On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released its long-overdue final rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The rule requires reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). As discussed below, the final rule is not what many of us expected nor wanted.
Background
TSCA Section 8(a)(7) requires the EPA collect information on chemical substances manufactured and imported for commercial purposes, including chemical substances present in a mixture that are “perfluoroalkyl or polyfluoroalkyl substances,” or PFAS. When the EPA proposed the rule, it declined to provide exemptions offered under other TSCA rules, i.e., impurity, de minimis, small business, byproduct and related exemptions. This invited significant pushback from industry and the small business community. The final rule surprisingly offers no relief.
Key Provisions
TSCA Section 8(a)(7) does not define “PFAS.” The EPA determined any TSCA chemical substance, as defined by TSCA Section 3(2), that falls within the structural definition at 40 C.F.R. Section 705.3 is subject to reporting if it has been manufactured for commercial purposes at any time since Jan. 1, 2011. The EPA determined a structural definition was more appropriate for this rule than a discrete list of specifically identified substances, contrary to what many requested. PFAS is defined as including at least one of these three structures:
- R-(CF2)-CF(R′)Rʺ, where both the CF2 and CF moieties are saturated carbons;
- R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; and
- • CF3C(CF3)R′Rʺ, where R′ and Rʺ can either be F or saturated carbons.
The EPA also defined fluoropolymers, including higher molecular weight fluoropolymers, as PFAS and thus reportable under the rule. The EPA “does not believe the requested data on fluoropolymers would be considered duplicative or unnecessary: this information is not reported to EPA otherwise, and any manufacturers’ existing information on such fluoropolymers will inform EPA’s understanding of such types of PFAS within U.S. commerce, including their downstream uses and their disposal methods.”
The final rule is limited to manufacturers, including importers of PFAS that are considered a “chemical substance.” Even though the definition of chemical substance excludes mixtures, PFAS as a chemical substance may be present in a mixture. The final rule requires reporting on each chemical substance that is a PFAS, including as a component of a mixture.
The final rule is not what many of us expected nor wanted.
The scope of “manufacturing” for the purposes of the final rule is limited to entities manufacturing for commercial purposes and includes the import, production or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer. This includes the manufacture of chemical substances or mixtures for commercial distribution, including test marketing, or for use by the manufacturer itself as an intermediate or for product research and development (R&D).
“Manufacture for commercial purposes” also includes the coincidental manufacture of byproducts and impurities produced during the manufacture, processing, use or disposal of another chemical substance or mixture. The EPA notes that “simply receiving PFAS from domestic suppliers or other domestic sources is not, in itself, considered manufacturing PFAS for commercial purposes.” Entities that process or use PFAS need to report only on the PFAS they have manufactured/imported.
Entities that have manufactured PFAS for a commercial purpose include those that have imported PFAS, including in wastes, or those that have coincidentally produced PFAS during the manufacture, processing, use or disposal of another chemical substance or mixture. In its proposed rule the EPA noted this may include certain waste management companies that imported PFAS in a waste or produced PFAS at their site during the disposal of another chemical substance or mixture. The EPA “has determined that waste management activities involving importing municipal solid waste streams for the purpose of disposal or destruction are not within [the] scope of this rule’s reporting requirements, per TSCA section 8(a)(5)(C).”
The reporting standard is information “known to or reasonably ascertainable by the manufacturer.” This includes “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.” Reporting entities must evaluate their current level of knowledge of their manufactured products (including imports) and whether additional information exists. This standard requires submitters to conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This may entail inquiries outside the organization to fill gaps in the submitter’s knowledge. Examples of information include:
- files maintained by the manufacturer, such as marketing studies, sales reports or customer surveys;
- information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a Safety Data Sheet (SDS) or a supplier notification;
- and information from the Chemical Abstracts Service (CAS) or from Dun & Bradstreet.
The final rule requires PFAS manufacturers submit information for each PFAS, for each year in which that substance was manufactured since Jan. 1, 2011, to the extent the information is known or reasonably ascertainable. For mixtures that contain at least one chemical substance that is a PFAS, manufacturers must submit information for each substance in the mixture that’s a PFAS. A mixture composed of PFAS A and PFAS B would result in the submission of two forms containing the information. For chemical substances of unknown or variable compositions, complex reaction products, and biological materials (UVCB), including polymers, a single form may be submitted for that UVCB. The EPA “encourages submitters of mixtures and UVCBs that contain PFAS to provide additional information in the optional free text box related to the composition of that mixture or UVCB at the time of manufacture, if known.”
Pursuant to TSCA Section 8(a)(2)€, EPA will require the submission of “all existing information concerning the environmental and health effects” of the chemical substances covered by the final rule. The EPA notes that “‘[a]ll existing information concerning environmental and health effects’ is defined as ‘any information of any effect of a chemical substance or mixture on health or the environment or both’ (to be codified at 40 CFR 705.3) and is intended to be interpreted broadly.” The scope of “all existing information concerning environmental and health effects” includes all health and safety studies but is not limited to formal studies.
Reporting Timeline
The final rule will provide a one-year information collection period following the final rule’s effective date, which will then be followed by a six-month reporting period. The EPA will grant an additional six months for reporting to small manufacturers, as defined at 40 C.F.R. Section 704.3, whose reporting obligations under the final rule are exclusively from article import. “Small manufacturers” include those that meet one of two standards:
- a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $120 million, and the annual production volume of a chemical substance is less than 100,000 pounds; or
- a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $12 million.
The EPA “acknowledges that the scope of reporting for this rule is broader than for [Chemical Data Reporting (CDR)], and that there may be some reporting entities who have not submitted information to EPA under a TSCA section 8(a) reporting rule before (e.g., some small manufacturers).” Therefore, the EPA agrees additional time is warranted for PFAS manufacturers to familiarize themselves with the scope of the reporting rule and reporting standard, collect the required information and create a Central Data Exchange (CDX) account, if necessary. Reporting forms will be due 18 months following the effective date of the final rule, except for small article importers, whose reporting forms are due 24 months following the effective date of the final rule.
Reporters also must retain records that document any information reported to the EPA for five years, beginning on the last date of the information submission period. The EPA notes that the five-year retention requirement “is consistent with the CDR rule and corresponds with the statute of limitations for violations and is necessary to preserve records to support future regulatory activities that will be informed by this information collection.”
Discussion
The regulated community has decidedly mixed views on the EPA’s final rule. The final rule is largely unchanged from the proposed rule, despite many comments about the undue burden potential reporters will face to determine if they have any information to report. The EPA appears to be indifferent to the due diligence burden, focusing almost entirely on the reporting burden. The EPA is likely to receive tens if not hundreds of thousands of reports that the information sought is not known or reasonably ascertainable, and reporters will have spent significant effort to fill the EPA’s databases with nearly useless information.
Most are relieved the EPA did not broaden the definition of PFAS to include substances with a single fluorinated carbon (trifluoromethyl groups). This larger universe of substances will not help the EPA with the concerns it is attempting to address. On the other hand, we are surprised the EPA eliminated the limitation on its structural definition wherein substances that had hydrogens adjacent to the carbons with fluorines were not considered PFAS, and we found its justification for this change lacking rigor, especially when the agency is aware that adjacent hydrogens allow for degradation via dehydrohalogenation, thereby significantly reducing the persistence concern.
Many are disappointed, however, that the EPA seemingly disregarded the significant concerns identified by potential reporters in the final rule. The agency has significantly underestimated the effort required to complete the due diligence, given that the only exemption is for the import of municipal solid waste. All other importers, regardless of size, must examine every product, including articles, imported since 2011 to determine if the reporter knew or if the reporter can reasonably ascertain whether a PFAS was present in the product at any level, what PFAS is or may be present, in what quantity, and for what purpose, and, in most cases, what happens to that PFAS during processing and use.
The EPA’s guidance on the due diligence standard is not yet available. It is unclear if the rule will be judicially challenged.
