Canada Issues Revised Draft Guidance For NSN Submissions: Environment and Climate Change Canada (ECCC), in March 2021, issued a draft document entitled “Guidance Document for the Notification and Testing of New Chemicals and Polymers.” ECCC states that the new Guidance Document:
- Helps the user to determine whether a substance is subject to notification and the applicable timelines;
- Outlines the treatment of confidential information;
- Provides guidance on acceptable test methods, alternative information, and waiver requests;
- Explains how the New Substances program assesses the submitted information; and
- Describes the possible decisions following the assessment of a new substance.
When issued in final, it will replace the current guidance for submitting New Substance Notifications (NSN) in Canada. Interested parties are encouraged to review the draft guidance and submit comments to ECCC by June 30, 2021.
Government Announces Bill Intended To Modernize CEPA: On April 13, 2021, the government of Canada announced that it will take steps to amend the Canadian Environmental Protection Act, 1999 (CEPA) through the Strengthening Environmental Protection for a Healthier Canada Act (Bill C-28). The press release states that the changes will strengthen protections for Canadians and the environment by:
- Recognizing a right to a healthy environment for every individual in Canada as provided for under CEPA;
- Assessing real-life exposure based on the cumulative effects of a substance in combination with exposure to other substances, and better protecting populations most at risk due to greater susceptibility or potential exposure to harmful substances;
- Implementing a new regime for toxic substances that pose the highest risk;
- Supporting the shift to less harmful chemicals through the establishment of a Watch List of substances capable of meeting the criteria in CEPA to be considered at risk if, for example, there should be an increase in exposure. The amendments would require the Ministers to publish and maintain a list of substances that are capable of becoming toxic;
- Creating a new Plan of Chemicals Management Priorities that will set out an integrated plan for the assessment and management of substances, as well as supporting activities such as research, monitoring, information gathering, and risk communication; and
- Amending the Food and Drugs Act to provide the ability to develop a regulatory framework to assess and manage the environmental risks of new drugs. This would remove the requirement to notify and assess new drugs under both the Food and Drugs Act and CEPA, providing a more efficient and effective approach to managing the risks of drugs in Canada.
Canada published a summary of the amendments in Bill C-28.
Canada Publishes Notice Of Intent To Address Broad Class Of PFAS: Canada published a Canada Gazette notice on April 24, 2021, announcing that it is considering activities that would address PFAS as a class. In 2021, Canada will:
- Continue to invest in research and monitoring on per- and polyfluoroalkyl substances (PFAS);
- Collect and examine information on PFAS to inform a class-based approach; and
- Review policy developments in other jurisdictions.
In addition, within the next two years, Canada will publish a State of PFAS Report that will summarize relevant information on the class of PFAS. Canada invites stakeholders to provide initial feedback on the intent to address PFAS as a class, including any challenges or opportunities they foresee.
Canada Adds Plastic Manufactured Items To CEPA Schedule 1: On May 12, 2021, Canada published an order in the Canada Gazette adding plastic manufactured items to CEPA Schedule 1. Adding a substance to Schedule 1 enables the Ministers of the Environment and of Health to propose risk management measures. A substance may be added to Schedule 1 under CEPA Section 64 if it is entering or may enter the environment in a quantity or concentration or under conditions that:
- Have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- Constitute or may constitute a danger to the environment on which life depends; or
- Constitute or may constitute a danger in Canada to human life or health.
The order states that based on the information provided in the science assessment, the Ministers are satisfied that “plastic manufactured items” meet the criteria set out in CEPA Section 64(a). Accordingly, the Ministers recommended that plastic manufactured items be added to Schedule 1, enabling them to propose risk management measures under CEPA on certain plastic manufactured items to manage the potential ecological risks associated with those items becoming plastic pollution. Using CEPA allows the Ministers to access the full range of authorities needed to manage plastic manufactured items along their entire life cycle. The order states that any risk management measures developed under CEPA will be guided by the precautionary principle as set out in Section 2(1)(a).
Bergeson & Campbell