The Environmental Protection Agency announced Dec. 4 finalized amendments on the regulation of new chemicals under the Toxic Substances Control Act (TSCA).
Specifically, the EPA targeted stricter regulations of certain exemptions under the TCSA for PFAS and PBT chemicals. As our blog has previously reported, the challenges surrounding the manufacturing of PFAS and PFAS PBT chemicals continue to steadily increase.
The EPA through the TCSA review program acts as a “gatekeeper” for the manufacture of “new chemicals” (i.e. chemicals not presently listed in the TCSA Inventory). As part of the review program, manufacturers can produce new chemicals without the rigors of a full Pre-Manufacturer Notice (PMN) or other TCSA requirements under several exemptions.
Two significant exemptions are the Low Volume Exemption (LVE) and Low Release and Exposure Exemption (LoREX). The LVE exemption applies to the manufacture of certain new chemicals that are produced at a low volume (10,000 kg/year). While the LRVE exemption applies to manufacturers that produce and dispose of chemicals in ways that minimize exposure risks to the public, workers, and the environment.
Previously, under the LRVE and LoREX exemptions, manufacturers could begin production of new chemicals if the EPA failed to act after the 30-day review period expired. Now, under the new amendments, the EPA must notify a manufacturer that their LRVE or LoREX exemption has been approved before production can begin. This presents challenges for manufacturers who previously benefited from this short review period. Significantly, PFAS are now categorically ineligible for the LVE and LoREX exemptions along with certain PBTs. In addition, manufacturers must submit a PMN 90 days before the production of any PFAS. The EPA, however, will work to fast track the review process where a new PFAS (or new use of an existing one) is “needed by a federal agency to meet its mission or is required in order to meet another critical need.” This will be determined on a case-by-case basis.
While it remains unclear precisely what could qualify as a “critical need,” the EPA emphasizes that new chemicals, particularly PFAS, can play “a critical role” in the manufacture of semiconductors specifically.
The EPA also cautions that the new exemption rules are not a result of EPA findings, that PFAS “may present unreasonable risks of injury to human health or the environment under the conditions of use due to levels of hazards and exposures identified and evaluated by EPA.” Rather, the EPA explains that these amendments stem from their experience reviewing PFAS for these exemptions, overall finding the 30-day review period insufficient to review PFAS due to their complexity and lack of data. Last, for PFAS that were previously granted these exemptions, the EPA has stated that they will be assessed on a “case by case basis.”
A copy of the announcement by the EPA can be found here. A full copy of the amendments can be found here. The final amendments will be in effect 30 days after publication in the Federal Register. The most current copy of the Federal Register, specifically filtered for results by the Environmental Protection Agency can be found here.
Additionally, instructions for how to subscribe to specific updates can be found here. As these finalized amendments have not been published, it remains unclear the possible impact that the incoming administration will have on these stricter regulations.
