In December 2019, the U.S. Environmental Protection Agency (EPA) amended the Toxic Substances Control Act (TSCA) to add section 8(a)(7) entitled “PFAS Data,” requiring that manufacturers and importers of any chemical substance considered per- and polyfluoroalkyl substances (PFAS) since 2011 to report certain data about these chemicals to EPA. The final rule became effective on November 13, 2023.

The required PFAS data include information related to PFAS chemical identity and structure, production, use, by-products, exposure, disposal, and any known health or environmental effects the substance may cause. This reporting is a one-time, retroactive requirement to collect historical data on PFAS manufacturing and importing in the United States since 2011. Exemptions are limited. Most entities have until May 8, 2025, to report, while small PFAS manufacturers and importers have until November 10, 2025.

Many have questioned whether the now-final reporting rule applies to them, how PFAS is defined, and what to do if they are not able to collect all data that EPA requires. To help with these questions, EPA hosted a webinar on PFAS reporting requirements on January 25, 2024, that aimed to clarify some of the reporting requirements. Here is what we learned.

How does EPA define PFAS?

EPA defines a PFAS compound reportable under section 8(a)(7) as having one of the following chemical 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
• CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.

On January 26, 2024, EPA released a list of 1,462 chemicals that match this PFAS definition. These chemicals are either currently in the TSCA inventory or identified on CompTox, a database for compound information maintained by EPA. The list is available for reference here. It is important to note that this list does not include all chemicals that could be considered PFAS under EPA’s definition. Instead, it focuses on the chemicals that are currently on EPA’s radar or have a Chemical Abstracts Service registry number (CAS RN).

Who Must Comply with TSCA Section 8(a)(7)?

Any company that has manufactured or imported a PFAS substance or PFAS-containing article at any time since 2011 must comply with TSCA Section 8(a)(7). It is explicitly stated in 40 CFR Part 705 that “importers of PFAS in articles are considered PFAS manufacturers.” For example, if an importer of waterproof gloves discovers that the gloves are coated with a PFAS substance and were imported into the U.S. any year since 2011, that importer must comply with this TSCA reporting rule. During the January 25 webinar, EPA clarified that fluoropolymers are included in the PFAS reporting rules. Consequently, packaging materials imported into the U.S. might also need to be reported if they are or contain PFAS.

As noted above, there are limited exemptions to this rule. First, there are no minimum volumes or concentrations that exempt reporting. Even small quantities of PFAS used for research and development must be reported, though a simplified form can be used for volumes of less than 10 kilograms per year. The inadvertent production of PFAS as a by-product must also be reported. The following entities, chemicals, articles, and sites are exempted from TSCA Section 8(a)(7):

• Entities only involved in processing, distributing in commerce, using, or disposing of PFAS¹
• Chemicals or articles not covered by TSCA, such as pharmaceuticals, pesticides, food, food additives, medical devices, and cosmetics
• Entities processing domestically-received PFAS (e.g., wastewater treatment plants)
• Sites importing municipal solid waste streams for disposal or destruction.

Reporting Standards

The reporting standard under TSCA Section 8(a)(7) is any data that is “known to or reasonably ascertainable by” the manufacturer. This includes information in their possession or control, as well as information that a reasonable person in a similar situation would be expected to possess or know.²

The key takeaway from EPA’s January 25 webinar is that if an entity suspects or has vague knowledge of having manufactured or imported a chemical or article that would be considered PFAS under this rule, it should survey its suppliers and/or employees and documents to understand what PFAS are in which products or were produced as by-products of manufacturing processes. Downstream usage and disposal must also be considered. If an entity is not sure if it is a PFAS manufacturer (or importer) as defined under the rule, then both due diligence and documentation of findings are warranted. If reasonably ascertainable sources of information show no evidence of PFAS as defined, reporting is not required. EPA does not mandate analytical testing to determine product composition.

Data already reported under other EPA programs—such as TSCA Section 4, 8(d), 8(3), Toxic Release Inventory, Chemical Data Reporting Rule, or Greenhouse Gas Reporting Program—can be indicated on the reporting form. Redundant reporting is not required. However, full data sets should be included in the section 8(a)(7) report if only partial data were submitted elsewhere.

Confidential Business Information

Confidential business information (CBI) can be claimed for required data on the reporting form, with appropriate substantiation. For example, a generic chemical name including “fluor” may be used. Article importers do not need to assert and substantiate CBI claims for chemical identity, but other manufacturers must coordinate with their suppliers or those who can provide the necessary data (like chemical name and structure) if the true identity of the PFAS compound is not known due to CBI.

Conclusion

The recent amendments to the TSCA under Section 8(a)(7) significantly expand the reporting requirements for manufacturers and importers of PFAS in the United States. While EPA has clarified these requirements through webinars and guidance documents, this regulation requires entities to perform their own due diligence to identify and report any PFAS compounds in their products.

At Integral, our team is ready to assist with PFAS risk evaluation and product stewardship. For inquiries and support in navigating the changing PFAS regulatory climate, reach out to Liz Hofstetter (lhofstetter@integral-corp.com) or Kristian Fried (kfried@integral-corp.com).

In an ever-evolving regulatory landscape, we want to make information about PFAS regulations accessible. Check out Integral’s interactive state-by-state PFAS regulatory criteria maps, open for public use and regularly updated.

¹ (88 Fed. Reg. 70519)

² (40 CFR Part 704.3)