Trump Gives Medical Device Sterilizers Two More Years to Comply with EtO Limits
President Donald Trump issued an executive order granting a two-year extension for medical device sterilization facilities to comply with the new limits for ethylene oxide (EtO).
President Donald Trump issued an executive order on July 17 granting a two-year extension for medical device sterilization facilities to comply with new limits for ethylene oxide emissions.
The action affects 39 specifically named facilities and reflects the administration's position that required emissions-control technology is not commercially viable.
The order extends compliance deadlines for facilities listed in Annex I by two years beyond the EPA rule's original requirements. During the extension period, these facilities will remain subject to the emissions and compliance obligations that were in effect before the EPA's EtO rule.
Quick background on the EPA's EtO rule
In March 2024, the Environmental Protection Agency issued a final rule updating National Emission Standards for Hazardous Air Pollutants for commercial sterilization facilities.
The rule was designed to reduce EtO emissions by more than 90% through installation of air pollution controls.
The EPA rule affects nearly 90 commercial sterilizer facilities operated by approximately 50 companies nationwide. It established new standards for building leaks, chamber exhaust vents, and requires continuous emissions monitoring and quarterly reporting.
The Trump Administration's rationale
The executive order states that the EtO rule "places severe burdens on commercial sterilization facilities" and risks making critical sterile medical devices unavailable.
It cites two specific determinations:
"The technology to implement the EtO Rule is not available. Such technology does not exist in a commercially viable form sufficient to allow implementation of and compliance with the EtO Rule by the compliance dates."
The exemption is "in the national security interests of the United States."
The proclamation emphasizes that about 50% of all sterile medical devices in the United States are sterilized with ethylene oxide, and sterilization with EtO may be the only method of sterilizing many medical devices without damaging them.
Industry and FDA concerns
Industry concerns about the EPA rule have been longstanding. During the rulemaking process, medical device trade groups warned about potential supply chain disruptions and implementation challenges.
FDA officials have also expressed concerns about potential device shortages.
At a Food and Drug Law Institute meeting in May 2024, Ryan Ortega from FDA's Center for Device and Radiological Health warned that rural and vulnerable populations could be at risk due to new EtO limits. He specifically cited the 2019 closure of the Sterigenics facility in Willowbrook, Illinois, which resulted in temporary shortages of tracheostomy tubes that significantly impacted the neonatal population.
Affected facilities
The order specifically names facilities operated by major medical device companies, including:
Becton Dickinson (facilities in Georgia, Utah, Nebraska, and Puerto Rico)
Sterigenics U.S., LLC (eight facilities across multiple states)
Medtronic companies (facilities in Florida and Puerto Rico)
Cosmed Group (facilities in Pennsylvania and New Jersey)
Cook Incorporated (Indiana facility)
Company response
Becton Dickinson, which has multiple facilities listed in the proclamation, expressed to RAPS support for the extension, stating that "some of the new provisions require new equipment that is manufactured by a limited number of manufacturers and may not be available in time to install and test before the original April 2026 deadline."
The company noted that following air monitoring conducted over several years, the Georgia Environmental Protection Division found that EtO levels measured near BD's Covington facilities were generally similar to concentrations recorded at background sites without known commercial sources of EtO, including a state park located 200 miles away.
Legal authority
The order invokes section 112(i)(4) of the Clean Air Act, which provides backstop authority allowing the President to grant compliance exemptions under specific circumstances.
The EPA had previously indicated that this presidential authority was available if necessary to protect the medical supply chain while facilities work in good faith to achieve compliance.
Looking forward
The two-year extension provides sterilization facilities additional time to develop and implement emissions-control technologies. However, it also delays the health protections that the EPA rule was designed to provide to communities near sterilization facilities.
The exemption applies only to the facilities specifically listed in Annex I of the proclamation. Other commercial sterilization facilities not named in the proclamation remain subject to the original EPA compliance timeline.
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