Encouraging Exemptions for Specific Static Energy Sources to Enhance Domestic Safety in Regard to Sterilized Medical Apparatus
The status of the 2024 ethylene oxide emissions standards for sterilization facilities in the United States has undergone a significant change following a proclamation issued by President Donald J. Trump in July 2025. This proclamation extends the compliance deadlines for certain facilities by two years, pushing back the implementation of the new emissions standards until April 2028[1][3].
The proclamation grants exemptions to "certain stationary sources," primarily those engaged in the sterilization of medical devices using ethylene oxide. While the specific names of the exempted facilities are not detailed in publicly available information, the exemptions were granted due to concerns about the lack of commercially viable technology to comply with the new standards and the potential for significant financial burdens and facility closures[1][2][3].
The broader context includes exemptions for other industrial facilities, such as chemical makers and coal-fired power plants, which were also granted waivers due to similar concerns about compliance costs and technological availability[2]. However, the exact list of sterilization facilities benefiting from the delay remains undisclosed in the provided documents[2].
Some of the companies known to have facilities affected by the rule include Advanced Product Solutions, Medtronic, DeRoyal Industries, Inc., KPR US, LLC d/b/a Kendall Patient Recovery, Sterigenics U.S., LLC, ALCON Research Ltd., Steri-Tech, Inc., Sterilization Services of Virginia, Inc., Medour X (Twitter) profile L, LLC, Aligned Medical Solutions, B. Braun U.S. Device Manufacturing LLC, Cook Incorporated, Covidien LPA, Sterilization Services of Georgia, Inc., Arthrex, Medtronic Puerto Rico Operations Company, Inc., Becton Dickinson and Company, and LivaNova USA, Inc.[1]
The proclamation was issued to ensure the best possible outcomes for patients in the Nation's medical system, as the new rule places severe burdens on commercial sterilization facilities, risking the unavailability of critical sterile medical devices[1]. Cosmed Group, Inc. and Trinity Sterile, Inc. are among the other companies with affected facilities[1].
The rule, titled National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, was published by the Environmental Protection Agency on April 5, 2024[1]. The proclamation was issued in the national security interests of the United States.
[1] "President Trump Issues Proclamation Delaying Ethylene Oxide Emissions Standards for Sterilization Facilities." White House, 17 July 2025. Web. 20 July 2025. [2] "Trump Administration Extends Deadline for Ethylene Oxide Emissions Standards for Sterilization Facilities." Environmental Protection Agency, 17 July 2025. Web. 20 July 2025. [3] "Ethylene Oxide Emissions Standards for Sterilization Facilities: Overview and Legal Context." Congressional Research Service, 15 July 2025. Web. 20 July 2025.
- The proclamation, issued in 2025 by President Donald J. Trump, extended compliance deadlines for certain sterilization facilities that use ethylene oxide, due to concerns about the lack of commercially viable technology and potential financial burdens.
- The exemptions were granted to specific stationary sources in the technology-driven industry, including chemical makers, coal-fired power plants, and various sterilization facilities.
- The rule, which was published by the Environmental Protection Agency in 2024, aims to reduce toxic emissions from these facilities to protect public health and the environment, in line with the principles of both science and environmental-science.
- The medical-conditions industry is impacted by the delay, as the compliance burden may interfere with the availability of sterile medical devices, crucial for health-and-wellness.
- The financial considerations related to this rule and its implications for the energy sector are significant, due to potential industry-wide facility closures and the investment needed for commercially viable technology.
