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U.S. EPA Finalized PFAS Reporting Rule Requires Submittal of 12 Years of PFAS Data

Siros

By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice

Per- and Polyfluoroalkyl Substances (PFAS) | FDA

On September 28, 2023, U.S. EPA released its final reporting rule that will require manufacturers (and importers) of PFAS and PFAS-containing articles to submit detailed PFAS-information going back as far as 2011.  Putting aside the difficulties posed by a reporting rule with a 12-year look-back, the final rule also adopts a structure-based PFAS definition.  Specifically, rather than listing out specific PFAS, the final rule defines PFAS as “including at least one of these three structures:  R-(CF2)-CF(R’)R”, where both the CF2 and CF moieties are saturated carbon; 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”.  U.S. EPA explains that it adopted this structure-based definition to “expand the universe of PFAS to include additional substances of potential concern” that U.S. EPA believes are likely to be persistent and to “capture certain fluorinated ethers”.

The final rule applies to the “manufacture for commercial purposes” of PFAS.  “Manufacture for commercial purposes” is defined to include the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance for the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer and includes the coincidental manufacture of PFAS as byproducts or impurities.   

Importantly, the final rule does not apply to entities that process, distribute in commerce, use, and/or dispose of PFAS and specifically exempts non-commercial R&D activities.  The comments accompanying the final rule further clarify that “waste management activities involving imported municipal solid waste streams for the purpose of disposal or destruction are not within the scope of the rule’s reporting requirements.”  The final rule does however, apply to waste management sites that import PFAS-containing waste (include municipal solid waste) for the purposes of recycling or reuse. 

The final rule requires that the following information be reported within 18 months of the effective date of the rule:

  • The common or trade name, chemical identity, and molecular structure of each PFAS (unless the PFAS is already on the TSCA inventory);
  • The physical form(s) of the PFAS as it is sent off-site;
  • Categories of use for each PFAS;
  • Total volume of PFAS manufactured on an annual basis;
  • Description of any byproducts resulting from the manufacturing, processing, use or disposal of each PFAS;
  • Any information concerning the environmental and health effects of each PFAS;
  • Worked exposure data; and
  • Information regarding PFAS disposal methods.

The above-referenced information must be reported to the extent the information is known or reasonably ascertainable.  Recognizing that importers of PFAS-containing articles may not have available to them the full range of information required to be reported, the final rule provides for the use of a streamlined form that requires reporting of the chemical identity, processing and use information, production volume, as well as the option to provide any additional information that the importer might have. 

Industry has criticized the reporting rule as being overbroad in that it requires reporting of all PFAS.  Critics have also pointed to the fact that U.S. EPA has estimated that industries’ costs to comply with the reporting rule will exceed $1B while the American Chemistry Council has estimated compliance costs to exceed $500B annually. 

We will continue to track U.S. EPA’s ongoing PFAS regulatory initiatives at the Corporate Environmental Lawyer Blog