On May 5, 2025, the U.S. Environmental Protection Agency (EPA) Environmental Appeals Board (EAB) issued a consent agreement and final order between EPA and Cytonix, LLC (Cytonix). According to the consent agreement, in 2022, EPA inspectors discovered Cytonix’s potential noncompliance with requirements under Section 5 of the Toxic Substances Control Act (TSCA) for a manufactured chemical substance consisting of short-chain polyfluorinated materials (Chemical A) that was developed as a replacement for a chemical substance containing long-chain (C8) perfluorinated alkyl groups. In 2024, EPA identified potential TSCA Section 5 violations for manufacturing Chemical A prior to submitting a premanufacture notice (PMN) or a low volume exemption (LVE) application. According to Cytonix, it mistakenly believed Chemical A was included on the TSCA Inventory at the time of manufacture. As soon as Cytonix learned of the illegal manufacture, it immediately ceased manufacture and quarantined all of its existing stocks of Chemical A. Cytonix does not intend to process or use the quarantined existing stocks of Chemical A but seeks only to dispose of them under the terms of the consent agreement. Cytonix neither admitted nor denied the specific factual allegations. Cytonix agreed to pay a civil penalty of $190,525 for the alleged violations. The terms of settlement state that:
- As a condition of the consent agreement, Cytonix shall consult the Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances-Version 2 (2024) for analyzing disposal options of quarantined existing stocks of Chemical A that minimize potential environmental releases;
- If Cytonix chooses to dispose of the existing quarantined stocks of Chemical A, Cytonix shall dispose of any unused portion of its existing stocks in accordance with applicable federal and state requirements. Cytonix should coordinate with the applicable state(s) where disposal may occur to determine if additional requirements or a preferred approach (e.g., incineration) should be considered before disposing of Chemical A; and
- Cytonix shall submit documentation showing compliance with these terms of settlement within 30 days of disposal of all existing quarantined stocks of Chemical A containing PFAS and specify the disposal method used.
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