EPA finalizes curbs on medical device sterilizer
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The Environmental Protection Agency on Thursday finalized a rule aimed at sharply reducing emissions of ethylene oxide, a cancer-causing chemical that's essential for sterilizing medical devices.
Why it matters: The FDA has expressed concern about the possibility of resulting device shortages. There are no ready alternatives that can be used at the scale of ethylene oxide, or EtO, at this point, according to the agency.
Zoom in: The new requirements will reduce the amount of EtO coming from commercial sterilizers by an estimated 90% over time. That's an additional 10% over what EPA estimated in its proposed standards.
- The final rule extends compliance timelines for sterilizing plants compared to the proposed standards.
- Its standards aim to protect people living near sterilizing facilities while "minimizing any potential impacts to the medical device supply chain," the EPA said in a release.
- The agency received more than 40,000 comments on its proposed standards and worked closely with the Health and Human Services Department to develop the final regulations, EPA officials said.
State of play: The FDA in April began a pilot program to reduce medical sterilizers' dependence on EtO, and put out guidance last month encouraging companies to use an alternative sterilizing chemical.
- FDA estimates that EtO is used on 20 billion devices in the United States.
Flash back: A 2016 report concluded with "high" confidence that ethylene oxide is "carcinogenic to humans." The odorless gas is the subject of many civil claims and lawsuits.
What they're saying: "For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution," HHS Secretary Xavier Becerra said in a news 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."
- "The EPA's final ethylene oxide standards for commercial sterilizers are grounded in science and will save lives," said Senate Environment and Public Works Committee Chair Tom Carper (D-Del.). "I'm grateful for the Biden administration's years of work to develop these strong standards."
Go deeper: Inside an interagency fight over a chemical tied to cancer risks
