Ethylene Oxide Emissions to Be Cut by 90 Percent in New EPA Ruling

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Ethylene oxide is the most common sterilant used for medical devices in the United States. The ruling will address emissions at nearly 90 facilities.

In a move to reduce Americans’ risk of cancer, the Environmental Protection Agency (EPA) announced measures to reduce ethylene oxide (EtO) use in commercial sterilization facilities by 90 percent. The ruling is to make it safer to live near commercial sterilization facilities by lowering toxic emission standards for the gas.

The new ruling, released on Thursday, is the most decisive measure taken against ethylene oxide in U.S. history and advances the Biden Administration’s commitment to ending cancer, an initiative called Cancer Moonshot, according to an EPA press release. It will address emissions at nearly 90 commercial sterilization facilities owned and operated by approximately 50 companies.

Commercial sterilization facilities, which sterilize consumer products and medical devices, are located in more than half of the states.

The EPA worked with communities and stakeholders to establish the ruling, holding public hearings, national webinars, and public meetings. The federal agency received more than 40,000 public comments that helped inform the final rule.

“For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution,” Xavier Becerra, U.S. Secretary of Health and Human Services, said in the press release. “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.”

What Is Ethylene Oxide?

Ethylene oxide (EtO) is a flammable, sweet-smelling gas and is the most common sterilant used for medical devices in the United States. According to the U.S. Food and Drug Administration (FDA), EtO may be the only effective method of sterilization that does not damage the product. It is used on medical devices made with polymers, metals, and glass or with multiple layers or hard-to-reach places. Research shows that about 50 percent of all sterile medical devices in the United States have been sterilized with ethylene oxide. This amounts to 20 billion devices a year, according to the EPA.

Short-term exposure can cause headaches, dizziness, fatigue, nausea, and irritate the eyes, skin, nose, and throat. Chronic exposure can harm the nervous system. The EPA reports that there is some evidence linking ethylene oxide exposure to adverse reproductive effects. In particular, exposure through inhalation increases the risk of lymphoid cancer and breast cancer for females.

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“This final rule to sharply cut toxic emissions of ethylene oxide responds to the ambition set forth by President Biden’s Cancer Moonshot,” EPA Administrator Michael S. Regan said in the press release. “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.”

The EPA estimates that implementing the new measure will cost roughly $313 million but will reduce emissions by 21 tons annually. The reduction will lower the risk of adverse health effects, especially cancer. According to the U.S. Centers for Disease Control and Prevention (CDC), breast cancer patients spent $29.7 billion on medical services and prescription drugs in 2020.

“I commend the EPA for finalizing regulations in a way that will reduce EtO emissions by more than 90% at facilities across the country,” Rep. Brad Schneider (D-Ill.) said in the press release. “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.”

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