The EPA has announced its long-awaited final rule regarding ethylene oxide (EtO) emissions from commercial sterilization facilities. As approximately 50% of all medical devices go through terminal sterilization using EtO, changes to this process could substantially affect the availability of medical devices for healthcare.
 
The agency has called for a 90% cut of emissions from commercial sterilizers, many of which serve as sterilization providers for medical devices. The final rule is intended to provide balance the time required for facilities to come into compliance, while also putting into place strong public health protection for nearby communities.
 
“This final rule to sharply cut toxic emissions of ethylene oxide responds to the ambition set forth by President Biden’s Cancer Moonshot,” said EPA Administrator Michael S. Regan. “We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution—including the health of children, who are particularly vulnerable to carcinogens early in life. We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
 
This rule will impact almost 90 facilities owned by approximately 50 companies. The EPA is also working on new rules to help protect workers within those facilities.
 
“For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution,” said Xavier Becerra, United States Secretary of Health and Human Services. “We will continue to work together with EPA to achieve our shared goals of lowering EtO exposure while also mitigating potential risks of medical device shortages.”
 
“I commend the EPA for finalizing regulations in a way that will reduce EtO emissions by more than 90% at facilities across the country,” said U.S. Rep. Brad Schneider (IL-10). “I appreciate that the EPA followed the science to keep Americans safe while also ensuring safe, reliable supply chains for hospitals, physicians and patients. I have long fought for sensible regulations to address EtO air emissions and assist impacted communities. Today’s regulations will rightly require continuous air monitoring to assure communities that the air they breathe is safe, as well as provide an on-ramp for facilities to comply so that we do not have to choose between safe air and a stable supply of medical products. I will continue to be an outspoken advocate for air monitoring in communities where sterilization facilities are present, and I will always fight to prevent harmful toxins from entering our air.”