Rule Summary for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)

Late last year, on October 11, 2023, the US Environmental Protection Agency (USEPA) published the final Toxic Substances Control Act (TSCA) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). The USEPA, to date, has identified over 1,462 chemical substances and mixtures subject to the published report that are drawn from the TSCA Inventory, those covered under Low Volume Exemption (LVE) notices, and those listed on USEPA’s CompTox Chemicals Dashboard. In general, substances within the scope of reporting are those that meet one of three structural definitions provided by USEPA, rather than those on a specific substance list.

Fluoropolymers that meet the act’s definition are also subject to the reporting.  This means anyone who has manufactured (including imported) a PFAS compound for a commercial purpose in any year since January 1, 2011, is covered by TSCA. Manufactured for commercial purposes includes the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer. Manufacturers (including importers) both small and large of PFAS compounds in any year since January 1, 2011 (final rule was published in the Federal Register on October 11, 2023 & effective date of the rule is November 13, 2023), must submit information to the EPA regarding the specific PFAS use, production volume, byproduct, disposal, exposure risks, and existing information on environmental or health effects.

Updates since October 2023

In Minnesota, any product that contains intentionally added per- and polyfluoroalkyl substances (PFAS) will be banned from January 1^st, 2032, by the by the Minnesota Pollution Control Agency (MPCA) unless the product has been designated as a currently unavoidable use (CUU).  Similarly, in the state of Maine, any product that contains intentionally added PFAS may not be sold starting January 1^st, 2030, unless the use of PFAS in that product has been approved by the Maine Department of Environmental Protection (MDEP) as a CUU.

Requirements for Reporting under Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)

The rule requires reporting of information “known to or reasonably ascertainable by” the submitter, which may also require inquiries outside the organization to fill gaps in knowledge. USEPA encourages manufacturers to document their activities to provide evidence of due diligence and documentation for their conclusions about presence or absence of PFAS. The information under the rule required to be reported for each chemical substance or mixture includes:

1. Chemical identity, and categories or proposed categories of use.
2. Total amount manufactured or processed for each use category.
3. Descriptions of byproducts.
4. All existing information concerning the environmental and health effects.
5. Number of individuals exposed and the durations of their exposure.
6. The manner or method of disposal.

Applicability for Reporting for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)

• Under TSCA, the rule requires reporting on each chemical substance that is a PFAS, including as a component of a mixture.
• There are no de minimis exemptions for companies that manufacture or import small amounts, or manufacture or import for research & development use only.
• Potentially affected entities may include companies in the following industries, among others:
  • Construction (NAICS code 23)
  • Manufacturing (NAICS code 31 through 33)
  • Wholesale trade (NAICS code 42)
  • Retail trade (NAICS code 44 through 45)
  • Waste management and remediation services (NAICS code 562)
• Importers of PFAS in articles are considered PFAS manufacturers by the US EPA. An “article” is a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles.
  • TSCA section 3(2) does not define ‘‘chemical substance’’ to exclude articles. Generally speaking, articles are manufactured goods or finished products—and the chemicals in them are subject to TSCA. When a chemical substance is manufactured (including imported into the United States) or is distributed or processed in the United States— whether in bulk form or in a manufactured good or finished product it may be subject to regulation under TSCA.
  • There is no definitional distinction for a chemical substance depending on whether it is incorporated into an article; nothing says that an ‘‘article’’ is exclusive or distinct from a ‘‘chemical substance.’’ While the Chemical Data Reporting (CDR) rule has exempted the import of articles from reporting, the domestic manufacture of a chemical substance within an article is still subject to CDR.
• Companies that process and/or use PFAS only need to report on PFAS they have manufactured (including imported), if any. Processing a substance means “preparation” of a PFAS substance or mixture, after its manufacture, for distribution in commerce, which can include repackaging for commercial distribution, the manufacture of mixtures (mixing the purchased chemicals), and the production of articles.
  • EPA has clarified that entities, such as noncommercial research and development, who solely process, distribute, and/or use PFAS, and do not manufacture (including import) PFAS for a commercial purpose, are not required to report under this rule.

Timeline for Reporting for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)

Reports under the Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) through TSCA are due 18 months following the effective date of this rule, except for small importers of items that qualify as “articles,” whose reports are due 24 months from the effective date of this rule. The reporting period will run from November 12, 2024, to May 8, 2025 & small businesses that import articles have an additional six months beyond that, with reports due November 10, 2025.

All reports must be submitted through USEPA’s Central Data Exchange (CDX) portal and records must be retained for five years.

Link to the final rule: https://www.federalregister.gov/documents/2023/10/11/2023-22094/toxic-substances-control-act-reporting-and-recordkeeping-requirements-for-perfluoroalkyl-and

How RHP Risk Management Can Help

At RHP Risk management we help our clients to improve safety plans across a wide variety of industries. We specialize in chemical exposure assessments and can ensure regulatory compliance is met. For more information on RHP’s conferences and service, please contact Ashish Jachak, PhD at ajachak@rhprisk.com, (678) 896-6042 and visit rhprisk.com.