On March 16, 2022, the U.S. Environmental Protection Agency (EPA) announced two actions intended to safeguard communities from products containing per- and polyfluoroalkyl substances (PFAS). First, as part of EPA’s efforts to identify, understand, and address PFAS contamination leaching from fluorinated containers, EPA states that it is notifying companies of their obligation to comply with existing requirements under the Toxic Substances Control Act (TSCA) to ensure unintentional PFAS contamination does not occur. 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 an open letter to manufacturers (including importers), processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE) containers and similar plastics (i.e., fluorinated polyolefins), EPA states that the presence of PFAS formed as a byproduct in these containers may be a violation of TSCA. EPA outlines notifications requirements under TSCA for such PFAS. Certain PFAS, including long-chain PFAS as defined in EPA’s 2020 long-chain perfluoroalkyl carboxylate (LCPFAC) significant new use rule (SNUR), that are found to be present in or on fluorinated polyolefins may be subject to TSCA regulations and enforcement. According to EPA, LCPFAC chemical substances that are byproducts of the manufacturing process for fluorinated polyolefins do not meet the requirements of the byproduct exemption. This means that the uses require notice to EPA via a significant new use notice (SNUN), EPA review of potential risks of this use under TSCA Section 5, and a determination of whether (and under what conditions) such uses can continue. More information on the LCPFAC SNUR is available in our July 27, 2020, memorandum.

EPA notes that in March 2021, it made testing results available related to PFAS found in fluorinated containers. The contamination was first noted in HDPE containers used to store and transport a pesticide product. EPA states that as it continues to determine the potential scope of the use of this fluorination process outside of its use for pesticide storage containers, it is issuing this letter to notify industry of its statutory obligations under TSCA and to help prevent unintended PFAS contamination. More information on EPA’s efforts to address PFAS in pesticide packaging are available in our October 4, 2021, blog item.

EPA has posted frequently asked questions (FAQ) related to plastic container fluorination that address questions concerning PFAS in pesticides, pesticide and other packaging questions, and state-specific questions. EPA will post updates “as the issue evolves.” For any stakeholder questions regarding this issue not covered in the FAQs, EPA states that stakeholders “are welcome to contact EPA at pesticides@epa.gov.”

Under the PFAS Strategic Roadmap issued by EPA Administrator Regan in October 2021, EPA committed to improve approaches for tracking and enforcement of PFAS requirements in new chemical consent orders and SNURs. According to EPA, the letter “supports this goal by ensuring that manufacturers, processors, distributors, users, and those that dispose of these containers are aware of and are complying with the SNUR requirements.” More information on EPA’s Strategic Roadmap is available in our October 19, 2021, memorandum.

Removing PFAS from the SCIL

EPA announced that it will remove two PFAS first listed on the SCIL in 2012 under EPA’s Safer Choice program to protect consumers better and ensure that products certified under the program are free from PFAS. The Safer Choice program is a voluntary program intended to help consumers, businesses, and purchasers find products containing 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 EPA has determined them to be among the safest for their functional uses.

According to EPA, under the PFAS Roadmap, it committed to taking a fresh look at previous PFAS decisions, and, as part of this review, undertook a review of the SCIL. The process for removing a chemical from the SCIL is first to mark the chemical with a grey square on the SCIL webpage to provide notice to chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice-certified products. A grey square notation on the SCIL means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain the chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list the chemical on the SCIL. EPA states that in general, data useful for making such a determination would provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, the chemical would then be removed from the SCIL 12 months after the grey square designation.

EPA initially listed these two PFAS on the SCIL in 2012 based on the data available and the state of its knowledge at the time. EPA states that it updated the SCIL listing for these PFAS to a grey square “because of a growing understanding of the toxicological profiles for certain PFAS, and incomplete information on the potential health and environmental effects of these substances.” This means that these two PFAS will not be allowed for use in new products applying for Safer Choice certification. Additionally, any existing Safer Choice-certified products that contain these two PFAS must be reformulated.

Commentary

EPA’s “letter” is more a reflection of the Agency’s commitment to its PFAS Strategic Roadmap than it is anything else. The LCPFAC SNUR was issued in 2020, and it is hardly a new development. That it could apply to substances in polyolefins is a predictable and logical extension of the rule, and EPA’s letter is a reminder to stakeholders to be mindful of this fact.