On March 16, 2022, the U.S. Environmental Protection Agency (EPA) announcement two actions intended to protect communities from products containing per- and polyfluoroalkyl substances (PFAS). First, as part of the EPA’s efforts to identify, understand, and address PFAS contamination from fluorinated containers, the EPA states that it is advising companies of their obligation to comply with existing requirements under the law. on Toxic Substances Control (TSCA) to ensure unintentional PFAS contamination. does not happen. The EPA will also remove two PFAS from its Safer Chemical Ingredients List (SCIL) following a review of these substances.
TSCA Compliance Notification Letter to Industry on PFAS in HDPE Containers
In one open letter to manufacturers (including importers), processors, distributors, users and those disposing of high-density fluorinated polyethylene (HDPE) containers and similar plastics (that is to say., fluorinated polyolefins), the EPA states that the presence of PFAS formed as a by-product in these containers may be a violation of TSCA. The EPA outlines the notification requirements under TSCA for these PFAS. Certain PFAS, including long-chain PFAS as defined in the 2020 EPA Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) Significant New Use Rule (SNUR), that are found in or on fluorinated polyolefins may be subject to TSCA regulations and enforcement. According to the EPA, LCPFAC chemicals that are by-products of the fluoropolyolefin manufacturing process do not meet the requirements for the by-product exemption. This means that uses must be notified to the EPA via a Notice of New Use (SNUN), a review by the EPA of the potential risks of that use under TSCA Section 5, and a determination of possibility ( and under what conditions) such uses. More information on the LCPFAC SNUR is available in our July 27, 2020, memorandum.
The EPA notes that in March 2021, it made the test results available related to PFAS found in fluorinated containers. The contamination was first observed in HDPE containers used to store and transport a pesticide product. The EPA states that as it continues to determine the potential scope of the use of this fluoridation process outside of its use for pesticide storage containers, it is issuing this letter to inform industry of its obligations legal under TSCA and to help prevent unintentional PFAS contamination. More information on EPA’s efforts to address PFAS in pesticide packaging is available in our October 4, 2021, blog post.
The EPA has published frequently asked questions (FAQs) relating to the fluoridation of plastic containers that address questions regarding PFAS in pesticides, questions about pesticides and other packagingand state-specific questions. The EPA will issue updates “as the issue evolves.” For questions from stakeholders regarding this issue not covered in the FAQ, EPA states that stakeholders “are encouraged to contact EPA at [email protected]”
Under the PFAS Strategic Roadmap issued by EPA Administrator Regan in October 2021, the EPA is committed to improving approaches to tracking and enforcing PFAS requirements in new chemical consent orders and SNURs. According to the EPA, the letter “supports this goal by ensuring that manufacturers, processors, distributors, users, and those disposing of these containers are aware of and comply with the requirements of the SNUR.” More information on the EPA’s strategic roadmap is available in our October 19, 2021, memorandum.
Removal of PFAS from the SCIL
The EPA has announced that it will retire two PFASs first listed on the SCIL in 2012 under the EPA SaferChoice Program to better protect consumers and ensure that products certified under the program are PFAS-free. The Safer Choice program is a voluntary program to help consumers, businesses and buyers find products with ingredients that are safer for human health and the environment. The SCIL includes chemicals that meet the criteria of the Safer Choice program and can be used in Safer Choice certified products because the EPA has determined them to be among the safest for their functional uses.
According to the EPA, as part of the PFAS Roadmap, it has committed to reviewing past PFAS rulings and, as part of that review, is undertaking a review of the SCIL. The process of removing a chemical from the SCIL involves first marking the chemical with a gray square on the SCIL webpage to notify chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice certified products. A gray square notation on the SCIL means that the use of the chemical may not be permitted in products that are candidates for the Safer Choice label, and all currently Safer Choice certified products that contain the chemical should be reformulated unless data relevant health and safety information is provided to justify the continued listing of the chemical on the SCIL. The EPA states that, in general, the data relevant to making such a decision would provide evidence of low concern for human health and environmental impacts. Unless the information provided to EPA adequately supports continued listing, then the chemical would be removed from the SCIL 12 months after the gray square designation.
The EPA originally listed these two PFASs on the SCIL in 2012 based on available data and the state of its knowledge at the time. The EPA says it has updated the SCIL list of these PFASs to a gray square “due to an increasing understanding of the toxicological profiles of some PFASs and incomplete information about the potential health and environmental effects of these materials”. This means that these two PFAS will not be allowed to be used in new products applying for Safer Choice certification. Additionally, all existing Safer Choice certified products that contain these two PFASs must be reformulated.
The EPA “letter” reflects the Agency’s commitment to its PFAS strategic roadmap more than anything else. The LCPFAC SNUR was released in 2020, and it is not a new development. That it could apply to substances contained in polyolefins is a predictable and logical extension of the rule, and the EPA’s letter reminds stakeholders to be aware of this fact.