On September 28, 2023, the United States Environmental Protection Agency (EPA) announced new per- and polyfluoroalkyl substances (PFAS) reporting and recordkeeping requirements, 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). On October 11, 2023, the rule was published in the Federal Register, with an effective date of November 13, 2023. As one of the more comprehensive and recently modernized statutes controlling industrial chemicals in the United States, TSCA is systematically used to advance EPA’s regulatory roadmap.
Top 3 article takeaways
- EPA issues new TSCA PFAS Reporting Rule retroactive to 2011
- Nearly 1,500 fluorinated compounds subject to reporting
- Article importers and previously exempt businesses, many with no prior TSCA obligations, may need to report in 2025
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 the potential for 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.
New reporting/recordkeeping requirements
Key elements from the EPA’s pre-publication notice of the 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:
- production volume
- 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
Which industries are required to comply with the new rule?
The rule names the following North American Industrial Classification System (NAICS) codes as potentially affected entities. Additional industrial and commercial activities may be impacted based on applicability criteria under 40 CFR 705.10 and 40 CFR 705.12. Thus, a careful examination of rule applicability to each organization is recommended.
NAICS code 23
NAICS code 31 through 33
NAICS code 42
NAICS code 44 through 45
Waste management and remediation services
NAICS code 562
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 subject to the rule introduces further complexity and a layer of difficulty for most reporters. Rather than equipping the regulated community with a discrete list of PFAS, the rule cites three unique structural formulas to define which PFAS to report:
- (c) 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.
Can anything be done to make PRR compliance easier?
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 and every 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.
What is the compliance timeline?
The PRR's effective date is November 13, 2023. Reports are due to EPA by May 8, 2025, for reporters submitting information pursuant to §§ 705.15 and 705.18(b) (research and development). For reporters submitting information pursuant only to § 705.18(a) (article importers), and that are also considered a small manufacturer under 40 CFR 704.3, reports are due to EPA by November 10, 2025.
The breadth of information requested under the new rule combined with the recurring CDR obligation coming up in 2024 translates into a heavy 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 PRR’s complexity and broad scope will require PFAS and TSCA expertise, as well as information management resources familiar with the company’s products, value chain structure, and associated documentation. With 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.
Curious about how the latest TSCA news impacts you? We can help.
If you have TSCA-related questions or require assistance in planning for the new PRR or preparing your 2024 CDR, drop your information into our contact form and we will schedule time to discuss how you can prepare for and manage your TSCA obligations.
Want more background on TSCA?
Check out our TSCA playlist, where Andrew Pawlisz, DABT, Senior Toxicologist, dives into TSCA history, CDR reporting considerations, and more.