29 Aug 2024

The EPA's new rule demands detailed PFAS reporting from November 13, 2023

Have you heard the news?

The United States Environmental Protection Agency (EPA) has finalized a new rule on reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS), effective 13 November 2023.   

PFAS have been popular globally due to their wide variety of uses and can be found in several consumer products such as cell phones, nonstick cookware, and stain‑resistant carpeting. Recently, PFAS have been labelled as “forever chemicals” due to their inability to break down easily in the body or the environment, causing concern from government protection agencies. This new rule would aid the EPA in crafting possible risk management strategies to safeguard communities from PFAS contamination.

The PFAS rule

The rule imposes one-time reporting requirements on manufacturers and importers of PFAS at any point since 01 January 2011 to 31 December 2022. There is a one-year data collection period, followed by a 6‑month reporting period. Data are due to the EPA within 18 months from the effective date of the rule (08 May 2025), or within 2 years (10 November 2025) for small businesses that solely import articles containing PFAS.

The EPA formed its own definition of PFAS in order to capture a wider range of substances. In addition to PFAS substances found on the Toxic Substances Control Act (TSCA) Inventory, any substance that meets the following definitions would also be reported:

  • R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons.
  • R-CF2 OCF2 -R′, where R and R′ can either be F, O, or saturated carbons.
  • CF3 C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.

Extensive information is required by this rule; effected entities would need to report the uses, production volumes, chemical identity, byproducts, worker exposures, disposal, and any existing information on environmental or health effects of their PFAS product.

What does this mean for your business?

If you have manufactured or imported PFAS for a commercial purpose at any point during 2011 to 2022, then this rule applies to you. Typical exemptions observed with other TSCA notifications, such as impurities, articles, and low volume exemptions, are not applicable here. So, not only are PFAS chemical manufacturers impacted, but those also who manufacture or import many consumer products will need to evaluate if they need to report. To ease reporting burdens, the EPA has made available a streamlined option only for those importing articles or manufacturing research and development substances under 10 kg.  

If you do not have concrete knowledge of the required reporting information after completing your due diligence, the EPA allows you to claim some data elements as “not known or reasonably ascertainable.” This means that the EPA expects you to conduct a reasonable inquiry within the scope of your business, which may require you to consult with business personnel, researchers, or your supply chain.

You may think that the 2025 deadline is far away, but it is critical to understand your reporting obligations under the rule. As such, compliance efforts should be taken as soon as possible to ensure timely submission of reports and resolution of any issues that may arise. 

Need assistance?                                                          

The new PFAS reporting rule will require extensive amounts of data and time from your business. If you need assistance or have questions about this topic or a related topic, contact our experts at Intertek Assuris – we’re here to help!

References

40 CFR 705

NIEHS Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) https://www.niehs.nih.gov/health/topics/agents/pfc/

Sarah Zupko
Sarah Zupko

Scientific & Regulatory Affairs Associate 1, Chemicals Group, Intertek Assuris

 

As part of the Notifications Team in the Chemicals Group, Sarah’s primary role is assisting clients in maintaining compliance with the relevant chemical regulations in the United States. Sarah is involved in preparing dossiers for submissions under Section 5 of the TSCA, interpreting and staying up to date on regulations related to VOCs and PFAS, and reviewing toxicological study reports.

Sarah attended the University of Guelph, where she received an Honours B.Sc. in Biomedical Toxicology.

 

You may be interested in...