Earlier this year, EPA released a letter to manufacturers, processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE), informing them of possible violations of the Toxic Substances Control Act (TSCA). EPA determined through recent testing that certain PFAS have unintentionally formed during or following the process of fluorinating polyolefins. Manufacturers and processors of fluorinated polyolefins modify polymers with fluorine to create high-performance barriers. These barriers are then used in the storage and transport of various products to keep the product inside the container without notable permeation. During some methods of fluorination, such as in the presence of oxygen, PFAS can occur as a byproduct.
EPA first noticed the unintentional formation of PFAS in containers used in storing and transporting pesticides, and it is researching whether this problem occurs in other HDPE products. This effort to restrict human health and environmental exposure to PFAS is one of many steps the Agency has outlined in its PFAS Strategic Roadmap.
EPA’s letter reminds the HDPE industry that certain long-chain PFAS are subject to a TSCA Significant New Use Rule (SNUR) (See 40 CFR § 721.10536). Generally, chemical substances created during the manufacturing process that does not have a separate commercial purpose are considered byproducts and are exempt from SNUR requirements under 40 CFR § 721.45(e). But certain long-chain PFAS byproducts produced during the manufacture of fluorinated polyolefins do not meet the requirements of the byproducts exemption and therefore require a SNUR. These rules require the manufacturer to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemicals for significant new use.
The Agency encourages the industry to review the relevant regulations at 40 CFR § 721. Any questions on the topic can be directed to the Existing Chemicals Risk Management Division in the Office of Pollution Prevention and Toxics at TSCA_PFAS@epa.gov.