State PFAS Notification Rules Present Complex Compliance Issues for Companies
Manufacturers of products that contain even small quantities of per- and polyfluoroalkyl substances (PFAS) will soon be required to submit “notifications” to the Maine Department of Environmental Protection (DEP or the Department) providing intricate, and potentially commercially-sensitive, details concerning the chemical makeup of their consumer and commercial-use products. Complying with the impending January 1, 2023 deadline, when the proposed implementing regulations and an electronic reporting portal have not yet been revealed to the regulated community, will be a steep challenge. However, what also should be considered carefully by the countless companies preparing reports is whether they will be revealing information that could implicate compliance issues under existing federal regulatory requirements, such as the federal Toxic Substances Control Act (TSCA).
Maine and a number of other states will soon be the recipients of reports to be submitted by the many US manufacturers and distributors of consumer and commercial-use products that contain “intentionally added” PFAS. The pertinent statute in Maine is the Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution, 38 M.R.S. § 1614, enacted in 2021. Understandably, the state’s program is of considerable interest to those who will be affected. The Department held a recent stakeholder meeting that was attended online by nearly 500 persons. It was the second public meeting addressing Maine’s steps that are preceding an eventual rulemaking process. To date, the Department has issued two pre-rulemaking “concept drafts” (in June and then late October of this year), each soliciting enormous attention and feedback in the form of written comments. What has become apparent from the discussions during the public meetings is that the Department does not intend to extend the statutory deadlines for the product sales prohibitions (i.e., PFAS-containing floor coverings, consumer-use fabric treatment) which take effect on January 1, 2023.
As discussed in our July 11, 2022 blog post, beginning January 1, 2023, the Maine law also requires manufacturers to submit a written notification to Maine DEP informing the Department of products they sell in the state that contain intentionally added PFAS. Even more far-reaching is the sales prohibition of all products containing intentionally added PFAS beginning in January 2030. More immediately of concern, perhaps, is a provision in the underlying law that prohibits the sale of products for which required notifications have not been submitted.
Maine DEP officials have informed stakeholders that the formal rulemaking process will likely not be completed prior to the January 1, 2023 date in the statute, and they now estimate it may require until at least April 2023 for a rulemaking to be completed. Nevertheless, the state officials participating in the public meetings have indicated that the Department views itself as statutorily bound by the dates in the law and unable to grant a blanket extension to all affected entities. The statute does allow DEP to grant extensions to manufacturers on an individual basis, however. The Department began receiving extension requests in July 2022, and it has either granted or denied all requests received to date. A list of all extensions granted was posted to Maine DEP’s website in late October 2022 and appears to include perhaps 1,000 manufacturers. According to the website, manufacturers “may request an extension if they do not know if their products or their components contain PFAS and/or if they cannot provide sufficient information to meet the reporting requirements in Maine law by the reporting deadline.” During the most recent public meeting, the Department confirmed that any extensions granted are measured from the date the regulations are finalized, not from January 1, 2023.
The statute also provides that intentionally added PFAS may be exempt from the state’s notification requirements and prohibitions should Maine DEP determine that the use of PFAS in the product is a “currently unavoidable use.” While the state’s most up-to-date concept draft for eventual rulemaking includes the statutory definition for the phrase (“a use of PFAS that the department has determined by rulemaking to be essential for health, safety or the functioning of society and for which alternatives are not reasonably available”), the Department advises a separate formal rulemaking must precede a decision to specifically exempt such products. The Department advises such uses will likely include climate change mitigation, critical infrastructure, the delivery of medicine, lifesaving equipment, public transportation, and construction. As of now, it is expected that this particular rulemaking will not begin until the Department has received data from the written notification requirements about PFAS-containing products sold in the state beginning January 1, 2023, which could mean that the rulemaking would not begin until the later months of 2023 or early 2024.
The Maine Requirements Are Not Unique and Are Bedeviling in Their Scope
More than 20 states have enacted PFAS laws or regulations of some variety, with a smaller, but growing, number of states imposing product content notification requirements. Making matters more complicated, such states are defining “PFAS” to include substances containing “one fully fluorinated carbon atom” (i.e., a carbon atom on which all the hydrogen substituents have been replaced by fluorine). The breadth of the definition appears to bring into scope chemical substances (including fluoropolymers and certain gases) that may have been in use by product (and component) manufacturers for decades without any reason to track their specific uses because they were not considered to be among those categories of chemicals often subject to regulatory limitations. The Maine regulators plan to require reporting on individual product components if distributed in Maine for further assembly or installation in another product, as well as the fully-assembled finished article distributed in Maine and the product’s packaging. Given that Maine finds itself at the forefront of developing its requirements, it is likely that multiple states will draw upon Maine’s approach as a template for their own programs. The level of detail that will be required in the notifications in Maine and other states will eventually include a description of the product; the functional purpose of the PFAS used in the product; the identity(ies) of the PFAS present in the product and the amount of each PFAS as a concentration; and contact information for a responsible company official.
State Reporting Can Lead to Federal Complications; Potential TSCA Violations
The US Environmental Protection Agency (EPA) is continuing to implement its Agency-wide “PFAS Strategic Roadmap” (Roadmap). See our December 2021 Chemical Compound Newsletter for background. As part of its Roadmap, EPA must soon issue a final rule under Section 8(a)(7) of TSCA requiring manufacturers and importers to report information on the sources and quantities of PFAS manufactured in, or imported to, the US during a preceding ten-year period. Such information is intended to assist the Agency in future research, monitoring and regulatory efforts.
What may be going unnoticed by many entities that are preparing to comply with various state reporting requirements, as well as the eventual TSCA § 8(a)(7) reporting rule, is that the information they may compile to comply with such efforts might reveal that products for which they are submitting notifications could contain certain “long-chain PFAS” substances that became subject to a TSCA “significant new use rule” (SNUR) in 2020.
TSCA Significant New Use Rule for Certain PFAS Surface Coatings
In July 2020, EPA issued a final SNUR modifying an existing TSCA regulation concerning certain PFAS by requiring a manufacturer or importer to submit a notice to EPA and await Agency approval before it manufactures or imports a product with a surface coating containing any one of a list of specific long-chain PFAS (that the Agency considered to have been phased out in the US). Thus, pursuant to that rule, most products containing those restricted long-chain PFAS as a surface coating could no longer be imported into the US without prior EPA review. The 2020 SNUR was intended to ensure that articles such as textiles, carpet, furniture, electronics, and household appliances that could contain the long-chain PFAS identified in the rule cannot be imported to the US unless EPA reviews and approves the use (or puts in place restrictions to address any unreasonable risks).
By implication, if a company preparing reports for Maine, or another state, acquires information indicating it is importing, or has previously imported, an article with a surface coating containing any one of the chemicals identified in the SNUR, the notification submitted to the state might reveal a TSCA compliance issue. EPA may assess civil penalties for TSCA violations at levels in excess of $40,000 per day, per violation through an administrative proceeding. An entity that discovers such a violation and fails to cease violating TSCA could be subject to multiple penalties that can accrue rapidly and potentially even result in criminal sanctions.
Potential TSCA 8(e) Implications?
Perhaps even more obscure to the entities compiling information for Maine and other states, but equally important, is a little-known interpretation of another TSCA requirement. Specifically, TSCA § 8(e) requires “[a]ny person who manufactures, processes or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.”
While it is arguable whether TSCA § 8(e) even applies to finished “articles,” it is conceivable, depending on the level of PFAS reported to be present in a particular product and the substance in question, that EPA enforcement personnel could take the position that the presence of a particularly hazardous substance in a widely used consumer or commercial product that has heretofore not been known to be present, might be subject to TSCA § 8(e) reporting. (The authors of this article are not aware of any EPA enforcement action against the makers of retail products for their alleged failure to meet the requirements of TSCA § 8(e) in such a context.)
The basis for this concern is not unfounded. When EPA issued a revision to the Agency’s TSCA § 8(e) reporting guidance in 2003, EPA also issued a Comment and Response Document which noted that situations involving the chemical content of a consumer product, if indicative of “product contamination,” could be reportable to EPA under Section 8(e) in certain circumstances. Moreover, in the preamble to the 2003 revised policy, EPA disagreed that “it should consider itself ‘adequately informed’ of all information in possession of Federal agencies” (the same should be presumed to be true of most state agencies), and explained that “product contamination information that could be required to be submitted to the Consumer Product Safety Commission (CPSC) under their regulations” is not exempt from reporting under TSCA § 8(e) because “CPSC has a more narrow purview (i.e., consumer product safety) and could not adequately assess or address chemical contamination from a product that may also have industrial/commercial applications or may present potential environmental risks during its manufacture and processing.” Accordingly, “reporting to EPA, as well as CPSC, would allow EPA, consistent with the intent of TSCA, to address all the potential risks presented, where appropriate.” The preamble further noted: “Consequently, EPA . . . concluded that section 8(e) reporting will continue to be required for chemical product contamination, because EPA, uniquely among Federal agencies, has the authority to address all potential health and environmental risk aspects of a chemical’s life cycle.” Such interpretations have been carried over to this day and remain in current EPA publications, including those available on the Agency’s website.
Of interest to those completing notifications for Maine is that, as part of a settlement of litigation with the Sierra Club in April 2007, EPA sent letters to 120 companies that “EPA ha[d] identified as having participated in a recall related to lead in a consumer product” to “ensure that [the company was] aware of the reporting requirements under [TSCA] section 8(e).” EPA’s letter included the following guidance from its then recently edited and updated TSCA § 8(e) “Question and Answer” guidance document, which remains available online and can be found on EPA’s website. In pertinent part, the Q&A states:
Q.25. Are studies or reports showing absorption from manufactured products or articles of a chemical known to be capable of causing serious health effects potentially reportable under TSCA §8(e)? For example, are studies or reports showing absorption of lead following oral or dermal exposure to a particular type of article for which it was not previously known that such absorption could occur potentially reportable under TSCA §8(e)?
A.25. Yes—The discovery of previously unknown and significant human exposure to a chemical, when combined with knowledge that the subject chemical is recognized or suspected as being capable of causing serious adverse health effects (e.g., cancer, birth defects, neurotoxicity), should be reported to EPA under § 8(e).
Q.26. Is the discovery of a hazardous or toxic constituent in a product reportable under TSCA § 8(e)?
A.26. Reporting of the presence of a hazardous or toxic constituent that was previously unknown to be contained in a product, including manufactured articles, should occur under TSCA § 8(e) where data shows that widespread or significant exposure to the toxic component has occurred or is substantially likely to occur, and such exposure presents a substantial risk of injury to health or the environment. Persons subject to TSCA § 8(e) reporting should consider the toxicity of the constituent, the constituent’s concentration in the product, and whether significant exposure to the toxic component has occurred or is likely to occur at any stage in the product’s lifecycle from production through disposal. In cases of extremely toxic chemical substances in products in commerce, exposure may generally be presumed.
The Agency’s 2007 letter to those companies closed by indicating that it hoped the “letter will assist you in assessing your company’s potential obligations under TSCA.”
In light of such an ominous statement from EPA concerning TSCA §8(e), and knowing the current Administration’s pronounced concerns regarding PFAS in general, it is important for entities compiling and submitting product information to a state regulatory agency to carefully consider the information they are assembling. In particular, to the extent an entity might be acquiring information that it did not previously have from its suppliers (of both chemicals and components that might be assembled into finished articles), care must be taken to cross-check the information acquired against other federal rules and, in particular, the TSCA requirements under the long-chain PFAS SNUR and Section 8(e).
Leigh Logan and Margaret Barry, of Arnold & Porter, also contributed to this Advisory.
© Arnold & Porter Kaye Scholer LLP 2022 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.