In keeping with the Biden-Harris administration’s commitments to strengthen federal regulation of per- and polyfluoroalkyl substances (PFAS), the US Environmental Protection Agency (EPA) announced three actions last week with respect to the agency’s regulation of the use, import, and manufacture of PFAS.
Affected industries should take note of these actions that will increase regulatory requirements and highlight the importance of maintaining processes that keep track of the shifting PFAS regulatory landscape.
On June 10, 2021, EPA proposed a new rule pursuant to its obligations under the Toxic Substances Control Act (TSCA), as amended by the National Defense Authorization Act for Fiscal Year 2020, which would require manufacturers and importers of any PFAS chemicals to provide information about the type and amounts of chemical produced in any year going back to January 1, 2011. The proposed rule would require manufacturers to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.
EPA has stated that there are no exemptions to its reporting proposal (although substances excluded from the definition of “chemical substance” under TSCA Section 3(2)(B) are also excluded under the proposed rule). A 60-day public comment period will commence after the proposed rule is published in the Federal Register. The proposed deadline for manufacturers to report this data to EPA is one year following the effective date of the final rule (which TSCA Section 8(a)(7) requires EPA to publish no later than January 1, 2023).
This proposed rule creates significant reporting obligations that should generate a large volume of data given the wide use of PFAS chemicals across a range of industries and the substantial number of PFAS potentially captured by this new rule. (EPA has identified 1,346 PFAS chemicals on the TSCA Chemical Substance Inventory as of April 2021, which would potentially be subject to reporting under the final rule.) The scope of the proposal is broad, mandating the disclosure of information for all PFAS chemicals used in “articles” (i.e., manufactured goods), including products such as cars and household appliances. While manufacturers (including importers) are only required to provide information “known or reasonably ascertainable,”[1] compliance with the rule may prove challenging, such as for manufacturers of products or articles made with PFAS-containing materials supplied by others, which may now be required to make inquiries of “upstream suppliers or downstream users or employees or other agents of the manufacturer.”[2]
On June 10, 2021, EPA announced the withdrawal of controversial guidance on a PFAS SNUR that had been issued by the Trump administration in January 2021. The SNUR, issued under TSCA in July 2020, prohibited parties from manufacturing, processing, or importing products containing certain long-chain PFAS chemicals[3] without prior EPA review and approval. The rule also prohibited the import of products containing certain long-chain PFAS chemicals as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances without EPA review. The compliance guide had narrowed the SNUR’s restrictions by defining, for example, “surface coatings” to mean only the parts of certain manufactured articles that come into “direct contact with humans or the environment during the article’s normal use or reuse.” This interpretation of the rule’s scope would not have covered potential exposures related to the disposal of articles otherwise subject to the PFAS SNUR.
In announcing its new action, EPA criticized the guidance as never having been “deemed necessary by career staff” and being driven by “political officials serving in the last Administration.” EPA’s withdrawal of the SNUR guidance follows other actions EPA has taken to reverse perceived political interference with PFAS regulation by the prior administration. The July 2020 PFAS SNUR remains in effect and EPA has indicated that it does not intend to issue a new set of interpreting guidelines. More information about the July 2020 SNUR can be found in Morgan Lewis’s June 29, 2020 LawFlash, EPA Issues Final PFAS Rule Under TSCA.
On June 3, 2021, EPA issued a final rule adding three PFAS substances—perfluorooctyl iodide, potassium perfluorooctanoate, and silver(I) perfluorooctanoate—to the Toxic Release Inventory (TRI), a program that tracks the management of more than 650 chemicals EPA has deemed pose a threat to human health and the environment. Businesses subject to the TRI’s reporting requirements must provide information about the management and release of TRI-listed chemicals above certain thresholds.
The 2020 National Defense Authorization Act (NDAA) provides the framework for adding certain PFAS to the TRI on an annual, automatic basis. Because the NDAA requirements specify that the addition of these three PFAS became retroactively effective as of January 1, 2021, data reporting forms for these substances for calendar year 2021 are due to EPA by July 1, 2022. Businesses that may use these chemicals should carefully evaluate TRI reporting requirements to assess their applicability and, as necessary, investigate past and current uses in products and manufacturing processes.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Princeton
John McGahren
Stephanie Feingold
Laurie Matthews
Los Angeles
Rick Rothman
Jeremy Esterkin
Yardena Zwang-Weissman
San Francisco
Ella Foley Gannon
Washington, DC
Duke McCall
Philadelphia
Glen Stuart
[1] The proposed rule provides that “known to or reasonably ascertainable by” would be defined to include “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” See Proposed Rule, Section 705.3. “This reporting standard would require reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.” Proposed Rule, Executive Summary at I.C.
[2] Proposed Rule, Executive Summary at I.C.
[3] Long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances.