Environment and Climate Change Canada (ECCC) announcement on February 9, 2022, that the government tabled in the Senate the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act (FDA). The bill was originally introduced in the 43rd Legislature in April 2021 as Bill C-28, but was not considered due to the September 2021 federal election. ECCC states that the bill “would encourage companies to switch to the production and use of chemicals”. which are safer for the environment and human health. Under the bill, ECCC would develop a new plan of chemicals management priorities and propose a new regime to manage the toxic substances most at risk. Canada would create a publicly available “watch list” of substances deemed capable of becoming toxic under CEPA to inform Canadians and businesses of substances they may wish to avoid. This brief presents a summary of the amendments and new measures contained in the bill.
A right to a healthy environment
ECCC information document states that the Government of Canada would recognize that every individual in Canada has the right to a healthy environment and that the government has a duty to protect this right when enforcing CEPA.
Protect vulnerable populations
The amendments would require the government to exercise its powers in a way that minimizes health risks to vulnerable populations. The vulnerable population would be defined as “a group of people within the Canadian population who, because of greater susceptibility or exposure, may be at increased risk of experiencing adverse health effects due to exposure to substances”. According to the briefing paper, those most vulnerable may include children and those in poor health, while those most at risk may include workers and people living in areas with particularly high pollution levels. The Amendments would require the Ministers of Environment and Climate Change and of Health (Ministers) to consider available information about vulnerable populations in risk assessments.
Assessment of actual exposures
The amendments would require the government to consider available information on 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 making and interpreting the results of risk assessments. The information document states that “[r]Recognizing that the science of cumulative effects assessment is still evolving and that data [are] not always available to support decisions made on this basis, amendments to CEPA will require the government to consider available information regarding cumulative effects that may result from exposure to the substance being assessed in combination with other substances.
A tougher regime for substances that are toxic under CEPA and pose the highest risk
The new regime would retain the risk-based approach in the current CEPA. For substances found to be toxic under CEPA, the amendments would require ministers to give priority to prohibiting activities related to toxic substances with the highest risk. Criteria for the highest risk substances would include persistence and bioaccumulation, as well as criteria for carcinogenicity, mutagenicity and reproductive toxicity. Under the Amendments, substances could be eliminated entirely, activities or releases of concern could be prohibited, or all new uses could be prohibited, unless it can be demonstrated that there are no more alternatives. safe and can be used safely. Schedule 1 of CEPA would be divided into two parts, with Part 1 listing the highest risk substances that would be prioritized for prohibition of activities and releases of concern, and Part 2 listing all other toxic substances according to CEPA.
Support the transition to safer chemicals
To support the switch to safer chemicals, the government would recognize “the importance of encouraging the gradual 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 deemed capable of becoming toxic under CEPA under certain circumstances, such as increased exposure. According to the backgrounder, the watchlist “will help Canadian importers, manufacturers and consumers select safer alternatives and avoid unfortunate substitutions – replacing a problematic chemical with one that, in turn, becomes a problem”.
A New Plan of Chemicals Management Priorities
The government would develop a new Chemicals Management Priorities Plan for substance assessment to better understand and protect Canadians and the environment from substances of concern. According to the backgrounder, when it was enacted in 1999, CEPA made it a priority to categorize 23,000 substances already in commerce based on bioaccumulation, persistence, inherent toxicity and greatest potential for harm. ‘exposure. The backgrounder indicates that work to address nearly 4,300 substances identified as priorities is largely complete and that, for this reason, a new process for prioritizing and evaluating substances is needed. The plan would include information gathering, monitoring and research to support 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 formally request that a chemical be assessed, obliging ministers to review and respond to any such request. Industry would be required to provide justification to support claims of business information confidentiality, and the government would establish the circumstances under which the names of masked substances or living organisms could be disclosed. The briefing note 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). »
Reduce reliance on animal testing
Amendments to the preamble of CEPA would recognize the need to reduce the use of animal testing when assessing the risks that substances may pose to human health and the environment.
FDA Changes to Strengthen Environmental Risk Assessment and Drug Risk Management
Canada is also proposing to amend the FDA to allow 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 drug ingredients are assessed under CEPA. According to the background paper, the proposed framework would streamline the regulatory process for industry while strengthening environmental risk assessment and drug risk management.
Labeling and information for consumers
The information document states that “[t]where address [the] growing demand for easily accessible information on chemicals in consumer products, the government has pledged to strengthen mandatory labeling requirements for certain consumer products and improve transparency of chemical ingredients in supply chains companies.
According to the briefing paper, the government intends to hold consultations to find 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 to require certain fragrance allergens to be disclosed on cosmetic product labels and plans to publish a regulatory proposal in summer 2022.
Update of the regulatory framework for biotechnology products
According to the backgrounder, the government will undertake a “full and comprehensive” review of the New Substances Notification Regulations (Organisms), which provide for the risk assessment of new living organisms before they are introduced into the Canadian market. . 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 to increase public participation and transparency in the assessment and management of risks associated with living organisms, “in particular with respect to higher living organisms (for example., genetically modified plants and animals).
The proposed amendments to CEPA would be the first major reform of the Act in over 20 years. CEPA uses a risk-based chemical regulatory regime, similar to the US TSCA, and the amendments would maintain this approach. The amendments are ambitious, giving ministers two years to develop and publish a chemicals management priority plan that establishes an integrated, multi-year plan for assessing substances. The creation of a “watch list” of chemicals could, however, be used effectively as a list of chemicals to be de-screened. Anyone could submit a written request to have a substance evaluated to determine if it is toxic or likely to become toxic. The Amendments allow the Watch List to be changed “from time to time,” but do not specify how to remove a chemical from the Watch List.
Regardless of the amendments, the government intends to hold consultations in early 2022 identify new ways to strengthen labeling and improve disclosure and communication of information about chemicals in supply chains. The government will use the information obtained during the consultations to propose regulatory changes or other actions. The government hosted a consultation in the summer of 2021 on potential cosmetic regulatory changes under the FDA, including adding a requirement to disclose specific fragrance allergens on cosmetic labels. The results of this consultation will inform a targeted regulatory proposal for summer 2022. Stakeholders should consider responding to consultations to ensure their interests are represented.