Delay in implementing stricter regulations on ethylene oxide emissions from device sterilizers instituted by Trump
The implementation of stricter emissions standards for medical device sterilizers, originally set to begin in April 2026, has been delayed by two years due to a proclamation issued by President Donald Trump in 2025. This decision extends the compliance deadline to April 2028.
The Environmental Protection Agency (EPA) finalized the new standards last year in response to its 2016 determination that ethylene oxide (EtO) is carcinogenic. The rule aims to cut EtO emissions by 90%, enforce continuous leak monitoring, and apply new controls to reduce cancer risks associated with EtO exposure in communities near sterilization facilities.
The delay was justified due to concerns over severe burdens on sterilization facilities, potential closures, and disruptions to the medical supply chain. Approximately half of all U.S. medical devices are sterilized using EtO daily, amounting to around 50 million devices. Facilities in multiple states, including Georgia and Southeast Los Angeles, may be impacted, with some already involved in lawsuits due to health concerns from long-term EtO exposure.
However, the EPA and environmental health advocates oppose the delay, emphasizing the known carcinogenic properties of EtO, linked to lymphoma, leukemia, and other cancers. They argue that delaying emissions reductions risks prolonging harmful community exposure.
Industry groups, such as AdvaMed, generally support the delay, citing the need for more time to adapt to the new regulations without disrupting the sterilized medical device supply chain. Georgia's Environmental Protection Division ordered BD to pause sterilization in 2019 after a facility experienced an eight-day valve leak.
Here's a summary of the original EPA rule and its current status post-delay:
| Aspect | Original EPA Rule (2024) | Current Status Post-Delay | |----------------------------|--------------------------------------|----------------------------------------| | Compliance Deadline | April 2026 | Extended to April 2028 | | Emissions Reduction Goal| 90% reduction in EtO emissions | Same rule, implementation delayed | | Scope | Continuous leak monitoring, new controls| Same, delayed | | Reason for Delay | Avoid supply chain disruptions, facility closures | Same | | Stakeholder Views | EPA & health advocates oppose delay | Industry supports delay | | Impacted Locations | Nationwide, including Georgia and SE LA | Same |
As of late July 2025, the emissions standards remain legally in place, but medical sterilization facilities have a two-year extension to meet the stricter limits, delaying the expected public health benefits. The EPA, under the second Trump administration, plans to reconsider the emissions standards for medical device sterilization facilities.
- The EPA's new analytical findings on the carcinogenic properties of ethylene oxide (EtO) led to the regulation of medical device sterilizers in 2016.
- The medtech industry and various state environmental divisions are grappling with the use of EtO for device sterilization, as facilities in multiple locations face legal challenges.
- The implementation of stricter emissions standards for medical device sterilizers, initially set to commence in April 2026, has been postponed to April 2028 due to industry concerns.
- The ongoing debate between the EPA, environmental health advocates, and industry groups involves the risks of prolonged community exposure to EtO versus disrupting the medical device supply chain.
- In the realm of science, research continues to explore the environmental impact of EtO emissions in relation to climate-change and public health issues.
- As the delay in emissions reductions continues, policymakers in the executive branch and FDA are scrutinizing the financial implications of this decision on the medtech industry, energy sector, and investing opportunities.
- Beyond the medical industry, this delay raises questions about the broader environmental-science principles that guide regulations aimed at protecting public health and the environment.
