Today, the U.S. Environmental Protection Agency (EPA) announced a final rule updating regulations for commercial sterilization facilities that use ethylene oxide for sterilizing medical equipment and spices. Ethylene oxide, one of the most toxic air pollutants EPA regulates, is a highly carcinogenic flammable gas capable of altering DNA. This update will require all sterilizer facilities to reduce emissions by installing new control technologies within the next two to three years. According to the EPA, these safeguards will eliminate an estimated 90% of ethylene oxide emissions once fully implemented.

Nearly 14 million people in the United States and Puerto Rico live within five miles of a commercial sterilizer, according to a recent report from the Union of Concerned Scientists. Children are particularly sensitive to ethylene oxide’s harmful effects. Many ethylene oxide-emitting facilities are in low-income neighborhoods and communities of color, compounding existing health risks from various forms of industrial pollution.

Commercial sterilizer facilities in the United States. Sources: Esri, USGS, EPA, NOAA. (Casey Chin / Earthjustice)

“Today is an important step forward in regulating toxic ethylene oxide emissions from commercial sterilization facilities, but there is still a lot of work to do,” said Patrice Simms, Earthjustice’s vice president for Healthy Communities. “This is a victory for our clients, whose years of advocacy led to increased regulations on an industry that has polluted our communities while cleaning our medical equipment. We look forward to reviewing these rules and ensuring that they are fully and effectively implemented.”

The final rule stems from a successful 2022 Earthjustice lawsuit, which sued EPA over the agency’s nearly decade-long failure to update protective safeguards for communities. Earthjustice filed this challenge on behalf of California Communities Against Toxics, Clean Power Lake County, Rio Grande International Study Center, Sierra Club, and the Union of Concerned Scientists.

These regulations are a long overdue and much needed first step, but there is still a lot of work to do to ensure that communities have the full protection that they deserve from toxic ethylene oxide emissions. Earthjustice, along with our partners and clients, will continue to advocate for the EPA to monitor emissions at the facilities’ fencelines and to regulate off-site warehouses where sterilized stored products can emit ethylene oxide, too. Furthermore, Earthjustice anticipates EPA’s forthcoming Interim Decision on ethylene oxide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will continue to urge the agency to ban the use of ethylene oxide to sterilize food products and ensure workers are protected from this carcinogen.

Quotes from Clients:

“We understand that industry applied heavy pressure to weaken this new rule. We also understand that industry remains unwilling to change its business practices that create unacceptably high cancer risks for people in my South Texas community of Laredo. We thank the EPA for having the courage to hold its ground and create a stronger rule whose goal is to protect our families, and the place we call home,” said Tricia Cortez, executive director of Rio Grande International Study Center.

“As a result of the collaboration of environmental justice communities and national environmental organizations, today marks a monumental step towards cleaner air,” said Celeste Flores, Co-Chair of Clean Power Lake County (IL). “The US EPA must continue to act swiftly to protect every community from breathing EtO. We will continue to advocate for the closure of all the loopholes used by industries that use EtO.”

“Communities in Texas are home to too many sterilizers that have gotten away with releasing unsafe levels of ethylene oxide and harming environmental justice communities. The EPA is finally taking action to reduce the unsafe pollution levels in impacted communities with new rules to require stronger compliance, improved ethylene oxide pollution controls and related oversight, ” stated Neil Carman, PhD, Lone Star Chapter Sierra Club.

“The sterilization industry has gotten away with poisoning environmental justice communities for far too long.  We are pleased that EPA has taken action to reduce the ethylene oxide emissions from these facilities and we look forward to working with the agency as it moves to implement the rule,” stated Jane Williams of California Communities Against Toxics.

“It’s been nearly eight years since EPA published its IRIS risk assessment that determined that ethylene oxide was up to 60 times more toxic than previously understood. And up until recently, many people had no idea that these facilities have been operating in their neighborhoods for decades,” said Darya Minovi, senior analyst at Union of Concerned Scientists. “It’s a relief to finally see the issuance of this rule, that, while not perfect, will significantly reduce the risk of ethylene oxide exposure for communities around these facilities.”