In October 2023, the United States Environmental Protection Agency (EPA) promulgated the final rule on per- and polyfluoroalkyl substances (PFAS) reporting and recordkeeping transpiring from the Toxic Substances Control Act (TSCA) Section 8(a)(7) amendment by the National Defense Authorization Act for Fiscal Year 2020 (FY 2020 NDAA). The intended reporting period was to commence in November 2024 through November 2025. On September 5, 2024, the agency issued a direct final amendment changing the reporting period to July 2025 through July 2026. EPA cites a lack of sufficient technological capacity and delays in reporting application development to accept data any sooner. 

Key Article Takeaways

1. EPA amends the TSCA PFAS Reporting Rule with a postponed reporting deadline
2. Nearly 1,500 fluorinated compounds are subject to reporting
3. Article importers and previously exempt businesses, many with no prior TSCA obligations, may need to report starting in July 2025
4. EPA is now requesting “unpublished study reports” vs “published study reports”

PFAS background

PFAS are manufactured chemicals with multiple fluorine atoms, which impart useful waterproofing, anti-stain, and fire resistance properties to consumer and industrial products. PFAS have been used for decades and have applications in a range of industries worldwide. Environmental releases related to PFAS production, use, and disposal led to PFAS detections in air, soil, food, and water. Environmental exposures are a concern due to potential adverse impacts on human health and the environment. As such, EPA formulated its PFAS Strategic Roadmap, which has served as the springboard for multiple PFAS regulatory actions, including the newly announced PFAS reporting and recordkeeping requirements.

TSCA PRR Reporting & Recordkeeping Requirements

Key elements of EPA’s final rule (Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; 7902-02-OCSPP; EPA-HQ-OPPT-2020-0549; PFAS Reporting Rule [PRR]) include:

• Requires a one-time reporting event
• Applies equally to importers and manufacturers
• Does not apply to processors, purchasers/distributors, and users of PFAS
• Waste disposal activities, such as PFAS waste importation, may be subject to the rule
• Annual lookback period spans 10 years starting on January 1, 2011
• EPA requests information on:
  1. Uses
  2. Production volume
  3. Byproducts
  4. Disposal
  5. Exposures
  6. Environmental impacts/health effects
• Denies typical TSCA exemptions (i.e., byproducts, impurities, non-isolated intermediates, low quantities, polymers, mixtures, commercial research and development [R&D], imported articles)
• Casts a wider net encompassing nearly 1,500 PFAS, with many not reported previously  
• Streamlines reporting for articles and commercial R&D for each PFAS compound below 10 kilograms per year
• Adverse health/environmental effects information/monitoring subject to reporting even if generated prior to January 1, 2011

What Industries Need to Comply? 

The rule names the following North American Industrial Classification System (NAICS) codes as potentially affected entities. Based on applicability criteria under 40 CFR 705.10 and 40 CFR 705.12, additional industrial and commercial activities may be impacted. The regulatory flexibility and economic analysis details businesses, sectors, and articles potentially subject to the new PFAS reporting rule. It is recommended that the rule be carefully examined for its applicability to each organization.   

Which PFAS need to be reported?

While the concept of one-time reporting seems straightforward, a closer look uncovers complexities and challenges. The rule calls for “…chemical identity and molecular structure of each chemical substance or mixture for which a report is required...” and “…descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture.” Several factors work together to make PRR compliance a formidable task, including the highly complicated fluorochemistry, occurrence of PFAS as largely undefined complex mixtures, absence of systematic PFAS reporting/tracking within the commercial value chains, and limited analytical methodologies, the latter of which only cover a handful of the thousands of PFAS compounds.

The definition of PFAS, which is subject to the rule, introduces further complexity and a layer of difficulty for most reporters. The rule cites three unique structural formulas to define which PFAS to report:

1. R-(CF₂)-CF(R’)R’’
2. R-CF₂OCF₂-R’
3. CF₃C(CF₃)R’R’’

Deciphering these chemical codes is beyond the scope of this article (and a systematic explanation can be found in the rule), but the key message from EPA is that there could be nearly 1,500 fluorinated species within the PRR that meet the three definitions for reportable PFAS. The regulated community will be responsible for figuring out which PFAS within their inventories are subject to reporting.

Navigating PRR Compliance 

Faced with information gathering gaps and rule interpretation challenges, TSCA reporters may consider that the typical reporting standard applies: Not Known or Reasonably Ascertainable (NKRA). EPA explains that a manufacturer/importer would reasonably search for the information not only within the organization but also lodge inquiries up/down their value chains. Fortunately, the level of information inquiry is not dissimilar from the Chemical Data Reporting (CDR) performed quadrennially. Also, EPA provides additional guidance on its TSCA page.  

While there are similarities with CDR in terms of data elements and the use of the Central Data Exchange (CDX), the PRR is unavoidably more onerous. Unlike CDR, which covers a 4-year lookback period and requires enhanced data only for the principal year, PRR requires complex data for each year over the 10-year lookback period. Moreover, with no standard TSCA exemptions, entities that were once exempt, such as small importers and manufacturers, may now need to report.

Additional resources are available from the agency in the form of the January 2024 webinar and reporting instructions for the PFAS reporting rule.

PRR Compliance Timeline

The revised reporting period will open on July 11, 2025, and end on July 11, 2026. The breadth of information requested under the new rule, combined with the recurring CDR obligation coming up in 2025, translates into a busy TSCA compliance calendar for many facilities.

PRR’s Regulatory Impact

The new rule imposes additional due diligence and reporting burden on importers and manufacturers engaged in commercial activity in the United States. The technical correction requesting “unpublished study reports” vs the previous “published study reports” significantly broadens the scope of the PRR. Moreover, the rule complexity will require PFAS and TSCA expertise and information management resources that are familiar with the company’s products, value chain structure, and associated documentation. With relatively little time left to prepare, examining and processing records over the 10-year lookback period may prove difficult for existing TSCA reporters and will introduce a tall challenge for entities new to TSCA.   

What's Next?

The rule amendment will become effective on November 4, 2024, without further notice if no adverse comments are filed by October 7, 2024. Should the agency receive adverse comments, the amendment will be withdrawn, and the corresponding changes will be nullified.

We Can Help

If you have TSCA-related questions or require assistance in planning for the PRR, drop your information into our contact form, and we will schedule time to discuss how you can prepare for and manage your TSCA obligations.