EPA Finalizes Rule to Slash Emissions of Cancer-Causing Chemical Used in Medical Sterilization

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The Environmental Protection Agency (EPA) has announced the “strongest measures in U.S. history” to curtail emissions of a toxic chemical used to sterilize medical equipment.

In a March 14 news release, the agency said its final rule on ethylene oxide would “reduce lifetime cancer risks” for people living near commercial sterilization facilities across the United States.

Ethylene oxide is a highly flammable, colorless gas widely used across many industries, including as a chemical intermediate in the manufacturing of ethylene glycol (antifreeze), textiles, detergents, medicine, and adhesives.

It is also used to sanitize medical and surgical equipment and plastic devices that cannot be sterilized by steam; and as a fumigating agent for spices.

Ethylene oxide is also one of the most potent cancer-causing chemicals, according to the EPA.

Under the agency’s new rule, sterilizer facilities will have to reduce emissions by installing new pollution-control technologies within the next two to three years, and continuously monitor emissions, including filing quarterly reports to the EPA.

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Such facilities will also have to establish standards for currently unregulated emissions, such as building leaks and chamber exhaust vents, to reduce cancer risk and account for technological developments in pollution control.

Additionally, facilities will also need to ensure communities, states, Tribes, and local governments are kept up to date with the most recent emissions data to ensure ethylene oxide is not entering the outdoor air.

‘Historically Strong’ Rule Protects Communities

The agency’s new rule will apply to nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies, EPA said. They will also reduce ethylene oxide emissions by 90 percent, according to officials.

“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 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,” Mr. Regan added.

The EPA’s updated rules were in response to a 2022 lawsuit by the non-profit Earthjustice over the agency’s nearly “decade-long failure to update protective safeguards for communities.”

According to an analysis published last year by the Union of Concerned Scientists, roughly 14 million people live within five miles of facilities that emit ethylene oxide.

Another 31 percent of those who live within five miles of facilities that emit the potent cancer-causing chemical are low-income, the analysis found.

A nurse cleans personal protective equipment (PPE) after being part of a team that performed a procedure on a COVID-19 patient at Regional Medical Center in San Jose, Calif., on May 21, 2020. (Justin Sullivan/Getty Images)
A nurse cleans personal protective equipment (PPE) after being part of a team that performed a procedure on a COVID-19 patient at Regional Medical Center in San Jose, Calif., on May 21, 2020. (Justin Sullivan/Getty Images)

Lymphoid, Breast Cancer Risks

Meanwhile, ethylene oxide is used to sterilize 20 billion medical devices in the United States each year, according to AdvaMed.

In a statement after the new EPA rule was announced, Earthjustice called it an “important step forward.”

“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,” Patrice Simms, Earthjustice’s vice president for Healthy Communities, said.

Individuals exposed to ethylene oxide may exhibit multiple symptoms including headaches, tiredness, trouble breathing, and vomiting, according to the Centers for Disease Control and Prevention (CDC).
Chronic (long-term) exposure to the toxic chemical can lead to brain and nervous system damage as well as reproductive issues, the health agency says. Ethylene oxide has been linked to multiple types of cancer, including lymphoid cancer and breast cancer.

Despite the risks, the Food and Drug Administration (FDA) notes that for many medical devices, sterilization with ethylene oxide “may be the only method that effectively sterilizes and does not damage the device during the sterilization process.”

Medical devices made from certain polymers, metals, or glass, or those that have multiple layers of packaging or are difficult to clean, such as catheters, are likely to be sterilized with ethylene oxide, according to the FDA.

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