EPA finds cancer risk from sterilization chemical, proposes usage limits

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Syringes lie on a tray at a vaccination center in Germany, on June 10, 2021. (Credit: THOMAS KIENZLE/AFP via Getty Images)

The Environmental Protection Agency proposed Tuesday to limit the use of the chemical ethylene oxide after finding higher than expected cancer risk at facilities that use it to sterilize billions of medical devices each year.

The EPA says its proposal will reduce ethylene oxide emissions by roughly 80% by targeting 86 medical sterilization facilities across the United States. The companies will also have to measure the antimicrobial chemical in the air.

"EPA’s number one priority is protecting people’s health and safety," EPA Administrator Michael Regan said in a statement. "Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide."

Darya Minovi, a senior research analyst with the Union of Concerned Scientists, called the action overdue by "almost a decade" and said it should have gone further to require monitoring at a facility property line so people know what is entering their neighborhoods.

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For the 86 percent of the U.S. population served by community water systems, the overall cumulative lifetime risk is equivalent to four lifetime cancer cases per 10,000 people.

"I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value," said Minovi in a statement.

The tightened safeguards are driven by a better understanding by EPA that ethylene oxide’s threat can be severe. The chemical is classified as a pesticide. A medical sterilization worker over the course of a career could see their risk shoot up by as much as one extra case of cancer for every ten people exposed. The EPA’s generally acceptable increase in lifetime cancer risk is 1 in 10,000.

Ethylene oxide is a gas used to sterilize roughly half of all medical devices and is also used to ensure the safety of certain spices and other food products. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. Brief exposure isn't considered a danger, but breathing it long-term elevates the risk of breast cancer and lymphoma, according to the agency.

The EPA said many facilities have already sharply reduced emissions, but those that haven't will now have to meet stricter requirements.

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Scott Whitaker, president and CEO of Advanced Medical Technology Association, said that medical sterilizers provide a vital service and that many devices "cannot be sterilized by another method." He said the EPA’s risk assessment overstates the threat employees face and the protections they are already provided.

He added that these facilities are already at capacity and the industry can’t afford shutdowns. The 18-month timeframe for installing technology to reduce emissions after the final rule is issued is "much too short."

"It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic," Whitaker said in a statement.

The agency is proposing two rules, one targeting emissions and another focused on worker safety. The emissions reductions aim to bring cancer risk within the EPA's generally acceptable level. Medical sterilizers would also need to continuously monitor air pollution to make sure controls function properly.

The EPA also wants to require protective gear for people who work with ethylene oxide, and says some workplaces, including museums, should stop using it altogether because safer alternatives exist.

In recent years, concern over emissions from medical sterilizers has grown sharply. Sterigenics shuttered a medical sterilization plant in a Chicago Suburb after monitoring found emissions spikes in nearby neighborhoods and settled numerous lawsuits.

The proposal follows the EPA’s announcement last week to cut emissions from chemical plants in general to reduce cancer risk. In part, that rule targeted manufactures of ethylene oxide. Tuesday’s proposal targets those who use it.

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