/>iOn October 11, 2023, the US Environmental Protection Agency (EPA) released its long-awaited final rule imposing detailed reporting requirements on entities that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for commercial purposes at any time since January 1, 2011. Notably, the reporting rule also applies to importers of articles containing PFAS, which could include many consumer, industrial, and commercial products, and requires reporting on PFAS as a component of a mixture. The rule does not have any exclusions for PFAS that are impurities, byproducts, used in commercial research and development (R&D), or only present in a mixture or article in trace amounts. And, unlike many state PFAS reporting laws, this reporting rule is not limited to only intentionally added PFAS.
Companies should be aware that this rule is more expansive in scope than most rules under the Toxic Substances Control Act (TSCA), and it will impact many companies that may be unfamiliar with TSCA. Because importing even one product or product component containing trace amounts of PFAS could trigger reporting obligations, chemical manufacturers, product manufacturers, distributors, and retailers must understand the implications of this new rule. Below, we provide responses to frequently asked questions about EPA’s new rule.
Who must report?
Anyone who has manufactured or imported consumer, industrial, or commercial products, goods, or other articles for commercial purposes containing PFAS, which includes mixtures containing PFAS, as well as manufacturing or importing PFAS substances, in any year since January 1, 2011 is subject to reporting requirements described by this rule.
How much time do we have to report?
The rule will be effective on November 13, 2023. The submission period begins one year after the effective date, on November 12, 2024, and lasts six months (through May 8, 2025).
EPA is granting an additional six months (until November 10, 2025) for small importers whose reporting obligations under the rule are exclusively from article importation. 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.
Why is EPA requiring companies to report information about PFAS?
EPA was required to promulgate this rule under TSCA Section 8(a)(7) as amended by the National Defense Authorization Act for Fiscal Year 2020.
What is EPA going to do with all of this PFAS information?
This data will enable EPA to “better characterize the sources and quantities” of manufactured and imported PFAS in the United States by creating “a more comprehensive database of previously manufactured PFAS to improve the Agency’s understanding of PFAS in commerce.” EPA plans to use this information to support actions to address PFAS exposure and contamination, including PFAS activities and programs under other environmental statutes (e.g., RCRA, CWA, SDWA, and CERCLA). The data EPA collects on PFAS “may allow EPA to more efficiently determine whether additional risk assessment and management measures are needed” and “may lead to reduced costs of risk-based decision making and improved decisions concerning PFAS.”
Do the typical TSCA exclusions for impurities, byproducts, or uses in commercial research and development (R&D) apply to this PFAS reporting rule?
No. The rule also applies to the coincidental manufacture of PFAS as byproducts or impurities and R&D PFAS that were manufactured, including imported, for a commercial purpose. There is no reporting threshold or de minimis level for PFAS, manufactured or imported. This rule also deviates from typical TSCA rules that normally include exemptions for low production volume chemicals (such as the TSCA Chemical Data Reporting rule).
Does EPA understand how difficult this rule will be for companies to comply with?
EPA was advised through many public comments and the Small Business Advocacy Review (SBAR) panel process about how challenging and expensive compliance with the rule will be. By EPA’s own estimates, manufacturers and importers as a whole will spend $876 million to comply with the rule.
How does EPA define PFAS?
Rather than providing a discrete list of individual PFAS subject to the reporting rule, EPA provides the following structural definition of PFAS:
PFAS is defined as including at least one of these three structures:
- R-(CF2)-CF(R’)R’’, 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’R’’, where R’ and R’’ can either be F or saturated carbons.
EPA used this approach to increase its ability to capture more substances commonly considered to be PFAS. Later, EPA will provide a list of substances containing 1,462 substances identified on the TSCA Inventory or subject to low volume exemptions (LVEs), but that list is not intended to exhaustively describe all PFAS subject to reporting requirements. Additionally, fluoropolymers meeting the rule’s definition of PFAS must be reported.
EPA’s PFAS definition is less expansive than many states’ definitions of PFAS (e.g., as a class of organic chemicals containing at least one fully fluorinated carbon atom). EPA believes reporting substances with only one fluorinated carbon or unsaturated fluorinated moieties is unnecessary because they are less likely to persist in the environment.
Are there any exemptions or exclusions from reporting?
Yes, the rule provides limited exemptions/exclusions. Persons who have only processed, distributed, used, or disposed of PFAS need not report. For example, entities that simply process PFAS they receive domestically are not covered by the rule, unless they also manufacture PFAS (a different PFAS is formed). Processing a substance means “preparation” of a PFAS substance or mixture, after its manufacture, for distribution in commerce, which can include repackaging for commercial distribution, the manufacture of mixtures (mixing the purchased chemicals), and the production of articles. However, whether the act of mixing a purchased PFAS with other chemicals qualifies as mere processing of the PFAS may depend on whether the mixture subsequently reacts to form any amount of a different PFAS.
The rule also excludes activities that are not considered to be “manufacture/import for a commercial purpose” under TSCA, such as non-commercial R&D activities (science experimentation, research, or analysis conducted by academic, government, or independent non-profit research organizations).
The reporting rule narrowly excludes waste management activities involving the importation of municipal solid waste (MSW) streams for the purpose of disposal or destruction. However, other waste management sites must report relevant information regarding PFAS contents in non-MSW imported waste and any waste (including MSW) imported for the purpose of recycling or reuse of PFAS-containing products.
Additionally, federal agencies are not required to report the import of PFAS when it is not for any immediate or eventual commercial advantage.
What information must be reported to EPA?
This is a one-time reporting requirement. Companies subject to the rule must submit a report that includes, for each year since January 1, 2011, detailed information on manufactured/imported PFAS, including: company and site information, chemical-specific information, categories of use, total amounts manufactured/imported of each PFAS (including the amounts manufactured in each calendar year for each category of use), number of individuals exposed, byproducts and disposal information, and health and environmental effects. Information is to be reported to EPA on a substance-by-substance basis (not on a per-product or per-article basis), but a single reporting form may be used for substances of unknown or variable compositions, complex reaction products, and biological materials (UVCBs), including polymers.
EPA has released more details on reporting in a draft “Instructions for Reporting PFAS under TSCA Section 8(a)(7)” document released with the final rule.
What if some of the information required to be reported has already been submitted to EPA in other contexts?
To reduce the potential for duplicative reporting, EPA is limiting the requirement for reporting duplicative information if a PFAS manufacturer/importer has previously submitted the information to EPA for the same PFAS in the same year through TSCA CDR, Toxics Release Inventory (TRI) reporting, TSCA Section 8(d) or 8(e) reporting, or Greenhouse Gas Reporting Rule, unless that information did not reflect all activities or quantities for which reporting is required under this rule.
What level of effort must a company undertake to find out if they have manufactured or imported PFAS or products and articles containing PFAS?
The reporting standard is information “known to or reasonably ascertainable by” the manufacturer or importer. “Known to or reasonably ascertainable by” 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.” 40 C.F.R. § 704.3. Information is in the “possession or control” of a person if it is:
- In the person’s own files, including files maintained by employees of the person in the course of their employment.
- In commercially available databases to which the person has purchased access.
- Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question. 40 C.F.R. § 704.3.
This standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers may vary from case to case. EPA provided the following examples of types of information that would be in a manufacturer’s possession or control or that a reasonable person similarly situated might be expected to possess, control, or know:
- 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 CAS or from Dun & Bradstreet (D-U-N-S).
If the rule requests information that is not currently in a company’s possession and is not in the possession of the company’s agents and subordinates, whom the company could order to share with it, then the rule’s reporting standard may require inquiries outside the organization to fill gaps in the submitting company’s knowledge, such as phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer, including employees involved in the research and development, import, production, or marketing of the PFAS.
However, if the information requested is not in the company’s possession or control and is not information that a similarly situated company would reasonably be expected to possess, control, or know, then it would not be “reasonably ascertainable” to the submitter. If the information cannot be found or reasonably estimated without conducting further customer surveys (i.e., without sending a comprehensive set of identical questions to multiple customers), it would not be “reasonably ascertainable” to the submitter. Thus, there is not a need to conduct new surveys for purposes of this rule. Conducting new surveys for purposes of this rule could prove counterproductive. First, new surveys would provide information not currently in a company’s possession or control, which by definition need not be provided under the rule generally. Second, if enough companies within an industry mistakenly believe that the reporting rule requires them to conduct new surveys to fill in information that few, if any, companies in that industry possess or control, then the industry could reach a tipping point where a company in that industry would need to conduct a new survey because most of its similarly situated peers had come to possess this previously missing information.
Companies should be aware that if they are collecting or possess information about PFAS they manufacture or import in order to ascertain compliance with other PFAS laws, such as state PFAS product bans or reporting requirements, this information is “known to” the company and could be reportable under this rule.
EPA has released some illustrative examples of the application of the reporting standard in a draft “Instructions for Reporting PFAS under TSCA Section 8(a)(7)” document released with the final rule.
Can a company provide estimates if actual data is not known?
Yes. If a company does not have actual data to report to EPA, it should consider whether reasonable estimates are ascertainable. If manufacturers do not know or cannot reasonably estimate certain data elements, except for production volumes, they may indicate such information is “Not Known or Reasonably Ascertainable” (NKRA) to them in lieu of the requested estimate or range.
Do article importers need to ask their suppliers if the products they imported contain PFAS?
Not necessarily, but, as described above, the standard of diligence could require some level of inquiry to certain suppliers to fill in gaps in knowledge. EPA provides a “Small Entity Compliance Guidance for the TSCA PFAS Data Call” for further guidance on the reporting standard of diligence. One example EPA’s guidance provides is a company imports stain-resistant garments, and the company does not know specifically what chemical is used to impart stain resistance, but the company does know that chemicals used to impart stain resistance are often fluorinated chemicals that could meet the definition of PFAS. EPA indicates that the company likely fulfills the reporting standard if it contacts its supplier to determine the name, CASRN, and molecular structure of the stain-resistant chemical. And the company likely does not fulfill the reporting standard if it does not contact its supplier to obtain information on the stain-resistant chemical.
Does the rule provide any reduced reporting requirements for some entities?
The rule offers reduced reporting options for article importers and companies that manufacture or import PFAS for R&D in volumes of under 10 kilograms per year, if they do not know nor can reasonably ascertain the information required on the longer reporting form. While not exempt from the scope of the rule, these entities can complete abbreviated reporting forms. One abbreviated requirement for article importers is that, rather than reporting on the amount of PFAS in the imported article, they can report on the total volume of the imported product or the quantity imported (e.g., number of vehicles imported). However, to the extent any information on the longer reporting form is known to or reasonably ascertainable by the company, the company would be required to submit that information to EPA through the “optional” field on the streamlined reporting form.
Can submitters claim information as confidential?
Yes. Information submitted to EPA can be claimed as confidential business information (CBI) so long as the submitters follows the requirements under Section 14 of TSCA and the revised implementing regulations. For CBI claims of chemical identity where generic names are used in lieu of specific chemical names, the generic name must include language indicating that the substance is fluorinated (i.e., contain “fluor”), or the name will be rejected, and the chemical substance identified publicly as a PFAS.
Other than article importers, entities who do not have knowledge of the CASRN, Accession number, CAS name, or LVE number of the PFAS being reported must initiate a joint submission with the supplier or other entity who can provide the identifying information, if such an entity is known or reasonably ascertainable by the manufacturer. The supplier would be responsible for the CAS name and CASRN (or similar identifiers) and substantiating the CBI claim for chemical identity. This way, the supplier does not have to disclose the specific chemical identity to its customer.
How must information be reported?
Information must be reported electronically through EPA’s Central Data Exchange (CDX).
What are the recordkeeping requirements?
Companies subject to the rule must retain records that document information reported to EPA for five years, beginning on the last date of the information submission period.
What are the penalties for noncompliance with the rule?
Noncompliance with the rule constitutes a violation of TSCA Section 15(3). Penalties for TSCA violations can be up to the statutory maximum of $46,989 per violation (per PFAS that is not reported per site), subject to annual inflationary adjustments. While EPA has not updated its Enforcement Response Policy (ERP) for Section 8 of TSCA to specifically include violations of this reporting rule, it is possible that EPA would treat non-reporting under this rule the same as it does for non-reporting under the TSCA CDR, which are one-time violations (rather than per day). Such violations could be approximately $32,620 per violation (per chemical per site) under the ERP.
