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.

His 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

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

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

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

• (a.‍2) protect the right of every individual in Canada to a healthy environment as provided under this Act, subject to any reasonable limits;

• (a.‍3) in relation to paragraph (a.‍2), uphold principles such as principles of environmental justice — including the avoidance of adverse effects that disproportionately affect vulnerable populations — the principle of non-regression and the principle of intergenerational equity;

• (k.‍1) encourage the development and timely incorporation of scientifically justified alternative methods and strategies in the testing and assessment of substances to replace, reduce or refine the use of vertebrate animals;

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

healthy environment means an environment that is clean, healthy and sustainable. (environnement sain)

precautionary principle means Principle 15 of the 1992 Rio Declaration on Environment and Development, which provides that the lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation if there are threats of serious or irreversible damage. (principe de précaution)

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

Right to a healthy environment

• (a) the process under subsection 76.‍1(1) in respect of the protection of the right to a healthy environment.

Content

• (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 — the principle of non-regression and the principle of intergenerational equity, according to which it is important to meet the needs of the present generation without compromising the ability of future generations to meet their own needs;

• (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);

• (c) the relevant factors to be taken into account in interpreting and applying that right and in determining the reasonable limits to which it is subject, including social, health, scientific and economic factors; and

• (d) mechanisms to support the protection of that right.

Consultation

Publication

Report

Contents of Environmental Registry

Form and manner of Environmental Registry

Additional rights

15 The rights conferred by this Part are in addition to the right to request, under section 76, that a substance be assessed, 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, including biomonitoring surveys, relating to the role of substances in illnesses or in health problems;

Vulnerable populations

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

• (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;

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

• (k.‍2) hydraulic fracturing;

• (k.‍3) tailings ponds;

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

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

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

• (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.

Alternatives

(1.‍1) The notice may include a requirement that the plan prioritize the identification, development or use of safer or more sustainable alternatives to the substance, group of substances or product.

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

Publication of notice of extension

Progress reports

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 product.

Domestic Substances List

66 (1) The Minister shall, for the purpose of section 81, maintain a list to be known as the Domestic Substances List and, subject to subsection 66.‍2(1), 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), unless the substance has been deleted from the Domestic Substances List under subsection 66.‍2(1); and

Domestic Substances List — Food and Drugs Act

66.‍1 (1) The Minister may, for the purpose of section 81, add a substance to the Domestic Substances List if

• (a) the substance was included on the version of the Revised In Commerce List that was prepared by the Minister of Health after the end, on November 3, 2019, of acceptance of substance nominations to that List and that is referred to in the Canada Gazette, Part I, Volume 152, Number 44, as the static list;

• (b) the substance is not referred to in Annex I to the notice entitled “Removal of substances with no commercial activity from the Revised In Commerce List” published in the Canada Gazette, Part I, Volume 156, Number 8; and

• (c) no conditions specified under paragraph 84(1)‍(a) in respect of the substance are in effect.

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

Designation

(2) The Minister may, by order, designate any person or class of persons to exercise the powers set out in subsection (1).

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, carcinogenicity, mutagenicity and reproductive toxicity;

• (d) respecting the conditions, test procedures and laboratory practices to be followed for analysing, testing or measuring the property or characteristic, including conditions, test procedures and laboratory practices to be followed for replacing, reducing or refining the use of vertebrate animals; and

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

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, a product that contains a substance or a product that may release a substance into the environment — 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 the substance or product including

• (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 or environment in relation to the substance,

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

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

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

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

• (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;

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

Restriction — vertebrate animals

68.‍1 (1) The Ministers shall, to the extent practicable, use scientifically justified alternative methods and strategies to replace, reduce or refine the use of vertebrate animals in the generation of data and the conduct of investigations under paragraph 68(a).

Methods and strategies to refine use

(2) For the purposes of subsection (1), methods and strategies to refine the use of vertebrate animals include minimizing pain and distress caused to vertebrate animals used in the generation of data and the conduct of investigations under paragraph 68(a).

Saving

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

Guidelines public

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, a product that contains a substance or a product that may release a substance into the environment — 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 or product, as the case may be, 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, as the case may be, requiring the person to conduct toxicological or 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)

• (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;

• (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;

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

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

Contents of notice under paragraph (1)‍(c)

• (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.

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

• (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;

• (a.‍1) the conditions, methods, test procedures and laboratory practices to be followed to replace, reduce or refine the use of vertebrate animals;

• (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.

Extension of time

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

Substances and Assessments of Substances

Plan — priorities

• (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;

• (b) that specifies 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; and

• (c) that specifies activities or initiatives to promote the development and timely incorporation of scientifically justified alternative methods and strategies in the testing and assessment of substances to replace, reduce or refine the use of vertebrate animals.

Consultation and considerations

• (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, with a view toward avoiding substitutions within the class that may be harmful; and

• (c) shall take into account the matters referred to in paragraph 68(a), including the manner in which the public may be provided with information regarding substances or products including, in the case of products, by labelling them.

Publication of proposed plan

Comments

Consideration of comments

Publication of plan

Review of plan

Application

Report to Parliament

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.

Deletion of item

(3) The Minister shall delete a substance from the List, as well as any information regarding the substance that is specified on the List, if

• (a) an order is made under subsection 90(1) adding the substance to the list of toxic substances in Schedule 1; or

• (b) the Ministers no longer have reason to suspect that the substance is capable of becoming toxic.

Publication

(4) 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

(5) 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 decide whether to add the substance to the plan developed under section 73 or deny the request.

Notification of decision

(2.‍1) Within 90 days after the day on which the request is filed, the Minister shall inform the person who filed the request of the decision, 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 (1) The Ministers shall apply a weight of evidence approach and the precautionary principle when they are conducting and interpreting the results of

• (a) an assessment conducted under this Part, other than under section 83, in order to determine 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 or environment in relation to the substance and on the cumulative effects on human health and the environment that may result from exposure to the substance in combination with exposure to other substances.

Publication after assessment or review

77 (1) If the Ministers have conducted an assessment under this Part, other than under section 83, to determine whether a substance is toxic or capable of becoming toxic 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) 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.

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 referred to in section 75.‍1, adding the substance to that List;

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

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

Mandatory proposal

(3) The Ministers shall propose to take the measure referred to in paragraph (2)‍(c) if 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 inherently toxic to human beings or non-human organisms, as determined by laboratory or other studies,

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

  • (iii) is present in the environment primarily as a result of human activity, and

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

• (b) the substance may constitute a danger in Canada to human life or health and is, in accordance with the regulations, carcinogenic, mutagenic or toxic for reproduction; or

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

Publication of final decision

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

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

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

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

  • (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.

Exemption

Delay — publication of final decision

Recommendation to Governor in Council

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 and the reasons for the amendment in the Environmental Registry and in any other manner that the Minister considers appropriate.

Progress report

(3) The Minister shall include in the annual report required by section 342 a report on the progress made in developing any subsequent proposed regulations or instruments.

Update on estimated timelines

(4) The report on progress referred to in subsection (3) shall include an update on estimated timelines and reasons for any delay.

Expiry of prohibition

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

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

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)

• (a) shall indicate, by inclusion or exclusion, the significant new activities in relation to the substance with respect to 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 on or before which it is to be provided and the period within which it is to be assessed under section 83; and

• (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.

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

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

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

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

• (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).

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) If a substance is on the Domestic Substances List or is to be added to the List under subsection (1) or 66.‍1(1), 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)

• (a) shall indicate, by inclusion or exclusion, the significant new activities in relation to the substance with respect to 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 on or before which it is to be provided and the period within which it is to be assessed under section 83; and

• (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.

Subsequent amendment

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

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

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

• (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).

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 to 66.‍2 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 Part 1 or 2 of the list of toxic substances in Schedule 1.

Priorities

(1.‍1) In developing a proposed regulation or instrument respecting preventive or control actions, including actions that lead to the use of safer or more sustainable alternatives for the environment or human health, in relation to a substance specified on the list of toxic substances in Schedule 1, the Ministers shall give priority to pollution prevention actions and, in particular, in the case of a substance specified in Part 1 of the list of toxic substances in that Schedule, to the total, partial or conditional prohibition of activities in relation to the substance or of releases of the substance into the environment.

Consideration of factors

(1.‍2) For the purposes of subsection (1.‍1), the Ministers shall, in respect of a substance specified in Part 1 of the list of toxic substances in Schedule 1, consider 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 in Part 1 or 2 of 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 that Part 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 (2), (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, in respect of a substance is a recommendation that the substance be added to Part 1 or 2 of the list of toxic substances in Schedule 1,

• (a) the Minister shall publish in the Canada Gazette

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

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

  • (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.

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).

Publication of preventive or control actions

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

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

• (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.

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 that contains the substance or a product that may release the substance into the environment may be imported, exported, manufactured, processed, used, offered for sale or sold;

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

• (i) the quantities or concentrations of the substance that 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, a product that contains the substance or a product that may release the substance into the environment;

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

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

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

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

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

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

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

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

Powers of Minister

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) if

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

Report and remedial measures

95 (1) If 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) If 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) If 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 If, in respect of a substance, a product that contains a substance or a product that may release a substance into the environment, 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 purpose of section 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

Domestic Substances List — Food and Drugs Act

105.‍1 (1) The Minister may, for the purpose of section 106, add a living organism to the Domestic Substances List if

• (a) the living organism was included on the version of the Revised In Commerce List that was prepared by the Minister of Health after the end, on November 3, 2019, of acceptance of substance nominations to that List and that is referred to in the Canada Gazette, Part I, Volume 152, Number 44, as the static list; and

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

Designation

(2) The Minister may, by order, designate any person or class of persons to exercise the power set out in subsection (1).

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), 105.‍1(1) or 112(1) is not being manufactured in Canada or imported into Canada 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.

Publication of notice of waiver

(9) The Minister shall, as soon as possible in the circumstances, 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.

Consultation

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

Notice

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

Expiry of prohibition

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

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

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

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

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

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

Contents of notice

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

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

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

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

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

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

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

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

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

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

Contents of amendment

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

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

• (b) may specify for the purpose of subsection 112.‍1(2) classes of persons who are not required to be notified under subsection 112.‍1(1) with respect to the living organism.

Subsequent amendment

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

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

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

• (c) to specify classes of persons for the purpose of subsection 112.‍1(2), if no such classes are specified with respect to the living organism;

• (d) to vary the classes of persons, if any, that are specified for the purpose of subsection 112.‍1(2); or

• (e) to delete any class of persons that is specified for the purpose of subsection 112.‍1(2).

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.

• (g.‍1) prescribing a living organism or group of living organisms for the purpose of subsection 108.‍1(1);

• (a) a substance or group of substances specified in Part 1 or 2 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 Part 1 or 2 of 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 that contains the substance or a product that may release the substance into the environment may be imported, exported, manufactured, processed, used, offered for sale or sold;

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

• (i) the quantities or concentrations of the substance that 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, a product that contains the substance or a product that may release the substance into the environment and the total, partial or conditional prohibition of the manufacture, 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, or that any such product may release into the environment;

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

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

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

• (q) the manner, conditions, places and method of disposal or recycling of the substance, a product that contains the substance or a product that may release the substance into the environment, 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, a product that contains the substance or a product that may release the substance into the environment;

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

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

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

Powers of Minister

Statutory Instruments Act

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

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

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

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

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

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

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

• (b) fails to comply with an obligation set out in section 70, 86, 87.‍1, 95, 111 or 112.‍1 or 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) or under regulations made under section 93 or 209;

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 loi, peut en même temps demander que les renseignements fournis soient considérés comme confidentiels.

Contents of request

Review of requests

• (a) trade secrets of any person;

• (b) financial, commercial, scientific or technical information that is confidential information and that is treated consistently in a confidential manner by any person;

• (c) information the disclosure of which could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of, any person; or

• (d) information the disclosure of which could reasonably be expected to interfere with contractual or other negotiations of any person.

Requests deemed not to have been made

Report — number of requests

Designation

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 any of sections 315 to 317.‍2.

• (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 or a board or agency of the Government of Canada, if

• (ii) the government, international organization, institution, other minister, board or agency 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).

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).

Disclosure — Ministers’ recommendation

(3) The Minister shall 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.

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.

Report to Parliament

317.‍3 The Minister shall include in the annual report required by section 342 a report respecting the explicit chemical or biological names of substances and the explicit biological names of living organisms disclosed under section 317.‍1 or 317.‍2.

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 any of sections 66 to 66.‍2, 87, 105 to 105.‍2 and 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

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

• (b) 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

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

Establishment of board of review

333 (1) If 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 a statement referred to in subparagraph 91(1)‍(a)‍(ii) or (b)‍(ii), 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 or statement is made or the order, regulation or instrument is proposed.

Report — aboriginal peoples

342.‍1 The Minister shall include in the annual report required by section 342 information related to

• (a) consultations with aboriginal peoples and aboriginal governments, including a summary of the key issues raised, in relation to matters under this Act;

• (b) the administration of this Act in respect of aboriginal peoples and aboriginal governments, including the measures taken to advance reconciliation as reflected in section 35 of the Constitution Act, 1982 and in the United Nations Declaration on the Rights of Indigenous Peoples Act; and

• (c) the key findings or recommendations of any report made under an Act of Parliament in respect of the administration of this Act and aboriginal peoples and aboriginal governments.

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.

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.

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.

Statutory Instruments Act

21.‍4 (1) For greater certainty, orders made under any of sections 21.‍1 to 21.‍33 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 21.‍33 is publicly available.

• (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;

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

• (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;

• (e) respecting the method of manufacture, preparation, preserving, packaging, 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 or to manage risks to the environment;

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

• (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;

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.

• (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;

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

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