iBack in October of 2023, we provided a list of “Frequently Asked Questions” and answers regarding the US Environmental Protection Agency’s (EPA’s) final reporting rule for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). As of May 8, 2024, many companies are facing a one-year countdown to the deadline for submitting their reports to EPA. To help you prepare for this impending deadline, we are providing a second installment of “Frequently Asked Questions” and answers about EPA’s rule.
Upcoming Reporting Deadline
The reporting rule requires entities that have manufactured or imported PFAS, or imported PFAS-containing products, for commercial purposes at any time between January 1, 2011 and December 31, 2022, to submit detailed reports within the applicable submission period. For many companies, the submission period begins on November 13, 2024 (which is one year after the rule’s effective date) and lasts six months, through May 8, 2025.
Small importers whose reporting obligations are exclusively due to article importation have until November 10, 2025 to report. An importer is “small” under TSCA if it meets one of two standards: (1) an importer whose total annual sales, when combined with those of its parent company, are less than $120 million, and the annual import volume of a chemical substance is less than 100,000 pounds; or (2) an importer whose total annual sales, when combined with those of its parent company, are less than $12 million.
It is crucial for companies to understand the expansive scope of this rule, which differs significantly from most TSCA reporting regulations and impacts many companies that may be unfamiliar with TSCA. Even the importation of one product or product component containing trace amounts of PFAS could trigger reporting obligations. Therefore, although reporting begins in November, it may take companies months to do their due diligence to ascertain what information is “known to or reasonably ascertainable by” the company and gather information required for reporting. This is particularly true for companies with complex supply chains and who manufacture or import many types of products.
New Frequently Asked Questions about PFAS Reporting Rule
- Who is obligated to report under this rule if a company changes ownership during the reporting period?
Although the PFAS Reporting Rule itself does not explicitly address changes in company ownership, dealing with an ownership change will be a common issue for companies subject to reporting under this rule because of its 12-year lookback period. This is also a common issue with any TSCA reporting requirement such as the chemical data reporting rule (CDR), which requires reporting every four years.
EPA’s Fact Sheet: Reporting After Changes to Company Ownership or Legal Identity provides guidance on reporting obligations after there are changes to company ownership or legal identity. While this guidance is for the CDR, these principles also apply to the PFAS Reporting Rule. Companies that have experienced changes in ownership since January 1, 2011 may find their scenarios listed in EPA’s Fact Sheet.
The guidance presents many examples of changes in company ownership and describes which entity is required to report information on chemicals produced or imported. One example involves the divestiture of a business unit, which is paraphrased below:
A part of one company becomes a part of a different company; two companies continue to exist (e.g., Company X combines with a part of Company Y, acquiring all of the assets of that unit of Company Y and assuming all of its liabilities. The remainder of Company Y continues to exist as a separate legal entity.)
- Company X submits data reports based on manufacturing/importing activities subject to a reporting obligation conducted during the years of the applicable reporting period, including the manufacturing that the newly combined unit did before it combined with Company X.
- Company Y submits data reports based on any manufacturing activities subject to a reporting obligation conducted during the years of the applicable reporting period, excluding the manufacturing that the divested unit did between those same calendar years.
Additionally, the Fact Sheet provides several examples applying General Scenario 6. One of these examples is a scenario where a company manufactured a chemical, then sold the unit of its business that manufactures the chemical to another company, and this other company now owns the business unit at the time of reporting. In this situation, “the transfer of ownership was for the whole manufacturing unit, including both the assets and the liabilities (e.g., the requirement to report under [the reporting rule]).” Thus, the company that now owns the business unit is responsible for reporting even for manufacturing activities that the business unit did prior to the transfer, and the first company that owned the business unit does not report.
- Has EPA provided additional guidance on which PFAS are covered by the rule?
EPA has posted lists of PFAS “examples” on both the Computation Toxicology (CompTox) Chemicals Dashboard and Substance Registry Services (SRS). These lists contain far more substances than the 1,462 PFAS substances on the TSCA Inventory (770 of which are active) that EPA referenced in the preamble as meeting the rule’s PFAS definition. The lists are available at:
The EPA SRS list provides 12,696 chemicals, but only the International Union of Pure and Applied Chemistry (IUPAC) names, Chemical Abstracts Service Registry Numbers (CASRNs), and molecular formulas (not their molecular structures) are provided. Before companies can compare any of these substances to the PFAS Reporting Rule’s definition of PFAS, they have to determine their molecular structures from the IUPAC names or by researching the CASRNs. The CompTox list, on the other hand, is more helpful and illustrative because it provides the molecular structures, in addition to IUPAC names and CASRNs, for 11,409 chemicals, which allows direct comparison to the structural definitions of PFAS in the Reporting Rule.
EPA has explained that roughly 90% of the chemicals on the CompTox and SRS lists are chemical substances that never went through premanufacture notification (PMN) or low volume exemption (LVE) application processes. This could be due to various reasons, including because the substances were manufactured or imported under PMN exemptions (e.g., byproducts, impurities, R&D substances, polymers, etc.) or because the substances were merely theoretical (e.g., no one has actually manufactured them). EPA also explained that there are fewer chemicals on the CompTox list, in part, because it does not contain all of the polymers or unknown or variable composition, complex reaction products, and biological materials (UVCB) structures currently in SRS. Thus, the SRS list is more comprehensive than CompTox.
- Who is an “importer” under this rule?
A person qualifies as the importer for purposes of the PFAS Reporting Rule by meeting one of two definitions of “importer” in 40 C.F.R. § 704.3:
(1) any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes:
(i) the person primarily liable for the payment of any duties on the merchandise, or
(ii) an authorized agent acting on his/her behalf.
(2) Importer also includes, as appropriate:
(i) The consignee.
(ii) The importer of record.
(iii) The actual owner if an actual owner’s declaration and superseding bond have been filed in accordance with 19 CFR 141.20.
(iv) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144.
Accordingly, a company or its subsidiary would qualify as an “importer” of an imported PFAS, PFAS-containing mixtures, or PFAS-containing articles/products if it meets the criteria of either subsections (1) or (2) above. However, it is possible that more than one entity can legally qualify as the importer of an article or product.
In situations where multiple entities meet the definition of “importer,” EPA has provided in its TSCA PFAS Reporting Rule guidance that it prefers that only one of the entities report to avoid duplicative reporting. But, under EPA’s CDR rules (which could apply to the PFAS Reporting Rule as well), if neither entity reports, each can be held liable under TSCA for failure to report. To avoid potential violations for failing to report, multiple entities that qualify as importers should work together to resolve who will be responsible for reporting.
- If I purchase PFAS chemicals domestically, could I still be considered a PFAS manufacturer?
The PFAS Reporting Rule does not require reporting for the use or processing of PFAS purchased domestically, but it does require reporting if the use or processing of the domestically purchased PFAS results in the manufacture of another PFAS (e.g., as the result of a chemical reaction that could occur in the process of formulating a product). And, notably, the manufacture of PFAS as a byproduct, an impurity, for research and development, and non-isolated intermediates are reportable under this rule. Under many other TSCA reporting rules, these types of substances would be exempt.
- What does it mean to manufacture a chemical for “commercial purposes”?
The rule requires companies to report PFAS that they manufactured for commercial purposes. “Manufactured for commercial purposes” is defined in 40 C.F.R. § 705.3(b) to include substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture containing a chemical substance, including both byproducts that are separated from that other substance or mixture containing a chemical substance and impurities that remain in that substance or mixture containing a chemical substance.
Therefore, “manufacture for commercial purposes” includes the coincidental manufacture of PFAS produced during the manufacture of another substance or mixture that is being made for a commercial purpose, even if the PFAS itself is not manufactured for commercial purposes. The determining factor is whether the PFAS are produced as part of the manufacture of another chemical product for a commercial purpose, and EPA defines “commercial purposes” broadly.
