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AdvaMed Calls for Extended Period for EPA’s Proposed Rules Governing EtO Sterilization


 AdvaMed, the medtech association, called upon the U.S. Environmental Protection Agency (EPA) to double the time it will allow for public comment on two proposed updates to regulations governing the use of ethylene oxide to sterilize, according to FDA, approximately 20 billion medical technologies in the U.S. annually. The rule that governs emissions from ethylene oxide sterilization plants (“the NESHAP”), by law under the Clean Air Act, should have been updated 17 years ago in 2006.

AdvaMed President and CEO Scott Whitaker said, “After waiting 17 years for an updated regulation from the EPA—an update we have welcomed—an extra 60 days to ensure that the final rule is clear, reasonable, based on clear science, and will not lead to a shortfall of the critical medical technologies patients depend on is critically important. Getting these rules right is essential to the millions of American patients who depend on the 20 billion medical technologies sterilized with EtO annually.

“All parties involved—the EPA, the FDA, and the medtech industry—are committed to one outcome, which the industry has been long been committed to over its 80-plus years of EtO use: a safe sterilization process that protects employees and the communities surrounding these facilities and maintains an uninterrupted supply of the surgical kits, heart valves, syringes, IVs, and countless other medical supplies millions of American patients depend on every day. The latter will immediately be at risk if the rules, as proposed, are finalized too quickly and do not reflect the input and guidance of toxicologists, medical technology companies, sterilizers, healthcare providers, and the patients themselves.”

AdvaMed sent letters to the EPA requesting 60 additional days for public comment on the proposed NESHAP rule and the proposed interim registration review decision (PID) and draft risk assessment addendum for ethylene oxide (EtO) (Draft RA).

The letters are available here and here.

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