EPA Proposes New Regulations to Reduce Cancer Risks from Ethylene Oxide Sterilization Facilities

Advocates urge agency to strengthen the final rules to fully protect communities and workers from this aggressive carcinogen


Erin Fitzgerald, Earthjustice, efitzgerald@earthjustice.org

Today, the U.S. Environmental Protection Agency (EPA) released two proposed actions to update the agency’s regulations of carcinogenic emissions from ethylene oxide 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 ethylene oxide emissions once implemented. The proposed rule is a long overdue and much needed first step, however it falls short of providing communities with the full protection they deserve. Today’s proposed rule does not require fenceline monitoring and it contains a potential loophole for off-site warehouses where sterilized products, which can continue to produce ethylene oxide emissions, are stored.

EPA also released a revised risk assessment and proposed interim registration review decision for ethylene oxide under the nation’s federal pesticide control law, the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).  In its latest risk assessment, EPA found that registered uses of ethylene oxide present up to a 1 in 10 lifetime cancer risk for workers inside sterilization facilities, among the highest risks ever calculated under FIFRA. 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.

Ethylene oxide is a mutagenic, colorless, typically odorless, flammable gas used to make products like antifreeze, plastics, detergents, and adhesives. Commercial sterilizers use ethylene oxide to sterilize medical equipment and some dried food products, like spices. Because ethylene oxide is used to sterilize products and dry foods, it is a registered pesticide under FIFRA, which covers sterilization agents and other antimicrobial products as well as agricultural pesticides. It is one of the most toxic air pollutants EPA regulates. It is a known carcinogen to humans, especially when inhaled. EPA updated ethylene oxide’s toxicity value in 2016 and admits that the chemical is 60 times more toxic than previously estimated. And despite knowing that emissions from commercial sterilizer facilities pose an elevated cancer risk to nearby communities, EPA has not reviewed its rules for sterilizers since 2006.

Today’s newly proposed rule comes after Earthjustice filed a lawsuit against the EPA over the agency’s failure to update standards to protect the public from harmful air emissions from ethylene oxide sterilization facilities. The Clean Air Act directs the EPA to review its ethylene oxide standards every eight years, but 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. 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.”

Children are particularly sensitive to ethylene oxide’s harmful effects. 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. This past August, EPA released a list of 23 high risk ethylene oxide sterilization facilities across the country, which includes facilities near communities in Laredo, TX, and Lakewood, CO. According to a February 2023 report from the Union of Concerned Scientists, nearly 14 million people in the United States and Puerto Rico live within five miles of a commercial sterilizer. The report also identified 12 metro areas in the U.S. that are sterilizer hotspots with two or more sterilizers within 10 miles of each other, meaning that people may be exposed to ethylene oxide emissions from multiple facilities. As each day passes, ethylene oxide threatens the health of many communities as they wait for EPA to fulfill its legal obligations under the Clean Air Act.

In the lawsuit to compel the EPA to take action to limit ethylene oxide emissions from sterilization facilities, Earthjustice represents California Communities Against Toxics, Clean Power Lake County, Rio Grande International Study Center, Sierra Club, and the Union of Concerned Scientists.

Quotes From Our Clients:

“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.”

“Here in Laredo, a South Texas border community that is 95% Latinx, our children attend schools with some of the worst air quality in the country because of ethylene oxide pollution. It is heartbreaking to think of how many children got sick or developed cancer while learning to read and write or playing outside while companies like Midwest Sterilization Corp. and the industry, as a whole, made incredible profits at our expense,” said Tricia Cortez, executive director of the Rio Grande International Study Center and co-founder of the Clean Air Laredo Coalition. “EPA must act swiftly to finalize a strong rule to prevent anymore needless suffering.”

“Frontline communities near ethylene oxide sterilizers deserve to be protected from incredibly carcinogenic and harmful air emissions,” said Jane Williams, executive director of California Communities Against Toxics. “While EPA’s announcement today shows that new emission limits on these dangerous facilities are coming, the agency is not doing enough in this rule to protect fenceline communities from this dangerous chemical.”

“Today, the EPA announced a long overdue proposal to reduce cancer risks from commercial sterilizer facilities. We encourage the EPA to pursue the strongest possible final rule so that those living near these facilities are no longer breathing unsafe levels of ethylene oxide,” said Darya Minovi, Senior Analyst for the Center for Science and Democracy at the Union of Concerned Scientists. “EPA must ensure that people living, working, and attending school near facilities that emit ethylene oxide have clear information about the risks and policies that actually protect them.”

“Ethylene oxide is a hazardous chemical posing serious health threats for many living in fenceline communities in Texas,” said Neil Carman, Sierra Club’s Lone Star Chapter’s Clean Air Program Director. “Today’s announcement is the first step to progress for countless families who have suffered while the sterilizer industry raked in profits at the expense of people’s health waiting for EPA to act. The agency needs to act as swiftly as possible to finalize this rule and prioritize protecting the environment and public health.”

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