Regulatory Relief for Certain Stationary Sources To Promote American Security With Respect to Sterile Medical Equipment
1. Purpose
This proclamation addresses the enforcement of emissions standards for ethylene oxide in sterilization facilities, emphasizing the need for an exemption due to national security concerns and the lack of commercially viable compliance technology.
2. Key Actions And Directives
- Proclamation of Exemption: Exempt certain stationary sterilization facilities from compliance with the EPA's EtO Rule for a period of 2 years.
- Maintain Prior Compliance Obligations: Exempted facilities must continue to adhere to emissions and compliance obligations that were in effect prior to the EtO Rule.
3. Important Points
- Critical Role of Ethylene Oxide: Ethylene oxide is essential for the sterilization of medical equipment, ensuring patient safety and preventing infection.
- EPA's EtO Rule Background: The EPA's EtO Rule imposes stringent emissions-control requirements on sterilization facilities, which could threaten the availability of vital medical devices.
- National Security Considerations: The President's proclamation focuses on how compliance with the EtO Rule could impact the supply chain of sterile medical supplies crucial for healthcare.
- Exemption Duration: The proclamation grants a 2-year exemption from the EtO Rule for affected facilities, recognizing the non-viability of compliance technology.
- Legal Authority and Implications: Signed by President Donald J. Trump on July 17, 2025, the proclamation reflects a balance between environmental standards and urgent national security needs.
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