The President of the United States, Donald J. Trump, has issued a proclamation regarding regulatory relief for certain stationary sources to promote American security in relation to sterile medical equipment. The proclamation addresses the critical role of ethylene oxide in sterilizing medical equipment, which is essential for protecting patients from infection and disease transmission.
On April 5, 2024, the Environmental Protection Agency (EPA) published a final rule under section 112 of the Clean Air Act titled "National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review." This rule introduces new emissions-control requirements on commercial sterilization facilities.
President Trump expressed concerns that the EtO Rule places severe burdens on these facilities, which are responsible for sterilizing about 50 percent of all sterile medical devices in the United States. He stated that compliance with standards based on emissions-control technologies that are not commercially viable could make critical sterile medical devices unavailable. This situation poses a risk to both civilian and military medical systems.
As a result, President Trump proclaimed an exemption from compliance with the EtO Rule for certain stationary sources identified in Annex I of the proclamation. This exemption extends compliance deadlines by two years beyond those originally set by the EtO Rule. During this period, affected facilities will adhere to previous emissions and compliance obligations.
The decision was made because technology necessary to implement the EtO Rule does not exist in a commercially viable form. The exemption is deemed necessary for national security interests as it ensures continued supply of essential sterilized medical equipment.
The affected facilities include International Sterilization Laboratory's Groveland Facility in Florida, KPR US LLC's Augusta Facility in Georgia, and Steri-Tech Inc.'s facility in Salinas, Puerto Rico.
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