Exploring PFAS Regulation: EPA’s New Reporting and Recordkeeping Requirements under TSCA

Introduction

The comprehensive requirements of EPA’s 2023 regulation on reporting and recordkeeping of PFAS (Per- and Polyfluoroalkyl Substances) have triggered questions and concerns for manufacturers and importers. The TSCA-governed reporting rule is structured by the EPA to collect considerable data on manufacture, use, and health effects of PFAS, in the US, during a particular period.

PFAS Reporting Rule: USA Reporting and Recordkeeping Requirements for Certain Per- and Polyfluoroalkyl Substances, 40 CFR 705, 2023

• The EPA published the final rule on October 11, 2023 and the regulation took effect on November 13, 2023. The rule mandates the reporting and recording of the manufacture of PFAS chemical substances in the US during the 12 years prior to 2024.
• Persons who manufacture (including import) or have manufactured PFAS chemical substances in any year since January 1, 2011 are to submit information to EPA regarding PFAS: on uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects.
• TSCA’s statutory definition of “manufacture” includes “importing” in the USA. The regulation enjoins “articles containing PFAS” to the reporting requirements. EPA regards finished consumer goods placed in commerce (such as toys) generally as “articles”, which if containing PFAS are reportable. 
• Entities who have not manufactured, and have only processed, distributed in commerce, used, and/or disposed of PFAS, and are not required to report under this rule.

Manufacturers Obligations

The submission and information collection period for all reporters is six months, from November 12, 2024 to May 08, 2025; excepting small business/article reporters from November 12, 2024, through November 10, 2025.

• For the one-time submission, reporters who have manufactured for commercial purposes a chemical substance identified as PFAS, at any period from January 1, 2011 to November 13, 2023, must report for each site of each of the chemical substances identified, “to the extent Known to or Reasonably Ascertainable” (“KRA”). 
• Article importers have the option to use a streamlined reporting form, designating the consumer and commercial product category that describes the products in which each PFAS chemical within an imported article is used.
• Domestic purchase of materials containing PFAS does not require reporting; though manufacturing PFAS is clearly reportable. Import of articles, mixtures and products containing PFAS must be reported.
• Each submitter [manufacturer or importer] maintains the records documenting the information reported for a period of 5 years, beginning on the last day of the submission period.
• Packaging is within the scope of the rule.
• Any amount of PFAS known to be manufactured is reportable.

EPA is developing a new reporting tool for this rule on CDX. To avoid duplicates, reporters should notify EPA if they have already submitted specific data. 

Defining PFAS

Per- and polyfluoroalkyl substances or PFAS is, for this rule, a chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub-structures:

• (1) R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons.
• (2) R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons.
• (3) CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.

Fluoropolymers may meet this scope and if confirmed by EPA would be reportable.

Any TSCA chemical substance meeting this definition which has been manufactured in any year since January 1, 2011, is reportable.