Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment

This proclamation exempts certain commercial sterilization facilities identified in Annex I from compliance with the EPA's April 5, 2024 final rule on ethylene oxide emissions standards (89 FR 24090), extending each compliance deadline under that rule by 2 years, pursuant to section 112(i)(4) of the Clean Air Act. During each 2-year extension, the listed facilities remain subject to the emissions and compliance obligations in effect before the rule's issuance. The President determines that the technology required to implement the rule is not commercially available and that the exemption is in the national security interests of the United States.

• Environmental Protection Agency
• Executive Office of the President (for interagency coordination and national-security determinations)
• Department of Health and Human Services (oversight of medical device supply chains)
• Department of Defense (reliance on sterile equipment for military medical facilities)

Upon signing; 30 days post signing; by EtO deadline + 2 years; by each extended deadline.

July 17, 2025: Proclamation signed; two-year exemption periods for all EtO compliance deadlines take effect immediately. By August 16, 2025 (30 days post-signing): EPA issues guidance to Annex I facilities detailing their extended deadlines and reaffirming the pre-rule EtO standards they must follow during the exemption period. Each original EtO compliance deadline + 2 years: Affected facilities continue operating under the prior EtO standards until their respective extended deadline. By each extended deadline: Facilities must fully implement and comply with the EtO Rule’s new emissions requirements.

No known legal challenges.