EPA proposes new regulations to reduce cancer risks from ethylene oxide sterilization facilities

[Photo by Takasuu-Getty Images]

Today, the U.S. Environmental Protection Agency (EPA) released two proposed actions to update its regulations of carcinogenic emissions from ethylene oxide (EtO) commercial sterilization facilities.

The first proposed rule will require sterilizer facilities to reduce emissions from both major and minor sources by installing control technology within 18 months of the publication of the final rule. According to the EPA, these regulations will eliminate an estimated 80% of EtO emissions once implemented.

The proposed rule is a long overdue and much needed first step, say advocates who have urged EPA to strengthen rules to fully protect communities and workers from this aggressive carcinogen.

However, today’s proposed rule falls short of providing communities with the full protection they deserve. One, it does not require fenceline monitoring. Two, it contains a potential loophole for off-site warehouses where sterilized products—which can continue to produce EtO emissions—are stored.

EPA also released a revised risk assessment and proposed interim registration review decision based on findings that registered uses of EtO present up to a 1 in 10 lifetime cancer risk for workers inside sterilization facilities. This is among the highest risks ever calculated under the nation’s federal pesticide control law.

EPA’s revised risk assessment and proposed interim registration includes new requirements for workers using ethylene oxide as a sterilizer, but it stops short of phasing out its use in food products.

Today’s proposed rule comes after Earthjustice filed a lawsuit against the EPA for failing to update standards to protect the public from harmful air emissions from EtO sterilization facilities.

The Clean Air Act directs the EPA to review its ethylene oxide standards every eight years. However, the agency has repeatedly missed this deadline—first in 2014 and again in April 2022.

“Today’s proposals are an important first step in remedying an injustice that affects far too many communities,” said Earthjustice attorney Marvin Brown. “Too many workers and community members have gotten cancer from facilities that are supposed to make sure that our medical equipment is safe. We know, and EPA knows, that ethylene oxide poses a dire cancer risk to anyone who breathes it in.”

Brown added, “While EPA must move quickly to reduce ethylene oxide emissions, it must go further and ensure that frontline communities have the data to know when their air is safe through fenceline monitoring. And the agency must move quickly to reduce and phase out the use of ethylene oxide for sterilizing products that can be safely sterilized by other means.”

“The EPA’s mission is to protect human health and the environment, and we are grateful that the agency has taken the first steps to follow through. However, we have been waiting too long for them to fulfill their legal obligation to us and communities across the country,” said Celeste Flores, steering committee member with Clean Power Lake County. “Ethylene oxide sterilizers emit harmful air emissions day in and day out, endangering those living, working, or going to school nearby. We’re looking forward to ensuring that the EPA is held accountable and enacts the strongest protection possible.”

Facilities that emit ethylene oxide are typically found in low-income neighborhoods and communities of color, many already grappling with elevated toxic exposure and health risks from multiple forms of industrial pollution. Children are particularly sensitive to ethylene oxide’s harmful effects.


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