Published Articles
February 12, 2025
The Impact of Biden’s Last-Minute Ethylene Oxide Decision
Indiana Lawyer
Environmental and energy practice team co-leader and partner Max Kelln authored an article for the Indiana Lawyer that discusses former President Joe Biden’s late-term environmental regulations that could have lasting impacts, including on key sectors in Indiana.
The Biden-era Environmental Protection Agency (EPA) posted a late “interim” decision for its review of ethylene oxide under the Federal Insecticide, Fungicide, and Rodenticide Act that classified ethylene oxide from a “probable” carcinogen to a “carcinogen.” Kelln writes that, given the timing, the Biden administration likely hastened to issue the decision before the transition to the Trump administration.
Kelln notes that, by issuing this decision, the EPA claims broad authority to regulate how ethylene oxide can be used, even if the decision encroaches on the jurisdiction of other federal agencies. Further, the decision could have a significant impact on Indiana’s health care and life science sectors.
“First and foremost, steps taken by the Biden administration to regulate ethylene oxide could limit the availability of sterilization for medical devices manufactured in Indiana,” Kelln writes. “Moreover, approximately one-third of health care facilities, including hospitals, veterinary clinics, and dentists, use ethylene oxide onsite to sterilize medical devices and equipment. These facilities may need additional ventilation and abatement devices, and respirators may be required. Health care facilities will likely need monitoring to ensure they are below the 0.1 ppm threshold.”
Kelln concludes with next steps for ethylene manufacturers and highlights that even if the Trump administration tries to undo the EPA’s action, affected industries may hesitate to revert back in term of recommended measures absent an overhaul of the EPA’s reassessment of ethylene oxide.
The full article is available to Indiana Lawyer subscribers.
The Biden-era Environmental Protection Agency (EPA) posted a late “interim” decision for its review of ethylene oxide under the Federal Insecticide, Fungicide, and Rodenticide Act that classified ethylene oxide from a “probable” carcinogen to a “carcinogen.” Kelln writes that, given the timing, the Biden administration likely hastened to issue the decision before the transition to the Trump administration.
Kelln notes that, by issuing this decision, the EPA claims broad authority to regulate how ethylene oxide can be used, even if the decision encroaches on the jurisdiction of other federal agencies. Further, the decision could have a significant impact on Indiana’s health care and life science sectors.
“First and foremost, steps taken by the Biden administration to regulate ethylene oxide could limit the availability of sterilization for medical devices manufactured in Indiana,” Kelln writes. “Moreover, approximately one-third of health care facilities, including hospitals, veterinary clinics, and dentists, use ethylene oxide onsite to sterilize medical devices and equipment. These facilities may need additional ventilation and abatement devices, and respirators may be required. Health care facilities will likely need monitoring to ensure they are below the 0.1 ppm threshold.”
Kelln concludes with next steps for ethylene manufacturers and highlights that even if the Trump administration tries to undo the EPA’s action, affected industries may hesitate to revert back in term of recommended measures absent an overhaul of the EPA’s reassessment of ethylene oxide.
The full article is available to Indiana Lawyer subscribers.
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