Yesterday, the EPA, through the Office of Pollution Prevention and Toxics, issued a statement that likely went well under the radar of many following PFAS developments. However, the impact of the new policy will have significant impacts on any company seeking ways to have PFAS enter the market through low volume exemptions (LVEs) under the Toxic Substances Control Act (TSCA). These PFAS exemptions eliminated by the EPA by yesterday’s policy shift may also have retroactive impacts, as the EPA is seeking to have companies that previously obtained PFAS LVEs voluntarily withdraw them. While on its surface the policy shift may seem insignificant, when considering the change in the context of the EPA considerably stepping up efforts to regulate PFAS, the news is yet another policy change that companies with any connection to or use of PFAS must pay attention to.
What Are LVEs?
The Toxic Substances Control Act permits certain categories of chemical substances to be exempt from full premanufacture notice (PMN) review – a thorough and significant review conducted by the EPA. The exemptions are granted to “low volume” chemicals based on whether the substances are manufactured at 10,000 kg per year or less. Companies applying for a LVE exemption will have their application considered and determined within 30 days, a significantly shortened window for review that benefits low-volume manufacturers. The EPA is obligated to perform a risk assessment for the substance for which a LVE exemption is sought. Substances that cannot be determined to pose any human health effects will not be granted a LVE exemption.
PFAS Exemptions Eliminated By EPA – What Is the Scope?
On April 27, 2021, the EPA’s Office of Pollution Prevention and Toxics issued a statement that for all intents and purposes eliminated PFAS from possible LVE exemptions moving forward. The announcement stated:
“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.”
Our prediction remains that in 2021, PFAS drinking water rules will be finalized at the federal level. Other regulations are likely during the Biden administration’s tenure, including air emissions, effluent, and disposal requirements. The elimination of PFAS exemptions from the LVEs is yet another step by the EPA towards a much more aggressive regulatory approach to PFAS than anything that we have seen before.