Following years of heightened concern about the dangers of exposure to ethylene oxide (EtO), increased regulatory oversight, and a steady hum of litigation, in 2025 it seems like things might be changing for the beleaguered industry dependent upon this highly effective but potentially cancer-causing sterilizing gas. With a new administration in the White House, a U.S. Environmental Protection Agency laser focused on deregulation, and with the first defense verdict issued in an EtO case out in Colorado this past spring (covered by ELM here), petrochemical companies with EtO operations have been breathing a collective sigh of relief. But other developments indicate that commercial sterilizers, although winning the current EtO regulatory battle, may not win the war.
On July 17, President Donald Trump issued an executive order (EO) granting a two-year extension to at least 30 medical device sterilization facilities – including many that the EPA found posed an increased risk to neighboring communities – throughout the U.S. that use EtO as a sterilizing agent in order to exempt them from complying with the prior administration’s more stringent EtO emissions rules. Following a years-long rulemaking process, President Joseph Biden’s EPA issued final EtO rules (covered by ELM here) that focused on establishing standards for previously unregulated emissions, strengthening already existing standards, and mandating certain reporting and monitoring.
The current administration’s view (the text of the EO can be found here), however, is that the final rules are too onerous and put Americans at risk by creating burdens for commercial sterilizers that could result in shortages of essential medical devices. It also argued that the technology needed to comply with the final rules does not exist in a “viable form.” The EO concluded that this exemption is “in the security interests of the United States….” Therefore, EtO facilities in states ranging from Louisiana to Indiana will have an additional two years, extending their compliance deadlines to 2028, or even 2029 in some cases, to comply with the final rules. Some suspect the Trump administration will jettison the 2024 EtO rules altogether or at least modify the rules to render them much less stringent.
Although the federal regulatory landscape for EtO facilities may be clearing up, personal injury suits filed by private individuals alleging EtO-exposure-related injuries are not going away. In late July, six plaintiffs filed a federal lawsuit against Eastman Chemical Company, claiming their respective cancers were caused by exposure to emissions from Eastman’s EtO facility in Longview, Texas.
Given the recently completed EtO rulemaking process took the lion’s share of a decade, it seems unlikely the new EPA, despite its zeal for deregulation, would be able to shepherd another round of rulemaking in the three years remaining in this administration. This delay, coupled with EtO lawsuits failing to abet – and even potentially increasing since the EPA will not require EtO facilities to comply with less forgiving emissions standards any time soon – may just end up a fleeting battle win in the overall EtO war.