Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act - Summary of Amendments

Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act received Royal Assent on June 13, 2023. The following is intended to provide a plain language summary of key amendments in Bill S-5. For the comprehensive and detailed list of the amendments, please refer to the Bill.

Preamble

• The preamble to the Canadian Environmental Protection Act, 1999 (CEPA or the Act)
  • Recognizes a right to a healthy environment as provided under CEPA.
  • Confirms the Government’s commitment to implement the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) including free, prior, and informed consent, and recognizes the role of Indigenous knowledge in decision making related to the protection of the environment and human health [clause 2(3), clause 2(5)].
  • Recognizes the importance of:
    • considering vulnerable populations in risk assessments and of minimizing the risks posed by the cumulative effects of toxic substances [clause 2(4)];
    • replacing, reducing or refining the use of vertebrate animal testing [clause 2(5)]; and
    • Canadians having information regarding the risks of toxic substances, including by labelling products [clause 2(6)].
  • Confirms the Government’s commitments to openness, transparency and accountability, and a risk-based approach to chemicals management [clause 2(6)].

Environmental rights

Right to a healthy environment under CEPA

• In addition to preambular recognition of the right to a healthy environment under CEPA, section 2 of the Act (respecting administrative duties) requires that the Government protect that right and uphold related principles, such as environmental justice, non-regression and intergenerational equity [clause 2(1), clause 3(2)].
  • Within 2 years of the amendments coming into force, the Ministers must develop an implementation framework to set out how that right will be considered in the administration of the Act [clause 5].
    • Interested persons (for example, Indigenous partners, representatives from industry, non-governmental organizations, academia, etc.) will have an opportunity to participate in the development of the implementation framework.
    • The Minister of Environment and Climate Change must publish the framework and report annually on its implementation.
  • The Ministers must conduct research, studies or monitoring activities to support the Government in protecting a right to a healthy environment [clause 7].

Advancing Indigenous reconciliation

• In addition to the preambular confirmation of the Government’s commitment to implement UNDRIP and take into account annual reporting on the operation of CEPA in respect of Aboriginal peoples of Canada.
  • The report must include information relating to: consultations, key issues raised; administration of the Act including measures taken to advance reconciliation; and, key findings or recommendations of any report made under an Act of Parliament in respect of the administration of CEPA and Aboriginal peoples and Aboriginal governments [clause 57].

Strengthening chemicals management

Risk assessment

Plan of chemicals management priorities and public request mechanism

• Within 2 years, the Ministers must develop, consult on and publish a Plan of Chemicals Management Priorities with timelines, which sets out a multi-year, integrated plan for the assessment of substances already in commerce in Canada, the activities and initiatives that support chemicals management, such as information-gathering, risk management, risk communications, research and monitoring, as well as a strategy 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 [clause 19, see “Animal Testing” section below].
  • The Ministers are empowered to consult with interested stakeholders and partners, such as Indigenous peoples, representatives of industry, labour and municipal authorities, and civil society, in the development and implementation of the Plan of Chemicals Management Priorities. A draft of the plan must be published for a 60-day comment period before it is finalized.
  • The Ministers must review the Plan within 8 years after it is published and every 8 years after that.
  • Public consultation and engagement requirements will also apply to any updates to the Plan following the Ministers’ review of it.
• In developing and implementing the Plan, the Government will continue to set priorities, and assess and manage substances by taking a risk-based approach that accounts for the properties of a substance as well as exposure to the substance, and a number of factors of importance to Canadians, including: 
  • vulnerable populations and cumulative effects;
  • particular properties and characteristics of substances, such as carcinogenicity, mutagenicity or neurotoxicity;
  • the capacity of substances to disrupt reproduction or endocrine systems;
  • the advantages of class-based assessments (for example, as a means of avoiding regrettable substitutions);
  • safer or more sustainable alternatives; and
  • the means of providing information to the public, such as through labelling and other risk communication strategies [clause 16].
• The Ministers must report annually to Parliament, as part of the CEPA annual report, on their progress in implementing the Plan of Chemicals Management Priorities [clause 19].
• The spent categorization provisions and dated Priority Substances List (PSL) provisions will be repealed [various clauses].
• A new provision will allow any person to request that the Ministers assess a substance to determine whether it is toxic or capable of becoming toxic.
  • The Ministers must decide whether to add the substance to the Plan of Chemicals Management Priorities or deny the request.
  • The Minister must inform the person within 90 days of the decision and rationale [clause 20].

Vulnerable populations, vulnerable environments, and cumulative effects

• The Ministers must consider available information regarding vulnerable populations, vulnerable environments and cumulative effects when conducting and interpreting the results of certain risk assessments under CEPA (for example all assessments other than assessments of new substances and significant new activities) [clause 20].
• These amendments complement the recognition of a right to a healthy environment and support the Government’s duty to protect it [clause 2(1), clause 3(2)].
  • The preamble to the Act includes new language recognizing the importance of considering vulnerable populations in risk assessments and of minimizing the risks posed by the cumulative effects of toxic substances [clause 2(4)].
  • The Act defines a “vulnerable population” in a manner that captures the sense of greater biological susceptibility (for example infants, pregnant people) and potential for greater exposure (for example Indigenous communities eating traditional foods, areas where pollution standards may be exceeded) [clause 4(2)].
  • Explicit recognition that the Government’s duty (under section 2) to exercise its powers in a manner that protects the environment and human health includes the health of vulnerable populations [clause 3(1)].
  • The Act provides an obligation for the Minister of Health to conduct biomonitoring surveys, as part of the obligation to conduct research and studies in relation to the health effects of substances, which may relate to vulnerable populations [clause 8].
  • Ensuring vulnerable populations or environments and cumulative effects are reflected under the list of matters that must be considered when developing and implementing the Plan of Chemicals Management Priorities [clause 16(2)].
• In addition, amendments facilitate the making of geographically targeted regulations that could, for example, be used to help address pollution “hot spots” [clause 54 – note this clause was renumbered due to a Senate amendment].

Animal testing

• Amendments add several provisions across the Act aimed at replacing, reducing or refining the use of vertebrate animals in toxicity testing, including by requiring that the Ministers, to the extent practicable use scientifically justified alternatives in the generation of data and the conduct of investigations under paragraph 68(a) and clarifying the meaning of “methods and strategies to refine” to include minimizing pain and distress [clause 2(5), clause 3(3), clause 15(2), clause 16.1, clause 18(6), clause 19].

Public accountability framework (Sections 77 and 91-92)

Transparency, participation and accountability in assessment and management of risks

• The public accountability framework under section 77 and the CEPA “time-clock” in sections 91 and 92 will now apply to all risk assessments of substances to determine whether they are “toxic” under CEPA, except for assessments of new substances and significant new activities [clause 21(1)].
  • This broadens the scope of section 77, which previously only applied to certain risk assessments of substances, and will have the resulting effect of broadening the scope of the CEPA time-clock obligation as well.
• Following an assessment of whether a substance is toxic or capable of becoming toxic, the Ministers must propose one of four measures under section 77:
  1. taking no further action – for example if the substance is not toxic;
  2. adding the substance to the Watch List – for example if the substance is of potential concern and requires monitoring (see “Watch List” section below);
  3. recommending that the substance be added to Part 1 of Schedule 1 (see “Prohibiting Toxic Substances that pose the Highest Risk” section below); or
     
  4. recommending that the substance be added to Part 2 of Schedule 1 [clause 21(1)].
• If the proposed measure is a recommendation that the substance be added to Schedule 1 (in other words either (c) or (d) as per above), then the CEPA time-clock obligation is triggered and the Ministers must develop a risk management instrument in relation to the substance [clause 21(2)].
  • The particular risk management approach will differ depending on whether the toxic substance is added to Part 1 (priority to prohibition) or Part 2 (priority to pollution prevention) of Schedule 1 (see “Prohibiting Toxic Substances that pose the Highest Risk” section below).

Timelines for finalizing risk assessment

• If a draft assessment conclusion has not been finalized within 2 years, the Minister must publish a statement in the Environmental Registry indicating the reasons for the delay and an estimated time frame for finalizing the assessment [clause 21(2)].

Timelines for additional planned risk management

Where the Ministers propose to develop more than one risk management instrument in respect of a substance, the Ministers must communicate the timelines for making the additional planned instruments when publishing the first finalized instrument. Any amendments to the statement must be published with reasons, and the Minister must report annually on progress, timelines and any delays in developing additional instruments [clause 22].

Risk management

Pollution prevention (P2) plans

• Amendments allow the Minister to require that the P2 plan prioritize the identification, development or use of safer or more sustainable alternatives to the substance, group of substances or product [clause 10(1)].
• Amendments also allow the Minister to require written progress reports respecting the implementation of a P2 plan [clause 10(4)].

Watch list

• The Minister must publish and maintain a list of substances of potential concern (to be known as the Watch list) due to their hazardous properties for example [clause 20].
• The decision to declare that a substance is “capable of becoming toxic” and add it to the Watch List will be one of the four options under section 77 that the Minister may take following a risk assessment (see “Transparency, Participation and Accountability in Assessment and Management of Risks” section above) [clause 21(1)].
• The Minister must remove a substance from the Watch List if it is added to Schedule 1 or if the Ministers no longer have reason to suspect that it is capable of becoming toxic [clause 20].

Prohibiting toxic substances that pose the highest risk

Generally

The unworkable provisions for virtual elimination (VE) of toxic substances that are persistent and bioaccumulative (PBTs) are repealed and replaced with a new regime that remains risk-based but provides that toxic substances of highest risk should be managed by giving priority to prohibition [various clauses].

• Recall that substances that are found “toxic” under section 64 of CEPA have been assessed as such according to a risk-based process that looks at both hazard and exposure.

The list of toxic substances in Schedule 1 is split into two parts to better implement the two-track approach for managing toxic substances under CEPA [clause 58].

• Toxic substances that are either: (i) persistent and bioaccumulative and inherently toxic (PBiT); (ii) carcinogenic, mutagenic, or toxic for reproduction (CMR); or, (iii) otherwise found to pose the highest risk will be added to Part 1 [clause 21(1), clause 29].
  • Initially, toxic substances on Part 1 will be those that have been found to meet the criteria in the existing Persistence and Bioaccumulation Regulations.
  • Going forward, those regulations will be amended or new regulations made to prescribe additional thresholds for carcinogenicity, mutagenicity and reproductive toxicity (CMR), and any other relevant circumstances or conditions (see proposed regulatory authorities under subsection 67(1)) [clause 15].
  • The Government will engage interested persons in the development of the new regulatory criteria to define toxic substances that pose the highest risk.
• Other toxic substances are added to Part 2 [clause 21(1), clause 29]. 
• Priority is to be given to preventing pollution of all substances added to Schedule 1, either Part 1 or Part 2. For those on Part 1, priority is to be given to prohibition.

Prohibiting PBiTs, CMRs and toxic substances that pose the highest risk

Under the amendments, the Ministers must recommend that PBiTs, CMRs and other toxic substances of highest risk, as defined by regulations made under section 67, be added to the new Part 1 of Schedule 1 [clause 15, clause 21(1)].

When developing risk management instruments in respect of these toxic substances, the Ministers must give priority to the total, partial or conditional prohibition of activities in relation to these substances [clause 29].

• Total prohibition could be implemented as a complete ban or phase out of all activities involving the substance (for example for persistent and bioaccumulative toxic substances in accordance with Canada’s international commitments).
• Partial prohibition could be implemented as a ban or phase out of activities of concern involving the substance, which may be most uses in some cases, with exemptions for critical or essential uses for which there are no feasible alternatives (for example prohibition of all uses except for essential medical uses or other similarly essential uses).
• Conditional prohibition could be implemented such that all new activities involving the substance are prohibited unless the Ministers have specifically authorized the use (for example through 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 summary, the amendments provide that prohibition would be the starting point for risk management of toxic substances added to Part 1 of Schedule 1, while recognizing that more tailored approaches to managing the risks may be needed depending on the substance’s properties or characteristics. As noted above, partial or conditional prohibitions may be more appropriate in some cases, and indeed necessary in other cases. For example, a partial prohibition could prohibit the non-critical use of a toxic substance in cosmetics, while allowing its critical use in pharmaceuticals, and a conditional prohibition might only allow uses of a toxic substance by an authorized person according to the specific terms and conditions set out in a permit issued by the Minister.

Supporting powers

In support of this new priority to be given to prohibition, amendments add a new provision to section 93 (in other words the main regulation-making authority for toxic substances) that explicitly enables ministerial permitting regimes [clause 33(7)].

• This permitting power allows the Minister to require that proponents first demonstrate that a prohibited activity can be undertaken safely and that there are no feasible alternatives before deciding whether to issue a permit authorizing the proponent to undertake the activity according to specific conditions or control measures.
• Permitting decisions by the Minister could also be discretionary under this new authority (this can be contrasted with existing regulatory permitting regimes that require the Minister to issue a permit if prescribed conditions are met).

Other toxic substances

As noted above, for toxic substances that do not meet the regulatory criteria (that is PBiT, CMR, or otherwise of highest risk), the Ministers will continue to recommend that these other toxic substances be added to Part 2 of Schedule 1, and they will continue to be required to give priority to pollution prevention actions (which may include prohibition) when managing the risks posed by those substances [clause 21(1), clause 29].

Application

The amendments to CEPA will not affect products, such as pesticides, which are specifically regulated under other federal Acts, such as the Pest Control Products Act (PCPA). This is consistent with certain frameworks and provisions under CEPA and the best-placed act approach to chemicals management.

As part of this work, the Government of Canada will consider updating its Toxic Substances Management Policy (TSMP). Any updates to the TSMP will be made in consultation with the relevant departments, agencies and interested persons in order to ensure that it is updated in a manner that accommodates the particularities posed by pesticides, for example.

Products that may release a toxic substance

• Information-gathering and regulatory authorities may be exercised in respect of products that may release a toxic substance (even though the products themselves do not contain the toxic substance) [various clauses].
  • New powers will allow control measures that target the design and functioning of products such as portable fuel containers (vis-à-vis the release of volatile organic compounds listed on Schedule 1).

Best-placed act / Best-placed minister

• The Ministers may identify and rely on an existing federal measure under another Act or regulation by clarifying how that measure addresses the risks of a toxic substance that were identified during the risk assessment [clause 21, clause 23, clause 30, clause 31, clause 40].
  • Examples of existing federal measures include the following general prohibitions:
    • subsection 36(3) of the Fisheries Act (prohibition on the deposit of deleterious substances);
    • section 16 of the Food and Drugs Act (prohibition on the sale of cosmetics containing substances that may cause injury); and
    • sections 7 and 8 of the Canada Consumer Product Safety Act (prohibitions on the manufacture, import, advertisement and sale of consumer products that are a danger to human health).
  • Where the Ministers decide to rely on an existing federal measure that addresses the risks identified for a toxic substance, they must make a statement to that effect and outline additional administrative measures that will be taken to ensure it is effective and, in which case, they do not need to develop a new risk management instrument.
• In cases where another federal Act or minister is best placed to manage the risks identified for a toxic substance, a new regulation or instrument can be made under that other federal Act in order to formally fulfill the legal obligation under CEPA to develop a risk management instrument [clause 30, clause 31].
• Similarly, the Minister of Health will be responsible for fulfilling the risk management obligation under CEPA where the Minister of Health will be leading the development and implementation of the new risk management instrument(s) in relation to substances that pose health concerns [clause 30, clause 31].

Renaming Schedule 1

The title of Schedule 1 (in other words “List of Toxic Substances”) is changed to simply “Schedule 1” [various clauses].

Domestic Substances List (DSL)

Power to add Revised In-Commerce List (ICL) substances to the DSL

• The Minister is able to add some substances on Health Canada’s “Revised In-Commerce List” (R-ICL) to the Domestic Substances List (DSL) under CEPA, provided that they are not subject to any risk management [clause 4(1), clause 14, clause 26, clause 28, clause 38, clause 56]. The Revised In-Commerce List is comprised of substances which were in products that were regulated under the Food and Drugs Act (FDA) and that were in Canadian commerce between January 1, 1987 and September 13, 2001.

Power to remove substances no longer in commerce from the DSL

• The Minister is able to remove substances from the Domestic Substances List (DSL) to reflect the fact that they are no longer in Canadian commerce [clause 4(1), clause 13, clause 14, clause 28, clause 38, clause 56].
• In the interests of transparency and fairness, the Minister must publish a notice of the proposed removal in the Canada Gazette and provide for a 60-day comment period [clause 14, clause 39].

New substances, animate products of biotechnology and significant new activities

Varying significant new activity (SNAc) information

The Minister is able to vary elements of a significant activity notice or order beyond the significant new activity itself, such as the data or information that needs to be submitted for evaluation prior to undertaking the activity, as well as the timelines for submitting that information [clause 24, clause 26, clause 41, clause 43].

Downstream communication of significant new activities (SNAc)

• The transferor of a new substance must notify transferees of any obligation to comply with the significant new activity provisions in respect of the new substance. This obligation is extended so that it also applies vis-à-vis any obligation to comply with the significant new activity provisions in respect of existing substances [clause 24, clause 25, clause 26, clause 27, clause 41, clause 42, clause 43, clause 44].
• The Minister is able to tailor the scope of that obligation by specifying, in the SNAc notice or order itself, the class of persons who are not required to be so notified.
  • For example, the Minister may specify that persons downstream of product formulators, such as retailers of finished products, do not need to be notified of the obligation to comply with the SNAc.

Animate products of biotechnology, including living organisms

• Amendments require that the Minister publish a notice of waived information requirements under Part 6 of the Act as soon as possible in the circumstances [clause 39.01].
• Amendments require that the Ministers consult any interested persons when assessing whether a new living organism that is a vertebrate animal, a prescribed living organism or group of living organisms, is toxic or capable of becoming toxic [clause 39.1, clause 44.1].

Amendments to the Food and Drugs Act (FDA)

• Amendments to the Food and Drugs Act (FDA) expand the Minister of Health's ability to manage environmental risks resulting from drugs, and enable the Government of Canada to create an environmental risk assessment and risk management framework for drugs under the FDA (currently limited to health risk) [clause 64, clause 65, clause 66, clause 67].
  • This regime would strengthen the environmental risk assessment and risk management of drugs and remove the duplicate notification process between the FDA and CEPA (for safety, efficacy and quality and environmental risk assessments), creating a more streamlined regulatory approach for industry with respect to the assessment and approval of drugs in Canada.

Information-gathering

Environmental Registry

• Amendments specify that the notices and other documents published or made publicly available by the Ministers or either Minister under CEPA must be published in the Registry [clause 5.1].
• Amendments require that the Registry be publicly accessible, searchable and in electronic form [clause 5.1].

Powers to compel information

• Amendments expand the Minister’s information-gathering authority in section 46 so that it can now be exercised to compel persons to provide information on activities that may contribute to pollution, including hydraulic fracturing and tailings ponds [clause 9(3)].
• Amendments strengthen the Minister’s primary information-gathering authority under section 71 by ensuring that it can be used to specify the methods for quantifying the required information as well as the test procedures or laboratory practices to be followed in performing any required tests including to replace, reduce or refine the use of vertebrate animals [clause 18].
• Amendments also allow the Minister to require supplementary information (for example models or methods used) as well as to require that samples be provided along with test results [clause 18].

Confidential business information (CBI)

• Amendments provide that confidentiality requests made under section 313 must be accompanied by reasons based on criteria set out in paragraphs 20(1)(a) to (d) of the Access to Information Act [clause 50].
• Amendments require that the Minister review a statistically valid representative sample of requests granted to verify that they meet the requirements (if not, they are deemed not to have been made). Amendments also require that the Minister report annually on these requests [clause 50].
• Amendments authorize the Minister to disclose the explicit name of a masked substance when risk management instruments have been put in place for the substance (for example when the significant new activity provisions have been applied to the substance) [clause 51, clause 53].
• Amendments also authorize the Minister to disclose explicit names after 10 years have passed from the date the name was masked, but will give proponents the opportunity to demonstrate that it should nevertheless remain confidential [clause 51, clause 53].
• Amendments require annual reporting on names disclosed under section 317.1 or 317.2 [clause 53].

Note on clause references: the references in this document are to the Bill clauses (in other words the bolded paragraphs in the Bill). There are 74 clauses in the Bill. Each clause may modify several different provisions (for example sections, subsections, paragraphs) of the Act.