Today, in support of the Biden-Harris Administration’s commitment to tackling pollution from Per-and Polyfluoroalkyl Substances (PFAS) and protecting human health and the environment, the U.S. Environmental Protection Agency (EPA) is announcing important policy shifts in its review of new PFAS before they can enter the market.
Historically, some new PFAS have been allowed to enter the market through low volume exemptions (LVEs). EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS to protect all Americans and the environment from the potentially harmful effects of these chemicals.
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. The regulations provide for the denial of LVE requests when EPA finds the chemical in question may cause serious human health effects or significant environmental effects, or when issues concerning toxicity or exposure require review that can’t be completed in 30 days.
Given 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, the agency generally expects that pending and new LVE submissions for PFAS would be denied. Doing this will allow the agency additional time to conduct a more thorough review through the pre-manufacture notice review process 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.
Additionally, EPA is exploring ways to work cooperatively with companies to voluntarily withdraw previously granted LVEs. 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.
Last month, EPA also announced important changes in the way the agency reviews and make determinations on new chemicals submissions to better align with TSCA, including using consent orders, when appropriate, to address any unreasonable risks. These policy shifts apply to all pending and new PMNs and significant new use notices, including those that involve PFAS.
These policy changes will ensure that if new PFAS are allowed to enter commerce, EPA will have reviewed all intended, known, and reasonably foreseen conditions of use and that these chemicals will not enter commerce absent appropriate and enforceable protections for human health, including that of workers, and the environment.