in effect
This is a presidential proclamation (Proclamation 10959, signed July 17, 2025) that grants a two-year compliance exemption to certain commercial ethylene oxide sterilization facilities, delaying their obligation to meet the EPA’s 2024 emissions standards. It is issued under the President’s authority in Section 112(i)(4) of the Clean Air Act.
The EPA finalized the Ethylene Oxide Emissions Standards for Sterilization Facilities rule on April 5, 2024 (89 FR 24090), which set new emissions-control requirements with specific compliance deadlines. This proclamation pushes every one of those deadlines back by exactly two years for the facilities named in Annex I. During that two-year window, the listed facilities remain governed by the emissions and compliance rules that were in place before the 2024 EPA rule took effect — meaning the stricter new standards do not yet apply to them. The President’s stated grounds for the exemption are that the required control technology does not currently exist in commercially viable form and that disruption to sterilization capacity poses a national security risk.
Commercial sterilization facilities specifically listed in Annex I of the proclamation gain the extra two years and avoid immediate compliance costs or potential closure under the tighter standards. Medical device manufacturers, hospitals, and other healthcare providers that rely on ethylene-oxide-sterilized equipment are indirectly affected, as the exemption is intended to keep the supply of those products from being interrupted. Residents living near the listed facilities remain exposed to emissions at pre-2024 rule levels for the duration of the exemption period, rather than benefiting from the reductions the 2024 rule was designed to achieve on its original schedule.