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  2. Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

EPA Orders Issued to Inhance Technologies Related to Long-Chain PFAS Significant New Use Notices

On December 1, 2023, EPA issued orders to Inhance Technologies LLC directing it not to produce per-and-polyfluroakyl substances PFAS, chemicals that are created in the production of its fluorinated high-density polyethylene HDPE plastic containers.  This action, taken under the authority of the Toxic Substances Control Act TSCA, will help protect the public from exposure to dangerous PFAS chemicals in containers used for a variety of household consumer, pesticide, fuel, automotive and other industrial products.

In December 2022,  Inhance submitted significant new use notices SNUNS for nine long-chain PFAS. Upon review of the SNUNs  and consistent with EPA's  Framework for Addressing new PFAS and New Uses of PFAS, EPA has determined that three of the PFAS (Perfluorooctanoic acid PFOA, perfluorononanoic acid PFNA and perfluorodecanoic acid PFDA) are highly toxic and present unreasonable risks that cannot be prevented other than through prohibition of manufacture. Therefore, under TSCA Section 5(f), EPA is prohibiting the continued manufacture of PFOA, PFNA and PFDA that are produced from the fluorination of HDPE. 

EPA also determined that the remaining six of the nine PFAS chemicals manufactured by Inhance (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA) may present an unreasonable risk of injury to health or the environment and, under TSCA section 5(e), is requiring the company to cease manufacture of these chemicals, and to perform additional testing if it intends to restart production. However, Inhance’s current fluorination process for plastics produces all nine of the PFAS chemicals subject to these orders simultaneously, including PFOA, PFNA, and PFDA. Thus, the production of the other six PFAS could not restart so long as the fluorination process continues to produce PFOA, PFNA and PFDA. These orders are effective 02/28/2024.

Risk Assessment of the Per- and Polyfluoroalkyl Substances (PFAS) in SN-23-0002-0006 and SN-23-0008-0011 (pdf) (7.27 MB)

TSCA Section 5 Order for a Significant New Use of Certain Chemical Substances (PFOA, PFDA, PFNA) (pdf) (16.65 MB)

TSCA Section 5 Order for a Significant New Use of Certain Chemical Substances (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA) (pdf) (19.67 MB)

Note: Publicly available versions of the risk assessment and orders have confidential business information CBI removed. 

Consumer Schematic for the Nine Significant New Use Notice Substances

Image depicts potential consumer exposure pathways for this PFAS such as  inhalation of fuel combustion,  or fuel containers, migration to groundwater from landfill,  bioaccumulation, or fish ingestion

Based on the wide variety of potential uses of the plastic containers fluorinated by Inhance, this schematic does not represent all of the potential exposure pathways for the nine SNUN substances from the containers fluorinated by Inhance.

Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

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  • Filing a Premanufacture Notice with EPA
  • Regulatory Actions Under TSCA section 5
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Reviewing New Chemicals under TSCA Contact Us
Reviewing New Chemicals under TSCA Contact Us to ask a question, provide feedback, or report a problem.
Last updated on November 25, 2024
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