U.S. EPA has announced two important actions to safeguard communities from products containing Per- and Polyfluoroalkyl Substances (PFAS). First, as part of EPA’s effort to identify, understand and address PFAS contamination leaching from fluorinated containers, the agency is notifying companies of their obligation to comply with existing requirements under the Toxics Substances Control Act (TSCA) to ensure unintentional PFAS contamination does not occur. The agency will also remove two PFAS from its Safer Chemical Ingredients List (SCIL) following a review of these substances (which were added to that list in 2012).
“Today’s action will help ensure that responsible parties are held accountable for any future PFAS contamination affecting communities,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “Additionally, keeping PFAS out of consumer products certified under the agency’s Safer Choice program will help prevent potential exposures to PFAS from occurring in the first place.”
TSCA Compliance Notification Letter to Industry on PFAS in High-Density Polyethylene (HDPE) Containers
Today, EPA notified manufacturers (including importers), processors, distributors, users, and those that dispose of fluorinated HDPE containers and similar plastics (i.e., fluorinated polyolefins) that the presence of PFAS formed as a byproduct in these containers may be a violation of TSCA.
In an open letter released today Letter to Fluorinated HDP Industry, 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. LCPFAC chemical substances that are byproducts of the manufacturing process for fluorinated polyolefins do not meet the requirements of the byproduct’s 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.
In March 2021, EPA 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. As the agency continues to determine the potential scope of the use of this fluorination process outside of its use for pesticide storage containers, EPA is issuing this letter to notify industry of their statutory obligations under TSCA and to help prevent unintended PFAS contamination.
Under the PFAS Strategic Roadmap issued by EPA Administrator Regan in October of 2021, EPA has committed to improve approaches for tracking and enforcement of PFAS requirements in new chemical consent orders and SNURs. The letter released today 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.
For questions concerning this matter, contact EPA at TSCA_PFAS@epa.gov.
Removing PFAS from the Safer Chemical Ingredients List
EPA will also remove two PFAS first listed on the SCIL in 2012 under EPA’s Safer Choice program to better protect consumers and ensure that products certified under this program are free from PFAS.
EPA’s Safer Choice program is a voluntary program that helps 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 they have been determined to be among the safest for their functional use.
Under the PFAS Roadmap, EPA committed to taking a fresh look at previous PFAS decisions, and, as part of this review, undertook a review of the SCIL.
EPA’s process for removing a chemical from the SCIL is to first mark the chemical with a grey square on the SCIL webpage to provide notice to chemical and product manufacturers that this 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 this chemical must be reformulated unless relevant health and safety data is provided to justify continuing to list this chemical on the SCIL. The data required would be determined on a case-by-case basis. 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, this 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 the agency’s knowledge at the time. EPA has 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.
For more information on the Safer Choice program and the SCIL, visit Safer Choice.