The US Environmental Protection Agency recently finalized a regulation under Section 8(a)(7) (15 U.S.C. Section1607(a)(7)) of the federal Toxic Substance Control Act (TSCA) requiring businesses to submit a one-time report about per- and polyfluoroalkyl substances (PFAS) that they have manufactured or imported for each year from January 1, 2011 through December 31, 2022. This reporting obligation also is imposed on importers (but not U.S. domestic manufacturers) of articles containing PFAS, e.g., consumer products containing PFAS. The deadline for submitting this one-time report is May 8, 2025. Importers of articles who qualify as “small” as defined under the rule (based on annual revenues) are allowed a later deadline, November 10, 2025, to submit the required report.
Typically, TSCA requirements exempt impurities, small businesses, research & development activities, and importers of articles. Many TSCA rules also do not apply to de minimis chemical amounts. In this rule, however, there is no exemption for any of the following: importers of articles; small businesses; de minimis amounts; impurities; unintentionally present PFAS; byproducts; or commercial research & development.
Even though the reporting deadlines are almost two years away, affected businesses should begin now to evaluate their obligations under the rule and to being collecting the necessary information for any reporting, given the extensive amount of information required to be reported as well as the long “lookback period.” Businesses should also be aware that internal information collection efforts like this one can sometimes reveal other TSCA violations. They should have a plan in place outlining what to do in those circumstances, before undertaking the information collection efforts for this rule.
Further details are below.
The rule covers broad categories of PFAS chemicals
PFAS chemicals have been widely used for their unique properties, such as oil and stain resistance. Commonly referred to as “forever chemicals” in the news media, these fluorine-containing chemicals are considered to be persistent in the environment. This new EPA rule is intended to provide EPA with information about the extent of PFAS use so that the agency can make future regulatory decisions about this class of chemicals.
Rather than providing a list of specific PFAS substances covered by this reporting rule, EPA defines “PFAS” by the following chemical structures, where “C” refers to carbon, “F” refers to fluorine, “O” refers to oxygen, and “R”/”R’” generically refers to other molecules/structures.
(1) R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons.
(2) R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons.
(3) CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.
Polytetrafluoroethylene (PTFE), a PFAS substance found in many products, would be covered by this rule under the first chemical structure.
The information required to be submitted is extensive, with lesser information required for article importers
Below is a table summarizing the information required to be submitted:
|Chemical substance info
|Yes (reduced requirement)
|Categories of use for each PFAS
|Yes (reduced requirement)
|Yes (reduced requirement)
|Worker exposure data
Businesses are required to report information that is “known or reasonably ascertainable”
A business must report information that is “known or reasonably ascertainable”(often referred to as “KRA”), a due diligence standard described by EPA in the Federal Register notice for the rule. This level of due diligence also goes to the threshold question of whether a business has manufactured or imported any PFAS, or has imported an article containing PFAS, in the first place. In a guidance document, EPA provides a hypothetical example of a business that imports stain-resistant garments. The business knows that fluorinated chemicals can be used to confer stain-resistant attributes, but does not know if the specific garments contain any PFAS. In such a circumstance, EPA says it would likely consider the business to meet its due diligence requirement if it asks its supplier whether the garments contain any PFAS. If the supplier says “no,” then there would be no reporting obligation. If the supplier says “yes,” then the business likely needs to make further inquiries to meet its due diligence and reporting obligations.
Note that obligations under other laws may affect the KRA standard for a particular business. For example, businesses who have collected/reported PFAS information to address state PFAS reporting laws likely have information relevant to this reporting rule.
The report must be submitted electronically to EPA
Businesses that are required to submit this one-time report must do so electronically. In order to submit the electronic report, businesses must first open an account in EPA’s electronic reporting portal, Central Data Exchange (“CDX”).
Particularly as a result of the long lookback period combined with the amount of information that must be provided, this rule will impose substantial burdens on businesses. Open questions remain, e.g., the impact of document retention policies. Businesses that historically have not been affected by TSCA – importers of articles – may have an especially difficult time navigating compliance with this rule. Even though the submission deadline is 18 months away – and two years away, for “small” importers of articles – the time is now for businesses to begin evaluating their potential reporting obligations and to begin collecting necessary information.
This is attorney advertising. Nothing herein is intended as legal advice.