WASHINGTON (CN) — The Environmental Protection Agency on Thursday finalized tougher regulations on toxic chemicals used to sterilize medical equipment.
The regulation aims to reduce pollution from commercial sterilizers that use ethylene oxide.
“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,” EPA Administrator Michael Regan said in a statement. “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.”
Ethylene oxide is used in the production of perfumes, lubricants and paint thinners, but is also an important chemical for sterilizing medical equipment. While that sterilization accounts for less than half a percent of all commercial ethylene oxide in the United States, it is used in half of all medical devices, more than 20 billion devices, according to AdvaMed, a medical technology association. Those devices include syringes, surgical kits, catheters, and implants like hip and knee replacements.
The EPA said the regulation will reduce cancer risks for people living near commercial sterilization facilities while the medical industry has warned that the proposal could disrupt the flow of hospital and clinical supplies.
“As we’ve said many times, the stakes are high,” AdvaMed president and CEO Scott Whitaker said before Thursday’s announcement.
The rule will apply to emissions at roughly 90 commercial sterilization facilities owned by 50 companies. The facilities would be required to use advanced source monitoring methods on emissions and report results to the EPA quarterly.
The White House said President Joe Biden is willing to provide a two-year compliance exemption to allow facilities to meet the new standards.
“Today's regulations will rightly require continuous air monitoring to assure communities that the air they breathe is safe, as well as provide an on-ramp for facilities to comply so that we do not have to choose between safe air and a stable supply of medical products,” said Illinois Representative Brad Schneider.
Sierra Club senior attorney Zachary Fabish applauded the announcement.
“Today’s announcement is a critical step toward rectifying the injustices faced by those who have been most impacted by EtO pollution, and demonstrates the Biden EPA’s commitment to protecting the health of workers, their families, and communities nationwide,” he said.
Delaware Senator Tom Carper, chair of the Senate Environment and Public Works Committee, said the regulation would protect Americans.
“Every American should have clean air to breathe — no matter their ZIP code,” he said. “The EPA’s final ethylene oxide standards for commercial sterilizers are grounded in science and will save lives.”
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