On April 5, 2024, the U.S. Environmental Protection Agency (EPA) published the National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review (2024 Final Rule). The 2024 Final Rule revised the Commercial Sterilization Facilities NESHAP based on a residual risk and technology review (RTR) pursuant to the Clean Air Act (CAA) sections. On March 12, 2025, the EPA announced that it was reconsidering the 2024 Final Rule. Based on its reconsideration of the RTR in the 2024 Final Rule, the EPA is proposing to amend the Commercial Sterilization Facilities NESHAP. The amendments would rescind the risk based standards, revise the standard for new aeration room vents that resulted from the technology review, revise the compliance demonstration requirements, and rescind a requirement related to permanent total enclosure (PTE). This proposal also includes technical corrections and clarifications to the Commercial Sterilization Facilities NESHAP and Performance Specification 19 to address erroneous cross-references, omissions of text, and typographical errors in the regulatory text that the EPA has identified after publication of the 2024 Final Rule.
DATES:
Comments must be received on or before May 1, 2026. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before April 16, 2026.
Public hearing: The EPA will hold a virtual public hearing on April 1, 2026. Please refer to the SUPPLEMENTARY INFORMATION section for information on registering for the public hearing.
