Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment – The White House

By the President of the United States of America

A Proclamation

1. Ethylene oxide plays a vital role in the sterilization of medical equipment, serving as a safeguard against infections and the spread of disease. Its ongoing use in commercial sterilization facilities is crucial for delivering optimal care to the sick and injured—an essential duty of the Federal Government towards the American populace.
2. On April 5, 2024, the Environmental Protection Agency (EPA) released a final regulation 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, 89 FR 24090 (EtO Rule). This regulation introduces stringent emissions-control mandates for commercial sterilization facilities.
3. The EtO Rule imposes significant challenges on these facilities. Approximately 50% of sterile medical devices in the U.S. are sterilized using ethylene oxide, which is often the sole method available that does not compromise the integrity of certain medical devices. By mandating compliance with standards based on emissions-control technologies that are not commercially viable, the EtO Rule jeopardizes the availability of critical sterile medical devices necessary for patient care within both civilian and military medical systems. The current compliance deadlines outlined at 89 FR 24101-24103 of the EtO Rule are likely to force many existing sterilization facilities to shut down, leading to a severe disruption in the supply of medical equipment. The nation would struggle to provide adequate sterilized medical supplies for healthcare professionals tasked with safely treating patients in hospitals, operating rooms, and other medical settings. In essence, the existing compliance timeline poses a risk to our national security.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by the authority vested in me by the Constitution and the laws of the United States, including section 112(i)(4) of the Clean Air Act, 42 U.S.C. 7412(i)(4), hereby proclaim that certain stationary sources subject to the EtO Rule, as specified in Annex I of this proclamation, are exempt from compliance with the EtO Rule for a period of two years beyond the established compliance deadlines (the Exemption). This Exemption extends all compliance deadlines set by the EtO Rule applicable to the stationary sources listed in Annex I by two years from their original due dates. Consequently, during this two-year exemption period, these stationary sources will continue to adhere to the emissions and compliance obligations that were in effect prior to the EtO Rule’s issuance. In support of this Exemption, I make the following determinations:

The technology required to implement the EtO Rule is currently unavailable. Such technology does not exist in a commercially viable form that would allow for compliance with the EtO Rule by the deadlines specified therein.

Issuing this Exemption serves the national security interests of the United States for the reasons articulated in paragraphs 1 and 3 of this proclamation.

IN WITNESS WHEREOF, I have hereunto set my hand this
seventeenth day of July, in the year of our Lord two thousand twenty-five, and of the Independence of the United States of America the two hundred and fiftieth.

                               DONALD J. TRUMP

ANNEX I
     1. International Sterilization Laboratory
           i. Affected Facility/Source: Groveland Facility, Florida

1. Becton Dickinson and Company

   1. Affected Facility/Source:

      1. BD Covington, Georgia
      2. BD Madison, Georgia
      3. BD Medical, Utah
      4. BD Medical Pharmaceutical Systems, Nebraska
      5. Edwards Lifesciences Technology Sàrl, Puerto Rico

  3. KPR US, LLC d/b/a Kendall Patient Recovery 
              i. Affected Facility/Source: Augusta Facility, Georgia 

1. MedXL, LLC

   1. Affected Facility/Source: Ardmore Facility, Oklahoma

1. Aligned Medical Solutions

   1. Affected Facility/Source:

      1. 1602 4th Ave. Facility, Billings, Montana
      2. 1400 Montana Ave. Facility, Billings, Montana

1. Professional Contract Sterilization, Inc.

   1. Affected Facility/Source: Taunton Facility, Massachusetts

1. Sterigenics U.S., LLC

   1. Affected Facility/Source:

      1. Atlanta Facility, Georgia
      2. Charlotte Facility, North Carolina 
      3. Grand Prairie Facility, Texas
      4. 4900 S Gifford Ave. Facility, Los Angeles, California
      5. 4801-63 E 50th St. Facility, Los Angeles, California
      6. Ontario Facility, California
      7. Queensbury Facility, New York
      8. Salt Lake City Facility, Utah
      9. Santa Teresa Facility, New Mexico

1. Cosmed Group, Inc.

   1. Affected Facility/Source:

      1. Erie Facility, Pennsylvania
      2. Franklin Facility, New Jersey
      3. Linden Facility, New Jersey

1. Arthrex

   1. Affected Facility/Source: Ave Maria Facilities (2), Florida

1. Cook Incorporated

   1. Affected Facility/Source: Ellettsville North Facility, Indiana

2. ALCON Research Ltd.

   1. Affected Facility/Source: ALCON Advance Optic Device Center, North Facility, West Virginia

1. B. Braun U.S. Device Manufacturing LLC

   1. Affected Facility/Source: Allentown Manufacturing Facility, Pennsylvania

1. DeRoyal Industries, Inc.

   1. Affected Facility/Source:

      1. 1135 Highway 33 South, New Tazewell, Tennessee
      2. 1211 Highway 33 South, New Tazewell, Tennessee

1. Sterilization Services of Georgia, Inc.

   1. Affected Facility/Source: Atlanta Facility, Georgia

1. Sterilization Services of Virginia, Inc.

   1. Affected Facility/Source: Richmond Facility, Virginia

1. Trinity Sterile, Inc.

   1. Affected Facility/Source: Trinity Sterile, Inc., Maryland

1. LivaNova USA, Inc.

   1. Affected Facility/Source: LivaNova Arvada Facility, Colorado

1. Covidien LP

   1. Affected Facility/Source: Covidien North Haven Facility, Connecticut

1. Medtronic Xomed LLC

   1. Affected Facility/Source: Jacksonville Facility, Florida

1. Medtronic Puerto Rico Operations Company, Inc.

   1. Affected Facility/Source:

      1. Villalba Facility, Puerto Rico
      2. Juncos Facility, Puerto Rico

1. Advanced Product Solutions

   1. Affected Facility/Source: Columbia Facility, Alabama

Affected Facility/Source: Salinas, Puerto Rico

Steri-Tech, Inc.