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As a result of the EPA Administrator’s March 12 announcement, EPA is proposing that the Biden-Harris Administration never had the statutory authority under the Clean Air Act (CAA) to conduct a second risk review of the EtO Commercial Sterilizers NESHAP. In line with Congressional intent, EPA’s proposal would remove the standards from the Biden-era review, and which justified the 2024 rule.
EPA is proposing amendments to several aspects of the rule in response to feedback from industry, including:
The removal of risk-based standards promulgated under CAA section 112(f)(2) for sterilizer chamber vents, aeration room vents, chamber exhaust vents, Group 1, and Group 2 room air emissions;
The reduction of emission limits, from 99.9 to 99.6 percent reduction, for new source aeration room vents at facilities where EtO use is 10 tons per year (tpy) or more; and
The removal of the continuous emission monitoring systems (CEMS) requirement as the only compliance method for facilities that use at least 100 pound per year (lb/yr) of EtO;
Instead, all facilities, regardless of the amount of EtO used, will be able to choose between CEMS and continuous parametric monitoring systems and performance testing.
The removal of the requirement for facilities to use permanent total enclosure to capture EtO to comply with the emission reduction standards.