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EPA Likely to Deny Pending and New LVE Submissions for PFAS
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 27, 2021, “important policy shifts in its review of new [per-and polyfluoroalkyl substances (PFAS)] before they can enter the market.”  According to EPA, although some new PFAS have been allowed to enter the market through low volume exemptions (LVE), EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS.  EPA states that due to the scientific complexities associated with assessing PFAS, and the hazard potential associated with various sub-classes of PFAS, “it is challenging to conduct an appropriately robust review of LVE requests for PFAS in the 30 days the regulations allow.”  Under the regulations, EPA can deny LVE requests if it finds the chemical may cause serious human health effects or significant environmental effects or when issues concerning toxicity or exposure require review that cannot be completed in 30 days.  According to EPA, “[g]iven the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE submission for a PFAS is unlikely to be eligible for this kind of exemption under the regulations.”  While EPA will consider each LVE application individually, it “generally expects” that it will deny pending and new LVE submissions for PFAS.  This will allow EPA more time to conduct a more thorough review and, as appropriate, “put measures in place to mitigate the potential risk of these chemicals as the agency determines whether to allow them to enter commerce.”  EPA states that in addition, it is “exploring ways to work cooperatively with companies to voluntarily withdraw previously granted LVEs.”  EPA states that this “would build upon a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that existed at the time.”