale or sold;

• (g) the manner in which and conditions under which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be imported, Insertion start exported Insertion end , manufactured, processed or used;

• (i) the quantities or concentrations of the substance that may be imported Insertion start or exported Insertion end ;

• (l) the total, partial or conditional prohibition of the manufacture, use, processing, sale, offering for sale, import or export of the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end ;

• (m) the total, partial or conditional prohibition of the Insertion start manufacture Insertion end , 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, Insertion start or that any such product may release into the environment Insertion end ;

• (o) the manner in which, conditions under which and the purposes for which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be advertised or offered for sale;

• (p) the manner in which and conditions under which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be stored, displayed, handled, transported or offered for transport;

• (q) the packaging and labelling of the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end ;

• (r) the manner, conditions, places and method of disposal of the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end , 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, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end ;

• (u) the conduct of sampling, analyses, tests, measurements or monitoring of the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end and the submission of the results to the Minister;

• (v) the submission of samples to the Minister of the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end ;

• (w) the conditions, test procedures and laboratory practices to be followed for conducting sampling, analyses, tests, measurements or monitoring of the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end ;

Powers of Minister

(5) Regulations made under this section may authorize the Minister, in the circumstances and subject to the conditions and limits that may be specified in the regulations, to issue, amend, suspend and revoke permits and other authorizations in relation to any matter that is the subject of the regulations and to set their terms and conditions.

Statutory Instruments Act

(6) A permit or other authorization issued under regulations made under this section is not a statutory instrument as defined in subsection 2(1) of the Statutory Instruments Act.

Interim orders

94 (1) The Minister may make an interim order in respect of a substance and the order may contain any provision that may be contained in a regulation made under subsection 93(1) Insertion start if Insertion end

• (a) the 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.

• (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 Insertion start Part 1 or 2 of that list Insertion end under section 90.

Report and remedial measures

95 (1)  Insertion start If Insertion end 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 93 or an order made under section 94, any person described in subsection (2) shall, as soon as possible in the circumstances,

Report by property owner

(3)  Insertion start If Insertion end 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.

Voluntary report

96 (1)  Insertion start If Insertion end 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.

Remedial measures

99  Insertion start If Insertion end , in respect of a substance, a product Insertion start that contains Insertion end a substance Insertion start or a product that may release a substance into the environment Insertion end , there is a contravention of this Part or any regulation made under this Part, the Minister may, in writing,

Adding living organisms to Domestic Substances List

105 (1) The Minister shall, for the Insertion start purpose Insertion end of Insertion start section Insertion end 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

Insertion start Domestic Substances List — Food and Drugs Act Insertion end

105.‍1 (1) The Minister may, for the purpose of section 106, add to the Domestic Substances List any living organism if the Minister is satisfied that, between January 1, 1987 and September 13, 2001, the living organism

• (a) was in Canadian commerce as a product to which the Food and Drugs Act applied; or

• (b) was in Canadian commerce as a living organism that was in or on such a product.

  End of inserted block

Amendment of List

(2) If the Minister includes a living organism on the Domestic Substances List and subsequently learns that, between January 1, 1987 and September 13, 2001, the requirements set out in paragraph (1)‍(a) or (b) were not met in respect of the living organism, the Minister shall delete the living organism from the List.

Designation

(3) 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.

Amendment of List

105.‍2 (1) If the Minister is satisfied that a living organism added to the Domestic Substances List under subsection 105(1) or 112(1) is not being manufactured in Canada or imported into Canada — or that a living organism added to the List under subsection 105.‍1(1) is not in Canadian commerce — the Minister may delete the living organism from the List.

Publication — notice of intent

(2) Before deleting a living organism from the Domestic Substances List under subsection (1), the Minister shall publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice indicating the Minister’s intention to delete it from the List.

Comments

(3) Within 60 days after the publication of the notice, any person may file written comments with the Minister.

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.

Expiry of prohibition

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

• Start of inserted block

  (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.

Contents of notice

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

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

• Start of inserted block

  (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.

  End of inserted block

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.

Subsequent notice

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

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

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

• Start of inserted block

  (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).

  End of inserted block

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.

Significant new activity

(3)  Insertion start If Insertion end a living organism is on the Domestic Substances List or is to be added to the List under subsection (1) Insertion start or 105.‍1(1) Insertion end , the Minister may amend the List to indicate that subsection 106(3) applies with respect to the living organism.

Contents of amendment

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

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

• Start of inserted block

  (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.

  End of inserted block

Subsequent amendment

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

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

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

• Start of inserted block

  (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).

  End of inserted block

Notification of persons required to comply

112.‍1 (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.

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.

• (a) a substance or group of substances Insertion start specified in Part 1 or 2 Insertion end of the list of toxic substances in Schedule 1; or

• (b) a substance or group of substances in relation to which there has been published in the Canada Gazette

  • (i) a statement of the Ministers 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 Insertion start Part 1 or 2 of Insertion end the list of toxic substances in Schedule 1, or

  • (ii) a copy of an order proposed to be made under subsection 90(1).

• (f) the purposes for which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be imported, Insertion start exported Insertion end , manufactured, processed, used, offered for sale or sold;

• (g) the manner in which and the conditions under which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be imported, Insertion start exported Insertion end , manufactured, processed or used;

• (i) the quantities or concentrations of the substance that may be imported Insertion start or exported Insertion end ;

• (l) the total, partial or conditional prohibition of the manufacture, use, processing, sale, offering for sale, import or export of the substance, a product Insertion start that contains Insertion end the substance or Insertion start a product that may release the substance into the environment Insertion end and the total, partial or conditional prohibition of the Insertion start manufacture Insertion end , import or export of a product that is intended to contain the substance;

• (m) the quantity or concentration of the substance that may be contained in any product manufactured, imported, exported, sold or offered for sale in Canada, Insertion start or that any such product may release into the environment; Insertion end

• (n) the manner in which, the conditions under which and the purposes for which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be advertised or offered for sale;

• (o) the manner in which and the conditions under which the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end may be stored, displayed, handled, transported or offered for transport;

• (p) the packaging and labelling of the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end ;

• (q) the manner, conditions, places and method of disposal or recycling of the substance, a product Insertion start that contains the substance or a product that may release the substance into the environment Insertion end , including standards for the construction, maintenance and inspection of disposal or recycling sites;

• (r) the submission to the Minister, on request or at any times that are prescribed, of information relating to the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end ;

• (t) the conduct of sampling, analyses, tests, measurements or monitoring of the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end and the submission of the results to the Minister;

• (u) the submission to the Minister of samples of the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end ;

• (v) the conditions, test procedures and laboratory practices to be followed for conducting sampling, analyses, tests, measurements or monitoring of the substance, Insertion start a product that contains the substance or a product that may release the substance into the environment Insertion end ;

Powers of Minister

(5) Regulations made under this section may authorize the Minister, in the circumstances and subject to the conditions and limits that may be specified in the regulations, to issue, amend, suspend and revoke permits and other authorizations in relation to any matter that is the subject of the regulations and to set their terms and conditions.

Statutory Instruments Act

(6) A permit or other authorization issued under regulations made under this section is not a statutory instrument as defined in subsection 2(1) of the Statutory Instruments Act.

• (a) there can be found in the place a substance Insertion start with respect Insertion end to which this Act applies, a product Insertion start that contains Insertion end such a substance or Insertion start a product that may release such a substance into the environment Insertion end ;

• (a) the exportation, importation, manufacture, transportation, processing or distribution of a substance, Insertion start a Insertion end product Insertion start that contains Insertion end a substance Insertion start or a product that may release a substance into the environment Insertion end ;

• (b) the possession, storage, use, sale, offering for sale, advertisement or disposal of a substance, Insertion start a Insertion end product Insertion start that contains Insertion end a substance or Insertion start a product that may release a substance into the environment Insertion end ;

• (c) the use, in a commercial manufacturing or processing activity, of a substance, Insertion start a Insertion end product Insertion start that contains Insertion end a substance or Insertion start a product that may release a substance into the environment Insertion end ; or

• (a) owns or has the charge, management or control of

  • Insertion start (i) Insertion end  the substance — or any product Insertion start that contains Insertion end the substance Insertion start or that may release the substance into the environment Insertion end — to which the alleged contravention relates, or

  • Insertion start (ii) Insertion end  the property on which the substance or product is located;

• (b) fails to comply with an obligation set out in section 70, 86, Insertion start 87.‍1 Insertion end , 95, 111 or Insertion start 112.‍1 or Insertion end subsection 169(1), 172(1), 179(1), 182(1), 201(1) or 212(1);

• (d) contravenes a condition of a permission granted under paragraph 84(1)‍(a) or 109(1)‍(a) Insertion start or under regulations made under section 93 or 209 Insertion end ;

Demande de confidentialité

313 (1) Quiconque fournit des renseignements au ministre sous le régime de la présente loi, ou à la commission de révision relativement à un avis d’opposition déposé aux termes de la présente Insertion start loi Insertion end , peut en même temps demander que les renseignements fournis soient considérés comme confidentiels.

Contents of request

(2) A request Insertion start for confidentiality Insertion end shall be submitted, Insertion start with reasons Insertion end , in writing and contain any supplementary information that may be prescribed.

Exceptions to requirement to give reasons

(3) In the case of information provided under a regulation, order or notice, reasons for a request for confidentiality are not required if the regulation, order or notice so specifies.

Prohibition of disclosure

314 The Minister shall not disclose any information in respect of which a request for confidentiality has been made under section 313, except in accordance with Insertion start any of sections Insertion end 315 Insertion start to 317.‍2 Insertion end .

• (c) under an agreement or arrangement between the Government of Canada or any of its institutions and any other government in Canada, the government of a foreign state or an international organization or any of its institutions, or between the Minister and any other minister of the Crown in right of Canada Insertion start or a board or agency of the Government of Canada, if Insertion end

• (ii) the government, international organization, institution, other minister, Insertion start board or agency Insertion end undertakes to keep the information confidential;

Disclosure — substance

317.‍1 (1) The Minister may disclose the explicit chemical or biological name of a substance in respect of which a request for confidentiality has been made if the Minister takes or has taken any of the following measures:

• (a) to permit, under paragraph 84(1)‍(a), the manufacture or importation of the substance, subject to any conditions that are specified;

• (b) to prohibit the manufacture or importation of the substance under paragraph 84(1)‍(b);

• (c) to publish, in respect of the substance, a notice under subsection 85(1) or (4); or

• (d) to amend the Domestic Substances List in respect of the substance under subsection 87(3) or (4.‍1).

  End of inserted block

Disclosure — living organism

(2) The Minister may disclose the explicit biological name of a living organism in respect of which a request for confidentiality has been made if the Minister takes or has taken any of the following measures:

• (a) to permit, under paragraph 109(1)‍(a), the manufacture or importation of the living organism, subject to any conditions that are specified;

• (b) to prohibit the manufacture or importation of the living organism under paragraph 109(1)‍(b);

• (c) to publish, in respect of the living organism, a notice under subsection 110(1) or (4); or

• (d) to amend the Domestic Substances List in respect of the living organism under subsection 112(3) or (5).

  End of inserted block

Disclosure — Ministers’ recommendation

(3) The Minister may disclose the explicit chemical or biological name of a substance or the explicit biological name of a living organism in respect of which a request for confidentiality has been made if the Ministers recommend or have recommended to the Governor in Council the addition of the substance or the living organism to Part 1 or 2 of the list of toxic substances in Schedule 1 under subsection 90(1).

Disclosure after expiry

317.‍2 (1) The Minister may disclose the explicit chemical or biological name of a substance or the explicit biological name of a living organism after the expiry of a period of 10 years after the day on which a request for confidentiality under section 313 is made.

Publication — notice of intent

(2) The Minister shall publish a notice in the Canada Gazette of the Minister’s intention to disclose the explicit chemical or biological name under subsection (1) at least 60 days before the proposed disclosure.

Comments

(3) Within 60 days after the publication of the notice, the person who made the request for confidentiality or the person’s successor or assign may file with the Minister comments respecting

• (a) whether the public interest in the disclosure of the name clearly outweighs in importance

  • (i) any material financial loss or prejudice to the competitive position of the person or the person’s successor or assign, and

  • (ii) any damage to the privacy, reputation or human dignity of any person that may result from the disclosure of that name; and

• (b) whether the disclosure is prohibited under section 20 of the Access to Information Act.

  End of inserted block

Notice of disclosure

(4) At least 24 hours before disclosing the name under subsection (1), the Minister shall give notice of the proposed disclosure to the person who made the request for confidentiality or the person’s successor or assign. The notice is not required if the person to whom it is to be given cannot be found after reasonable efforts have been made to do so.

Emergency

(5) If an emergency exists, subsections (2) and (3) do not apply and the notice of disclosure required in subsection (4) may be given later than the time provided for in that subsection.

Regulation, order or notice

(2) The regulation, order or notice under which information is provided to the Minister or board of review may specify that the requirement to give reasons for a request for confidentiality under section 313 with respect to the information in question does not apply.

Publication of proposed orders and regulations

332 (1) The Minister shall publish in the Canada Gazette a copy of every order or regulation proposed to be made by the Minister or the Governor in Council under this Act, except a list, or an amendment to a list, referred to in Insertion start any of sections Insertion end 66 Insertion start to 66.‍2 Insertion end , 87, 105 Insertion start to 105.‍2 and Insertion end 112 or an interim order made under section 94, 163, 173, 183 or 200.‍1.

Notice of objection

(2) Any person may file with the Minister comments, or a notice of objection requesting that a board of review be established under section 333 and stating the reasons for the objection, within 60 days after the publication of

• Insertion start (a) Insertion end  a proposed order or regulation Insertion start referred to Insertion end in subsection (1);

• Insertion start (b) Insertion end  a proposed instrument respecting preventive or control actions in relation to a substance that is required by section 91 to be published in the Canada Gazette; or

• Start of inserted block

  (c) a statement referred to in subparagraph 91(1)‍(a)‍(ii) or (b)‍(ii).

  End of inserted block

Establishment of board of review

333 (1)  Insertion start If Insertion end a person files a notice of objection under subsection 332(2) in respect of a decision or a proposed order, regulation or instrument made by the Governor in Council, a decision or a proposed order or instrument made by either or both Ministers or Insertion start a statement referred to in subparagraph 91(1)‍(a)‍(ii) or (b)‍(ii) Insertion end , the Minister or the Ministers may establish a board of review to inquire into the nature and extent of the danger posed by the substance in respect of which the decision Insertion start or statement Insertion end is made or the order, regulation or instrument is proposed.

Risk to environment

11.‍1 It is prohibited for a person to sell, or to manufacture, prepare, preserve, package or store for sale, any drug that contains a prescribed substance, unless the Minister has conducted an assessment, in accordance with the regulations made under paragraph 30(1)‍(l.‍1), of the risk to the environment presented by the substance.

Information — serious environmental risk

21.‍301 (1) If the Minister believes that a therapeutic product may present a serious risk to the environment, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk.

Disclosure — serious environmental risk

(2) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk to the environment.

Disclosure —  protection of the environment

(3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection of the environment and the disclosure is to

• (a) a government;

• (b) a person from whom the Minister seeks advice; or

• (c) a person who carries out functions relating to the protection of the environment, including the assessment and management of risks to the environment.

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Definition of government

(4) In this section, government has the same meaning as in subsection 21.‍1(4).

Labelling or packaging — serious risk to environment

21.‍302 The Minister may, if he or she believes that doing so is necessary to prevent a serious risk to the environment, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package.

Minister’s powers — serious risk to environment

21.‍303 (1) If the Minister believes that a therapeutic product presents a serious or imminent risk to the environment, he or she may order a person who sells the product to

• (a) recall the product; or

• (b) send the product, or cause it to be sent, to a place specified in the order.

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Subsections 21.‍3(2) to (6) apply

(2) Subsections 21.‍3(2) to (6) apply, with any modifications that the circumstances require, in respect of any order made under subsection (1).

Power — information relating to environmental effects

21.‍33 Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on the environment, order the holder of a therapeutic product authorization to

• (a) compile information or conduct tests, studies or monitoring in respect of the therapeutic product; and

• (b) provide the Minister with the information or the results of the tests, studies or monitoring.

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Statutory Instruments Act

21.‍4 (1) For greater certainty, orders made under any of sections 21.‍1 to Insertion start 21.‍33 Insertion end are not statutory instruments within the meaning of the Statutory Instruments Act.

Availability of orders

(2) The Minister shall ensure that any order made under any of sections 21.‍1 to Insertion start 21.‍33 Insertion end is publicly available.

• Start of inserted block

  (a.‍01) declaring that any drug is adulterated if the Minister believes that a prescribed substance contained in that drug presents a serious risk to the environment;

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• Start of inserted block

  (a.‍02) prescribing the substances that are subject to an assessment under section 11.‍1;

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  (b.‍01) respecting, for the purposes of managing risks to the environment, any of the following:

  • (i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,

  • (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

  • (iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and

  • (iv) the use of any substance as an ingredient in any food, drug, cosmetic or device;

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• (e) respecting the method of manufacture, preparation, preserving, Insertion start packaging Insertion end , storing and testing of any food, drug, cosmetic or device in the interest of, or for the prevention of injury to, the health of the purchaser or consumer Insertion start or to manage risks to the environment Insertion end ;

• (l.‍1) respecting the assessment of Insertion start the risk to the Insertion end environment or human life and health of the release into the environment of any food, drug, cosmetic or device;

• Start of inserted block

  (l.‍2) respecting, for the purpose of managing risks to the environment identified as part of an assessment under this Act, measures in respect of selling or importing, manufacturing, preparing, preserving, packaging or storing for sale any food, drug, cosmetic or device;

• (l.‍3) authorizing the Minister to waive any requirement respecting the assessment under this Act of the risk to the environment presented by a food, drug, cosmetic or device;

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Relevant factor

(1.‍01) Before recommending to the Governor in Council that a regulation be made under paragraph (1)‍(a.‍02), the Minister must take into account the degree of uncertainty respecting the risks to the environment associated with the use of a substance as an ingredient in a drug, including its release into the environment.

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  (d.‍01) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk to the environment, that the holders receive or become aware of and that is relevant to the therapeutic product to which the authorization relates, regarding

  • (i) risks that have been communicated outside Canada, and the manner of the communication,

  • (ii) changes that have taken place to labelling outside Canada, and

  • (iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;

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• (e) respecting modifications of labels and modifications and replacements of packages referred to in Insertion start sections Insertion end 21.‍2 Insertion start and 21.‍302 Insertion end ;

• (f.‍3) respecting the compilation of information, the conducting of tests and studies and the monitoring that are referred to in Insertion start paragraphs Insertion end 21.‍32(a) Insertion start and 21.‍33(a) Insertion end , and the provision to the Minister of the information or results referred to in Insertion start paragraphs Insertion end 21.‍32(b) Insertion start and 21.‍33(b) Insertion end ;

Whereas the Government of Canada acknowledges the need to virtually eliminate the most persistent and bioaccumulative toxic substances and the need to control and manage pollutants and wastes if their release into the environment cannot be prevented;

Whereas the Government of Canada will endeavour to remove threats to biological diversity through pollution prevention, the control and management of the risk of any adverse effects of the use and release of toxic substances, pollutants and wastes, and the virtual elimination of persistent and bioaccumulative toxic substances;