In October 2023, the U.S. Environmental Protection Agency (“EPA”) released a final rule imposing a one-time reporting requirement that will require certain companies to assess their supply chain to determine if they have manufactured or imported per- and polyfluoroalkyl substances (“PFAS”) or imported any articles containing PFAS dating back to 2011. This PFAS Reporting Rule is just the latest regulatory development related to PFAS, which are a group of thousands of synthetic chemicals that have been widely used in consumer products (e.g., cookware, clothing, carpets, cosmetics, etc.) along with many aspects of the aerospace, automotive, construction, and electronics industries. Due to their chemistry, PFAS do not break down in the environment and are widely present in the natural environment, which has prompted growing regulatory scrutiny. EPA developed this PFAS Reporting Rule pursuant to the National Defense Authorization Act (2020) in an effort to collect additional information regarding the presence of PFAS in the U.S. marketplace.
Who must comply?
The PFAS Reporting Rule applies to anyone who has “manufactured for a commercial purpose” a PFAS chemical. Notably, this includes coincidental manufacture of PFAS as byproducts or impurities, as well as importing PFAS chemicals or PFAS-containing articles. The domestic manufacturing of PFAS-containing articles from domestically-sourced PFAS is not covered by the PFAS Reporting Rule.
For purposes of the PFAS Reporting Rule, EPA defines “PFAS” as: “any 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″.” EPA is providing a list of substances that meet this definition, which is available at https://comptox.epa.gov/dashboard. However, any substance that meets the structural definition in the PFAS Reporting Rule is covered, even if not on that specific list. There is no threshold quantity or percentage.
What will companies have to do?
Companies will need to undergo a certain amount of diligence to determine if the PFAS Reporting Rule applies to them. Information to be reported will include PFAS uses, production volumes, byproducts, disposal, exposures and existing information on environmental or health effects. The inquiry standard is intended to vary based on the size of the company and the complexity of its supply chain. While the inquiry is intended to be reasonable, it does focus on the full scope of the organization, not just the information known to managerial or supervisory employees. EPA has made clear that there is no obligation to conduct new testing to determine the presence of PFAS. Additionally, EPA does not expect companies to conduct surveys – where identical questions are sent to a group of customers and/or suppliers – in order to satisfy this rule. The focus is on existing information that a company has or can reasonably obtain. However, some level of inquiry is required. EPA provides the following examples of the type of information that could be considered to fall within this diligence standard:
- Files maintained by the manufacturer, such as marketing studies, sales reports, or customer surveys
- Information contained in standard references, such as a safety data sheet (SDS) or a supplier notification
- Information from the Chemical Abstracts Service (CAS) and from Dun & Bradstreet D-U-N-S®.
Although not required, companies are advised to document diligence efforts to demonstrate compliance – both with respect to information obtained (and reported) and any unsuccessful efforts to obtain information. Documentation should also be maintained related to the various internal and external stakeholders contacted – again, to support the appropriateness of the diligence undertaking. Noncompliance will bring possible penalties up to $46,989 per violation per the underlying statute, the Toxic Substances and Control Act (“TSCA”).
Reports will be due to EPA by May 8, 2025 (though reports can start being submitted on November 12, 2024). The reporting tool is currently under development, but is likely to look similar to the existing TSCA Chemical Data Reporting tool. EPA has issued instructions for reporting and small entity compliance guidance. An FAQ resource is expected from the Agency sometime this summer.
Key Takeaways
This PFAS Reporting Rule is expected to have a much wider reach and impact companies that traditionally have not been subject to TSCA chemical reporting requirements, since the rule does not have any de minimis thresholds and since the rule includes imported PFAS-containing articles. While the rule does not require testing or supplier surveys, the diligence obligation has the potential to be significant and companies are well advised to prepare early for the 2025 reporting deadline and document those efforts.
