Briefing book for Minister Guilbeault’s appearance before the Standing Committee on Environment and Sustainable Development, December 2, 2022

Ministerial questions and answers

Tab 1/2: Ministerial questions and answers

Strengthening the Canadian Environmental Protection Act, 1999 and amendments to the Food and Drugs Act (FDA)

Q1. What is the Canadian Environmental Protection Act, 1999 (CEPA)?

The Canadian Environmental Protection Act, 1999 (CEPA) is one of Canada’s core environmental laws addressing pollution. It allows the Government of Canada to take action to protect Canadians and the environment from the impacts of a wide range of pollution sources, such as:

  • Chemicals;
  • Animate products of biotechnology;
  • Vehicles, engines, and equipment;
  • Hazardous wastes; and
  • Environmental emergencies.

CEPA provides a wide range of authorities that enable the Government to protect the environment and human health through programs administered by Environment and Climate Change Canada and Health Canada, such as the Chemicals Management Plan (CMP) and the Air Quality Management System (AQMS).

CEPA is also the legislative and regulatory basis to implement Canada’s obligations under numerous international environmental agreements, including the Stockholm Convention (persistent organic pollutants), Minamata Convention (mercury), Basel Convention (transboundary movements of hazardous wastes), the London Protocol (marine dumping), and the Rotterdam Convention (prior informed consent for trade in various substances).

Q2. What does this bill actually accomplish?

The amendments include:

  • A proposal to recognize that every individual in Canada has a right to a healthy environment as provided under the Act. This would be paired with an implementation framework, to be developed with the participation of Canadians within two years from the date of Royal Assent.
  • The amendments would also make changes to the chemicals management provisions to:
    • Require the Government to develop a Plan of Chemicals Management Priorities, which will set out an integrated, transparent, multi-year plan for the assessment of substances and the activities and initiatives that support chemicals management, such as information-gathering, risk management, risk communications, research and monitoring;
    • Require the Ministers to consider available information regarding vulnerable populations and cumulative effects in risk assessments;
      • Senate amended Bill S-5 to require the Ministers to also consider available information on vulnerable environments when conducting risk assessments.
    • Create a new regime that will prioritize the prohibition of activities and releases of toxic substances of the highest risk, in accordance with the regulations;
      • Senate amended Bill S-5 to highlight that the new regime for toxic substances of highest risk will include substances that are carcinogenic, mutagenic, or toxic for reproduction.
    • Require the Minister to publish and maintain a list of substances that are capable of becoming toxic (‘Watch List’); and
      • Senate amended Bill S-5 to specify how substances might be removed from the Watch List
    • Improve transparency by, for example, clarifying the framework respecting the disclosure of confidential business information, and requiring that the Ministers communicate timelines for developing additional planned risk management instruments.

The amendments to CEPA would enable adaptation to a changing global chemicals landscape and consideration of new science, while maintaining a stable and predictable regulatory environment for industry and promoting greater transparency for Canadians.

These changes, among others, would ensure that the Government has the right tools to protect human health and the environment. In particular, they would help address disproportionate effects experienced by vulnerable populations and would contribute to a stronger more resilient Canada.

Q3. What is a right to a healthy environment?

For the first time in a federal statute in Canada, CEPA would recognize that every individual in Canada has a right to a healthy environment as provided under the Act.

The meaning of a right to a healthy environment under CEPA will be elaborated on through an implementation framework. The implementation framework will be developed within two years from the date of Royal Assent based on consultations with Canadians. An implementation framework would set out how a right to a healthy environment will be considered in the administration of the Act. The framework would also elaborate on principles such as environmental justice (e.g., avoiding adverse effects that disproportionately affect vulnerable populations) and non-regression (e.g., continuous improvement in environmental protection). The Senate amended Bill S-5 to require that the implementation framework also elaborate on the principle of intergenerational equity, the reasonable limits to which the right is subject, and mechanisms to support the protection of the right.

Applying the lens of a right to a healthy environment in CEPA would support and encourage:

  • Strong environmental and health standards now and in the future;
  • Robust engagement with Canadians; and
  • New thinking about how to protect populations that are particularly vulnerable to environmental and health risks.

Q4. How will the right to a healthy environment be enforced?

Existing mechanisms under CEPA continue to be available to individuals to address concerns regarding environmental harm. CEPA has a robust regime under Part II relating to public participation, investigation of offences, and Environmental Protection Actions. There are also actions to prevent or compensate loss which could arise from conduct that contravenes the Act (i.e., against a defendant causing environmental harm; note that such actions do not exist in relation to the right).

Recognition of a right to a healthy environment will establish a new lens for decision making under CEPA which will ensure that there is continual, progressive improvement in protecting all Canadians and the environment.

The meaning of the right and how it will be considered in the administration of that Act will be developed through consultations with Canadians on the Implementation Framework. This will ensure that the right is meaningful in the CEPA context.

Q5. What does chemical exposure mean for Canadians and the environment?

Chemicals are found in our air, water, food and in the household and commercial products that Canadians and our businesses use routinely. While they can be beneficial and lifesaving, some substances can be harmful to Canadians and the environment at certain exposure levels.

Some harmful effects can be immediate. Others can occur gradually, accumulating in organisms. Some effects may happen over a lifetime of exposure leading to chronic diseases.

Vulnerable populations can be disproportionately impacted by exposure to harmful substances. Where you live, what work you do, as well as age, sex and health status can all make some people have greater exposure or be more susceptible to the hazardous effects of substances than others.

Q6. How will CEPA reform help protect vulnerable populations, including racialized communities?

Vulnerable populations, including racialized communities, may be disproportionately exposed to or negatively impacted by harmful substances due to factors such as, health status, socio-economic status, geography, and cultural practices. In order to address these issues, it is important to understand actual exposure from the multiple substances from different sources to which Canadians are exposed to daily.

As introduced, Bill S-5 proposed amendments to CEPA that would require the Government to consider vulnerable populations and cumulative effects when assessing risks where information is available. Senate amendments added a requirement to consider vulnerable environments. Existing information gathering authorities under CEPA allow the Government to obtain information on vulnerable populations and cumulative effects if additional information is needed to inform risk assessments.

Amendments to CEPA would also require the Government to conduct research and biomonitoring, which may relate to vulnerable populations. Research and biomonitoring would facilitate generating additional data on how exposure to harmful substances impacts vulnerable populations.

Q7. How does strengthening CEPA enhance reconciliation and environmental and health protections for Indigenous peoples and communities?

As introduced, Bill S-5 proposed several amendments to CEPA that would support Indigenous reconciliation and environmental and health protections for Indigenous peoples. The Bill proposed to:

  • Add a new paragraph to the preamble confirming the Government’s commitment to implement the United Nations Declaration on the Rights of Indigenous peoples (UNDRIP);
  • Provide for consultations with Indigenous peoples as part of the development of the Plan of Chemicals Management Priorities and the implementation framework for the right to a healthy environment; and
  • Require biomonitoring and consideration of vulnerable populations and cumulative effects in risk assessments.

Senate amendments to Bill S-5 included additional changes to support Aboriginal reconciliation:

  • Reference to free, prior and informed consent (FPIC) in the preamble;
  • Recognition in the preamble of the role of Indigenous knowledge in decision making; and
  • A requirement to prepare a report every five years on the operation of the Act as it relates to the Aboriginal peoples of Canada.

Q8. How does this strengthening of CEPA address the recommendations of past Parliamentary committees?

Strengthening CEPA responds to recommendations of three parliamentary committee reviews over the past decade, including the latest review by the Standing Committee on Environment and Sustainable Development (ENVI) in 2017. The amendments to CEPA respond to 30 recommendations made by the ENVI Committee in its 2017 report either partially or completely, as well as 23 recommendations from reviews of previous parliamentary committees, including the House and Senate Committees that completed reviews of the Act in 2007 and 2008.

The following key 2017 recommendations are addressed:

  • Environmental rights (e.g., recognizing the right to a healthy environment, strengthening protections for vulnerable populations, increasing transparency, accountability and public participation); and
  • Chemicals management (e.g., improving information-gathering, replacing the virtual elimination regime, expanding the considerations to be taken into account in risk assessment, providing new tools for use in risk management).

Q9. What is virtual elimination and why reform it?

The current virtual elimination (VE) regime was intended to reduce the release of persistent and bioaccumulative substances to below detectable limits. The three parliamentary committees that have reviewed CEPA all agreed that these particular provisions are unworkable. They require actions that are unnecessarily duplicative of other obligations in the Act, as well as actions that are unachievable for technical reasons in many cases.

The VE regime will be replaced by the new requirements to prioritize the prohibition of activities and releases of toxic substances of the highest risk, in accordance with the regulations.The criteria for substances of the highest risk will be set out in regulations, and will include the persistence and bioaccumulation focus of the previous VE regime. The Senate amended Bill S-5 to highlight that the new regime for managing toxic substances that pose the highest risk will apply to substances that are carcinogenic, mutagenic or toxic for reproduction in accordance with future regulations.

Q10. Why establish a Plan of Chemicals Management Priorities?

The assessment of substances on the Domestic Substances List that were identified as priorities in 2006 through the categorization process is almost complete and a new approach is required.

The Bill sets out a framework to develop a new, public process for establishing and communicating chemicals management priorities. This will result in an integrated Plan of Chemicals Management Priorities for a specific period for the assessment of substances as well as other activities to support chemicals management, such as information-gathering, risk management, risk communications, research and monitoring.

In developing and implementing the Plan, the Government will continue to set priorities, and assess and manage substances by taking a risk-based approach. Such an approach takes into account the properties of a substance as well as exposure to the substance and must consider a number of factors of importance to Canadians, including:

  • Vulnerable populations and cumulative effects;
    • Senate amended Bill S-5 to add the concept of a vulnerable environment to the list of matters the Ministers must consider when developing the Plan.
  • 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 (e.g., as a means of avoiding regrettable substitutions);
  • Safer or more sustainable alternatives; and
  • Means of providing information to the public, such as through labeling and other risk communication strategies.

Senate amendments to Bill S-5 included a requirement that the Plan also address animal testing.

Canadians will be consulted to help shape this Plan, and an update on progress will be provided in the annual report on CEPA that is tabled in Parliament.

The first Plan of Chemicals Management Priorities must be published within two years from the date of Royal Assent. Until that time, the Government will continue to complete the assessment and management work associated with the remaining substances that were prioritized according to the categorization requirement, as well as other substances that were identified as priorities through the Government’s more recent Identification of Risk Assessment Priorities (IRAP) approach.

Q11. What is happening to Schedule 1 to CEPA?

The title “List of Toxic Substances” from Schedule 1 to CEPA will be removed. This will address the stigmatizing effect of the word “toxic”, as some substances on this list are not considered toxic in the common understanding of the term but only as it is determined under CEPA (e.g., carbon dioxide). Schedule 1 will be unnamed and divided into two parts:

  1. Toxic substances that pose the highest risk, for which the Act will prioritize the prohibition of activities and releases; and
  2. Other toxic substances.

The Senate amended Bill S-5 to clarify that the risk management objective of pollution prevention applies to all toxic substances on Schedule 1, while prohibition remains the priority objective for toxic substances placed on Part 1 of Schedule 1.

Q12. Why isn’t all of CEPA being amended?

CEPA is a very broad and complex piece of legislation which allows the Government of Canada to take action to protect Canadians from the environmental and human health impacts of a wide range of pollution sources, such as: chemical substances, animate products of biotechnology, vehicles, engines, and equipment, hazardous wastes, disposals at sea and emergencies.

The proposed amendments to CEPA would address key concerns and expectations of Canadians and Parliamentarians, reflect new science, and address gaps.

Q13. What are the next steps for CEPA and Bill S-5?

While strengthening of CEPA marks an important step it is not the last one as sustained efforts to further improve the Act will be ongoing. Should the legislature pass Bill S-5, work to implement its changes will commence. This work would include development of:

  • The Implementation Framework for the right to a healthy environment;
  • A Plan of Chemicals Management Priorities, which will set out a multi-year, integrated plan for the assessment of substances as well as the activities and initiatives that support chemicals management, such as information-gathering, risk management, risk communications, research and monitoring;
  • The Watch list;
  • Associated regulations, such as those respecting substances that pose the highest risk.

Q14. What is the point of the Watch List?

Currently, departments publicly explain findings related to substances of potential concern including hazards associated with the substance. They also track any follow-up actions such as section 71 requirements to notify about significant new activities and other information-gathering or monitoring activities. However, there is no list that is easy-to-access by the public of substances of potential concern that consolidates the follow-up actions for these substances. The Watch List is intended to fill this gap.

The Watch List will also facilitate informed substitution by clearly identifying to producers, supply chain managers and consumers the substances that could meet the CEPA-toxic criteria in the future if the use of the substance changes or new information emerges.

Q15. What is the Food and Drugs Act (FDA)?

The FDA applies to all food, drugs, cosmetics and medical devices sold in Canada, whether manufactured in Canada or imported. The FDA and its regulations help to ensure the safety of and prevent deception in relation to those products by governing their importation, sale, manufacturing and advertising.

Q16. Why is the Food and Drugs Act (FDA) being amended?

Currently, new drugs need to be notified under the FDA for consideration of health risks and their ingredients need to be notified under CEPA for consideration of environmental risks. The amendments to the FDA will enable the Government to move towards creating a modernized environmental risk assessment and risk management framework for drugs under the FDA that would be eligible to be considered for CEPA-equivalency. This would simplify the regulatory process for industry to bring products to the Canadian market, while strengthening the environmental risk assessment and risk management of drugs.

Q17. What purpose will the consultations to enhance supply chain transparency and strengthen mandatory labelling serve?

The Government of Canada is currently consulting interested parties on how it can take action to enhance supply chain transparency and mandatory labelling of substances in products. Launched in March 2022, these consultations are being held using a process designed to foster collaboration among interested parties to help develop solutions through a series of workshops and interactive events that will conclude in fall 2022.

Following completion of the consultations, the Government of Canada will develop and publish a strategy in 2023 to enhance supply chain transparency and labelling for substances in products. The strategy will include regulatory measures and voluntary, collaborative initiatives. Consistent with the “best placed act” approach, the strategy will take into account other federal authorities respecting labelling, such as those under the Canada Consumer Product Safety Act.

Q18. How is the Government addressing issues related to genetically modified organisms?

Part 6 of CEPA provides a framework to regulate the assessment and management of new living organisms, which include Genetically Modified Organisms.

On October 13, 2022, Environment and Climate Change Canada and Health Canada launched consultations to ensure that the New Substance Notification Regulations (Organisms) continue to encourage innovation in the biotechnology sector while protecting human health and the environment.

In addition to regulating products of biotechnology under CEPA, there are several other federal Acts that address uses of biotechnology such as food, feed, probiotics, pesticides and drugs (Feeds Act, Seeds Act, Fertilizers Act, Pest Control Products Act, and the Food and Drugs Act).

In July 2021 the Minister of Innovation, Science and Industry and the Minister of Health published Canada's Biomanufacturing and Life Sciences Strategy (the BLSS).

  • The BLSS outlines an ambitious five pillar approach to grow Canada's capacity to rapidly develop and produce vaccines, with strengthened capabilities across the value chain, in order to improve pandemic readiness and sector growth.
  • One priority area of the BLSS is to enable innovation by ensuring world class regulations so as to address made-in-Canada solutions to global challenges.

Q19. What is the Government’s position on the amendments made in the Senate?

The Government appreciates the work of the Senate of Canada in its consideration of Bill S-5.

The Government supports many of the amendments that were made, for example amendments made to the proposals relating to the right to a healthy environment.

There are a few amendments that the Government will propose be modified to be workable. For example, the amendments to the provisions on substances of highest risk which introduced additional terminology.

There were also some changes that were not in keeping with the principles of the Act – including for example the removal of language that reflects the Rio Declaration Other changes are premature given ongoing consultations, including for example most of the changes made to part 6 of the Act.

The Government will continue to work will all partners and stakeholders to deliver on the important changes contained in Bill S-5.

Clause-by-clause explanations of Bill S-5

Tab 3/4: Clause-by-clause explanations of Bill S-5

(as amended by Senate)

Guide to Interpretation
Blue Amendments to CEPA from Bill S-5 as introduced in February 2022
Red Senate amendments
(NEW) Clause was added in the Senate (NEW)

(Refer to LEGISinfo for Official Bill Text)

Short Title

Clause 1 – Short Title

Bill Text

1 This Act may be cited as the Strengthening Environmental Protection for a Healthier Canada Act.

Plain Language Summary

Clause 1 establishes the short title of the Act.

Amendments to the Canadian Environmental Protection Act, 1999

Clause 2 - Preamble

Bill Text

2 (1) The preamble to the Canadian Environmental Protection Act, 1999 is amended by adding the following after the first paragraph:

Whereas the Government of Canada recognizes that every individual in Canada has a right to a healthy environment as provided under this Act;

(2) The third paragraph of the preamble to the Act is replaced by the following:

Whereas the Government of Canada acknowledges the need to control and manage pollutants and wastes if their release into the environment cannot be prevented;

(3) The preamble to the Act is amended by adding the following after the eighth paragraph:

Whereas the Government of Canada is committed to implementing the United Nations Declaration on the Rights of Indigenous Peoples, including free, prior and informed consent;

(4) The preamble to the Act is amended by adding the following after the ninth paragraph:

Whereas the Government of Canada recognizes the importance of considering vulnerable populations in assessing whether substances are toxic or capable of becoming toxic;

Whereas the Government of Canada recognizes the importance of minimizing the risks posed by exposure to toxic substances and the cumulative effects of toxic substances;

(5) The preamble to the Act is amended by adding the following after the 10th paragraph:

Whereas the Government of Canada recognizes the role of science and Indigenous knowledge in the process of making decisions related to the protection of the environment and human health, as well as the importance of promoting 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;

(6) The 13th paragraph of the preamble to the Act is replaced by the following:

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

Whereas the Government of Canada recognizes the importance of encouraging the progressive substitution of substances, processes and technologies with alternatives that are safer for the environment or human health, when they are economically and technically viable;

Whereas the Government of Canada recognizes the importance of Canadians having information, including by means of the packaging and labelling of products, regarding the risks posed by toxic substances to the environment or to human health;

Plain Language Summary

Clause 2 amends the preamble to the Canadian Environmental Protection Act, 1999 (the Act) to:

  • recognize that every individual in Canada has a right to a healthy environment as provided under the Act;
  • recognize the Government of Canada’s commitment to implementing the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), including free, prior and informed consent;
  • recognize the importance of considering vulnerable populations in risk assessments, and of minimizing the risks posed by the cumulative effects of toxic substances;
  • recognize the Government’s commitment to the role of science and Indigenous knowledge in decision-making, and to replace, reduce or refine the use of animal testing;
  • recognize the importance of encouraging informed substitution, and of Canadians having information regarding the risks posed by toxic substances, including by means of product labelling and packaging; and
  • make consequential amendments to the preamble to remove references to virtual elimination, as a result of the changes made by clause 21 and various others to replace those provisions with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk.

Additional Context

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

Senate Amendments

  • reordered the phrase “reduce, refine or replace” as “replace, reduce or refine” to reflect the order of precedence for the “3 Rs”;
  • added a reference to “Indigenous knowledge” to the paragraph that acknowledges the role of science in decision-making; and
  • added an explicit reference to “free, prior and informed consent” to the paragraph that recognizes the Government’s commitment to implementing UNDRIP.  

Related Clauses

  • Right to a Healthy Environment (see clauses 2, 3, 5 and 7)
  • Vulnerable Populations, Environments and Cumulative Effects (see clauses 2, 3, 4, 8, 16 and 20)
  • Animal Testing (see clauses 2, 3, 15, 16.1, 18, 19)
  • Indigenous Reconciliation (see clauses 2, 57)

Clause 3 – Duties (s.2)

Bill Text

3 (1) Paragraph 2(1)(a) of the Act is replaced by the following:

(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 effective measures to prevent environmental degradation if there are threats of serious or irreversible damage, and

(iii) promotes and reinforces enforceable pollution prevention approaches;

(2) Subsection 2(1) of the Act is amended by adding the following after paragraph (a.1):

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

(3) Subsection 2(1) of the Act is amended by adding the following after paragraph (k):

(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;

Plain Language Summary

Clause 3 amends subsection 2(1) of the Act to:

  • add explicit recognition that the Government of Canada’s duty to exercise its powers in a manner that protects the environment and human health includes the health of vulnerable populations;
  • change the articulation of the precautionary principle in the English version of the paragraph setting out the duty to apply that principle by changing “cost-effective measures” to “effective measures”;
  • add a duty to protect the right of every individual in Canada to a healthy environment as provided under the Act, subject to any reasonable limits; and, 
  • add a duty to encourage the development and incorporation of scientifically justified alternative methods and strategies to replace, reduce or refine the use of vertebrate animals.

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.

Senate Amendments

  • Amended the English version of subparagraph 2(1)(a)(ii) to remove the word “cost-” from the phrase “cost-effective measures” in an attempt to better align the English provision with the French provision, which simply refers to « mesures effectives ».
  • Replaced the qualifier “which right may be balanced with relevant factors, including social, economic, health and scientific factors” with “subject to any reasonable limits”. While the list of factors was removed from this clause, these factors remain important to the reasonable limits. The implementation framework will elaborate on the reasonable limits and how the factors, including social, health, scientific and economic factors, will be considered when assessing reasonable limits;
  • Added a new duty to encourage scientifically justified alternatives to the use of vertebrate animals. This was one of several amendments aimed at replacing, reducing or refining the use of vertebrate animals in toxicity testing.

Related Clauses

  • Vulnerable Populations, Environments (see clauses 2, 3, 4, 8, 16 and 20)
  • Right to a Healthy Environment (see clauses 2, 3, 5 and 7)
  • Animal Testing (see clauses 2, 3, 15, 16.1, 18, 19)

Clause 4 – Definitions (s.3)

Bill Text

4 (1) The portion of the definition substance in subsection 3(1) of the Act after paragraph (d) and before paragraph (e) is replaced by the following:

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

(2) Subsection 3(1) of the Act is amended by adding the following in alphabetical order:

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)

Plain Language Summary

Clause 4 amends subsection 3(1) of the Act to:

  • add a reference to sections 66.1 and 66.2, added by clause 14, to the definition of ‘substance’; and
  • define ‘vulnerable population’.

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, Environments (see clauses 2, 3, 4, 8, 16 and 20)

Clause 5 - Implementation Framework (s. 5.1)

Bill Text

5 The Act is amended by adding the following after the heading of Part 1:

Implementation of Right to a Healthy Environment

Implementation framework

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

Content

(2) The implementation framework, in a manner consistent with the purposes of this Act, shall, among other things, elaborate on

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

(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 reasonable limits to which that right is subject, resulting from the consideration of relevant factors, including social, health, scientific and economic factors; and

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

Consultation

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

Publication

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

Report

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

Plain Language Summary

Clause 5 adds section 5.1 to the Act to:

  • require the Ministers to develop an implementation framework that sets out how the right to a healthy environment will be considered in the administration of the Act; and
  • require that the implementation framework elaborate on, among other things:
    • the principles to be considered in the administration of the Act, such as the principles of environmental justice, non-regression; and intergenerational equity;
    • research, studies or monitoring activities to support the protection of the right to a healthy environment;
    • the reasonable limits to which that right is subject, resulting from the consideration of relevant factors, including social, health, scientific and economic factors; and
    • the mechanisms to support the protection of that right.

Additional Context

Section 5.1 of the Act also provides a timeline for the development and publication of the implementation framework as well as requirements respecting consultations and annual reporting.

Senate Amendments

  • As in section 2(1), the language of “balancing” was replaced with “reasonable limits”, so that the implementation framework will elaborate on the reasonable limits to which the right is subject resulting from consideration of relevant factors, rather than on how the right will be balanced with relevant factors; and
  • Added a requirement that the implementation framework elaborate on how the principle of intergenerational equity will be considered in the administration of CEPA, along with a requirement to elaborate on the mechanisms to support the protection of the right.

Related Clauses

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

Clause 5.1 (NEW) – Registry (s.13)

Bill Text

5.1 (1) Subsection 13(1) of the Act is amended by striking out “and” at the end of paragraph (b), by adding “and” at the end of paragraph (c), and by adding the following after that paragraph:

(d) for each substance on the Domestic Substances List,

(i) every action, process, decision, assessment, request or activity — however called — that is carried out in relation to the substance under any provision of this Act, whether it has occurred, is in progress, or is proposed, and

(ii) every international instrument to which Canada is a signatory that applies in respect of that substance.

(2) Subsection 13(2) of the Act is replaced by the following:

Form and manner of Environmental Registry

(2) The Minister may determine the form of the Environmental Registry and how it is to be kept, so long as the registry is maintained in the form of a publicly accessible and searchable electronic database.

Plain Language Summary

Clause 5.1 amends section 13 of the Act to:

  • specify information that must be published in the Environmental Registry for substances on the Domestic Substances List; and
  • require that the Minister maintain the Environmental Registry as a publicly accessible and searchable electronic database.

Additional Context

Section 12 of the Act establishes the Environmental Registry. Section 13 describes the documents that the Minister must publish in the Registry.

Senate Amendments

As introduced, Bill S-5 did not propose any changes to the Environmental Registry. The Senate amendments to section 13 add new requirements related to information the Minister must publish, and how the Minister must maintain the Registry.

Related Clauses

  • Notices of Consultations, Decisions (see clause 55)

Clause 6 - Additional Rights (s.15)

Bill Text

6 Section 15 of the Act is replaced by the following:

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.

Plain Language Summary

Clause 6 amends section 15 of the Act to:

  • remove a reference to the Priority Substances List and associated provisions, repealed by clause 20 and various others; and
  • add a reference to the right to request that a substance be assessed under section 76 as amended by clause 20.

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)

Clause 7 – Protection of Right to a Healthy Environment (s.44)

Bill Text

7 Section 44 of the Act is amended by adding the following after subsection (3):

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).

Plain Language Summary

Clause 7 adds subsection 44(3.1) to the Act to require that the Ministers conduct research, studies or monitoring activities to support the Government in protecting the right to a healthy environment under the Act referred to in paragraph 2(1)(a.2), as amended by clause 3.

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)

Clause 8 – Biomonitoring and Vulnerable Populations (s.45)

Bill Text

8 (1) Paragraph 45(a) of the Act is replaced by the following:

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

(2) Section 45 of the Act is renumbered as subsection 45(1) and is amended by adding the following:

Vulnerable populations

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

Plain Language Summary

Clause 8 amends section 45 of the Act to:

  • specify that biomonitoring surveys are included in the research and studies that the Minister of Health is required to conduct under paragraph 45(1)(a); and
  • add subsection 45(2), which provides that such research and studies may relate to vulnerable populations.

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, Environments (see clauses 2, 3, 4, 8, 16 and 20)

Clause 9 – Notice Requiring Info (s.46)

Bill Text

9 (1) Paragraph 46(1)‍(a) of the Act is replaced by the following:

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

(2) Subsection 46(1) of the Act is amended by adding the following after paragraph (e):

(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;

(3) Subsection 46(1) of the Act is amended by adding the following after paragraph (k):

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

(k.‍2) hydraulic fracturing;

(k.3) tailings ponds;

Plain Language Summary

Clause 9 amends subsection 46(1) of the Act to:

  • replace a reference in paragraph 46(1)(a) to the Priority Substances List, repealed by clause 20, with a reference to the plan of priorities that the Ministers are required to develop under section 73 as amended by clause 19;
  • add paragraph 46(1)(e.1), which broadens the scope of the Minister’s information gathering power so that it may be exercised in respect of products that contain or that may release a toxic substance into the environment; and
  • add paragraphs 46(1)(k.1), 46(1)(k.2) and 46(1)(k.3) which broadens the scope of the Minister’s information gathering power so that it may be exercised in respect of activities that may contribute to pollution, hydraulic fracturing and tailings ponds.

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.

Senate Amendments

References to “hydraulic fracturing” and “tailings ponds” were added as subjects for information gathering.

Related Clauses

  • Plan of Chemicals Management Priorities (see clause 19)
  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 10 – Requirement Pollution Prevention Plans (s.56)

Bill Text

10 (1) Subsection 56(1) of the Act is replaced by the following:

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.

(1.‍1) Subsection 56(1) and the portion of subsection 56(2) of the Act before paragraph (a) are replaced by the following:

Requirement for pollution prevention plans

56 (1) The Minister may

(a) identify every person or group of persons that manufactures, imports, processes or releases, or that uses in a commercial manufacturing or processing activity,

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

(ii) a substance or group of substances to which subsection 166(1) or 176(1) applies, or

(iii) a product that contains a substance or group of substances specified on the list of toxic substances in Schedule 1 or that may release such a substance or group of substances into the environment; and

(b) publish in the Canada Gazette, and in any other manner that the Minister considers appropriate, a notice requiring any person or class of persons identified by the Minister to prepare and implement a pollution prevention plan in respect of a matter referred to in subparagraphs (a)‍(i) to (iii).

Publication

(1.‍1) For the purpose of identifying the persons or groups of persons referred to in paragraph (1)‍(a), the Minister may publish in the Canada Gazette, and in any other manner that the Minister considers appropriate, a notice requiring any person or group of persons described in the notice to provide the Minister with any information that may be in their possession or to which they may reasonably be expected to have access, including information regarding their engagement in any activity involving a matter referred to in subparagraphs (1)‍(a)‍(i) to (iii).

Contents of notice

(2) The notice referred to in paragraph (1)‍(b) may specify

(2) Paragraph 56(2)(a) of the Act is replaced by the following:

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

(2.‍1) Subsection 56(5) of the Act is replaced by the following:

Application for waiver

(5) On written request of a person who is the subject of a notice under paragraph (1)‍(b), the Minister may waive the requirement for that person to consider a factor specified under paragraph (2)‍(c) if the Minister is of the opinion that it is not reasonable or practicable to consider the factor on the basis of reasons provided in the request.

Plain Language Summary

Clause 10 amends section 56 of the Act:

  • extend the scope of the Minister’s pollution prevention planning authority so that it may be exercised in respect of products that contain or that may release a toxic substance into the environment;
  • allow the Minister to publish a notice in the Canada Gazette identifying users, manufacturers and importers (etc.) of certain substances and require those identified to prepare a pollution prevention plan; and
  • allow the Minister to publish a notice requiring identified persons to provide the Minister with requested information.

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.

Senate Amendments

As introduced, clause 10(1) replaced subsection 56(1). The Senate added clause 10(1.1) which also replaces subsection 56(1). Thus, the Bill contains two subsections 56(1), with a different content.

The version of subsection 56(1) that the Senate added allows the Minister to identify users, manufacturers, and importers (etc.) of certain substances and require information from them. The Minister would have the authority to publish a notice requiring identified persons to prepare and implement a pollution prevention plan.

Related Clauses

  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 10.1 (NEW) - Declaration of Preparation – consequential amendment (s.58)

Bill Text

10.‍1 Subsection 58(1) of the Act is replaced by the following:

Declaration of preparation

58 (1) Every person who is required to prepare a pollution prevention plan under section 56 or 291 or under an agreement in respect of environmental protection alternative measures shall file, within 30 days after the end of the period for the preparation of the plan specified in the notice referred to in paragraph 56(1)(b) or extended under subsection 56(3), or specified by the court under section 291 or in the agreement, as the case may be, a written declaration to the Minister that the plan has been prepared and is being implemented.

Plain Language Summary

Clause 10.1 makes a consequential amendment to subsection 58(1) of the Act. It specifies paragraph 56(1)(b) in the text of subsection 58(1), which clause 10(1.1) added to section 56.

Additional Context

Under subsection 58(1), persons that are required to prepare a pollution prevention plan must submit a written declaration to the Minister that the plan was prepared and is being implemented.  

Senate Amendments

The Senate amended subsection 58(1) to add a reference to paragraph 56(1)(b) as a result of changes clause 10 made to section 56. Clause 10 added paragraph 56(1)(b) to section 56 which allows the Minister to publish a notice requiring identified persons to prepare a pollution prevention plan. Subsection 58(1) of the Act currently references subsection 56(1), not paragraph 56(1)(b).

Related Clauses

  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 11 – Requirement to Submit Certain Plans consequential amendment (s.60)

Bill Text

11 Subsection 60(1) of the Act is replaced by the following:

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.

Plain Language Summary

Clause 11 makes a consequential amendment to subsection 60(1) of the Act to add a reference to ‘product’, as a result of the changes made to subsections 56(1) and (2) by clause 10.

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, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 11.1 (NEW) - Requirement to submit Certain Plans – consequential amendment (s. 60)

Bill Text

11.‍1 Subsection 60(1) of the Act is replaced by the following:

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 who is the subject of a notice under paragraph 56(1)‍(b) 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.

Plain Language Summary

Clause 11.1 makes a consequential amendment to subsection 60(1) of the Act to add a reference to paragraph 56(1)(b) to the text.

Additional Context

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

Senate Amendments

As introduced, clause 11 replaced subsection 60(1). The Senate added clause 11.1, which also replaces subsection 60(1). Thus, the Bill contains two subsections 60(1), with a different content..

Clause 11.1 amended subsection 60(1) to add a reference to paragraph 56(1)(b). Clause 10(1.1) added paragraph 56(1)(b) to section 56 which allows the Minister to publish a notice requiring identified persons to prepare a pollution prevention plan. Subsection 60(1) currently references section 56, not paragraph 56(1)(b).

Related Clauses

  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 12 – Virtual Elimination (repealed) (s. 65 and 65.1)

Bill Text

12 Sections 65 and 65.1 of the Act are repealed.

Plain Language Summary

Clause 12 repeals sections 65 and 65.1 of the Act.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Clause 13 – Domestic Substances List (s. 66)

Bill Text

13 (1) The portion of subsection 66(1) of the Act before paragraph (a) is replaced by the following:

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,

(2) Paragraph 66(2)(a) of the Act is replaced by the following:

(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

Plain Language Summary

Clause 13 amends subsection 66(1) of the Act to:

  • remove references to sections 73 and 74, which required that the Ministers categorize and assess the substances on the Domestic Substances List according to whether they presented the greatest potential for exposure or were persistent or bioaccumulative and inherently toxic, and which are replaced by clause 19 and no longer relevant to subsection 66(1); and
  • add a reference to subsection 66.2(1), added by clause 14, which is an authority allowing the Minister to delete substances from the DSL.

It also makes a consequential amendment to paragraph 66(2)(a) to provide that the Minister’s obligation to add certain substances to the Non-domestic Substances List does not apply to substances that are deleted from the Domestic Substances List pursuant to the Minister’s new power under subsection 66.2(1), added by clause 14.

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).

Substances on the NDSL which are notified as new substances under CEPA are subject to reduced data requirements versus substances that are notified and not listed on the NDSL. This is a concession put forward to reduce trade barriers, while upholding the general intent of CEPA.

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)

Clause 14 – Domestic Substances List – Food and Drugs Act (s.66.1 and 66.2)

Bill Text

14 The Act is amended by adding the following after section 66:

Domestic Substances List — Food and Drugs Act

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

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

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

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

Amendment of Lists

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

Designation

(3) The Minister may, by order, designate any person or class of persons to exercise the powers and perform the duties and functions set out in this section.

Amendment of Lists

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

Publication — notice of intent

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

Comments

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

Designation

(4) The Minister may, by order, designate any person or class of persons to exercise the powers and perform the duties and functions set out in this section.

Plain Language Summary

Clause 14 adds section 66.1 to the Act to enable the Minister to add substances that are on Health Canada’s Revised In Commerce List published in Canada Gazette Nov 3, 2019 to the Domestic Substances List, and to remove such substances from the Non-domestic Substances List.  

It also adds section 66.2 to the Act to enable the Minister to remove substances that are no longer in Canadian commerce from the Domestic Substances List, and to add such substances to the Non-domestic Substances List.

Additional Context

Section 66.1

The Revised In Commerce List (R-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). The R-ICL is administrative and based on historical use of substances between 1987 and 2001. The list is periodically revised to reflect updates and corrections. The substances’ absence from the DSL but continued listing on the administrative R-ICL creates legal ambiguity about the status of these substances.  It can also 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 express authority in the Act enabling the Minister to remove substances that are no longer in Canadian commerce from the DSL.

Section 66.2 clarifies that the Minister has 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)

Clause 15 – Regulation of Criteria (s.67)

Bill Text

15 (1) Paragraph 67(1)(a) of the Act is replaced by the following:

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

(2) Subsection 67(1) of the Act is amended by striking out “and” at the end of paragraph (c), by replacing paragraph (d) with the following:

(d) respecting the conditions, test procedures and laboratory practices to be followed for analysing, testing or measuring the property or characteristic, including procedures and practices 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 is carcinogenic, mutagenic, toxic to reproduction or poses other risks of highest concern.

Plain Language Summary

Clause 15 amends subsection 67(1) of the Act to:

  • add carcinogenicity, mutagenicity and reproductive toxicity to the list of properties or characteristics of a substance in paragraph 67(1)(a) in respect of which the Governor in Council may make regulations;
  • add paragraph 67(1)(d), which provides that the regulation-making authority in paragraph 67(1)(d) may be exercised to prescribe procedures and practices for replacing, reducing or refining the use of vertebrate animals; and
  • add paragraph 67(1)(e), which provides the Governor in Council with the authority to make regulations respecting the classification of a substance as a substance that is carcinogenic, mutagenic, toxic to reproduction or poses other risks of highest concern for the purpose of subsection 77(3) as amended by clause 21.

Additional Context

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

As introduced in Bill S-5, the expanded regulatory authorities under paragraphs 67(1)(e) and (a), respectively, enable the making of 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.

Senate Amendments

Amendment made by the Senate to paragraph 67(1)(e) shifts the focus from “risk” to “concern.” Subsection 77(3), the operative provision to which paragraph 67(1)(e) relates, maintains a focus on risk.

As introduced, Bill S-5 did not propose changes regarding animal testing to the regulation-making authority in section 67 of the Act. The Senate amendment to paragraph 67(1)(d) clarifies that this authority can also be used to prescribe procedures and practices for replacing, reducing or refining the use of vertebrate animals.

Related Clauses

  • Prohibiting Toxic Substances that Pose the Highest Risk/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
  • Animal Testing (see clauses 2, 3, 15, 16.1, 18, 19)

Clause 16 – Research, Investigation, Evaluation (s.68)

Bill Text

16 (1) The portion of section 68 of the Act before subparagraph (a)‍(i) is replaced by the following:

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

(2) Paragraph 68(a) of the Act is amended by adding the following after subparagraph (iii):

(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,

(3) Subparagraphs 68(a)‍(v) and (vi) of the Act are replaced by the following:

(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,

(4) Subparagraph 68(a)‍(xii) of the Act is replaced by the following:

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

(5) Paragraph 68(a) of the Act is amended by striking out “and” at the end of subparagraph (xiii), by adding “and” at the end of subparagraph (xiv) and by adding the following after subparagraph (xiv):

(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;

(6) Paragraph 68(c) of the Act is replaced by the following:

(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.

Plain Language Summary

Clause 16 amends section 68 of the Act to broaden the scope of the Ministers’ research, investigation and evaluation powers so that they may be exercised in respect of products that contain or that may release a substance into the environment.

It also amends paragraph 68(a) of the Act to add the following items to the list of matters in respect of which the Ministers may collect or generate data or conduct investigations, and that the Ministers must consider when developing and implementing the plan of priorities required under section 73 as amended by clause 19:

  • cumulative effects;
  • vulnerable populations or environments;
  • carcinogenic, mutagenic or neurotoxic effects;
  • endocrine disrupting effects;
  • safer or more sustainable alternatives; and
  • product labelling.

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.

Senate Amendments

The Senate added the concept of a “vulnerable environment” to the list of matters which the Ministers may collect or generate data or conduct investigations, and that the Ministers must consider when developing and implementing the plan of priorities under section 73.

Related Clauses

  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)
  • Plan of Chemicals Management Priorities (see clause 19)
  • Vulnerable Populations, Environments and Cumulative Effects (see clauses 2, 3, 4, 8, 16 and 20)

Clause 16.1 (NEW) - Restriction – Vertebrate Animals (s. 68.1)

Bill Text

16.‍1 The Act is amended by adding the following after section 68:

Restriction – vertebrate animals

68.1 (1) The Ministers shall not generate data or conduct investigations using vertebrate animals for the purpose of assessing

(a) whether a substance is toxic or capable of becoming toxic; or

(b) either the need to or the manner in which to control

(i) a substance, or

(ii) a product that contains a substance, or

(iii) a product that may release a substance into the environment, including a substance specified on the List of Toxic Substances in Schedule 1.

Exceptions

(2) Subsection (1) does not apply if

(a) it is not reasonably possible to obtain the data or to conduct the investigation by methods other than using vertebrate animals; and

(b) the data or investigation is necessary to achieve objectives related to protecting the environment or human health.

Plain Language Summary

Clause 16.1 adds section 68.1 to the Act. It prohibits the Ministers from generating data or conducting investigations using vertebrate animals unless it is not reasonably possible to do so otherwise and the data or investigation is necessary.

Additional Context

As introduced, Bill S-5 did not propose changes regarding animal testing to the Ministers’ research powers under section 68 of the Act. Bill S-5 only proposed to add a paragraph to the preamble regarding animal testing.

Senate Amendments

Following this Senate amendment, the Ministers would first need to demonstrate that it is not reasonably possible to obtain the data or conduct investigations without the use of vertebrate animals before undertaking any research that involves animals.

Related Clauses

  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)
  • Plan of Chemicals Management Priorities (see clause 19)
  • Animal Testing (see clauses 2, 3, 15, 16.1, 18, 19)

Clause 17 – Guidelines (s. 69)

Bill Text

17 (1) Subsection 69(2.1) of the Act is replaced by the following:

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).

(2) Subsection 69(3) of the English version of the Act is replaced by the following:

Guidelines public

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

Plain Language Summary

Clause 17 amends section 69 of the Act to correct two minor inconsistencies.

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.

Clause 18 – Notice for Info, Samples, Testing (s.71)

Bill Text

18 (1) The portion of subsection 71(1) of the Act before paragraph (b) is replaced by the following:

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;

(2) Paragraph 71(1)‍(c) of the Act is replaced by the following:

(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.

(3) The portion of subsection 71(2) of the English version of the Act before paragraph (a) is replaced by the following:

Contents of notice under paragraph (1)‍(b)

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

(4) Paragraph 71(2)‍(a) of the Act is replaced by the following:

(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;

(5) Subsection 71(2) of the Act is amended by adding “and” at the end of paragraph (b) and by adding the following after that paragraph:

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

(6) Section 71 of the Act is amended by adding the following after subsection (2):

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

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

Contents of notice under paragraph (1)(c)

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

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

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

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

(2.3) The notice sent under paragraph (1)(c) may, among other things, specify

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

(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.

(7) Subsection 71(4) of the English version of the Act is replaced by the following:

Extension of time

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

Plain Language Summary

Clause 18 amends section 71 of the Act to:

  • broaden the scope of the Minister’s information gathering power so that it may be exercised in respect of products that contain or that may release a substance into the environment;
  • provide that the Minister may specify methods for quantifying requested information, conditions, procedures for conducting requested tests, as well as the manner in which information, samples or test results are to be submitted;
  • provide that the Minister may specify the conditions, methods, tests procedures and laboratory practices to be followed to replace, reduce or refine the use of vertebrate animals when performing the required test; and
  • provide that the Minister may request information on the methods used to quantify requested information and on the procedures followed when conducting requested tests.

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.

Senate Amendments

Bill S-5 (as introduced) added to the Minister of Environment’s information-gathering power under section 71 by ensuring that the Minister can specify the conditions, methods, test procedures and laboratory practices to be followed in performing any required tests. The Senate amended paragraph 71(1)(c) to clarify that a notice requiring that a person conduct toxicological or other tests may specify conditions, methods, test procedures and laboratory practices to be followed to replace, reduce or refine the use of vertebrate animals.

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)
  • Animal Testing (see clauses 2, 3, 15, 16.1, 18, 19)

Clause 19 – Plan of Priorities (s. 72, 73, 74)

Bill Text

19 Sections 72 to 74 of the Act are replaced by the following:

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

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

Substances and Assessments of Substances

Plan — priorities

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

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

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

(c) that specifies activities or initiatives to promote the development and implementation of methods not involving the use of vertebrate animals that would provide information sufficient for assessing risks to health or the environment posed by substances assessed under this Part.

Review

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

Consultation and considerations

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

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

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

Publication of proposed plan

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

Comments

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

Consideration of comments

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

Publication of plan

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

Application

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

Report to Parliament

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

Plain Language Summary

Clause 19 makes a consequential amendment to section 72 of the Act to add a reference to ‘a product that contains a substance or a product that may release a substance into the environment’, as a result of the changes made to subsection 71(1) by clause 18.

It also repeals and replaces sections 73 and 74 of the Act, provisions respecting the categorization exercise, with requirements that the Ministers develop, consult on and publish a plan of priorities respecting substance assessments and complementary activities or initiatives. The Plan must also specify activities or initiatives to promote the development and implementation of methods not involving the use of vertebrate animals. The Ministers must also report annually to Parliament on their progress implementing the Plan.

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. As of November 2022, the Government has addressed approximately 95% (4144/4363 substances),  therefore, 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.

Senate Amendments

The Senate added a requirement that the Plan specify activities or initiatives to promote the development and implementation of methods not involving the use of vertebrate animals for substances assessed under Part 5.

The Senate amended paragraph 73(3)(b) to clarify that one of the advantages of class-based assessments can be to help avoid cases of “regrettable substitution”.

Related Clauses

  • Products that Contain or that May Release a Toxic Substance (see clauses 9, 10, 10.1, 11, 11.1, 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)

Clause 20 – List of Substances Capable of Becoming Toxic (Watchlist) (s. 75.1, 76)

Bill Text

20 Sections 76 and 76.‍1 of the Act are replaced by the following:

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

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

Form and manner

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

Weight of evidence and precautionary principle

76.‍1 (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.

Plain Language Summary

Clause 20 adds section 75.1 to the Act to:

  • require that the Minister compile and maintain a list of substances that are capable of becoming toxic; and
  • sets out when a substance may be removed from the list of substances that are capable of becoming toxic (‘Watch List’).

It also amends section 76 of the Act to:

  • repeal provisions respecting the Priority Substances List, which has not been used in the more than twenty years that the Act has been in force;
  • provide any person with a right to request that a substance be assessed.

It also amends section 76.1 of the Act to require that the Ministers consider available information on vulnerable populations, vulnerable environments and cumulative effects on human health and the environment when conducting and interpreting the results of certain risk assessments.

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.

As introduced, clause 20 amended section 76 of the Act to allow any person to 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.

As introduced, clause 20 amended section 76.1 of the Act to 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.

Senate Amendments

Section 75.1 was amended by the Senate to clarify that the Minister can remove substances from the Watch List once added to Schedule 1. 

Section 76.1 was amended by the Senate to require the Ministers to consider available information on vulnerable environments, in addition to considering available information on cumulative effects and vulnerable populations.

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, Environments and Cumulative Effects (see clauses 2, 3, 4, 8, 16 and 20)

Clause 21 – Publication after Assessment or Review (s. 77)

Bill Text

21 (1) Subsections 77(1) to (4) of the Act are replaced by the following:

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.

(2) Subsections 77(6) to (8) of the Act are replaced by the following:

Publication of final decision

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

(a) a summary of the assessment or of the review, as the case may be, 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

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

(3) Subsection 77(9) of the Act is replaced by the following:

Recommendation to Governor in Council

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

Plain Language Summary

Clause 21 amends section 77 of the Act to:

  • broaden its scope of application so that it applies to a larger subset of substance assessments;
  • allow the risks associated with certain toxic substances to be managed by preventive or control actions under another federal statute;
  • allow the Ministers to propose that a substance be added to the list of substances that are capable of becoming toxic in section 75.1, added by clause 20;
  • clarify the new toxic substances regime will address carcinogens, mutagens and reproductive toxicants; and
  • replace provisions respecting virtual elimination with a requirement on the Ministers to propose that toxic substances that are persistent and bioaccumulative or that pose the highest risk be added to Part 1 of Schedule 1, as amended by clause 58.

It also makes consequential amendments to section 77 of the Act to remove references to screening assessments and the Priority Substances List, as a result of the changes made to sections 73 and 74 by clause 19, and the changes made to section 76 by clause 20, respectively.

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:

  • taking no further action;
  • adding the substance to the “Watch List” (e.g. if the substance is of potential concern and requires monitoring);
  • 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
  • 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 of pollution prevention will apply for all toxic substances on Schedule 1 but priority shall be given to prohibition for toxic substances on Part 1 of Schedule 1.

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.

Senate Amendments

Subsection 77(3) was restructured in the Senate to clarify that the new regime for toxic substances will address substances that are carcinogens, mutagens and reproductive toxicants.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Clause 22 – Susbsequent Regs or Instruments (s. 78, 79)

Bill Text

22 Sections 78 and 79 of the Act are replaced by the following:

Subsequent regulations or instruments

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

Amendments to statement

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

Plain Language Summary

Clause 22 amends section 78 of the Act to replace provisions respecting the Priority Substances List with a requirement on the Ministers to commit to and communicate timelines for developing any additional planned risk management instruments in respect of toxic substances that are recommended to be added to Schedule 1.

It also repeals section 79 of the Act.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Clause 23 – Expiry of Prohibition (s.84)

Bill Text

23 Subsection 84(4) of the Act is replaced by the following:

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.

Plain Language Summary

Clause 23 amends subsection 84(4) of the Act to provide for additional types of regulations that can be made to replace an interim ministerial prohibition imposed under paragraph 84(1)(b), including regulations that are made under another federal Act.

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)

Clause 24 – Notice – Significant New Activity (s.85)

Bill Text

24 Subsections 85(2) and (3) of the Act are replaced by the following:

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).

Plain Language Summary

Clause 24 amends section 85 of the Act to:

  • allow the Minister to specify in a significant new activity notice, for the purpose of subsection 86(2), persons that are not required to be notified under subsection 86(1); and
  • allow the Minister to vary any part of a significant new activity notice.

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)

Clause 25 – Downstream Notifications – Significant new activity (s.87.1)

Bill Text

25 Section 86 of the Act is renumbered as subsection 86(1) and is amended by adding the following:

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.

Plain Language Summary

Clause 25 adds subsection 86(2) to the Act to exclude specified persons from the requirement to be notified under subsection 86(1) of a significant new activity in respect of a new chemical substance when such a substance is transferred to them.

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)

Clause 26 – Amendments List – Significant new activity (s.87)

Bill Text

26 Subsections 87(3) and (4) of the Act are replaced by the following:

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

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).

Plain Language Summary

Clause 26 amends section 87 of the Act to:

  • allow the Minister to specify in a significant new activity publication, for the purpose of subsection 87.1(2), persons that are not required to be notified under subsection 87.1(1); and
  • allow the Minister to vary any part of a significant new activity publication.

It also makes a consequential amendment to subsection 87(3) of the Act to add a reference to subsection 66.1(1), added by clause 14.

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)

Clause 27 – Downstream Notifications – SNACs (s.86)

Bill Text

27 The Act is amended by adding the following after section 87:

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.

Plain Language Summary

Clause 27 adds section 87.1 to the Act to impose an obligation, analogous to the obligation in section 86, but that applies in respect of significant new activities that involve existing chemical substances. 

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)

Clause 28 – Regulations – consequential amendment (s.89)

Bill Text

28 Paragraph 89(1)(k) of the Act is replaced by the following:

(k) generally for carrying out the purposes and provisions of sections 66 to 66.2 and 80 to 88.

Plain Language Summary

Clause 28 makes a consequential amendment to paragraph 89(1)(k) of the Act, to add a reference to sections 66.1 and 66.2, added by clause 14.

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)

Clause 29 – Addition to Schedule 1 (s.90)

Bill Text

29 Subsections 90(1) to (2) of the Act are replaced by the following:

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 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.

Plain Language Summary

Clause 29 amends subsection 90(1.1) of the Act to:

  • clarify that the risk management objective of pollution prevention applies to all toxic substances on Schedule 1; and
  • require that the Ministers prioritize the prohibition of activities and releases of toxic substances that are added to the new Part 1 of Schedule 1.

It also adds subsection 90(1.2) to the Act to provide the Ministers with factors that must be considered as part of the requirement to prioritize activities and releases of those toxic substances.

It also makes consequential amendments to subsections 90(1) and (2) of the Act to reflect the bifurcation of Schedule 1, as a result of the changes made by clause 58.

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.

As introduced, Bill S-5 amended subsection 90(1.1) to require that the Ministers prioritize prohibition for activities and releases of toxic substances added to Part 1 of Schedule 1.

  • 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.

As introduced, Bill S-5 added subsection 90(1.2) to the Act to assist with determining the particular approach to take with developing regulations or instruments in subsection 90(1.1). Subsection 90(1.2) provided that the Ministers could consider relevant factors, such as whether the activity or release could be undertaken safely and whether there were feasible alternatives to the substance.

Senate Amendments

Subsection 90(1.1) was amended by the Senate to clarify that the Ministers must prioritize pollution prevention actions for all toxic substances on Schedule 1.

Language in subsection 90(1.2) was adjusted to make it mandatory to consider certain factors.

Related Clauses

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

Clause 30 – Publication of Proposed RM measures (s. 91)

Bill Text

30 Subsections 91(1) to (5) of the Act are replaced by the following:

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).

Plain Language Summary

Clause 30 amends section 91 of the Act to provide that a regulation or instrument respecting preventive or control actions that is required to be proposed under that section may be proposed to be made under another federal Act, and to provide for the rules and process that apply in such a case.

It also amends section 91 of the Act to provide that the requirement to propose a regulation or instrument respecting or control actions does not apply in respect of:

  • a substance that is already on Schedule 1 and is moved from one part to the other; or
  • a substance in relation to which the Ministers have published a statement under subparagraph 77(6)(c)(ii), as amended by clause 21, identifying another federal Act, regulation or instrument and indicating the manner in which the substance is regulated by it.

It also makes consequential amendments to section 91 of the Act to

  • reflect the bifurcation of Schedule 1, as a result of the changes made by clause 58; and
  • repeal provisions related to virtual elimination, as a result of the changes made by clause 21 and various others to replace those provisions with a new risk-based regime focused on prohibiting toxic substances that pose the highest risk.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
  • Renaming and Bifurcating Schedule 1 (see clause 58)

Clause 31 – Publication of Risk Management measures – consequential amendment (s.92)

Bill Text

31 Subsection 92(1) of the Act is replaced by the following:

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.

Plain Language Summary

Clause 31 makes consequential amendments to subsection 92(1), as a result of the changes made to section 91 by clause 30.

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)

Clause 32 – Regulations – Virtual Elimination (s.92.1)

Bill Text

32 Section 92.1 of the Act is repealed.

Plain Language Summary

Clause 32 repeals section 92.1 of the Act.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Clause 33 – Regulations (s.93)

Bill Text

33 (1) The portion of subsection 93(1) of the Act before paragraph (a) is replaced by the following:

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,

(2) Paragraphs 93(1)(f) and (g) of the Act are replaced by the following:

(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;

(3) Paragraph 93(1)(i) of the Act is replaced by the following:

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

(4) Paragraphs 93(1)(l) to (s) of the Act are replaced by the following:

(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;

(5) Paragraphs 93(1)(u) and (v) of the Act are replaced by the following:

(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;

(6) Paragraph 93(1)(w) of the English version of the Act is replaced by the following:

(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;

(7) Subsection 93(5) of the Act is replaced by the following:

Powers of Minister

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

Statutory Instruments Act

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

Plain Language Summary

Clause 33 amends section 93 of the Act to:

  • broaden the scope of the Governor in Council’s regulation making authorities in subsection 93(1) so that they may be exercised in respect of products that contain or that may release a substance into the environment;
  • correct minor oversights in subsection 93(1) by adding the term ‘exported’ to paragraphs 93(1)(f), (g) and (i), and the term ‘manufacture’ to paragraph 93(1)(m); and
  • clarify that regulations made under section 93 may include ministerial permitting regimes.

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, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)
  • Corresponding amendment to analogous provision under Part 9 of the Act (see clause 46)

Clause 34 – Interim Orders significant danger human health or environment – consequential amendment (s.94)

Bill Text

34 (1) Subsection 94(1) of the Act is replaced by the following:

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.

(2) Paragraph 94(5)(b) of the Act is replaced by the following:

(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.

Plain Language Summary

Clause 34 makes consequential amendments to section 94 of the Act to reflect the renaming and bifurcation of Schedule 1, as a result of the changes made by clause 58. 

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)

Clause 35 – Report on Remedial Measures– consequential amendment (s.95)

Bill Text

35 (1) The portion of subsection 95(1) of the Act before paragraph (a) is replaced by the following:

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,

(2) Subsection 95(3) of the Act is replaced by the following:

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.

Plain Language Summary

Clause 35 makes consequential amendments to section 95 of the Act to:

  • remove a reference to section 92.1, repealed by clause 32; and
  • reflect the renaming of Schedule 1, as a result of the changes made by 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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
  • Renaming and Bifurcating Schedule 1 (see clause 58)

Clause 36 – Voluntary Reporting (s.96)

Bill Text

36 Subsection 96(1) of the Act is replaced by the following:

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.

Plain Language Summary

Clause 36 makes a consequential amendment to subsection 96(1) of the Act to reflect the renaming of Schedule 1, as a result of the changes made by 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)

Clause 37 – Remedial Measures (s.99)

Bill Text

37 The portion of section 99 of the Act before paragraph (a) is replaced by the following:

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,

Plain Language Summary

Clause 37 amends section 99 of the Act to broaden the scope of the Minister’s remedial measures powers so that they may be exercised in respect of products that contain or that may release a toxic substance into the environment.

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, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 38 – Adding Living Organism to Domestic Susbstances List – consequential amendment (s.105)

Bill Text

38 The portion of subsection 105(1) of the Act before paragraph (a) is replaced by the following:

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

Plain Language Summary

Clause 38 makes a consequential amendment to subsection 105(1) of the Act to remove a reference to section 74, which is replaced by clause 19 and no longer relevant to subsection 105(1).

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)

Clause 39 – Domestic Substances List – Food and Drugs Act (s.105.1)

Bill Text

39 The Act is amended by adding the following after section 105:

Domestic Substances List — Food and Drugs Act

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

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

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

Amendment of List

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

Designation

(3) The Minister may, by order, designate any person or class of persons to exercise the powers and perform the duties and functions set out in this section.

Amendment of List

105.2 (1) If the Minister is satisfied that a living organism added to the Domestic Substances List under subsection 105(1) or 112(1) is not being manufactured in Canada or imported into Canada — or that a living organism added to the List under subsection 105.1(1) is not in Canadian commerce — the Minister may delete the living organism from the List.

Publication — notice of intent

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

Comments

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

Designation

(4) The Minister may, by order, designate any person or class of persons to exercise the powers and perform the duties and functions set out in this section.

Plain Language Summary

Clause 39 adds section 105.1 to the Act to enable the Minister to add living organisms that are on Health Canada’s Revised In Commerce List published in Canada Gazette Nov 3, 2019 to the Domestic Substances List.

It also adds section 105.2 to the Act to enable the Minister to remove living organisms that are no longer in Canadian commerce from the Domestic Substances List.

Additional Context

Section 105.1

The Revised In Commerce List (R-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). The R-ICL is administrative and based on historical use of substances between 1987 and 2001. The list is periodically revised to reflect updates and corrections. The substances’ absence from the DSL but continued listing on the administrative R-ICL 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)

Clause 39.1 (NEW) - Demonstrable need/public participation in assessment of LOs (s.108)

Bill Text

Subsection 108(1) of the Act is replaced by the following:

Assessment of information

108 (1) Subject to subsection (4), the Ministers shall, within the prescribed assessment period, assess information provided under subsection 106(1), (3) or (4) or paragraph 109(1)‍(c) or otherwise available to them in respect of a living organism in order to determine whether

(a)it is toxic or capable of becoming toxic; and

(b) it shows a demonstrable need for the living organism.

Meaningful participation

(1.‍1) The Ministers shall ensure that the public is provided with opportunities to participate meaningfully in the Ministers’ assessment.

Public comments

(1.2) The Ministers shall, within the prescribed assessment period, solicit public comments in respect of the testing of all evidence and may request additional evidence from any individual.

Plain Language Summary

Clause 39.1 amends section 108 of the Act. In addition to requiring the Ministers to determine whether a new living organism is toxic or capable of being toxic, the new paragraph 108(1)(b) requires the Ministers to determine whether the information shows a “demonstrable need” for the new living organism.

It also adds subsections 108(1.1) and (1.2). These subsections require the Ministers to ensure meaningful public participation in the assessment process.

Additional Context

Part 6 of the Act establishes an assessment process for new animate products of biotechnology (i.e. living organisms). The provisions under 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.

As introduced, Bill S-5 did not propose changes to the framework for assessing living organisms. Bill S-5 proposed minor technical amendments to the significant new activity provisions in Part 6 of the Act.          

Senate Amendments

The amendments related to this clause were made in the Senate. Bill S-5 (as introduced) did not propose any amendments to section 108 of the Act.

Related Clauses

  • Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
  • Ministerial Prohibition (see clause 40)
  • Varying Significant New Activity Information (see clauses 24, 26, 41, 43)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 40 – Expiry of prohibition (s.109)

Bill Text

40 Subsection 109(4) of the Act is replaced by the following:

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.

Plain Language Summary

Clause 40 amends subsection 109(4) of the Act to provide for additional types of regulations that can be made to replace an interim ministerial prohibition imposed under paragraph 109(1)(b), including regulations that are made under another federal Act.

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)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 41 – Notice - Significant new activity (s. 110)

Bill Text

41 Subsections 110(2) and (3) of the Act are replaced by the following:

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).

Plain Language Summary

Clause 41 amends section 110 of the Act to:

  • allow the Minister to specify in a significant new activity notice, for the purpose of subsection 111(2), persons that are not required to be notified under subsection 111(1); and
  • allow the Minister to vary any part of a significant new activity notice.

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)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 42 – Downstream notification – Significant new activity (s.111)

Bill Text

42 Section 111 of the Act is renumbered as subsection 111(1) and is amended by adding the following:

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.

Plain Language Summary

Clause 42 adds subsection 111(2) to the Act to exclude specified persons from the requirement to be notified under subsection 111(1) of a significant new activity in respect of a new living organism when such a living organism is transferred to them.

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)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 43 – Amendments List – Significant new activity (s.112)

Bill Text

43 Subsections 112(3) and (4) of the Act are replaced by the following:

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).

Plain Language Summary

Clause 43 amends section 112 of the Act to:

  • allow the Minister to specify in a significant new activity publication, for the purpose of subsection 112.1(2), persons that are not required to be notified under subsection 112.1(1); and
  • allow the Minister to vary any part of a significant new activity publication.

It also makes a consequential amendment to subsection 112(3) of the Act to add a reference to subsection 105.1(1), added by clause 39.

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)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 44 – Downstream notification – Significant new activity (s.112.1)

Bill Text

44 The Act is amended by adding the following after section 112:

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.

Plain Language Summary

Clause 44 adds section 112.1 to the Act to impose an obligation, analogous to the obligation in section 111, but that applies in respect of significant new activities that involve existing living organisms. 

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)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 44.1 (NEW) – Prescribe process public participation (s.114)

Bill Text

44.‍1 Subsection 114(1) of the Act is amended by adding the following after paragraph (g):

(g.‍1) prescribing processes for meaningful public participation in

(i) an assessment under section 108, and

(ii) the determination of whether to grant a waiver requested under subsection 106(8);

Plain Language Summary

Clause 44.1 amends subsection 114(1) of the Act to allow the Governor-in-Council to prescribe processes for public participation in the regulations. It is a complement to the Senate amendment which added a new requirement for the Ministers to ensure meaningful public participation under section 108 (clause 39.1). 

Subparagraph 114(1)(g.1)(ii) is the remnant of a Senate amendment that was withdrawn. This amendment imposed requirements on the Ministers regarding the assessment of living organisms with a wild counterpart, including requiring the Ministers to provide public notice of a request for a waiver.

Additional Context

Subsection 114(1) of the Act is the enabling authority which establishes the New Substances Notification Regulations (Organisms) (NSNR(O)). The NSNR(O) are the implementing regulations for Part 6 of the Act. 

Senate Amendments

The amendments related to this clause were made in the Senate. Bill S-5 (as introduced) did not propose any amendments to section 114 of the Act.

Related Clauses

  • Downstream Communication of Significant New Activities (see clauses 24, 25, 26, 27, 41, 42, 43 and 44)
  • Ministerial Prohibition (see clause 40)
  • Varying Significant New Activity Information (see clauses 24, 26, 41, 43)
  • Assessment of Living Organisms (see clauses 39.1, 44.1)

Clause 45 – Requirements for Environment Emergency Plans – consequential amendment (s.199)

Bill Text

45 Paragraphs 199(1)(a) and (b) of the Act are replaced by the following:

(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).

Plain Language Summary

Clause 45 makes consequential amendments to subsection 199(1) of the Act to reflect the renaming and bifurcation of Schedule 1, as a result of the changes made by clause 58

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)

Clause 46 – Regulations (s.209)

Bill Text

46 (1) Paragraphs 209(2)(f) and (g) of the Act are replaced by the following:

(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;

(2) Paragraph 209(2)(i) of the Act is replaced by the following:

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

(3) Paragraphs 209(2)(l) to (r) of the Act are replaced by the following:

(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;

(4) Paragraphs 209(2)(t) and (u) of the Act are replaced by the following:

(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;

(5) Paragraph 209(2)(v) of the English version of the Act is replaced by the following:

(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;

(6) Section 209 of the Act is amended by adding the following after subsection (4):

Powers of Minister

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

Statutory Instruments Act

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

Plain Language Summary

Clause 46 amends section 209 of the Act to:

  • broaden the scope of the Governor in Council’s regulation making authorities in subsection 209(2) so that they may be exercised in respect of products that contain or that may release a substance into the environment;
  • correct minor oversights in subsection 209(2) by adding the term ‘exported’ to paragraphs 209(2)(f), (g) and (i), and the term ‘manufacture’ to paragraph 209(2)(l); and
  • clarify that regulations made under section 209 may include ministerial permitting regimes.

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, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)
  • Corresponding amendment to analogous provision under Part 5 of the Act (see clause 33)

Clause 47 – Inspection (s.218)

Bill Text

47 Paragraph 218(1)(a) of the Act is replaced by the following:

(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;

Plain Language Summary

Clause 47 makes a consequential amendment to paragraph 218(1)(a) of the Act, as a result of the changes made by various clauses to the Act that broaden scope of various provisions so that they apply in respect of products that contain or that may release a substance into the environment.

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, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 48 – Compliance Order – consequential amendment (s.235)

Bill Text

48 (1) Paragraph 235(2)(a) of the Act is replaced by the following:

(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;

(2) Paragraphs 235(2)(b) and (c) of the English version of the Act are replaced by the following:

(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

(3) Paragraph 235(3)(a) of the Act is replaced by the following:

(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;

Plain Language Summary

Clause 48 makes consequential amendments to section 235 of the Act, as a result of the changes made by various clauses to the Act that broaden scope of various provisions so that they apply in respect of products that contain or that may release a substance into the environment.

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, 10.1, 11, 11.1, 16, 18, 19, 33, 37, 46, 47 and 48)

Clause 49 – Offences – Persons (s. 272)

Bill Text

49 (1) Paragraph 272(1)(b) of the Act is replaced by the following:

(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);

(2) Paragraph 272(1)(d) of the Act is replaced by the following:

(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;

Plain Language Summary

Clause 49 amends subsection 272(1) of the Act to designate contraventions of the new provisions added by clauses 27, 33, 44 and 46 as subject to the more serious penalties under the Act.

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)

Clause 50 – Request for Confidentiality (s.313)

Bill Text

50 (1) Subsection 313(1) of the French version of the Act is replaced by the following:

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.

(2) Subsection 313(2) of the Act is replaced by the following:

Contents of request

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

Plain Language Summary

Clause 50 amends section 313 of the Act to:

  • correct an inconsistency between the English and French versions of subsection 313(1);
  • require that requests for confidentiality under section 313 be submitted with reasons; and
  • remove the ability to exempt persons from the requirement to provide reasons with certain requests for confidentiality.

Additional Context

The current version of section 313 of the Act provides that persons who submit information to the Minister or to a board of 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 of, 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. 

Senate Amendments

As introduced, Bill S-5 included subsection 50(3), which exempted persons from providing reasons in support of a request for confidentiality if this exemption was specified in the regulation, order or notice. The Senate deleted subsection 50(3), removing the ability to exempt persons from this requirement.

Related Clauses

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

Clause 51 – Prohibition of Disclosure (s.314)

Bill Text

51 Section 314 of the Act is replaced by the following:

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.

Plain Language Summary

Clause 51 makes a consequential amendment to section 314 of the Act to reflect the new bases for disclosing certain confidential information in sections 317.1 and 317.2, added by clause 53.

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)

Clause 52 – Certain Purposes for which info may (s.316(1)(c))

Bill Text

52 (1) The portion of paragraph 316(1)(c) of the Act before subparagraph (i) is replaced by the following:

(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

(2) Subparagraph 316(1)(c)(ii) of the Act of the Act is replaced by the following:

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

Plain Language Summary

Clause 52 amends paragraph 316(1)(c) of the Act to broaden the scope of federal entities contemplated by that paragraph.

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.

Clause 53 – Disclosure (s.317.1, 317.2) - Disclosure

Bill Text

53 The Act is amended by adding the following after section 317:

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

Disclosure after expiry

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

Publication — notice of intent

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

Comments

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

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

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

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

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

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.

Plain Language Summary

Clause 53 adds sections 317.1 and 317.2 to the Act to enable the Minister to disclose, under certain circumstances, the explicit chemical or biological name of a substance or living organism that has been masked.

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 to provide 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)

Clause 54 (Former Clause 55) – Geographical Application (s. 330)

Bill Text

54 Subsections 330(3) and (3.1) of the Act are repealed.

Plain Language Summary

Clause 54 repeals subsections 330(3) and (3.1) of the Act.

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 54 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”.

Senate Amendments

Clause 54 was deleted in the Senate. As a result, clauses 55 to 57 have been renumbered.

Clause 55 (Former Clause 56) – Publication of Proposed Orders and Regulations (s. 332)

Bill Text

55 (1) Subsections 332(1) and (2) of the Act are replaced by the following:

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).

(2) Section 332 of the Act is amended by adding the following after subsection (3):

Notice made public

(4) In addition to any other requirement of this Act, a notice under this Act, a notice of any consultation to be held in relation to a matter under this Act and any decision made under this Act for which a notice is not otherwise required under this Act must be made public, including by being published

(a) by the Minister on their departmental website;

(b) in a newspaper or other periodical that, in the Minister’s opinion, has a large circulation;

(c) in the Environmental Registry; and

(d) in the Canada Gazette.

Notice — public participation

(5) A notice published in accordance with paragraphs 4(a) to (c) must include an indication of any opportunities for public participation that may be available in relation to the content of the notice

Notice — public consultation

(6) In addition to any other requirements of this Act, a notice of a public consultation is to be published in accordance with paragraphs (4)‍(a) to (c) at least 60 days before the consultation is to occur.

Plain Language Summary

Clause 55 makes consequential changes to section 332 of the Act to:

  • add references to sections 66.1 and 66.2, added by clause 14, and sections 105.1 and 105.2, added by clause 39; and
  • reflect that a statement may be published under subsection 91(1), as a result of the changes made by clause 30.

It also amends section 332 to require the publication of all notices under the Act, including notices of consultations and of any decision made under the Act.

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.

Senate Amendments

Clause 54 was deleted in the Senate. As a result, clauses 55 to 57 have been renumbered.

As introduced, Bill S-5 proposed minor consequential amendments to the “prepublication” requirement in section 332 of the Act. The Senate amended section 332 to require the publication of all notices under the Act, including notices of consultations and of any decision made under the Act. The Minister would be required to publish these notices and decisions on the departmental website, in newspapers, the Environmental Registry, and the Canada Gazette.

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)
  • Environmental Registry (see clause 5.1)

Clause 56 (Former Clause 57) – Establishment of Board of Review – consequential amendment (s. 333)

Bill Text

57 (1) Subsection 333(1) of the Act is replaced by the following:

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.

(2) Subsection 333(6) of the Act is repealed.

Plain Language Summary

Clause 56 makes consequential amendments to section 333 of the Act to:

  • reflect that a statement may be published under subsection 91(1), as a result of the changes made by clause 30; and
  • remove a reference to subsection 77(8) from subsection 333(1) and repeal subsection 333(6), as a result of the changes made by clauses 21 to 22 that replace provisions respecting the Priority Substances List with a right to request that a substance be assessed.

Additional Context

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

Senate Amendments

Clause 54 was deleted in the Senate. As a result, clauses 55 to 57 have been re-numbered.

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)

Clause 57 (NEW) –Report impact on aboriginal peoples (s. 342.1)

Bill Text

57 The Act is amended by adding the following after section 342:

Report — impact on aboriginal peoples

342.‍1 (1) The Minister shall, five years after the coming into force of this section and every fifth year after that, prepare a report regarding the operation of this Act in respect of the aboriginal peoples of Canada during the preceding five years.

Report content

(2) The report referred to in subsection (1) must include details on

(a) consultations with aboriginal peoples and aboriginal governments in relation to matters under the Act;

(b) measures implemented to ensure that the Act is administered in a way that complies with

(i) section 35 of the Constitution Act, 1982,

(ii) the principle of the honour of the Crown, and

(iii) Canada’s treaty relationships with and its fiduciary obligations to the aboriginal peoples of Canada;

(c) any evaluation completed in respect of the effectiveness or implementation of the measures described in paragraph (b); and

(d) any findings or recommendations in respect of the administration of this Act in respect of the aboriginal peoples of Canada

Tabling of report

(3) The Minister must cause the report to be laid before each House of Parliament no later than six months after the conclusion of the five-year period to which the report relates.

Plain Language Summary

Clause 57 adds a requirement on the Minister to report to Parliament every five years on the operation of CEPA in respect of aboriginal peoples of Canada.

Additional Context

Bill S-5 proposed to add a new paragraph to the preamble, which confirms the Government’s commitment to implement the United Nations Declaration on the Rights of Indigenous Peoples.

Senate Amendments

As introduced, Bill S-5 did not propose any amendments that would require the Minister to specifically report on issues related to Indigenous peoples under the Act. This new report would cover a variety of topics related to the operation of CEPA in respect of aboriginal peoples. The Senate’s amendment provides that the report must include details on topics including: consultations; measures implemented to ensure that CEPA is administered in a way that complies with section 35 of the Constitution Act, 1982, the principle of the honour of the Crown, and Canada’s treaty relationships with and its fiduciary obligations to the aboriginal peoples of Canada; evaluations of effectiveness or implementation of such measures; and findings and recommendations in respect of the administration of the Act..

Related Clauses

  • Indigenous Reconciliation (see clauses 2, 57)

Clause 58 – Schedule 1

Bill Text

58 Schedule 1 to the Act is replaced by the Schedule 1 set out in the schedule to this Act.

Plain Language Summary

Clause 58 renames and bifurcates Schedule 1 to the Act.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Transitional Provisions

Clause 59 – Transitional – Words and Expressions in s. 60-62

Bill Text

Words and expressions

59 Unless the context otherwise requires, words and expressions used in sections 60 to 62 have the same meaning as in the Canadian Environmental Protection Act, 1999.

Plain Language Summary

Clause 59 provides that, unless the context otherwise requires, the words and expressions used in clauses 60 to 62 have the same meaning as in the Act.

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.

Clause 60 - Transitional – deemed recommendation to add to Part 1/Part 2

Bill Text

Statement under subsection 77(1) — deemed recommendation to add to Part 1

60 (1) If, before the day on which subsection 21(1) of this Act comes into force, a statement is published under subsection 77(1) of the Canadian Environmental Protection Act, 1999 indicating that the measure that the Ministers propose to take in respect of a substance is a recommendation to add the substance to the List of Toxic Substances in Schedule 1 of that Act and to implement virtual elimination under subsection 65(3) of that Act and no statement confirming or amending that measure has been published under paragraph 77(6)(b) of that Act before that day, the measure is deemed to be a recommendation, made under paragraph 77(2)(c) of that Act, as that paragraph reads after that day, to add the substance on the list of toxic substances in Part 1 of Schedule 1, as that Schedule reads after that day.

Statement under subsection 77(1) — deemed recommendation to add to Part 2

(2) If, before the day on which subsection 21(1) of this Act comes into force, a statement is published under subsection 77(1) of the Canadian Environmental Protection Act, 1999 indicating that the measure that the Ministers propose to take in respect of the substance is a recommendation to add the substance to the List of Toxic Substances in Schedule 1 of that Act without implementing virtual elimination under subsection 65(3) of that Act and no statement confirming or amending that measure is published under paragraph 77(6)(b) of that Act before that day, the measure is deemed to be a recommendation, made under paragraph 77(2)(d) of that Act, as enacted by that subsection 21(1), to add the substance on the list of toxic substances in Part 2 of Schedule 1, as that Schedule reads after that day.

Plain Language Summary

Clause 60 establishes transitional rules as follows:

  • a subsection 77(1) proposed recommendation to add a substance to Schedule 1 and implement virtual elimination that is published under the current Act is deemed to be a subsection 77(2)(c) proposed recommendation to add the substance to Part 1 of Schedule 1 under the new amended Act; and,
  • a subsection 77(1) proposed recommendation to add a substance to Schedule 1 without implementing virtual elimination that is published under the current Act is deemed to be a subsection 77(2)(d) proposed recommendation to add the substance to Part 2 of Schedule 1 under the new amended Act.

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).

Clause 61 - Transitional – deemed recommendation to add to Part 1/Part 2

Bill Text

Statement under paragraph 77(6)(b) — deemed recommendation to add to Part 1

61 (1) If, before the day on which subsection 21(2) of this Act comes into force, a statement is published under paragraph 77(6)(b) of the Canadian Environmental Protection Act, 1999 indicating that the measure that the Ministers propose to take, as confirmed or amended, in respect of a substance is a recommendation to add the substance to the List of Toxic Substances in Schedule 1 of that Act and to implement virtual elimination under subsection 65(3) of that Act, the statement is deemed to be a statement, published under paragraph 77(6)(b) of that Act, as it reads after that day, indicating that the measure, as confirmed or amended, is a recommendation to add the substance on the list of toxic substances in Part 1 of Schedule 1, as that Schedule reads after that day.

Statement under paragraph 77(6)(b) — deemed recommendation to add to Part 2

(2) If, before the day on which subsection 21(2) of this Act comes into force, a statement is published under paragraph 77(6)(b) of the Canadian Environmental Protection Act, 1999 indicating that the measure that the Ministers propose to take, as confirmed or amended, in respect of the substance is a recommendation to add the substance to the List of Toxic Substances in Schedule 1 of that Act without the implementation of virtual elimination under subsection 65(3) of that Act, the statement is deemed to be a statement, published under paragraph 77(6)(b) of that Act, as it reads after that day, indicating that the measure, as confirmed or amended, is a recommendation to add the substance on the list of toxic substances in Part 2 of Schedule 1, as that Schedule reads after that day.

Plain Language Summary

Clause 61 establishes transitional rules as follows:

  • a paragraph 77(6)(b) final recommendation to add a substance to Schedule 1 and implement virtual elimination that is published under the current Act is deemed to be a paragraph 77(6)(b) final recommendation to add the substance to Part 1 of Schedule 1 under the “new” amended Act; and,
  • a paragraph 77(6)(b) final recommendation to add a substance to Schedule 1 without implementing virtual elimination that is published under the current Act is deemed to be a paragraph 77(2)(d) final recommendation to add the substance to Part 2 of Schedule 1 under the “new” amended Act.

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).

Clause 62 - Transitional – substance added/removed

Bill Text

Schedule 1 — substance added

62 (1) If a substance is added to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 before the day on which section 58 of this Act comes into force but the substance is not specified on the list of toxic substances in Part 1 or 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 on that day, the Governor in Council must as soon as feasible after that day make an order adding the substance

(a) to the list of toxic substances in Part 1 of Schedule 1 of that Act, if the Governor in Council is satisfied that the substance is toxic within the meaning of section 64 of that Act and if the Ministers recommended the implementation of virtual elimination under subsection 65(3) of that Act in relation to the substance; or

(b) to the list of toxic substances in Part 2 of Schedule 1 of that Act, if the Governor in Council is satisfied that the substance is toxic within the meaning of section 64 of that Act and if the Ministers did not recommend the implementation of virtual elimination under subsection 65(3) of that Act in relation to the substance.

Schedule 1 — substance deleted

(2) If a substance is deleted from the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 before the day on which section 58 of this Act comes into force but the substance is specified on the list of toxic substances in Part 1 or 2 of Schedule 1 of that Act as it reads after that day, the Governor in Council must as soon as feasible after that day make an order deleting the substance from the list of toxic substances on which it is specified.

Plain Language Summary

Clause 62 establishes transitional rules as follows:

  • if a substance is added to the List of Toxic Substances in Schedule 1 to the current Act, then the Governor in Council must add it to either Part 1 or Part 2, as the case may be, of Schedule 1 to the new amended Act as soon as feasible following Royal Assent; and,  
  • if a substance is removed from the List of Toxic Substances in Schedule 1 to the current Act, then the Governor in Council must remove it from Schedule 1 to the new amended Act as soon as feasible following Royal Assent.

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.

Clause 63 – Transitional – substances added/removed

Bill Text

Regulations

63 The Minister of the Environment and the Minister of Health may, by regulation,

(a) repeal the Virtual Elimination List; and

(b) repeal the Regulations Adding Perfluorooctane Sulfonate and Its Salts to the Virtual Elimination List.

Plain Language Summary

Clause 63 provides the Ministers with the authority to repeal the Virtual Elimination List and the Regulations Adding Perfluorooctane Sulfonate and Its Salts to the Virtual Elimination List.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Related Amendments to the Food and Drugs Act

Clause 64 – Risk to Environment (s.11.1)

Bill Text

64 The Food and Drugs Act is amended by adding the following after section 11:

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.

Plain Language Summary

Clause 64 adds section 11.1 to the Food and Drugs Act to prohibit certain activities in respect of a drug unless the Minister of Health has assessed the risks to the environment presented by certain substances contained in that drug.

Additional Context

The Food and Drugs Act and its associatedregulations 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)

Clause 65 – Info – serious risk to environment (s.21.3)

Bill Text

65 The Act is amended by adding the following after section 21.3:

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).

Plain Language Summary

Clause 65 adds section 21.301 to the Food and Drugs Act to enable the Minister of Health to

  • order a person to provide information that is in their control, that is believed to be necessary to determine whether a therapeutic product presents a serious risk to the environment; and
  • disclose confidential business information about a therapeutic product in certain circumstances.

It also adds section 21.302 to the Food and Drugs Act to enable the Minister of Health to order the holder of a therapeutic product authorization to modify the product’s label, or modify or replace its packaging where it is believed to be necessary to prevent a serious risk to the environment.

It also adds section 21.303 to the Food and Drugs Act to enable the Minister to order a person who sells a therapeutic product to recall it, or to send it to a specified place, if that Minister believes that the product presents a serious or imminent risk to the environment. Section 21.303 also enables the Minister of Health to order a person who sells to request corrective actions from the products owner or user if the Minister believes that corrective actions is an effective means of dealing with the risk. 

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 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)

Clause 66 – Power – info regarding environmental effects (s.21.33 and 21.4)

Bill Text

66 Section 21.4 of the Act is replaced by the following:

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.

Plain Language Summary

Clause 66 adds section 21.33 to the Food and Drugs Act to enable the Minister of Health 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 for the purpose of obtaining additional information about the product’s effects on the environment.

It also amends subsection 21.4(1) of the Food and Drugs Act so that it applies to an order made under section 21.33.

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)

Clause 67 – Regulations (s. 30)

Bill Text

67 (1) Subsection 30(1) of the Act is amended by adding the following after paragraph (a):

(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;

(2) Subsection 30(1) of the Act is amended by adding the following after paragraph (a.01):

(a.02) prescribing the substances that are subject to an assessment under section 11.1;

(3) Subsection 30(1) of the Act is amended by adding the following after paragraph (b):

(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;

(4) Paragraph 30(1)(e) of the Act is replaced by the following:

(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;

(5) Paragraph 30(1)(l.1) of the Act is replaced by the following:

(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;

(6) Section 30 of the Act is amended by adding the following after subsection (1):

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.

(7) Subsection 30(1.2) of the Act is amended by adding the following after paragraph (d):

(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;

(8) Paragraph 30(1.2)(e) of the Act is replaced by the following:

(e) respecting modifications of labels and modifications and replacements of packages referred to in sections 21.2 and 21.302;

(9) Paragraph 30(1.2)(f.3) of the Act is replaced by the following:

(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);

Plain Language Summary

Clause 67 amends subsections 30(1) and (1.2) of the Food and Drugs Act to broaden the scope of the Governor in Council’s regulation making authorities under those subsections so that they may be exercised in respect of the environment (in addition to human health and safety).

It also adds subsection 30(1.01) to the Food and Dugs Act to require that the Minister of Health take into account the degree of uncertainty respecting environmental risks before recommending that regulations be made prescribing the substances that are subject to an assessment under the prohibition in section 11.1.

It also makes consequential amendments to subsection 30(1.2) of the Food and Drugs Act to add references to sections 21.302 and 21.33, added by clauses 65 and 66, respectively.

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)

Report

Clause 67.1 (NEW) - Minister of ISED Report on Imported Products

Bill Text

Report — manufactured and imported goods

67.‍1 (1) The Minister of Industry must, no later than one year after the day on which this Act receives royal assent, cause to be tabled in both Houses of Parliament a report regarding measures to

(a) ensure that manufactured goods that come to Canada meet the environmental requirements imposed on Canadian manufacturers; and

(b) test imported products for compliance with Canadian standards to ensure that they are safe for Canadian consumers and that Canadian producers are not at a disadvantage.

Report content

(2) The report must include

(a) an evaluation of existing measures and their effectiveness;

(b) recommendations for any new measures; and

(c) a proposed timetable and cost estimate for the implementation of new measures recommended under paragraph (b).

 

Plain Language Summary

Clause 67.1 adds a requirement that the Minister of Industry prepare and table in Parliament, within one year of Royal Assent, a compliance-focused report regarding imported goods and products with Canadian standards.

Additional Context

Bill S-5 proposed amendments across the Act in order to ensure that 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). Examples of such products include portable fuel containers and wood stoves. The Bill also proposed changes to the preamble, and to the list of matters under paragraph 68(a) of the Act that recognize the importance of providing the public with information, including by means of the packaging and labelling of products. However, as introduced, the Bill did not propose to create any new product-focused reporting requirements.

Senate Amendments

The Senate added clause 67.1 to Bill S-5 to require the Minister of Industry to table a report regarding measures that ensure manufactured goods that are imported into Canada meet the environmental requirements imposed on Canadian manufacturers and to require the Minister of Industry test imported products for compliance with Canadian standards.

Repeal

Clause 68 - Repeal Perfluourooctane Sulfonate Act

Bill Text

Repeal

68 The Perfluorooctane Sulfonate Virtual Elimination Act, chapter 13 of the Statutes of Canada, 2008, is repealed.

Plain Language Summary

Clause 68 repeals the Perfluorooctane Sulfonate Virtual Elimination Act.

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/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)

Coming Into Force

Clause 69 - Coming into Force

Bill Text

Order in council

69 Section 64 and subsections 67(2), (5) and (6) come into force on a day to be fixed by order of the Governor in Council.

Plain Language Summary

Clause 69 delays the coming into force of section 11.1 of the Food and Drugs Act, added by clause 64, as well as associated provisions, added by clause 67, to a day to be fixed the Governor in Council.

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)

*SCHEDULE

Schedule

Bill Text

SCHEDULE

(Section 58)

SCHEDULE 1

(Paragraphs 56(1)(a) and (c), section 68, section 68.1, subsection 71(1) and paragraphs 77(2)(c) and (d), subsections 77(7) and (9), 90(1) to (2) and 91(1), paragraph 91(2)(a), subsection 93(1), paragraphs 94(1)(a) and (5)(b), subsections 95(1) and (3) and 96(1), paragraph 199(1)(a) and subparagraph 199(1)(b)(i) and subsection 317.1(3))

Note: For molecular formulae in this Schedule, “n”, “x” and “y” refer to the number of atoms.

PART 1

1 Chlorobiphenyls that have the molecular formula C12H(10-n)Cln in which “n” is greater than 2

2 Dodecachloropentacyclo [5.3.0.02,6.03,9.04,8] decane (Mirex)

3 Polychlorinated dibenzo-para-dioxins that have the molecular formula C12H(8-n)ClnO2 in which “n” is greater than 2

4 Polychlorinated dibenzofurans that have the molecular formula C12H(8-n)ClnO in which “n” is greater than 2

5 Hexachlorobenzene

6 Hexachlorobutadiene, which has the molecular formula C4Cl6

7 Dichlorodiphenyltrichloroethane (DDT), which has the molecular formula C14H9Cl5

8 Tetrachlorobenzenes, which have the molecular formula C6H2Cl4

9 Pentachlorobenzene, which has the molecular formula C6HCl5

10 Polybrominated diphenyl ethers that have the molecular formula C12H(10-n)BrnO in which 4≤n≤6

11 Perfluorooctane sulfonate and its salts

12 Phenol, 2,4,6-tris(1,1-dimethylethyl)-, which has the molecular formula C18H30O

13 Tributyltins, which contain the grouping (C4H9)3Sn

14 Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)-, which has the molecular formula C18H30O

15 Chlorinated alkanes that have the molecular formula CnHxCl(2n+2-x) in which 10≤ n≤ 20

16 Polychlorinated naphthalenes, which have the molecular formula C10H8-nCln in which “n” is greater than 1

17 Hexabromocyclododecane, which has the molecular formula C12H18Br6

18 Reaction products of 2-propanone with diphenylamine

19 Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, which has the molecular formula C14H10Cl4

PART 2

1 Polybrominated Biphenyls that have the molecular formula C12H(10-n)Brn in which “n” is greater than 2

2 Chlorofluorocarbon: totally halogenated chlorofluorocarbons that have the molecular formula CnClxF(2n+2-x)

3 Polychlorinated Terphenyls that have a molecular formula C18H(14-n)Cln in which “n” is greater than 2

4 Asbestos

5 Lead

6 Mercury and its compounds

7 Vinyl Chloride

8 Bromochlorodifluoromethane that has the molecular formula CF2BrCl

9 Bromotrifluoromethane that has the molecular formula CF3Br

10 Dibromotetrafluoroethane that has the molecular formula C2F4Br2

11 Fuel containing toxic substances that are dangerous goods within the meaning of the Transportation of Dangerous Goods Act, 1992 and that

(a) are neither normal components of the fuel nor additives designed to improve the characteristics or the performance of the fuel; or

(b) are normal components of the fuel or additives designed to improve the characteristics or performance of the fuel, but are present in quantities or concentrations greater than those generally accepted by industry standards.

12 Dibenzo-para-dioxin that has the molecular formula C12H8O2

13 Dibenzofuran that has the molecular formula C12H8O

14 Tetrachloromethane (carbon tetrachloride, CCl4)

15 1,1,1-trichloroethane (methyl chloroform, CCl3-CH3)

16 Bromofluorocarbons other than those set out in items 8 to 10

17 Hydrobromofluorocarbons that have the molecular formula CnHxFyBr(2n+2-x-y) in which 0<n≤3

18 Methyl Bromide

19 Bis(chloromethyl) ether that has the molecular formula C2H4Cl2O

20 Chloromethyl methyl ether that has the molecular formula C2H5ClO

21 Hydrochlorofluorocarbons that have the molecular formula CnHxFyCl(2n+2-x-y) in which 0<n≤3

22 Benzene that has the molecular formula C6H6

23 (4-Chlorophenyl)cyclopropylmethanone,O-[(4-nitrophenyl)methyl]oxime that has the molecular formula C17H15ClN2O3

24 Inorganic arsenic compounds

25 Benzidine and benzidine dihydrochloride, that have the molecular formula C12H12N2 and C12H12N2•2HCl, respectively

26 Bis(2-ethylhexyl)phthalate

27 Inorganic cadmium compounds

28 Chlorinated wastewater effluents

29 Hexavalent chromium compounds

30 Creosote-impregnated waste materials from creosote-contaminated sites

31 3,3′-Dichlorobenzidine

32 1,2-Dichloroethane

33 Dichloromethane

34 Effluents from pulp mills using bleaching

35 Inorganic fluorides

36 Refractory ceramic fibre

37 Oxidic, sulphidic and soluble inorganic nickel compounds

38 Polycyclic aromatic hydrocarbons

39 Tetrachloroethylene

40 Trichloroethylene

41 Tributyltetradecylphosphonium chloride that has the molecular formula C26H56P•Cl

42 Bromochloromethane, that has the molecular formula CH2BrCl

43 Acetaldehyde, which has the molecular formula C2H4O

44 1,3-Butadiene, which has the molecular formula C4H6

45 Acrylonitrile, which has the molecular formula C3H3N

46 Respirable particulate matter less than or equal to 10 microns

47 Acrolein, which has the molecular formula C3H4O

48 Ammonia dissolved in water

49 Nonylphenol and its ethoxylates

50 Effluents from textile mills that use wet processing

51 Inorganic Chloramines, which have the molecular formula NHnCl(3-n), where 0≤n≤2

52 Ethylene oxide, which has the molecular formula H2COCH2

53 Formaldehyde, which has the molecular formula CH2O

54 N-Nitrosodimethylamine, which has the molecular formula C2H6N2O

55 Gaseous Ammonia, which has the molecular formula NH3(g)

56 Ozone, which has the molecular formula O3

57 Nitric oxide, which has the molecular formula NO

58 Nitrogen dioxide, which has the molecular formula NO2

59 Sulphur dioxide, which has the molecular formula SO2

60 Volatile organic compounds that participate in atmospheric photochemical reactions, excluding the following:

(a) methane;

(b) ethane;

(c) methylene chloride (dichloromethane);

(d) 1,1,1-trichloroethane (methyl chloroform);

(e) 1,1,2-trichloro-1,2,2-trifluoroethane (CFC-113);

(f) trichlorofluoromethane (CFC-11);

(g) dichlorodifluoromethane (CFC-12);

(h) chlorodifluoromethane (HCFC-22);

(i) trifluoromethane (HFC-23);

(j) 1,2-dichloro-1,1,2,2-tetrafluoroethane (CFC-114);

(k) chloropentafluoroethane (CFC-115);

(l) 1,1,1-trifluoro-2,2-dichloroethane (HCFC-123);

(m) 1,1,1,2-tetrafluoroethane (HFC-134a);

(n) 1,1-dichloro-1-fluoroethane (HCFC-141b);

(o) 1-chloro-1,1-difluoroethane (HCFC-142b);

(p) 2-chloro-1,1,1,2-tetrafluoroethane (HCFC-124);

(q) pentafluoroethane (HFC-125);

(r) 1,1,2,2-tetrafluoroethane (HFC-134);

(s) 1,1,1-trifluoroethane (HFC-143a);

(t) 1,1-difluoroethane (HFC-152a);

(u) parachlorobenzotrifluoride (PCBTF);

(v) cyclic, branched or linear completely methylated siloxanes;

(w) acetone;

(x) perchloroethylene (tetrachloroethylene);

(y) 3,3-dichloro-1,1,1,2,2-pentafluoropropane (HCFC-225ca);

(z) 1,3-dichloro-1,1,2,2,3-pentafluoropropane (HCFC-225cb);

(z.1) 1,1,1,2,3,4,4,5,5,5-decafluoropentane (HFC43-10mee);

(z.2) difluoromethane (HFC-32);

(z.3) ethylfluoride (HFC-161);

(z.4) 1,1,1,3,3,3-hexafluoropropane (HFC-236fa);

(z.5) 1,1,2,2,3-pentafluoropropane (HFC-245ca);

(z.6) 1,1,2,3,3-pentafluoropropane (HFC-245ea);

(z.7) 1,1,1,2,3-pentafluoropropane (HFC-245eb);

(z.8) 1,1,1,3,3-pentafluoropropane (HFC-245fa);

(z.9) 1,1,1,2,3,3-hexafluoropropane (HFC-236ea);

(z.10) 1,1,1,3,3-pentafluorobutane (HFC-365mfc);

(z.11) chlorofluoromethane (HCFC-31);

(z.12) 1-chloro-1-fluoroethane (HCFC-151a);

(z.13) 1,2-dichloro-1,1,2-trifluoroethane (HCFC-123a);

(z.14) 1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxybutane (C4F9OCH3);

(z.15) 2-(difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoropropane ((CF3)2CFCF2OCH3);

(z.16) 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane (C4F9OC2H5);

(z.17) 2-(ethoxydifluoromethyl)-1,1,1,2,3,3,3-heptafluoropropane ((CF3)2CFCF2OC2H5);

(z.18) methyl acetate and perfluorocarbon compounds that fall into the following classes, namely,

(i) cyclic, branched or linear completely fluorinated alkanes,

(ii) cyclic, branched, or linear completely fluorinated ethers with no unsaturations,

(iii) cyclic, branched or linear completely fluorinated tertiary amines with no unsaturations, or

(iv) sulfur containing perfluorocarbons with no unsaturations and with sulfur

bonds only to carbon and fluorine;

(z.19) 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane (HFE-7000);

(z.20) 3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl) hexane (HFE-7500);

(z.21) 1,1,1,2,3,3,3-heptafluoropropane (HFC-227ea);

(z.22) methyl formate (HCOOCH3);

(z.23) t-butyl acetate;

(z.24) 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane (HFE-7300);

(z.25) propylene carbonate;

(z.26) dimethyl carbonate;

(z.27) trans-1,3,3,3-tetrafluoropropene (HFO-1234ze);

(z.28) HCF2OCF2H (HFE-134);

(z.29) HCF2OCF2OCF2H (HFE-236cal2);

(z.30) HCF2OCF2CF2OCF2H (HFE-338pcc13);

(z.31) HCF2OCF2OCF2CF2OCF2H;

(z.32) 2,3,3,3-tetrafluoropropene (HFO-1234yf);

(z.33) trans 1-chloro-3,3,3-trifluoroprop-1-ene [HCFO-1233zd(E)]; and

(z.34) 2-amino-2-methyl-1-propanol.

61 Particulate matter containing metals that is released in emissions from copper smelters or refineries, or from both

62 Particulate matter containing metals that is released in emissions from zinc plants

63 2-butoxyethanol, which has the molecular formula C6H14O2

64 2-methoxyethanol, which has the molecular formula C3H8O2

65 Carbon dioxide, which has the molecular formula CO2

66 Methane, which has the molecular formula CH4

67 Nitrous oxide, which has the molecular formula N2O

68 Hydrofluorocarbons that have the molecular formula CnHxF(2n+2–x) in which 0<n<6

69 The following perfluorocarbons:

(a) those that have the molecular formula CnF2n+2 in which 0<n<7; and

(b) octafluorocyclobutane, which has the molecular formula C4F8.

70 Sulphur hexafluoride, which has the molecular formula SF6

71 Methanone, bis[4-(dimethylamino)phenyl]-, which has the molecular formula C17H20N2O

72 2-Butanone, oxime, which has the molecular formula C4H9NO

73 n-Butyl glycidyl ether, which has the molecular formula C7H14O2

74 Polybrominated diphenyl ethers that have the molecular formula C12H(10-n)BrnO in which 7≤n≤10

75 Compounds that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N

76 Methyloxirane, which has the molecular formula C3H6O

77 Ethyloxirane, which has the molecular formula C4H8O

78 Naphthalene, which has the molecular formula C10H8

79 Toluene diisocyanates, which have the molecular formula C9H6N2O2

80 1,2-Benzenediol, which has the molecular formula C6H6O2

81 1,4-Benzenediol, which has the molecular formula C6H6O2

82 Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethylpoly(difluoromethylene), C16-20-branched alcohols and 1-octadecanol

83 2-propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate

84 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5-furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate initiated

85 2-propen-1-ol reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine

86 Phenol, 4,4′ -(1-methylethylidene)bis-, which has the molecular formula C15H16O2

87 Thiourea, which has the molecular formula CH4N2S

88 1,3-Butadiene, 2-methyl-, which has the molecular formula C5H8

89 Oxirane, (chloromethyl)-, which has the molecular formula C3H5ClO

90 Colour Index Pigment Yellow 34

91 Colour Index Pigment Red 104

92 Cyclotetrasiloxane, octamethyl-, which has the molecular formula C8H24O4Si4

93 Ethanol, 2-methoxy-, acetate, which has the molecular formula C5H10O3

94 1-Propanol, 2-methoxy-, which has the molecular formula C4H10O2

95 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]-, which has the molecular formula C17H13N3O3

96 Ethanol, 2-(2-methoxyethoxy)-, which has the molecular formula C5H12O3

97 Sulfuric acid, diethyl ester, which has the molecular formula C4H10O4S

98 Sulfuric acid, dimethyl ester, which has the molecular formula C2H6O4S

99 2-Propenamide, which has the molecular formula C3H5NO

100 Ethanol, 2-chloro-, phosphate (3:1), which has the molecular formula C6H12Cl3O4P

101 Tetrabutyltins, which have the molecular formula (C4H9)4Sn

102 Benzene, (chloromethyl)-, which has the molecular formula C7H7Cl

103 Propane, 2-nitro-, which has the molecular formula C3H7NO2

104 Benzene, 1-methyl-2-nitro-, which has the molecular formula C7H7NO2

105 Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)3-methylphenyl]-, acetate, which has the molecular formula C27H34N3.C2H3O2

106 Benzene, 1,2-dimethoxy-4-(2-propenyl)-, which has the molecular formula C11H14O2

107 Vanadium pentoxide, which has the molecular formula V2O5

108 Oxirane, 2,2′,2′′,2′′′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis-, which has the molecular formula C38H38O8

109 Bromic acid, potassium salt, which has the molecular formula KBrO3

110 Hydrazine, which has the molecular formula N2H4

111 Quinoline, which has the molecular formula C9H7N

112 Perfluorooctanoic acid, which has the molecular formula C7F15CO2H, and its salts

113 Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which n is equal to 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom

114 Perfluorocarboxylic acids that have the molecular formula CnF2n+1CO2H in which 8≤n≤20 and their salts

115 Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which 8≤n≤ 20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom

116 Plastic microbeads that are less than or equal to 5mm in size

117 The following petroleum and refinery gases:

(a) tail gas (petroleum), catalytic polymerized naphtha fractionation stabilizer (a complex combination of hydrocarbons — obtained from the fractionation stabilization products that result from the polymerization of naphtha — consisting predominantly of hydrocarbons having carbon numbers in the range of C1 through C4);

(b) fuel gases (a combination of light gases consisting predominantly of hydrogen or low molecular weight hydrocarbons or both);

(c) hydrocarbons, C2-C4, C3-rich (a complex combination of hydrocarbons — obtained from a treating process to remove sulphur and other acidic compounds — consisting of hydrocarbons having carbon numbers in the range of C2 through C4, predominantly propane and propene);

(d) gases (petroleum), butane splitter overhead (a complex combination of hydrocarbons — obtained from the distillation of the butane stream — consisting of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4);

(e) gases (petroleum), catalytic cracked gas oil depropanizer bottom, C4-rich acid-free (a complex combination of hydrocarbons — obtained from the fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulfide and other acidic components — consisting of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4);

(f) gases (petroleum), catalytic cracked naphtha debutanizer bottom, C3-C5-rich (a complex combination of hydrocarbons — obtained from the stabilization of catalytic cracked naphtha — consisting of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C5);

(g) gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-rich acid-free (a complex combination of hydrocarbons — obtained from the fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities — consisting of hydrocarbons having carbon numbers in the range of C2 through C4, predominantly C3);

(h) gases (petroleum), catalytic cracker, C1-C5-rich (a complex combination of hydrocarbons — obtained from the distillation of products that result from a catalytic cracking process — consisting of aliphatic hydrocarbons having carbon numbers in the range of C1 through C6, predominantly C1 through C5);

(i) gases (petroleum), catalytic polymerized naphtha stabilizer overhead, C2-C4-rich (a complex combination of hydrocarbons — obtained from the fractionation stabilization of catalytic polymerized naphtha — consisting of aliphatic hydrocarbons having carbon numbers in the range of C2 through C6, predominantly C2 through C4);

(j) gases (petroleum), catalytic reformed naphtha stripper overhead (a complex combination of hydrocarbons — obtained from the stabilization of catalytic reformed naphtha — consisting of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4);

(k) gases (petroleum), deethanizer overhead (a complex combination of hydrocarbons — obtained from the distillation of the gas and gasoline fractions that result from a catalytic cracking process — consisting predominantly of ethane and ethene);

(l) gases (petroleum), deisobutanizer tower overhead (a complex combination of hydrocarbons — obtained from the atmospheric distillation of a butane-butene stream — consisting of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4);

(m) gases (petroleum), gas concentration reabsorber distillation (a complex combination of hydrocarbons — obtained from the distillation of products from combined gas streams in a gas concentration reabsorber — consisting predominantly of hydrogen, carbon monoxide, carbon dioxide, nitrogen, hydrogen sulfide and hydrocarbons having carbon numbers in the range of C1 through C3);

(n) gases (petroleum), hydrogen-rich (a complex combination — separated as a gas from hydrocarbon gases by chilling — consisting predominantly of hydrogen with small amounts of carbon monoxide, nitrogen, methane and C2 hydrocarbons);

(o) gases (petroleum), recycle, hydrogen-rich (a complex combination — obtained from recycled reactor gases — consisting predominantly of hydrogen with small amounts of carbon monoxide, carbon dioxide, nitrogen, hydrogen sulfide and saturated aliphatic hydrocarbons having carbon numbers in the range of C1 through C5);

(p) gases (petroleum), reformer make-up, hydrogen-rich (a complex combination — obtained from the reformers — consisting predominantly of hydrogen with small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(q) gases (petroleum), thermal cracking distillation (a complex combination — obtained from the distillation of products that result from a thermal cracking process — consisting of hydrogen, hydrogen sulfide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6);

(r) tail gas (petroleum), catalytic cracker refractionation absorber (a complex combination of hydrocarbons — obtained from the refractionation of products that result from a catalytic cracking process — consisting of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3);

(s) tail gas (petroleum), cracked distillate hydrotreater separator (a complex combination of hydrocarbons — obtained by treating cracked distillates with hydrogen in the presence of a catalyst — consisting of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(t) tail gas (petroleum), saturate gas plant mixed stream, C4-rich (a complex combination of hydrocarbons — obtained from the fractionation stabilization of straight-run naphtha, distillation tail gas and catalytic reformed naphtha stabilizer tail gas — consisting of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly butane and isobutane);

(u) tail gas (petroleum), vacuum residue thermal cracker (a complex combination of hydrocarbons — obtained from the thermal cracking of vacuum residues — consisting of hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(v) hydrocarbons, C3-C4-rich, petroleum distillates (a complex combination of hydrocarbons — obtained from the distillation and condensation of crude oil — consisting of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C3 and C4);

(w) gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich (a complex combination of hydrocarbons — obtained from the distillation of products that result from a hydrocracking process — consisting predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4);

(x) gases (petroleum), light straight-run naphtha stabilizer off (a complex combination of hydrocarbons — obtained from the stabilization of light straight-run naphtha — consisting of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6);

(y) gases (petroleum), reformer effluent high pressure flash drum off (a complex combination — obtained from the high pressure flashing of the effluent from the reforming reactor — consisting predominantly of hydrogen with small amounts of methane, ethane and propane);

(z) hydrocarbons, C1-C4 (a complex combination of hydrocarbons — obtained from thermal cracking and absorber operations and from the distillation of crude oil — consisting of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -164°C to -0.5°C);

(z.1) hydrocarbons, C1-C4, sweetened (a complex combination of hydrocarbons — obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities — consisting of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -164°C to -0.5°C);

(z.2) hydrocarbons, C1-C3 (a complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately -164°C to -42°C);

(z.3) gases (petroleum), C1-C5, wet (a complex combination of hydrocarbons — obtained from the distillation of crude oil or the cracking of tower gas oil or both — consisting of hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(z.4) gases (petroleum), secondary absorber off, fluidized catalytic cracker overhead fractionater (a complex combination — obtained from the fractionation of the overhead products that result from a catalytic cracking process in the fluidized catalytic cracker — consisting of hydrogen, nitrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3);

(z.5) gases (petroleum), alkylation feed (a complex combination of hydrocarbons — obtained from the catalytic cracking of gas oil — consisting of hydrocarbons having carbon numbers predominantly in the range of C3 through C4);

(z.6) petroleum products, refinery gases (a complex combination consisting predominantly of hydrogen with small amounts of methane, ethane and propane);

(z.7) gases (petroleum), refinery (a complex combination — obtained from various petroleum refining operations — consisting of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3);

(z.8) gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off (a complex combination — obtained from the depentanizer stabilization of hydrotreated kerosine — consisting predominantly of hydrogen, methane, ethane and propane with small amounts of nitrogen, hydrogen sulfide, carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C4 through C5);

(z.9) gases (petroleum), crude oil fractionation off (a complex combination of hydrocarbons — obtained from the fractionation of crude oil — consisting of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(z.10) gases (petroleum), fluidized catalytic cracker fractionation off (a complex combination — obtained from the fractionation of the overhead products that result from a fluidized catalytic cracking process — consisting of hydrogen, hydrogen sulfide, nitrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(z.11) gases (petroleum), heavy distillate hydrotreater desulfurization stripper off (a complex combination — stripped from the liquid product that results from a heavy distillate hydrotreater desulfurization process — consisting of hydrogen, hydrogen sulfide and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(z.12) gases (petroleum), preflash tower off, crude distillation (a complex combination — produced from the first tower used in the distillation of crude oil — consisting of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5);

(z.13) gases (petroleum), straight-run stabilizer off (a complex combination of hydrocarbons — obtained from the fractionation of the liquid produced from the first tower used in the distillation of crude oil — consisting of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4);

(z.14) tail gas (petroleum), catalytic hydrodesulfurized naphtha separator (a complex combination of hydrocarbons — obtained from the catalytic hydrodesulfurization of naphtha — consisting of hydrogen, methane, ethane and propane);

(z.15) gases (petroleum), C3-C4 (a complex combination of hydrocarbons — obtained from the distillation of products that result from the cracking of crude oil — consisting of hydrocarbons having carbon numbers in the range of C3 through C4, predominantly propane and propene, and boiling in the range of approximately -51°C to -1°C);

(z.16) gases (petroleum), C3-C4, isobutane-rich (a complex combination of hydrocarbons — obtained from the distillation of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C3 through C6, predominantly butane and isobutane — consisting of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C4, predominantly isobutane);

(z.17) gases (petroleum), C4-rich (a complex combination of hydrocarbons — obtained from the distillation of products that result from a catalytic fractionation process — consisting of aliphatic hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4);

(z.18) hydrocarbons, C1-C4, debutanizer fraction (a complex combination of hydrocarbons — obtained from a debutanizing process — having carbon numbers in the range of C1 through C4);

(z.19) petroleum gases, liquefied (a complex combination of hydrocarbons — obtained from the distillation of crude oil — consisting of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C); and

(z.20) petroleum gases, liquefied, sweetened (a complex combination of hydrocarbons — obtained by subjecting liquefied petroleum gases to a sweetening process to convert mercaptans or to remove acidic impurities — consisting of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C).

118 Hexanedioic acid, bis(2-ethylhexyl) ester, which has the molecular formula C22H42O4

119 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, which has the molecular formula C22H16N4O

120 Fuel Oil No. 2

121 Natural gas condensates (a complex combination of hydrocarbons primarily in the carbon range of C5 to C15 that are condensed during production at a well head, in a natural gas processing plant, natural gas pipeline or straddle plant), including any of their liquid distillates that are primarily in the carbon range of C5 to C15

122 Phenol, 5-chloro-2-(2,4-dichlorophenoxy)-, which has the molecular formula C12H7Cl3O2

123 Acetamide, N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]-, which has the molecular formula C15H15N3O2

124 Cobalt and soluble cobalt compounds

125 N,N′-mixed phenyl and tolyl derivatives of 1,4-benzenediamine

126 Benzene, 1,1′-methylenebis[4-isocyanato-, which has the molecular formula C15H10N2O2

127 Benzene, 1,1′-methylenebis[2-isocyanato-, which has the molecular formula C15H10N2O2

128 Benzene, 1-isocyanato-2-[(4-isocyanatophenyl)methyl]-, which has the molecular formula C15H10N2O2

129 Benzene, 1,1′-methylenebis[isocyanato- (nonisomeric-specific), which has the molecular formula C15H10N2O2

130 Isocyanic acid, polymethylenepolyphenylene ester, which has the molecular formula C15H10N2O2•[C8H5NO]n in which 0≤n≤4

Plain Language Summary

Further to clause 58, the schedule replaces the current Schedule 1 with the new bifurcated Schedule 1.

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 added 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.

Senate Amendments

Corrected grammatical error in the Note above Part 1.

As a consequential change to clause 16.1, included section 68.1 in the provisions listed under Schedule 1.

Related Clauses

  • Renaming and Bifurcating Schedule 1 (see clause 58)
  • Prohibiting Toxic Substances that Pose the Highest Risk/Concern (see clauses 12, 15, 21, 22, 29, 30, 32, 35, 58, 63 and 68)
  • Animal Testing (see clauses 2, 3, 15, 16.1, 18, 19)

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