• Posted April 12, 2023

EPA Proposes Limits on Dangerous Chemical Used by Medical Sterilization Plants

The Environmental Protection Agency on Tuesday proposed limiting the use of a chemical used to clean medical equipment in sterilizing plants because it also raises cancer risks for workers.

The agency plans to slash emissions of the odorless gas, called ethylene oxide, by about 80% at 86 medical sterilization facilities.

"EPA's number one priority is protecting people's health and safety, and we are committed to taking decisive action that's informed by the best available science," EPA Administrator Michael Regan said in an agency news release. "These proposals build on EPA's extensive outreach to communities across the nation and reflects close coordination among key federal partners. Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide."

Long-term exposure to the chemical over the course of a working career or from living near a sterilizing plant can increase the risk of certain types of cancer, including lymphoma and breast cancer, the agency explained. People who go to school near places where ethylene oxide is used are also potentially at an elevated risk of cancer.

Ethylene oxide, which classified as a pesticide, is used to sterilize about half of all medical devices in the United States, including pacemakers, syringes, catheters and plastic surgical gowns, according to the agency.

While the EPA's acceptable increase in lifetime cancer risk is 1 in 10,000, someone who works in a medical sterilizing plant has a risk over their career of an increase of one extra case of cancer per 10 people exposed, the Associated Press reported.

Under the proposal, sterilization facilities will need to test for the antimicrobial chemical in the air. They also will need to make sure pollution controls are working.

The agency also proposed requiring protective vapor masks for those working near high amounts of ethylene oxide. Some workplaces, including museums, should stop using the gas, it said.

Reaction to the proposal was swift.

"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,"Darya Minovi, a senior research analyst with the Union of Concerned Scientists, said in a statement.

Minovi added that the proposal should have also required monitoring at facility fence lines, to reassure neighbors.

"These proposed rules are the first step to addressing elevated and unnecessary cancer risks that Laredo and other impacted communities face... However, we have more work ahead of us to make sure that the final rules are as protective as possible," Sheila Serna, climate science and policy director at the environmental group Rio Grande International Study Center, said in a statement.

The group sued the EPA in December to try to tighten ethylene oxide protections. Serna also thinks the EPA should require fence line monitoring.

But Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a statement that the EPA risk assessment overstates threats to employees.

Not only that, but many devices "cannot be sterilized by another method,"Whittaker explained, and if some facilities close medical care may be delayed. Whitaker also called the 18 months allowed for installing technology to reduce emissions "much too short."

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

More information

The National Cancer Institute has more on ethylene oxide.

SOURCE: U.S. Environmental Protection Agency, news release, April 11, 2023; Associated Press