Dive Brief:
- Environmental groups have filed a lawsuit against the Trump administration for exempting medical device sterilizers from emissions requirements designed to reduce exposure to cancer-causing chemicals.
- The complaint was filed in the U.S. District Court for the District of Columbia last week against President Donald Trump, the Environmental Protection Agency and EPA Administrator Lee Zeldin. The Southern Environmental Law Center and the National Resources Defence Council filed the lawsuit on behalf of environmental nonprofits in North Carolina, Georgia and Virginia.
- Ethylene oxide, also known as EtO, has been a focus for the medtech and environmental groups, as it is one of the main chemicals used to sterilize medical devices, but is also a carcinogen. EtO is used to sterilize about half of medical devices.
Dive Insight:
The EPA estimated that 8.5 million people living near medical sterilizers have an elevated cancer risk, and that sterilizers could pose a lifetime cancer risk that is 60 times higher than the EPA’s threshold for unacceptable risk.
In 2024, the EPA passed a final rule setting new emissions standards for EtO, which the regulator said would reduce emissions by 21 tons per year and reduce the lifetime cancer risk for people who live near sterilization facilities.
The rule added new standards for building leaks and chamber exhaust vents, which previously hadn’t been regulated, and restrictions for facilities that use less than one ton of EtO per year.
However, the Trump administration put many of these actions on pause. In July, Trump issued a proclamation to push back the new emissions standards by two years while the EPA reconsiders them. The proclamation listed 40 facilities, about 45% of commercial sterilizers, according to the lawsuit, allowing them to delay more stringent emissions controls and forgo emissions monitoring and quarterly reporting.
Plaintiffs argue Trump overstepped his authority by making sweeping exemptions without providing facts to back them. While the president may exempt sources from hazardous air pollutant standards for two years under the Clean Air Act, the president must determine the technology needed to implement the standard is not available, and that the exemption is in the U.S.’ national security interests.
No president has used this exemption authority in the 55 years since it was enacted by Congress, while Trump invoked it seven times in 2025, according to the complaint.
Trump claims the EPA’s final rule places “severe burdens” on commercial sterilization facilities and that the technology needed to implement the rule is not available. However, the Trump administration did not provide any analysis showing the 40 facilities could not meet the statutory standard. In addition, the technology needed to comply with the rule is widely available, and already in use at many facilities that received exemptions, according to the lawsuit.
For example, the EPA found that 20 of 40 facilities with chamber exhaust vents already met revised standards, and seven commercial sterilizers didn’t need to make any changes to meet the new requirements.
The plaintiffs are requesting the court declare the proclamation invalid and prohibit the EPA from implementing or relying on it. They also want the EPA to notify exempted sterilization facilities that the proclamation is invalid and to not delay compliance with the deadlines listed in the EtO final rule.
