EPA Puts Industry on Notice of Potential TSCA Violations for PFAS Contamination in Plastic Containers

Does your organization manufacture, course of, distribute, use, or dispose of fluorinated high-density polyethylene (HDPE) containers and related plastics? If that’s the case, it could be time for provide chain and course of critiques geared toward figuring out and eliminating doable per- and polyfluoroalkyl substance (PFAS) contamination.

In a March 16, 2022 open letter to HDPE producers and customers, EPA introduced that the versatile plastic generally used for storing and transporting pesticides, meals merchandise, private care merchandise, and a variety of different merchandise could also be contaminated with PFAS—and that firms could also be violating the Poisonous Substances Management Act (TSCA). As a result of TSCA civil penalties could be assessed as much as $43,611 for every day a violation happens, probably affected firms ought to fastidiously think about EPA’s letter.

Within the letter, EPA defined that fluorination—the method creating the high-performance barrier designed to cut back permeation by means of container partitions and shield in opposition to degradation—might outcome in the unintentional manufacture of PFAS. The presence in HDPE containers (or every other merchandise) of long-chain PFAS recognized in EPA’s 2020 long-chain perfluoroalkyl carboxylate (LCPFAC) Significant New Use Rule (SNUR) could also be violations beneath TSCA. Though the LCPFAC SNUR incorporates a restricted exemption for long-chain PFAS current solely as byproducts, the exemption applies solely to byproducts used as gasoline, disposed of as waste, or from which part chemical substances are extracted for industrial functions.

Accordingly, any firm whose course of outcomes in the manufacture of a long-chain PFAS recognized in the LCPFAC SNUR that doesn’t meet the byproduct exemption standards should notify EPA 90 days previous to commencing manufacture (together with import) or processing of the substance and wait for EPA’s evaluation and approval. Advance notification necessities additionally apply to any firm that plans to import a product containing sure LCPFAC chemical substances as half of a floor coating on the product.

Given EPA’s present stance on PFAS, it’s extremely unlikely that any approval could be granted, which means that the LCPFAC SNUR operates successfully as a ban, together with for HDPE processes that outcome in the manufacture of PFAS that continues to be in the completed HDPE container (or in any other case doesn’t meet the byproduct exemption standards for SNURs). And in the absence of particular EPA approval, the presence of long-chain PFAS in HDPE containers might topic firms to vital and expensive TSCA penalties.

EPA has been investigating PFAS contamination in HDPE containers since at the very least September 2020, when it was alerted (by means of “citizen science testing”) to potential PFAS contamination of a mosquito management pesticide product. In March 2021, EPA announced that testing had decided that an HDPE container used to retailer and transport a mosquito management pesticide contained PFAS compounds that leached into the pesticide. EPA’s March 16, 2022 letter discloses that EPA has continued to research the scope of potential PFAS contamination in HDPE containers, even past pesticide merchandise.

EPA just isn’t the one company involved about PFAS contamination in HDPE containers. As we beforehand reported, in August 2021, the Meals and Drug Administration (FDA) issued an open letter to producers, distributors, and customers of fluorinated polyethylene meals contact articles warning of the doable unintended manufacture of PFAS throughout fluorination. FDA reminded stakeholders that fluorinated polyethylene containers for meals contact use could also be manufactured solely in accordance with 21 C.F.R. § 177.1615, which specifies that solely gaseous nitrogen could also be used in mixture with fluorine gasoline throughout fluorination.  In its March 16, 2022 letter, EPA likewise directed the HDPE business to gaseous nitrogen as a doable various to fluorination processes that will result in the manufacture of PFAS (e.g., the use of oxygen).

EPA’s letter to the HDPE group is simply the most recent in a sequence of aggressive actions taken by the company in assist of its PFAS Strategic Roadmap. Given these warning pictures EPA has not too long ago fired with respect to PFAS, firms that manufacture or use HDPE containers could be nicely suggested to undertake cautious critiques of their provide chains and processes—and make swift modifications if wanted—to make sure that there is no such thing as a threat of PFAS formation throughout manufacture.

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