Canadian Government Introduces Bill Intended to Modernize CEPA
Environment and Climate Change Canada (ECCC) announced on February 9, 2022, that the government introduced in the Senate the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act (FDA). The bill was initially introduced in the 43rd Parliament in April 2021 as Bill C-28, but it was not considered due to the federal election in September 2021. ECCC states 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, ECCC would develop a new plan of chemical management priorities and would propose a new regime to manage toxic substances of highest risk. Canada would create a publicly available “Watch List” of substances determined to be capable of becoming toxic under CEPA to inform Canadians and businesses of substances that they may wish to avoid. This memorandum provides a summary of the amendments and new measures in the bill.
A Right to a Healthy Environment
ECCC’s backgrounder states that the government of Canada would recognize that every individual in Canada has a right to a healthy environment and that the government has a duty to protect that right when administering CEPA.
Protecting Vulnerable Populations
The amendments would require that the government exercise its powers in ways that minimize risks to the health of vulnerable populations. Vulnerable population would be defined 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.” According to the backgrounder, those with a greater susceptibility may include children and those in poor health, while those with greater exposure may include workers and those living in areas where levels of pollution are particularly high. The amendments would require the Ministers of Environment and Climate Change and of Health (the Ministers) to consider available information regarding vulnerable populations in risk assessments.
Assessing Real-Life Exposures
The amendments would require that the government consider available information about the cumulative effects on human health and the environment that may result from exposure to a particular substance in combination with exposure to other substances when conducting and interpreting the results of risk assessments. The backgrounder states that “[r]ecognizing that the science of assessing cumulative effects is still evolving, and data [are] not always available to support decisions made on this basis, amendments to CEPA will require the Government to consider information that is available with respect to the cumulative effects that may result from exposure to the substance being assessed in combination with other substances.”
A Stronger Regime for Substances That Are Toxic under CEPA and of the Highest Risk
The new regime would retain the risk-based approach in the current CEPA. For substances determined to be toxic under CEPA, the amendments would require that the Ministers give priority to prohibiting activities in relation to toxic substances of the highest risk. The criteria for substances of the highest risk would include persistence and bioaccumulation, as well as criteria for carcinogenicity, mutagenicity, and reproductive toxicity. Under the amendments, substances could be phased out entirely, activities or releases of concern could be prohibited, or all new uses could be prohibited unless it can be shown that there are no safer alternatives and the use can be undertaken safely. CEPA Schedule 1 would be divided into two parts, with Part 1 listing substances of the highest risk that would be prioritized for the prohibition of activities and releases of concern, and Part 2 listing all other CEPA-toxic substances.
Supporting the Shift to Safer Chemicals
To support the shift to safer chemicals, the government would recognize “the importance of encouraging the progressive substitution of substances with alternatives that are safer for the environment or human health.” The Minister of Environment and Climate Change would be required to publish and maintain a “Watch List” of substances determined to be capable of becoming toxic under CEPA under certain circumstances, such as increased exposure. According to the backgrounder, the Watch List “will help importers, manufacturers and Canadian consumers to select safer alternatives and avoid regrettable substitutions — replacing one problem chemical with another that in turn becomes a problem.”
A New Plan of Chemicals Management Priorities
The government would develop a new Plan of Chemicals Management Priorities for the assessment of substances to understand and protect better Canadians and the environment from substances of concern. According to the backgrounder, when enacted in 1999, CEPA set as a priority the categorization of 23,000 substances already in commerce based on bioaccumulation, persistence, inherent toxicity, and the greatest potential for exposure. The backgrounder states that the work to address almost 4,300 substances identified as priorities has largely been completed, and for this reason, a new process to prioritize and assess substances is needed. The plan would include information-gathering, monitoring, and research to support the assessments. It would also consider ways to provide meaningful information to the public through labeling and other means.
Increased Transparency in Decision-Making
The amendments would provide a means to request formally that a chemical be assessed, requiring the Ministers to consider and respond to any such request. Industry would be required to provide a rationale to support requests for confidentiality for business information, and the government would establish the circumstances under which the names of masked substances or living organisms might be disclosed. The backgrounder notes that this proposal “is consistent with the approach taken by the United States Environmental Protection Agency based on similar requirements under the Toxic Substances Control Act (TSCA).”
Reducing Reliance on Animal Testing
Amendments to the preamble of CEPA would recognize the need to reduce reliance on animal testing when assessing the risks that substances may pose to human health and the environment.
Changes to the FDA to Strengthen the Environmental Risk Assessment and Risk Management of Drugs
Canada is also proposing to amend the FDA to enable it to create an environmental notification, risk assessment, and risk management framework for drugs. Currently, the safety, efficacy, and quality of drugs are assessed under the FDA, and the environmental risks of the drug ingredients are assessed under CEPA. According to the backgrounder, the proposed framework would streamline the regulatory process for industry while strengthening the environmental risk assessment and risk management of drugs.
Labeling and Information for Consumers
The backgrounder states that “[t]o address [the] growing demand for readily accessible information on chemicals in consumer products, the Government is committed to enhancing mandatory labelling requirements for certain consumer products and to improving the transparency of chemical ingredients in business supply chains.”
According to the backgrounder, the government intends to hold consultations to identify new ways to strengthen labeling and improve disclosure and communication of information about chemicals in supply chains in early 2022. The government will use the consultations to propose regulatory changes or other actions. In addition, the government will propose requiring certain fragrance allergens to be disclosed on cosmetic product labels and plans to release a regulatory proposal in summer 2022.
Updating the Regulatory Framework for Products of Biotechnology
According to the backgrounder, the government will undertake a “full and comprehensive” review of the New Substances Notification Regulations (Organisms), which provide for the assessment of risks posed by new living organisms prior to their being introduced into the Canadian marketplace. The backgrounder states that the objectives are to amend the regulations to respond effectively to advances in biotechnology to ensure that Canadians and the environment continue to be protected, and increase public participation and transparency when assessing and managing the risks associated with living organisms, “particularly with respect to higher living organisms (e.g., genetically modified plants and animals).”
The proposed CEPA amendments would be the first significant reform to the Act in more than 20 years. CEPA uses a risk-based chemical regulatory scheme, similar to the U.S. TSCA, and the amendments would maintain this approach. The amendments are ambitious, giving the Ministers two years to develop and publish a Plan of Chemicals Management Priorities that sets out a multi-year, integrated plan for the assessment of substances. The creation of a “Watch List” of chemicals, however, could effectively serve as a list of chemicals for deselection. Any person would be able to file a written request that a substance would be assessed to determine whether it is toxic or capable of becoming toxic. The amendments allow for the Watch List to be amended “from time to time,” but do not address how to remove a chemical from the Watch List.
Separate from the amendments, the government intends to hold consultations in early 2022 to identify new ways to strengthen labeling and improve disclosure and communication of information about chemicals in supply chains. The government will use information obtained from the consultations to propose regulatory changes or other actions. The government held a consultation in summer 2021 on potential changes to the Cosmetic Regulations under the FDA, including adding a requirement to disclose specific fragrance allergens on labels of cosmetics. The results of this consultation will inform a regulatory proposal targeted for summer 2022. Stakeholders should consider responding to the consultations to ensure their interests are represented.