Appearance before the Senate Committee on Energy, the Environment and Natural Resources – April 28, 2022

Additional context

Clause 2 adds and replaces paragraphs in the preamble of the Act.

Related clauses

• Right to a Healthy Environment (see clauses 2, 3, 5 and 7)
• Vulnerable Populations and Cumulative Effects (see clauses 2, 3, 4, 8, 16 and 20)

Additional context

Subsection 2(1) of the Act outlines the duties of the Government in administering the Act. The implementation framework, to be developed by the Ministers in accordance with section 5.1, added by clause 5, will set out how the duty to protect the right of every individual in Canada to a healthy environment will be considered in the administration of the Act.

Related clauses

• Vulnerable Populations (see clauses 2, 3, 4, 8, 16 and 20)
• Right to a Healthy Environment (see clauses 2, 3, 5 and 7)

Additional context

Subsection 3(1) of the Act defines a number of words and phrases for the purposes of the Act.

Related clauses

• Power to Add and Remove Substances from the Domestic Substances List (see clause 14)
• Vulnerable Populations (see clauses 2, 3, 4, 8, 16 and 20)

Additional context

Section 5.1 of the Act also provides:

• that the implementation framework shall, among other things, elaborate on the principles to be considered in the administration of the Act such as the principles of environmental justice and non-regression; research, studies or monitoring activities to support the protection of the right to a healthy environment; and the balancing of that right with relevant factors, including social, economic, health and scientific factors; and
• a timeline for the development and publication of the implementation framework as well as requirements respecting content, consultations and annual reporting.

Related clauses

• Right to a Healthy Environment (see clauses 2, 3, 5 and 7)

Additional context

Section 15 of the Act references a number of procedural rights that are provided for under various parts of the Act other than Part 2.

Related clauses

• Replace Priority Substances List with Right to Request an Assessment (see clauses 20, 21, 22 and 57)

Additional context

Section 44 of the Act outlines certain mandatory obligations respecting environmental data and research.

Subsection 44(3.1) will complement the requirement in section 45, as amended by clause 8.

Related clauses

• Right to a Healthy Environment (see clauses 2, 3, 5 and 7)

Additional context

Section 45 of the Act obliges the Minister of Health to conduct certain research and studies and undertake associated activities related to publishing data and distributing information.

As amended, section 45 will complement the requirement in subsection 44(3.1) added by clause 7.

Related clauses

• Vulnerable Populations (see clauses 2, 3, 4, 8, 16 and 20)

Additional context

Subsection 46(1) of the Act grants broad information gathering powers to the Minister of the Environment and includes a non-exhaustive list of topics in respect of which that Minister may require persons to submit information.

Related clauses

• Plan of Chemicals Management Priorities (see clause 19)
• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Section 56 of the Act provides the Minister with the authority to require persons to prepare and implement pollution prevention plans in respect of certain substances, including toxic substances specified on Schedule 1.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Section 60 of the Act provides the Minister with the authority to require persons to submit pollution prevention plans.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Section 65 and 65.1 are currently components of the virtual elimination regime, which is replaced with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk.

Section 65 currently defines ‘virtual elimination’, obligates the Ministers to compile a Virtual Elimination List and specify a level of quantification for each substance on that list.

Section 65.1 currently defines ‘level of quantification’ for the purpose of section 65.

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

Section 66 of the Act requires that the Minister maintain the Domestic Substances List (DSL) and the Non-domestic Substances List (NDSL). It also provides rules for amending and publishing both lists, and allows the Minister to delegate those powers, duties and functions.

The DSL is the inventory of substances manufactured in, or imported into Canada on a commercial scale, and is used to divide the Government’s chemicals management program into its two main constituent parts:

• the pre-market notification and assessment regime for “new” substances (i.e. for substances that are not on the DSL); and,
• the post-market assessment regime for “existing” substances (i.e. for substances that are on the DSL).

The NDSL is comprised of chemical substances other than those listed on the DSL and is based on the United States Environmental Protection Agency’s (US EPA) inventory of chemical substances established under the Toxic Substances Control Act (TSCA).

Related clauses

• Power to Add and Remove Substances from the Domestic Substances List (see clause 14)
• Plan of Chemicals Management Priorities (see clause 19)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 38)

Additional context

Section 66.1

The In Commerce List (ICL), administered by Health Canada, is comprised of substances used in products regulated under the Food and Drugs Act (e.g. pharmaceuticals, biologics, cosmetics, and food additives) and known to be in Canadian commerce between January 1, 1987 and September 13, 2001.

These substances were not added to the Domestic Substances List (DSL) when it was drawn up nor have they been added to the DSL since then. As such, they are subject to the provisions of the Act respecting “new” substances, even though they are or have been in Canadian commerce for many years and, for policy purposes, are analogous to “existing” substances. The substances’ absence from the DSL can lead to duplication of efforts and associated burden.

Section 66.1 gives the Minister the power to add the substances that meet the provision’s criteria to the DSL to reflect that they are in Canadian commerce and to have them treated as “existing” substances under the Act. This reduces duplication and increases regulatory certainty regarding the status of these substances for the purposes of the Act and the Food and Drugs Act.

Section 66.2

The DSL is an inventory of substances manufactured in, or imported into Canada on a commercial scale. Although section 87 of the Act sets out a process for adding “new” substances to the DSL once certain conditions have been met (i.e. they have entered Canadian commerce and can be considered “existing” substances under the Act), there is no clear authority for the Minister to remove substances that are no longer in Canadian commerce from the DSL.

Section 66.2 gives the Minister the power to remove substances that are no longer in Canadian commerce from the DSL. Prior to doing so, the Minister must publish a notice of intent in the Canada Gazette for a 60-day comment period. This provides an opportunity to interested or affected parties to voice any concerns with the proposed removal.

Once removed from the DSL, a substance is considered “new” and any person that wants to reintroduce that substance into Canadian commerce must comply with the pre-market notification and assessment regime for “new” substances.

Related clauses

• Consequential amendments to related provisions of the Act (see clauses 4, 13, 26, 28 and 56)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 39)

Additional context

Section 67 provides the Governor in Council with authority to make regulations respecting properties and characteristics of substances such as the Persistence and Bioaccumulation Regulations.

The new and expanded regulatory authorities under paragraphs 67(1)(e) and (a), respectively, enable the making regulations that set out which toxic substances pose the highest risk by reference to properties or characteristics such as carcinogenicity, mutagenicity and reproductive toxicity. These substances would be prioritized for prohibition pursuant to subsection 90(1.1) as amended by clause 29.

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

Section 68 of the Act provides both Ministers with broad research, investigation and evaluation powers for the purposes of assessing whether a substance is toxic or capable of becoming toxic, and determining whether and how to control a substance.

The Ministers will be required to take into account the matters listed under paragraph 68(a) when developing and implementing the “Plan of Chemicals Management Priorities” required under section 73 as amended by clause 19.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)
• Plan of Chemicals Management Priorities (see clause 19)

Additional context

Subsection 69(1) of the Act provides that either Minister or both Ministers, as the case may be, may issue guidelines. However, subsection 69(2.1) of the Act only refers to the Minister of the Environment. The English version of subsection 69(3) of the Act contains a similar inconsistency. This corrects both inconsistencies.

Additional context

Section 71 of the Act grants broad information gathering powers to the Minister of the Environment and is the primary authority for requesting information to assess whether a substance is toxic or capable of becoming toxic, and to determine whether and how to control a substance.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Section 72 of the Act provides that the Minister may only require a person to conduct toxicological or other tests and submit the results of the tests if the Ministers have reason to suspect that the substance is toxic or capable of becoming toxic, or if it has been determined as such under the Act.

The current versions of sections 73 and 74 of the Act, provide the statutory mandate for the categorization exercise that was completed in 2006 and which identified approximately 4,300 substances that were made subject to additional risk assessment, and if appropriate, risk management actions under the Act. By the end of 2022, the Government will have completed the assessments for all of these substances, and so a new process for prioritizing substances for assessment is required.

Section 73 of the Act, as amended by clause 19, establishes a transparent and public priority-setting process by requiring that the Ministers develop, consult on and publish the “Plan of Chemicals Management Priorities”. Section 74 of the Act, as amended by clause 19, requires that the Ministers report annually to Parliament on the progress made in implementing the Plan.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)
• Consequential amendments to related provisions of the Act (see clauses 9, 13, 16, 21 and 38)

Additional context

Section 75.1

It is possible that, despite having hazardous properties, some substances will not be added to the list of toxic substances in Schedule 1 to the Act. This may be the case, for example, if a substance is only used or created in very limited circumstances in which there is no risk of exposure.

Departments often monitor and track these substances, for example, by applying the significant new activity (SNAc) provisions to ensure that the Government can revisit the conclusion about the substance if industry proposes to use it in a different manner. Similarly, while the Departments publically explain their assessment conclusions (e.g. the hazardous properties of the substance) and any follow-up measures that will be taken (e.g. information gathering or monitoring activities), this information is not captured in a systematic way, and there is no easily accessible or consolidated list of such substances.

To help remedy this, section 75.1 of the Act requires that the Minister compile and maintain a new “Watch List” of substances that the Ministers have reason to suspect are capable of becoming toxic or that they have formally determined to be capable of becoming toxic under section 77, as amended by clause 21.

Section 76

The current section 76 of the Act provided for the Priority Substances List (PSL). The PSL was part of the original Canadian Environmental Protection Act that was enacted in 1988 and represented an early approach to a prioritization framework. It proved, however, to be relatively slow and cumbersome, resulting in approximately 70 substance assessments during the ten years that the original Act was in force.

When the original Act was repealed and replaced by the Canadian Environmental Protection Act, 1999, the PSL provisions were maintained but were quickly eclipsed by the categorization requirement added to the Act at that time. As such, the Departments have not used the PSL provisions in the more than twenty years that the Act has been in force.

Section 76 of the Act, as amended by clause 20, provides that any person may request that the Ministers assess a substance to determine whether it is toxic or capable of becoming toxic.

Section 76.1

The current version of section 76.1 of the Act requires that the Ministers apply a weight of evidence approach and the precautionary principle when conducting and interpreting the results of certain risk assessments and reviews.

Section 76.1 of the Act, as amended by clause 20, will also require that the Ministers consider available information on vulnerable populations and on cumulative effects when conducting and interpreting the results of those assessments and reviews.

Related clauses

• Watch List (see clauses 20 and 21)
• Replace Priority Substances List with Right to Request an Assessment (see clauses 20, 21, 22 and 57)
• Vulnerable Populations and Cumulative Effects (see clauses 2, 3, 4, 8, 16 and 20)

Additional context

As currently written, section 77 of the Act provides a framework for transparency, public participation, and accountability in the steps to assess and manage some but not all substances. The Ministers must publish their draft assessment conclusions and proposed measures for a 60-day scientific consultation period, and they must consider the comments received when finalizing their assessment conclusions and proposed measures.

In cases where the Ministers conclude that a substance is toxic and meets certain additional criteria, including regulatory persistence and bioaccumulation thresholds, the current version of section 77 requires that the Ministers propose that the toxic substance be added to Schedule 1 and that environmental releases of that substance be virtually eliminated.

If the Ministers propose that a toxic substance be added to Schedule 1, then additional obligations are triggered under sections 91 and 92 of the Act: the Ministers must propose a risk management instrument in relation to the toxic substance within two years and finalize that instrument within a further 18 months. These additional obligations are colloquially referred to as the CEPA “time-clock”.

Section 77, as amended by clause 21, applies this framework to all toxicity assessments except those in respect of “new” substances and significant new activities.

The amendment also provides that following an assessment or review, the Ministers must propose one of four measures:

1. taking no further action;
2. adding the substance to the “Watch List” (e.g. if the substance is of potential concern and requires monitoring);
3. recommending that the toxic substance be added to Part 1 of Schedule 1 (i.e. if the toxic substance also meets the additional criteria to be considered a substance of highest risk under subsection 77(3)); or
4. recommending that the toxic substance be added to Part 2 of Schedule 1.

If the Ministers recommend that the toxic substance be added to Schedule 1 (i.e. either measure (c) or (d)), then the CEPA “time-clock” is triggered and the Ministers must develop a risk management instrument in relation to the substance either under CEPA or another federal Act. Pursuant to subsection 90(1.1) of the Act, as amended by clause 29, the risk management objective will differ depending on whether the toxic substance is added to Part 1 of Schedule 1 (i.e. priority to prohibition) or Part 2 of Schedule 1 (i.e. priority to pollution prevention).

If the Ministers are of the opinion that the risks associated with a toxic substance are adequately regulated under another federal Act, regulation or instrument, then instead of developing a new CEPA measure, the Minister may identify that federal risk management measure in a joint statement with the Minister responsible for administering it, and indicate how it addresses the risks identified. This enables better use of the “best placed Act” to address risks identified under CEPA.

Related clauses

• Plan of Chemicals Management Priorities (see clause 19)
• Replace Priority Substances List with Right to Request an Assessment (see clauses 20, 21, 22 and 57)
• Best Placed Act (see clauses 21, 23, 30, 31 and 40)
• Watch List (see clauses 20 and 21)
• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

The current version of section 78 provides for rules regarding the filing of notices of objection in respect of substances specified on the Priority Substances List.

The provisions respecting the Priority Substances List, including section 78, are repealed. In the case of section 78, it is replaced with a new accountability mechanism that requires the Ministers to commit to timelines for developing additional planned risk management actions in respect of a toxic substance.

Section 78, as amended by clause 22, applies in cases where the Ministers have proposed to develop more than one risk management instrument in respect of a toxic substance and requires that the Minister publish, at the same time as the first such instrument is finalized and published, an estimated time frame for developing the subsequent instrument(s).

The current version of section 79 imposes requirements respecting virtual elimination, including that the Minister require certain persons to prepare and submit virtual elimination plans.

Related clauses

• Replace Priority Substances List with Right to Request an Assessment (see clauses 20, 21, 22 and 57)
• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

Following an assessment of a new substance or a significant new activity under section 83, the Minister may prohibit any person from manufacturing or importing the substance under paragraph 84(1)(b).

The current version of subsection 84(4) provides that a ministerial prohibition imposed under paragraph 84(1)(b) must be replaced within two years by Governor in Council regulations made under section 93 in respect of that substance.

Subsection 84(4), as amended by clause 23, continues to provide that a ministerial prohibition must be replaced by regulations within two years, but provides that those regulations may be made using other regulation-making authorities under CEPA or another federal Act.

Related clauses

• Best Placed Act (see clauses 21, 23, 30, 31 and 40)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 40)

Additional context

Section 85 of the Act is one of several significant new activity (SNAc) provisions. Generally speaking, the Minister can apply the SNAc provisions to require that a person first provide the Minister with information about a substance prior to using, importing or manufacturing that substance for a significant new activity described in the SNAc publication. The Ministers assess that information to determine whether the significant new activity involving the substance presents potential risks to human health and the environment. If risks are identified, the Minister may impose risk management measures.

Section 85 of the Act relates to significant new activities in respect of “new” chemical substances (i.e. chemical substances that are not specified on the Domestic Substances List).

Related clauses

• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 41)

Additional context

The current version of section 86 provides that significant new activities (SNAc) in respect of new chemical substances must be communicated through the supply chain. That is, every person who transfers a new chemical substance that is subject to a SNAc must notify all persons to whom that new substance is transferred of their obligation to comply with the relevant SNAc provision in respect of that substance.

This obligation is important and promotes transparency across industrial supply chains, but it can be problematic when applied to certain downstream supply chain actors (e.g. product distributors, final retailers) that no longer need to be notified, as they are incapable of engaging in the SNAc.

Section 86, as amended by clause 25, maintains the obligation in subsection 86(1) but provides for an exception in subsection 86(2) such that a transferor of a new chemical substance need not notify persons that are part of a class specified by the Minister in the SNAc notice.

Related clauses

• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 42)

Additional context

Subsections 87(3) and (4) of the Act are among several significant new activity (SNAc) provisions. Generally speaking, the Minister can apply the SNAc provisions to require that a person first provide the Minister with information about a substance prior to using, importing or manufacturing that substance for a significant new activity described in the SNAc publication. The Ministers assess that information to determine whether the significant new activity involving the substance presents potential risks to human health and the environment. If risks are identified, the Minister may impose risk management measures.

Subsections 87(3) and (4) of the Act relate to significant new activities in respect of “existing” chemical substances (i.e. chemical substances that are specified on the Domestic Substances List).

Related clauses

• Power to Add and Remove Substances from the Domestic Substances List (see clause 14)
• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 43)

Additional context

Although the current version of the Act includes an obligation in section 86 for transferors of a “new” chemical substance to notify transferees of any obligation to comply with the relevant significant new activity provision in respect of that substance, there is no analogous obligation in respect of “existing” chemical substances.

As amended by clause 27, the Act imposes an analogous obligation in section 87.1 for transferors of an “existing” chemical substance to notify transferees of any obligation to comply with the relevant significant new activity provision in respect of that substance.

Related clauses

• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 6 of the Act (see clause 44)

Additional context

Section 89 provides the Governor in Council with the authority to make certain regulations, including regulations generally for carrying out the purposes and provisions of sections 66 and 80 to 88—i.e. provisions respecting the Domestic Substances List (DSL), the Non-domestic Substances List (NDSL), new substances and significant new activities.

Related clauses

• Power to Add and Remove Substances from the Domestic Substances List (see clause 14)

Additional context

The current version of section 90 provides the Governor in Council with the authority to add toxic substances to, as well as remove them from, Schedule 1. It also requires that the Ministers prioritize pollution prevention actions when developing proposed regulations or instruments respecting preventive or control actions in relation to toxic substances specified on Schedule 1.

Section 90, as amended by clause 29, continues to require that the Ministers prioritize pollution prevention actions for toxic substances that are added to Part 2 of Schedule 1, and imposes a new requirement that the Ministers prioritize prohibition measures (a specific approach to pollution prevention) for toxic substances that are added to Part 1 of Schedule 1.

Specifically, when developing a risk management instrument in respect of a toxic substance specified on Part 1 of Schedule 1, paragraph 90(1.1)(a) requires that the Ministers give priority to the total, partial or conditional prohibition of activities or releases involving that toxic substance.

• A total prohibition could be implemented as a complete ban or phase out of all activities involving the toxic substance (e.g. prohibiting certain PBTs in accordance with Canada’s international commitments).
• A partial prohibition could be implemented as a ban or phase out of activities of concern involving the toxic substance, which may be most uses in some cases, with exemptions for critical or essential uses for which there are no feasible alternatives (e.g. prohibiting all uses of the toxic substance except for medical or therapeutic uses).
• A conditional prohibition could be implemented such that all new activities involving the substance are prohibited unless the Ministers have specifically authorized the use (e.g. by issuing a permit) on the basis that the activity can be undertaken in a manner that minimizes or eliminates any harmful effect on human health or the environment, and there are no feasible alternatives.

In determining the particular approach, subsection 90(1.2) provides that the Ministers may consider relevant factors, such as whether the activity or release can be undertaken safely and whether there are feasible alternatives to the substance.

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
• Renaming and Bifurcating Schedule 1 (see clause 58)

Additional context

For every toxic substance that the Ministers recommend for addition to Schedule 1 under subsection 77(6), section 91 of the Act requires that the Minister propose a regulation or instrument respecting preventive or control actions in relation to that substance within two years. The requirement in the current version of section 91 is to propose a regulation or instrument to be made under the Canadian Environmental Protection Act, 1999.

Section 91 of the Act, as amended by clause 30, provides that a regulation or instrument respecting preventive or control actions may be proposed to be made under any federal Act, and assigns responsibility for the obligation in that section to the minister who is best placed to fulfill it.

Related clauses

• Best Placed Act (see clauses 21, 23, 30, 31, 40 and 56)
• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
• Renaming and Bifurcating Schedule 1 (see clause 58)

Additional context

Section 92 of the Act requires that a regulation or instrument proposed under section 91 be finalized within 18 months.

Related clauses

• Best Placed Act (see clauses 21, 23, 30, 31 and 40)

Additional context

Section 92.1 was a component of the virtual elimination regime, which is repealed and replaced with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk. It provided the Ministers with the authority to make regulations prescribing release limits in respect of a substance for the purposes of the implementation of virtual elimination.

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

Subsection 93(1) of the Act provides the Governor in Council with the authority to make regulations respecting substances specified on Schedule 1. It is the primary regulation making authority respecting toxic substances.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)
• Corresponding amendment to analogous provision under Part 9 of the Act (see clause 46)

Additional context

Section 94 of the Act provides the Minister with the power to make an interim order in respect of certain substances if the Ministers believe that immediate action is required to deal with a significant danger to the environment or to human life or health.

Related clauses

• Renaming and Bifurcating Schedule 1 (see clause 58)

Additional context

Section 95 of the Act imposes obligations on certain persons to take actions in response to an unauthorized release of a toxic substance into the environment.

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
• Renaming and Bifurcating Schedule 1 (see clause 58)

Additional context

Section 96 of the Act provides for the voluntary reporting of releases of a toxic substance and associated whistleblower protections.

Related clauses

• Renaming and Bifurcating Schedule 1 (see clause 58)

Additional context

Section 99 of the Act provides the Minister with the power to require that certain persons take certain remedial measures in respect of a substance or a product containing a substance, if there is a contravention of Part 5 or regulations made under that Part.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Part 6 of the Act establishes an assessment process for new animate products of biotechnology (i.e. living organisms) that is analogous to the assessment process for new (chemical) substances under Part 5. As such, the provisions of Part 6 (i.e. sections 104 to 115) generally mirror the provisions respecting new substances and activities under Part 5 (i.e. sections 80 to 89), but with some differences to account for the special characteristics of living organisms.

Section 105 of the Act requires that the Minister add certain living organisms to the Domestic Substances List (DSL). It also provides rules for amending and publishing the DSL, and allows the Minister to delegate those powers, duties and functions. It is analogous to section 66 under Part 5 of the Act.

Related clauses

• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 13)
• Plan of Chemicals Management Priorities (see clause 19)

Additional context

Section 105.1

The In Commerce List (ICL), administered by Health Canada, is comprised of substances used in products regulated under the Food and Drugs Act (e.g. pharmaceuticals, biologics, cosmetics, and food additives) and known to be in Canadian commerce between January 1, 1987, and September 13, 2001.

These substances were not added to the Domestic Substances List (DSL) when it was drawn up, nor have they been added to it since then. As such, they are subject to the provisions of the Act respecting “new” substances even though they are already in Canadian commerce (some for many years) and, for policy purpose, are analogous to “existing” substances under the Act. The substances’ absence from the DSL creates legal ambiguity about the status of these substances. It can also lead to duplication of efforts and associated burden.

Section 105.1 gives the Minister the power to add living organisms that meet the provision’s criteria to the DSL to reflect that they are in Canadian commerce and to have them treated as “existing” substances under the Act. This reduces duplication and increases regulatory certainty regarding the status of these living organisms for the purposes of the Act and the Food and Drugs Act.

Section 105.2

The DSL is an inventory of substances manufactured in, or imported into Canada on a commercial scale. Although section 112 of the Act sets out a process for adding “new” living organisms to the DSL once certain conditions have been met (i.e. they have entered Canadian commerce and can be considered “existing” substances under the Act), there is no clear authority for the Minister to remove living organisms that are no longer in Canadian commerce from the DSL.

Section 105.2 gives the Minister the power to remove living organisms that are no longer in Canadian commerce from the DSL. Prior to doing so, the Minister must publish a notice of intent in the Canada Gazette for a 60-day comment period. This provides an opportunity to interested or affected parties to voice any concerns with the proposed removal.

Once removed from the DSL, a living organism is considered “new” and any person that wants to reintroduce that living organism into Canadian commerce must comply with the pre-market notification and assessment regime for “new” living organisms.

Related clauses

• Consequential amendments to related provisions of the Act (see clauses 43 and 56)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 14)

Additional context

Following an assessment of a new living organism or a significant new activity under section 108, the Minister may prohibit any person from manufacturing or importing the living organism under paragraph 109(1)(b).

The current version of subsection 109(4) provides that a ministerial prohibition imposed under paragraph 109(1)(b) must be replaced within two years by Governor in Council regulations made under section 114 in respect of that substance.

Subsection 109(4), as amended by clause 40, continues to provide that a ministerial prohibition must be replaced by regulations within two years, but provides that those regulations may be made using other regulation-making authorities under CEPA or another federal Act.

Related clauses

• Best Placed Act (see clauses 21, 23, 30, 31 and 40)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 23)

Additional context

Section 110 of the Act is one of several significant new activity (SNAc) provisions. Generally speaking, the Minister can apply the SNAc provisions to require that a person first provide the Minister with information about a substance prior to using, importing or manufacturing that substance for a significant new activity described in the SNAc publication. The Ministers assess that information to determine whether the significant new activity involving the substance presents potential risks to human health and the environment. If risks are identified, the Minister may impose risk management measures.

Section 110 of the Act relates to significant new activities in respect of “new” living organisms (i.e. living organisms that are not specified on the Domestic Substances List).

Related clauses

• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 24)

Additional context

The current version of section 111 provides that significant new activities (SNAc) in respect of new living organisms must be communicated through the supply chain. That is, every person who transfers a new living organism that is subject to a SNAc must notify all persons to whom that new living organism is transferred of their obligation to comply with the relevant SNAc provision in respect of that living organism.

This obligation is important and promotes transparency across industrial supply chains, but it can be problematic when applied to certain downstream supply chain actors (e.g. product distributors, final retailers) that no longer need to be so notified as they are incapable of engaging in the SNAc.

Section 111, as amended by clause 42, maintains the obligation in subsection 111(1) but provides for an exception in subsection 111(2) such that a transferor of a new living organism need not notify persons that are part of a class specified by the Minister in the SNAc notice.

Related clauses

• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 25)

Additional context

Subsections 112(3) and (4) of the Act are among several significant new activity (SNAc) provisions. Generally speaking, the Minister can apply the SNAc provisions to require that a person first provide the Minister with information about a substance prior to using, importing or manufacturing that substance for a significant new activity described in the SNAc publication. The Ministers assess that information to determine whether the significant new activity involving the substance presents potential risks to human health and the environment. If risks are identified, the Minister may impose risk management measures.

Subsections 112(3) and (4) of the Act relate to significant new activities in respect of “existing” living organisms (i.e. living organisms that are specified on the Domestic Substances List).

Related clauses

• Power to Add and Remove Living Organisms from the Domestic Substances List (see clause 39)
• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 26)

Additional context

Although the current version of the Act includes the obligation in section 111 for transferors of a “new” living organism to notify transferees of any obligation to comply with the relevant significant new activity provision in respect of that living organism, there is no analogous obligation in respect of “existing” living organisms.

As amended by clause 44, the Act imposes an analogous obligation in section 112.1 for transferors of an “existing” living organism to notify transferees of any obligation to comply with the relevant significant new activity provision in respect of that living organism.

Related clauses

• Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 27)

Additional context

Section 199 of the Act provides the Minister with the authority to require persons to prepare and implement environmental emergency plans in respect of certain substances including toxic substances specified on Schedule 1.

Related clauses

• Renaming and Bifurcating Schedule 1 (see clause 58)

Additional context

Part 9 of the Act pertains to Government of Canada operations and federal and Aboriginal land. It applies to what is often collectively referred to as the “Federal House”:

• federal departments, boards, agencies, and Crown corporations;
• federal works and undertakings; and
• Aboriginal land, federal land, including persons who occupy or use those lands.

Section 209 provides the Governor in Council with the authority to make regulations that apply to the Federal House for the protection of the environment. This broad regulation making authority closely mirrors other regulation making authorities under the Act, particularly the authority under section 93, with slight but necessary modifications to reflect its broader scope of application (i.e. to the Federal House).

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)
• Corresponding amendment to analogous provision under Part 5 of the Act (see clause 33)

Additional context

Section 218 provides enforcement officers with certain inspection powers including the power under paragraph 218(1)(a) to enter and inspect any place if the enforcement officer has reasonable grounds to believe that there can be found in the place a substance to which the Act applies or a product contain such a substance.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Section 235 provides enforcement officers with the authority to use an environmental protection compliance order (EPCO) as a means of handling an offence under the Act without using the court system. The purpose of an EPCO is to bring the offender back into compliance with the Act or regulations as quickly as possible.

Related clauses

• Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 11, 16, 18, 19, 33, 37, 46, 47 and 48)

Additional context

Subsection 272(1) designates certain offences under the Act as subject to mandatory minimum penalties. The penalties imposed for offences designated under subsection 272(1) are more serious than those imposed for offences designated under subsection 272.1(1).

Related clauses

• Downstream Communication of Significant New Activities (see clauses 27 and 44)
• Ministerial Permitting Regimes (see clauses 33 and 46)

Additional context

The current version of section 313 of the Act provides that persons who submit information to the Minister or to a board or review may request that the information be treated as confidential, and section 314 provides that the Minister shall not disclose such information except in accordance with sections 315, 316 or 317.

In other words, regardless of whether information has been claimed confidential under section 313 such information may nevertheless be disclosed in accordance with the circumstances and processes set out under sections 315, 316 and 317.

Section 315 allows the Minister to disclose information where disclosure is in the public interest, and sets out a test and process for doing so.

Section 316 outlines a number of circumstances under which and purposes for which information may be disclosed or shared with certain other entities.

Section 317 allows the Minister to disclose information so long as the disclosure would not be prohibited under section 20 of the Access to Information Act (ATIA). Section 20 of the ATIA prohibits heads of government institutions from disclosing records that contain confidential business information, subject to a limited set of exceptions.

Despite having broad discretion to disclose information under these provisions—particularly under section 317—without knowing the reasons for which confidentiality is claimed under section 313 it is often difficult for the Minister to determine whether the circumstances outlined in these provisions are met, and thus whether certain information can be disclosed.

Section 313 of the Act, as amended by clause 50, requires that confidentiality requests be submitted with reasons. This will better enable the Minister to determine whether such information can be disclosed under sections 315, 316 or 317.

Related clauses

• Consequential amendment to related provision of the Act (see clause 54)

Additional context

Section 314 prohibits the Minister from disclosing information that has been claimed as confidential under section 313 unless disclosure is done in accordance with certain provisions of the Act.

Related clauses

• Disclosure of Masked Names (see clause 53)

Additional context

Subsection 316(1) of the Act sets out circumstances under which information may be disclosed, and paragraph 316(1)(c) provides for disclosure under certain agreements or arrangements between the Minister and any other federal minister.

The current version of paragraph 316(1)(c) fails to account for agreements or arrangements between the Minister and certain other federal entities, specifically federal boards or agencies.

Paragraph 316(1)(c), as amended by clause 52, accounts for federal boards and agencies in the list of entities contemplated thereunder.

Additional context

In some cases, the chemical or biological name of a new substance or living organisms itself, is confidential business information.

To protect against the release of such confidential business information, sections 88 and 113 of the Act provides for the use of masked names when identifying a substance or living organism in public documents such as the Domestic Substances List. However, there are cases where the explicit name of a masked substance or living organism should be disclosed, for example, when compliance by the broader regulated community depends on knowledge of the substance or organism being regulated.

Section 317.1

This provision allows the Minister to disclose the explicit name of a masked substance or living organism if certain conditions or restrictions are placed on its use, or if it is recommended to be added to the list of toxic substances in Schedule 1.

Section 317.2

This provision allows the Minister to disclose the explicit name of a masked substance or living organism after a period of 10 years. This promotes openness and transparency, while also providing the person who made the initial request with an opportunity to demonstrate that the explicit name should continue to remain confidential.

These changes are consistent with the Department’s published approach to disclosing confidential information and promoting transparency in chemicals management.

Related clauses

• Consequential amendment to related provision of the Act (see clause 51)

Additional context

Subsection 313(3) of the Act, added by clause 50, provides for an exception to the requirement under subsection 313(2), as amended by clause 50, to provide reasons in support of a subsection 313(1) request for confidentiality in cases where the particular regulation, order or notice under which the information is provided specifies that reasons are not required.

Subsection 319(2) clarifies and ensures that regulations, orders and notices may so specify on an instrument-by-instrument basis.

Related clauses

• Reasons in Support of Confidentiality Requests (see clause 50)

Additional context

Subsection 8(1) of the Interpretation Act provides that federal statutes and regulations apply to the whole of Canada, unless a contrary intention is expressed therein. In other words, federal statutes and regulations apply to whole of Canada by default, but may be expressly tailored to apply in only a specific geographic region.

Similar rules are provided for in CEPA. Subsection 330(3) of the Act provides that regulations made under the Act apply throughout Canada by default. However, subsection 330(3.1) of the Act provides that the scope of application of certain regulations can be geographically limited. That is, in order to protect the environment or its biological diversity or human health, certain regulations can be made applicable in only a certain part or parts of Canada.

However, not only are these provisions redundant (i.e. in light of subsection 8(1) of the Interpretation Act), subsection 330(3.1) of the Act has the added and undesirable effect of limiting the types of CEPA regulations that can be geographically limited (i.e. only regulations made under sections 93, 140, 167 or 177 of the Act can be geographically limited).

The preferred approach is to rely instead on the general rule in the Interpretation Act. As such, clause 55 repeals subsections 330(3) and (3.1) of the Act so that any CEPA regulations can be made to apply in a geographically limited manner. This will facilitate the making of CEPA regulations that help address pollution “hot spots”.

Additional context

Section 332 of the Act promotes transparency and public participation under the Act by requiring that the Minister publish a draft copy of most orders and regulations proposed to be made under the Act. This is known as the “prepublication” requirement and provides persons with an opportunity to submit comments, or to file a notice of objection in relation to the draft order or regulation and request that a board of review be established to inquire into the matter.

The current version of subsection 332(1) of the Act excludes orders amending the Domestic Substances List (DSL) from the prepublication requirement. Subsection 332(1), as amended by clause 56, provides that the Minister’s new powers to amend the DSL, added by clauses 14 and 39, are similarly excluded from the prepublication requirement.

Similarly, subsection 332(2) of the Act, as amended, ensures that persons may file a notice of objection in respect of a proposed statement published under subsection 91(1), as amended by clause 30.

Related clauses

• Power to Add and Remove Substances from the Domestic Substances List (see clause 14)
• Power to Add and Remove Living Organisms from the Domestic Substances List (see clause 39)
• Best Placed Act (see clause 30)

Additional context

Section 333 of the Act outlines the circumstances under which a board of review may or shall be established.

Related clauses

• Best Placed Act (see clause 30)
• Replace Priority Substances List with Right to Request an Assessment (see clauses 20, 21, 22 and 57)

Additional context

Several important authorities under the Act, including the regulation-making authority in section 93, may only be exercised in respect of substances listed on Schedule 1.

Schedule 1 to the Act lists substances that meet at least one of the criteria set out in section 64 of the Act, and that have been added to it by the Governor in Council. Section 64 of the Act sets out the criteria of a substance that, if met, justifies its addition to Schedule 1.

Given the breadth of the criteria set out in section 64, there are a number of substances on Schedule 1 that are not commonly understood to be toxic in the ordinary sense of the word such as carbon dioxide and methane. The term ‘CEPA-toxic’ is sometimes used to avoid the confusion.

The title of Schedule 1, as amended by clause 58, is simply “Schedule 1”. Consequential amendments to various other provisions in the Act are also made so that all references are now to the list of toxic substances in Schedule 1—the change from upper case to lower case reflects that the language is now descriptive.

Clause 58 also bifurcates Schedule 1 to the Act as part of the broader suite of amendments that replace the provisions in the Act respecting virtual elimination with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk.

Related clauses

• Renaming and Bifurcating Schedule 1 (see clause 58)
• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

The transitional provisions provide rules which apply during the transitional period between the date the Bill was introduced in Parliament and the date that it comes into force.

Additional context

Depending on when the Bill comes into force, there is a possibility that some subsection 77(1) proposed recommendations that were made under the current Act—and, more specifically, according to the provisions respecting virtual elimination—will not have been finalized and therefore will remain outstanding on the date this Bill becomes law and comes into force.

The transitional rules established by clause 60 address this possibility by treating subsection 77(1) proposed recommendations made under the current Act (according to the provisions respecting virtual elimination) as if they were made under the new amended Act (according to the provisions respecting the prohibition of toxic substances that pose the highest risk).

Additional context

If Bill S-5 becomes law, there is a possibility that some paragraph 77(6)(b) final recommendations that were made under the current Act—and, more specifically, according to the provisions respecting virtual elimination—will have been published during Parliament’s consideration of Bill S-5 but the substance in question will not yet have been added to Schedule 1 on the date the Bill comes into force. This is because the addition itself (i.e. of a substance to Schedule 1) is done separately via Order in Council, which process also involves publishing draft and final versions.

The transitional rules established by clause 61 addresses this possibility by treating paragraph 77(6)(b) final recommendations made under the current Act (according to the provisions respecting virtual elimination) as if they were made under the new amended Act (according to the provisions respecting the prohibition of toxic substances that pose the highest risk).

Additional context

Schedule 1 to the Act is a dynamic list. Substances are added to it on an ongoing basis and, although rare, substances may also be removed from it.

If the Bill becomes law, there is a possibility that substances are added to, or removed from, the List of Toxic Substances in Schedule 1 to the current Act during Parliament’s consideration of Bill S-5. In such a case, the addition or removal of those substances would not be reflected in Schedule 1 to the new amended Act.

The transitional rules established by clause 62 addresses this possibility by requiring that the Governor in Council update Schedule 1 to the new amended Act as soon as feasible after it comes into force to reflect any changes that were made to the List of Toxic Substances in Schedule 1 to the current Act during the transition period.

Additional context

The authority provided by clause 63 is part of the broader suite of amendments that replace the provisions in the Act respecting virtual elimination with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk.

The Ministers will be able to repeal the defunct Virtual Elimination List and the spent Regulations Adding Perfluorooctane Sulfonate and Its Salts to the Virtual Elimination List. Clause 68 also repeals the spent Perfluorooctane Sulfonate Virtual Elimination Act under which those Regulations were made.

Perfluorooctane sulfonate and its salts were added to the Virtual Elimination List as well as Schedule 1 to the current Act. In the Schedule to the Bill, and consequently in Schedule 1 to the new amended Act if it becomes law and comes into force, perfluorooctane sulfonate and its salts can be found in Part 1 of Schedule 1 (i.e. entry 11).

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

The Food and Drugs Act and Food and Drug Regulations regulate the safety and nutritional value of foods, as well as the safety, efficacy and quality of health products, such as prescription and non-prescription drugs, natural health products and medical devices.

The addition of this prohibition to the Food and Drugs Act demonstrates the intention to also regulate drugs based on an assessment of their environmental risks. This prohibition applies to a person conducting certain activities in respect of a drug for the purposes of sale, unless the Minister of Health has conducted an environmental risk assessment of substances contained in that drug. A corresponding environmental risk assessment framework is required in regulation in order to support this prohibition

This prohibition, in conjunction with the other amendments to the Food and Drugs Act in clauses 65 to 67, will allow for the creation of an environmental risk assessment and risk management regulatory framework under the Food and Drugs Act. This will enable the Government to make more informed decisions and to better assess risks to the environment from drugs based on sound science.

Related clauses

• Food and Drugs Act – Environmental Impact Initiative (see clauses 64, 65, 66, 67 and 69)

Additional context

Sections 21.1 to 21.3 of the Food and Drugs Act provide the Minister of Health with powers related to therapeutic products to order a person to provide information that is in their control, to disclose certain confidential business information, to order the modification of product labelling and packaging, and to order product recalls. However, these existing powers may only be exercised in relation to a serious risk of injury to health.

Clause 65 provides the Minister of Health with new powers that are analogous to the powers in sections 21.1 to 21.3 of the Food and Drugs Act, but which may be exercised in relation to a serious risk to the environment.    

Related clauses

• Food and Drugs Act – Environmental Impact Initiative (see clauses 64, 65, 66, 67 and 69)

Additional context

Section 21.32 of the Food and Drugs Act provides the Minister of Health with the power to order the holder of a therapeutic product authorization to compile certain information, conduct certain tests, studies or monitoring and to provide such information or results to the Minister. However, this existing power may only be exercised in relation to a therapeutic product’s effects on health or safety.

Clause 66 provides the Minister of Health with a new power that is analogous to the power in section 21.32 of the Food and Drugs Act, but which may be exercised in relation to the effects of a therapeutic product on the environment.

Related clauses

• Food and Drugs Act – Environmental Impact Initiative (see clauses 64, 65, 66, 67 and 69)

Additional context

Section 30 of the Food and Drugs Act provides the Governor in Council with broad regulation-making authorities in order to carry out the purposes and provisions of the Act.

Clause 67 amends existing authorities in, and adds new authorities to, section 30 in order to extend their scope so that they may be exercised in respect of the environment. It also ensures that the Governor in Council has the necessary authorities to operationalize the new prohibition in section 11.1 and will enable the creation of an environmental risk assessment and risk management framework in regulation.

Related clauses

• Food and Drugs Act – Environmental Impact Initiative (see clauses 64, 65, 66, 67 and 69)

Additional context

The Perfluorooctane Sulfonate Virtual Elimination Act required that the Ministers make a regulation to add perfluorooctane sulfonate and its salts to the Virtual Elimination List. This was done via the Regulations Adding Perfluorooctane Sulfonate and Its Salts to the Virtual Elimination List.

As such, clause 68 repeals the Perfluorooctane Sulfonate Virtual Elimination Act and is part of the broader suite of amendments that replace the provisions in the Act respecting virtual elimination with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk.

Similarly, clause 63 provides the Ministers with the authority to repeal the Regulations Adding Perfluorooctane Sulfonate and Its Salts to the Virtual Elimination List (i.e. the regulations made under the Perfluorooctane Sulfonate Virtual Elimination Act).

Related clauses

• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Additional context

Regulatory amendments are required in order to operationalize the new prohibition in section 11.1 of the Food and Drugs Act. As such, clause 69 delays the coming into force of section 11.1 and related provisions in order to provide the Government with the time needed to develop the supporting regulatory framework.

Related clauses

• Food and Drugs Act – Environmental Impact Initiative (see clauses 64, 65, 66, 67 and 69)

Additional context

The toxic substances listed under Part 1 of Schedule 1, as amended, are those that were found to meet the criteria for virtual elimination under the current version of subsection 77(4).

The toxic substances listed under Part 2 of Schedule 1, as amended, are those that were found not to meet the criteria for virtual elimination under the current version of subsection 77(4).

Going forward, toxic substances will be recommended for addition to Part 1 (or Part 2) of Schedule 1 according to the criteria set out under subsection 77(3), as amended by clause 21.

Related clauses

• Renaming and Bifurcating Schedule 1 (see clause 58)
• Prohibiting Toxic Substances that Pose the Highest Risk (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

@NewsroomGC tweet: Government of Canada reintroduces bill to keep moving forward on strengthening the Canadian Environmental Protection Act and protecting the health of Canadians and the environment.