25 Aug 2023

Environment and Climate Change Canada and Health Canada Introduce Bill S-5: Strengthening Environmental Protection for a Healthier Canada Act

Have you heard the news?

On 09 February 2022, the Government of Canada announced that the Senate of Canada introduced Bill S-5, the Strengthening Environmental Protection for a Healthier Canada Act. This is the first bill intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA 1999). The bill received Royal Assent on 13 June 2023, giving the Canadian government 2 years to implement all of amendments in the new CEPA.

So, what's in the bill?

In a statement, the government stated that the bill would "encourage businesses to transition to the production and use of chemicals that are safer for the environment and human health." Under the bill, Environment and Climate Change Canada (ECCC) will develop a new plan of chemical management priorities, replacing the categorization provisions and the Priority Substances List provision that were added to CEPA 1999. This integrated, multi-year plan will set timelines for assessing substances already in commerce in Canada. The plan will also focus on the activities and initiatives that support chemicals management, such as information gathering, risk management, risk communications, and research and monitoring, and implement a strategy to promote the development and timely incorporation of scientifically justified alternative methods and strategies in the testing and assessment of substances to replace, reduce, or refine the use of vertebrate animals.

The Canadian government will also rename "Schedule 1, List of Toxic Substances" to "Schedule 1." Schedule 1 will now be separated into 2 parts:

  • Schedule 1, part 1 will identify substances of concern (previously known as "CEPA toxic" substances) that are either:
    • Persistent and bioaccumulative and inherently toxic (PBiT);
    • Carcinogenic, mutagenic, or toxic for reproduction (CMR); or
    • Otherwise found to pose the highest risk.
  • Schedule 1, Part 2 will identify all other substances of concern in an effort to prevent pollution.

Under the new CEPA, the government will also create a new publicly available list called the "Watch List." This will be a list of substances of concern that can pose a risk if, for example, there are changes to how the substance can be used, or there is an increase in exposure to the substance in the environment posing a risk to human health. The Watch List will help importers, manufacturers, and Canadian consumers select safer alternatives to such substances and avoid regrettable substitutions.

The new CEPA - or as I like to call it, CEPA 2023 - recognizes the right to a healthy environment and to protection for vulnerable people.1 Over the next 2 years, the Canadian government will develop an implementation framework to establish how this right will be considered in administering the Act. This will include identifying populations that may be more susceptible to, or disproportionately impacted by, higher exposure to environmental and health risks. The framework will also lead to more informed and protective environmental and health standards, and confirm the government's commitment to the United Nations Declaration on the Rights of Indigenous Peoples. The Ministers will have to report annually to the Parliament of Canada on the progression of the implementation framework, including any public consultations, findings, recommendations, or measures taken in that regard.

1 The amendments define a vulnerable population as "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." These populations may include pregnant people, children, people in poor health, workers, and those living in areas where levels of pollution are particularly high.

"Dear Ministers" Letters

Under CEPA 2023, a new measure will allow any person in Canada to submit a written request for a substance to be assessed to determine if the substance meets the definition of Section 64 (CEPA toxic) or is otherwise capable of becoming CEPA toxic. The Minister must then decide, within 90 days, whether the substance will be added to the list of Chemicals Management Priorities, and inform the requestor of the decision and why the request was accepted or rejected.

Confidential Business Information

Under CEPA 2023, any persons submitting information will be required to provide a justification to support a request for confidentiality of business information at the time of the request. The Ministers will be required to review and validate the request and, if rejecting it, will be required to inform the person in writing with the reasons for rejection, based on criteria set out in paragraphs 20(1)(a) to (d) of the Access to Information Act.

CEPA 2023 establishes circumstances whereby the Ministers may disclose the explicit name of a masked substance when risk management instruments have been put in place for the substance (for example, when the "significant new activity" provisions have been applied to the substance or when a substance is subject to Ministerial Conditions). It would also authorize the Minister to disclose the explicit names of substances claimed "confidential" after 10 years. However, the Minister will give proponents the opportunity, in writing, to update their claim if they wish the substance identity to remain confidential for an additional period of 10 years.

Best Placed Act/Regulations

For the purposes of assessing toxic substances, CEPA 2023 allows the Ministers to identify and rely on an existing federal measure under any other Act or regulation if the government can show how that the measure addresses the risks that were identified during the risk assessment. For example, under section 16 (prohibition on the sale of cosmetics containing substances that may cause injury) of the Food and Drugs Act (F&DA), the Ministers could use this statute to show that a relevant substance being assessed can cause injury to Canadians. Where Ministers decide to rely on an existing federal measure that addresses the risks identified for a toxic substance, they must make a statement to that effect and outline additional administrative measures that will be taken to ensure the measure is effective.

Amending the Domestic Substances List

As you know, substances added to the Domestic Substances List (DSL) remained there in perpetuity unless the government could show that a substance was included by error. Now, under CEPA 2023, the Minister is able to remove a substance if the Minister can show that the substance is no longer sold, manufactured, or distributed in Canada (i.e., is no longer on the Canadian marketplace). When this occurs, the Minister will have to publish a notice of removal in the Canada Gazette and provide a 60-day comment period. This will be the only opportunity to justify why a substance should not be removed from the list. Any substance removed will be added to the Non-domestic Substances List and will become a new substance (i.e., the substance will be notifiable if any person imports or manufactures it in the future).

The Minister will now also be allowed to include substances from the Health Canada administrative substances list, known as the "Revised In Commerce List," provided that they are not subject to any risk management. These substances will be considered "existing substances" and will be exempt from notification under the regulations.

Environmental Assessment Regulations

Changes to the Food and Drugs Act (F&DA) strengthen the environmental risk assessment and risk management of drugs, expand the Minister of Health's ability to manage environmental risks resulting from drugs, and enable the government to create an environmental risk assessment and risk management framework for drugs under the Act (previously limited to health risks). The changes also remove the need to duplicate the notification process between the F&DA and CEPA, and thus result in a more streamlined regulatory approach for industry with respect to drug assessment and approval in Canada.

Animal Testing

CEPA 2023 includes several provisions aimed at replacing, reducing, or refining the use of vertebrate animals in toxicity testing, including requiring that the Ministers use scientifically justified testing alternatives, when possible, in the generation of data that minimize pain and distress to animals.

New Substances Notification Regulations (Organisms)

The CEPA amendments also pertain to Canada's regulatory framework for products from biotechnology; they establish that the government will undertake a "full and comprehensive" review of the regulations as they pertain to "Organisms and Microorganisms." Ministers must consult with interested parties when assessing new living organisms that are vertebrate animals or assessing those otherwise prescribed by regulation, and must consider whether there is a "demonstrable need" for the organisms (for example, genetically modified plants and animals).

What's coming up?

CEPA 2023 is the first significant update since the CEPA was published in 1999. Suffice to say, there will be many changes over the next 2 years. The Canadian government intends to hold consultations, likely via the online platform PlaceSpeak (www.placespeak.com), on the following topics:

Strategies, Policies, Guidance, and Processes

  • Public request for assessment
  • Consideration of available information on vulnerable populations, environments, and cumulative effects
  • Consultations on assessments of new living vertebrate organisms
  • Strategy to replace, reduce, and refine vertebrate animal testing
  • Watch List
  • Instrument choice: appropriate use of "best placed act," power to regulate product design, use pollution prevention plans to prioritize safer alternatives, etc.
  • Process for Confidential Business Information (CBI) claims

Regulations and Orders

  • Regulations concerning toxic substances of highest risk
  • Regulations enabling health and environmental risk assessment and risk management under the F&DA
  • Order of adding Revised In Commerce List substances to the DSL

Research and Monitoring

  • Conducting biomonitoring surveys and design studies to support the right to a healthy environment

Transparency and Accountability

  • Audits and reports on requests for CBI
  • Updating web pages, CEPA registry, etc.
  • Implementing new timelines and reporting requirements (e.g., new content in the CEPA annual report)

We encourage you to stay engaged with industry associations and participate in these consultations to ensure your interests are represented. Stay tuned for more information on workshops and webinars, and make your voice count.

Do you need assistance?

Do you have questions about this topic, the development of the new plan of chemical management priorities, the New Substances Notification program, or a related topic?

Contact our experts at Intertek Assuris—we're here to help!

References:

Dan Bastien Intertek headshot

Dan Bastien,
Associate Director, Chemicals Group, Intertek Assuris

Dan is a subject matter expert in Canada with specific experience in the Chemical Management Plan. Prior to joining Intertek, Dan managed the Substances Management Information Line and delivery of client services for the Chemical Management Plan of the Government of Canada. His main responsibilities were to provide regulatory advice to industry stakeholders on the obligations to submit notifications of new chemicals, polymers and product of biotechnology substances in Canada. Dan was also responsible in the development and delivery of training materials, webinars and written material such as pamphlets, flyers and posters. He also designed and then managed the substances website.

As a Government representative, Dan has participated and contributed to numerous industry/government and multi-stakeholder consultations regarding such topics as: toxic substance management; the re-engineering of the CEPA; the New Substances Notification Regulations (NSNR); the Environmental Assessment Regulations for substances regulated under Food and Drug Act; Categorization and Screening of the Domestic Substances List; and the Canadian Chemical Management Plan (CMP).