Doria Keys

Associate Editor

Loyola University Chicago School of Law, JD 2025

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized its rule for manufactures of per- and polyfluoroalkyl substances (PFAS), which requires that these manufacturers provide information about what chemicals and the amount that they produce. Effective November 13, 2023, persons that manufacture, have manufactured, or have imported PFAS in any year since January 1, 2011, will now be required to report a wide range of information of PFAS including chemical identity and structure, uses, production volumes, exposures, by-products and health and environmental effects. EPA is taking this action not only to fulfill its obligations under the Toxic Substances Control Act (TSCA) Section 8(a)(7), but also to address this legacy pollution that has been, and continues to be, endangering people across the nation.

What are PFAS?

Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals, that were first introduced in the 1940’s, and are now found in a wide range of industrial and consumer products. PFAS are specifically known for their resistance to heat, water, and oil, making them useful in applications such as non-stick cookware, stain- and water-resistant fabrics, cleaning products, paints, and fire-fighting foams. PFAS do not break down easily in the environment and have been found to accumulate overtime, resulting in contamination of air, water, soil, and wildlife. Exposure to certain PFAS compounds have been associated with serious health effects such as cancer, developmental issues, liver damage, and immune system suppression.

Because of these concerns, many government and regulatory agencies, such as the EPA and Food & Drug Administration (FDA) have taken steps in order to limit or regulate the use of PFAS in products. The FDA has been working to better understand PFAS in food through testing of the general food supply, and even work with manufacturers to resolve issues with high levels of PFAS in foods. This testing and regulation has led to two firms voluntarily recalling their products that were found to have levels of PFAS which were determined to be health concerning.

Rule history: TSCA section 8(a)(7)

The TSCA regulates the manufacture, use, and distribution of chemical to protect human health and the environment. TSCA Section 8(a)(7) mandates EPA to promulgate a rule in order to collect various types of information on chemical substances, like PFAS, including:

• Production Volume: Companies are required to report the total quantity of each substance or mixture produced, imported, and distributed into commerce.
• Use and Exposure Information: All information concerning uses of the chemical, potential exposure to humans and environment, and any other-exposure related data, such as number of individuals exposed and who are reasonably estimated to gain exposure.
• Health and Safety Data: Details on potential health and safety effects of each substance or mixture, including any known health studies and information on risk management practices.
• Chemical Identity: Detailed chemical identity information, including molecular formula and structural formula of each substance or mixture.
• Recordkeeping: Companies subject to these reporting requirements are required to maintain records of the data collected.
• Disposal: manner or method of disposal of each substance or mixture, or the byproducts resulting from disposal.

Recordkeeping requirements

Each person subject to reporting requirements must retain records that document any information reported to the EPA for five years from the last date of the information submission period. The five-year rule is correspondent with statute of limitations for violations and required to support future regulatory activities.

Entities who may be subject to this action include companies throughout the construction, manufacturing, wholesale trade, retail trade, and waste management & remediation services industries. Additionally, those who could potentially be regulated by this action specifically are those who have, since January 1, 2011, manufactured (or imported) PFAS for commercial purposes.

Comprehensive approaches to combat PFAS pollution

Eight agencies, including the EPA, have taken steps toward addressing and preventing harm PFAS pollutants being released in the air, drinking systems, and food supply. The Department of Defense (DOD) has initiated and is expected to complete cleanup assessments at DOD sites throughout the country. As previously mentioned, the FDA has significantly advanced its work to estimate dietary exposure to PFAS from food and have has offered support to states when there are suspect areas of PFAS contamination that can impact food supply. Further, the Department of Agriculture (USDA), Department of Homeland Security (DHS) and Department of Health and Human Services have conducted extensive research and review to prevent and address PFAS contamination.

Moreover, Maine and Minnesota are the leaders in states passing expansive reporting requirements and state-wide ban in all products containing PFAS. Beginning January 1, 2032, Minnesota’s legislation will prohibit offer, sale, or distribution in the state of any product with “intentionally added” PFAS, only excluding products in which the use of such chemicals can be determined to be “unavoidable”.

PFAS pollution control is a complex and ongoing challenge, requiring a multi-faceted approach involving government regulations, technological innovation, and public awareness. Further actions toward banning and eliminating these “Forever Chemicals” in products are important to protect both the environment and public health.