On May 20, 2023, Canada published a Canada Gazette notice announcing the availability of its Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Draft Report). Canada proposes to conclude that the class of PFAS meets one or more criteria set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the notice, the Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of PFAS be added to the CEPA Schedule 1 List of Toxic Substances. The Draft Report provides a qualitative assessment of the fate, sources, occurrence, and potential impacts of PFAS on the environment and human health to inform decision-making on PFAS in Canada. The ministers have released a risk management scope document for PFAS to initiate discussions with stakeholders on the development of risk management options. Comments on the Draft Report and risk management scope document are due July 19, 2023.
Draft Report
According to the Draft Report, the common chemical characteristic of PFAS is their perfluoroalkyl moiety, “which is extremely stable in the environment, to the extent that PFAS have often been termed ‘forever chemicals.’” The Draft Report states that simple PFAS are highly persistent, whereas more complex molecules transform into stable PFAS. In the Draft Report, the term PFAS refers to the Organization for Economic Cooperation and Development’s (OECD) broad chemical definition, “which -- with a few noted exceptions -- includes any chemical with at least a perfluorinated methyl group (–CF3) or a perfluorinated methylene group (–CF2–).” The Draft Report notes that this definition “captures substances with a wide range of structures and properties, from discrete chemicals such as perfluorocarboxylic acids, perfluorosulfonic acids, and fluorotelomer alcohols, to side-chain fluorinated polymers and high molecular weight fluoropolymers.” Some PFAS on the market also possess structural attributes other than perfluoroalkyl chains (e.g., inclusion of ether linkages or chlorine atoms in the fluorinated hydrocarbon chains).
The Draft Report states that typical uses of PFAS include surfactants, lubricants, and repellents (for dirt, water, and grease). PFAS can also be found in certain firefighting foams (i.e., aqueous film-forming foams (AFFF)), textiles (e.g., carpets, furniture, and clothing), cosmetics, and food packaging materials.
According to the Draft Report, there are many potential sources of PFAS in Canada that can lead to human exposure and releases to the environment. Humans can be exposed to PFAS from various sources such as food and food packaging, cosmetics, products available to consumers, ambient air, indoor air and dust, and drinking water. The Draft Report states that PFAS-impacted contaminated sites represent “hot spot” areas where Canadians and the environment may be exposed to elevated concentrations of PFAS. Such sites include those associated with the use of AFFFs. The Draft Report notes that as it is not possible to separate PFAS-containing waste from the general waste stream, PFAS-containing products can be found in municipal solid waste (MSW) landfills or are destined for MSW incineration. Composting of PFAS-containing food packaging, releases into wastewater treatment systems, and the application of biosolids to land provide additional routes of entry for PFAS into the environment. The Draft Report states that “[i]t should be noted that PFAS contamination is present throughout Canada and is not limited to a few sources or areas.”
The Canadian government has been actively studying the ecological and human health effects associated with exposure to PFAS, including through the use of new approach methods, to characterize multiple PFAS in biological and environmental media at the same time. The Draft Report states that these studies “confirm the environmental presence of PFAS mixtures that include many substances that are not targeted in typical monitoring and surveillance studies.” According to the Draft Report, in addition to specific initiatives, there are ongoing environmental and human monitoring and surveillance programs to address subpopulations that may be more susceptible or highly exposed, including pregnant women and children, Indigenous and northern communities in Canada, and firefighters.
The Draft Report states that Canada has acted to address PFAS for which early evidence indicated potential concerns for the environment or human health and that a limited number of subgroups of PFAS are subject to risk management controls in Canada. The manufacture, use, sale, offer for sale, and import of perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), long-chain perfluorocarboxylic acids (LC-PFCA), and their salts and precursors are prohibited under the Prohibition of Certain Toxic Substances Regulations, 2012, with a limited number of exemptions. Canada published proposed regulations in May 2022 that would repeal and replace the Prohibition of Certain Toxic Substances Regulations, 2012, proposing to restrict further these groups of substances by removing or providing time limits for most remaining exemptions. According to the Draft Report, some PFAS notified under the New Substances Notification Regulations (Chemicals and Polymers) have also been subject to prohibitions, ministerial conditions, and significant new activity provisions under CEPA. The Draft Report notes that “[i]t has been observed that shorter-chain PFAS have been used as substitutes for long-chain PFAS (carbon chain length of 8 or more) following the implementation of regulatory restrictions on the latter.”
Other domestic activities that target PFAS include the development of water and soil guidelines for the protection of human health and the environment by the Canadian government or through the Canadian Council of Ministers of the Environment (CCME), the reduction of risks from known federal contaminated sites through the Federal Contaminated Sites Action Plan, and the reduction of the anthropogenic release of chemicals of mutual concern into the Great Lakes under the Great Lakes Water Quality Agreement. The Draft Report notes that regulations for the import, export, and manufacture of certain ozone-depleting substances and concerning halocarbon alternatives are also set out under the Ozone-depleting Substances and Halocarbon Alternatives Regulations.
According to the Draft Report, despite uncertainties associated with understanding the characteristics of substances across the range of PFAS structures from toxicological, epidemiological, and monitoring data sets that are focused on a limited number of PFAS, “there is a growing body of evidence suggesting that concerns identified for well-studied PFASs are more broadly applicable than previously believed.” Similarly, while the specific hazards associated with mixtures of PFAS are largely unknown, “there are many potential sources of PFAS that can lead to exposure and it is reasonable to assume that cumulative effects may occur from exposure to multiple PFAS.” The Draft Report states that consistent with application of precautionary assumptions that are protective of human health and the environment when addressing gaps in information, “it is necessary to anticipate that hazardous properties identified for PFAS that have been well studied may also be inherent in other substances in the class, and that combined exposure to multiple PFAS increases the likelihood of detrimental impacts.” The Draft Report includes the following proposed overall conclusion:
Owing to the extreme persistence of these substances, impacts on the environment are expected to increase if entry to the environment continues. On the basis of what is known about well-studied PFAS and the potential for other PFAS to behave similarly, it is proposed to conclude that the class of PFAS meets the criterion under paragraph 64(a) of CEPA, as these substances are entering or may enter the environment in a quantity or concentration or under conditions that have or may have immediate or long-term harmful effects on the environment or its biological diversity. However, it is proposed to conclude that the class of PFAS does not meet the criterion under paragraph 64(b) of CEPA, as these substances are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends.
Owing to the widespread use of PFAS combined with their ubiquitous presence in the environment, humans are continuously exposed to multiple PFAS, which have the potential to cause adverse effects of concern. On the basis of what is known about well-studied PFAS and the potential for other PFAS to behave similarly, and on the expectation that combined exposures to multiple PFAS increase the likelihood of detrimental impacts, it is proposed to conclude that the class of PFAS meets the criterion under paragraph 64(c) of CEPA, as these substances are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Therefore, it is proposed to conclude that the class of PFAS meets one or more of the criteria set out in section 64 of CEPA.
Risk Management Scope Document
The risk management scope document outlines the proposed risk management options under consideration for the class of PFAS, which has been proposed to be harmful to the environment and human health. According to the risk management scope document, while there are various potential sources of PFAS in Canada, exposure sources of concern include firefighting foams containing PFAS, and other sources and products that contain PFAS. In particular, Canada is considering:
- Regulatory and/or non-regulatory controls to minimize environmental and human exposure to the class of PFAS from firefighting foams;
- Gathering information necessary to identify and prioritize options for reducing environmental and human exposure from the class of PFAS from other sources and products; and
- Aligning with actions in other jurisdictions, where appropriate.
To inform risk management decision-making, Canada asks that information on the following topics be provided (“ideally on or before July 19, 2023”):
- Availability of alternatives to PFAS, in products including but not limited to firefighting foams;
- Socio-economic impacts of replacing PFAS, including costs and feasibility of replacement; and
- Types, quantities, and concentrations of PFAS (including Chemical Abstracts Service Registry Numbers® (CAS RN®), units of measurement, and applications) in products manufactured in, imported into, and sold in Canada.
Canada notes that the risk management options outlined may evolve through consideration of assessments and risk management options or actions published for other Chemicals Management Plan (CMP) substances as required to ensure effective, coordinated, and consistent risk management decision-making, as well as through consideration of additional information obtained from the public comment period, literature, and other sources.
Commentary
As with any new and ambitious PFAS regulatory initiative, this proposal merits a close read and active engagement. Its scope is broad. The Government of Canada estimates more than 4,700 substances are implicated, no surprise given the alignment with the OECD definition of PFAS. No list of substances is available, consistent with other regulatory programs keying off structural definitions of PFAS.
As noted, comments are due by July 19, 2023.
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