Tech Watch: EPA Finalises PFAS Data Reporting Rule

On 28 September 2023, the U.S. Environmental Protection Agency (EPA) finalised one-time reporting requirements for Per- and Polyfluoroalkyl Substances (PFAS) under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). Under the final rule, any person that manufactures or imports or has manufactured or imported PFAS or PFAS-containing articles in any year since 1 January 2011 will be required to electronically report information to the EPA. Reports must cover in-scope activities in each calendar year from 2011 through 2022. Additionally, there is no de minimis threshold for reporting.

In the final regulation, the EPA decided that a broad structural definition was more suitable for this rule than a specific list of named substances. 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 carbons;
• 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

The EPA has determined that at least 1,462 PFAS that are known to have been made or used in the US since 2011 will meet this definition. The EPA will provide a list of substances that meet this definition on the CompTox Chemicals Dashboard.

The final rule will be effective on 13 November 2023. Under the final rule, companies will have one year to collect the information required to be reported, followed by a six-month period during which reports must be submitted to the EPA. Most companies obligated to submit reports will have a reporting deadline of 8 May 2025. They can start reporting from 12 November 2024. However, “small manufacturers” only involved in importing articles will have an additional 6 months to collect the data and have until 10 November 2025, to report. All submissions should be made via the EPA's CDX portal.

The rule prescribes information required to be reported by a person manufacturing or importing PFAS substance or PFAS in a mixture using the Standard Form. The rule also allows person that imported articles containing PFAS to use a Streamlined Form. The following information will be required for the Streamline Form:

• Company and plant site information
• Chemical-specific information
• Categories of use
• Imported article production volume
• Additional article data: The submitter has the option to provide relevant additional information to EPA including supplemental attachments

Recordkeeping Requirement: Each person who is subject to the reporting requirements of this rule must retain records that document any information reported to the EPA. Relevant records must be retained for a period of 5 years beginning on the last day of the submission period.

Small manufacturer means a manufacturer (including importer) that meets either of the following standards:

• First standard. A manufacturer (including importer) of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $120 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms (100,000 lbs), the manufacturer (including importer) will not qualify as small for purposes of reporting on the production or importation of that substance at that site unless the manufacturer (including the importer) qualifies as small under paragraph (2) of this definition.
• Second standard. A manufacturer (including importer) of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $12 million, regardless of the quantity of substances produced or imported by that manufacturer (including importer).
• Inflation index. EPA shall make use of the Producer Price Index for Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor Statistics, for purposes of determining the need to adjust the total annual sales values and for determining new sales values when adjustments are made. EPA may adjust the total annual sales values whenever the Agency deems it necessary to do so, provided that the five-year average of the Producer Price Index for Chemicals and Allied Products has changed more than 20 per cent since either the most recent previous change in sales values or 28 May 2020, whichever is later. EPA shall provide Federal Register notification when changing the total annual sales values.

Source: Final rule - 40 CFR part 705

For questions and additional information, please contact Dr. Pratik Ichhaporia (pratikichhaporia@eurofinsus.com,+1-669-837-2257) or David Hong (David.Hong@cpt.eurofinscn.com)