On October 11, 2023, the United States Environmental Protection Agency (USEPA) finalized revisions to TSCA Section 8(a)(7) rulemaking and reporting. TSCA Section 8(a)(7) provides authority for the USEPA to collect existing information on per- and polyfluoroalkyl substances (PFAS).
The goal of the rule is to enable USEPA to better characterize the sources and quantities of manufactured PFAS in the United States including information on uses, production volumes, disposal, exposures, and hazards. The rule would require companies to make a one-time disclosure with no exemptions for by-products, impurities, or small businesses.
Who May Be Impacted?
The rule is applicable to persons who manufacture (including import) or have manufactured PFAS for a commercial purpose in any year since January 1, 2011. USEPA has stated that the final rule extends to manufacturers, including importers, and that importers of PFAS in articles are considered PFAS manufacturers. Unlike Chemical Data Report (CDR) reporting, TSCA Section 8(a)(7) reporting does not provide any exemptions.
What Substances Are Covered?
Per TSCA Section 8(a)(7), PFAS are defined as any chemical substance that structurally contains at least one of the following three sub-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.
USEPA has identified 1,462 PFAS from both the TSCA Inventory and Low Volume Exemption Claims that meet this definition. However, this list of 1,462 PFAS is not exhaustive and may encompass an even larger number of PFAS (estimated by USEPA as large as ~11,409).
This rule is limited to manufacturers (including importers) of PFAS that are considered a “chemical substance” under TSCA section 3(2). This rule does not require reporting on activities that are excluded from the definition of “chemical substance” in TSCA section 3(2)(B). As a result, the final rule excludes PFAS from reporting only if the PFAS is produced solely for use as a pesticide, or in food, food additive, drug, cosmetic, or medical device uses.
Note that while the TSCA definition of chemical substances excludes mixtures, PFAS as a chemical substance may be present in a mixture and thus is subject to reporting requirements.
How Do I Comply?
Information “to the extent known to or reasonably ascertainable by” the manufacturer (importer) to be reported for each PFAS includes:
- Chemical Name, trade name, CAS RN, and molecular structure
- Physical form of chemical or mixture
- Industrial processing and use information (i.e., type, sector, function category)
- Consumer and commercial use information (i.e., product or function category, use type, maximum concentration in product)
- Production quantities including total volume recycled
- Byproduct information
- All existing information related to health and environmental effects
- Worker exposure information
- Disposal processes
The reporting deadline is 18 months from the effective date of the final rule, except for small article importers whose reporting forms are due 24 months from the effective date.
Reporting will be accomplished electronically via USEPA’s web-based reporting tool within the Central Data Exchange (CDX) system. The online reporting software will guide users through the data elements required and assess qualifications for streamlined reporting.
How Can EHS Support Help?
Compliance with this new rule may be complicated and time-consuming. Companies should act soon to understand how this rule may impact their business. EHS Support has a reputation for developing innovative approaches to client advocacy and offers a wide range of services to support your PFAS challenges in the changing regulatory landscape. Reach out to Dana McCue or Beth Hesse today and explore how the EHS Support Team can help you stay in compliance with rapidly changing PFAS regulations and achieve your goals.
