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# AdvaMed Device Sterilization Reg Proposals for EPA
- URL: https://www.fdaweb.com/advamed-device-sterilization-reg-proposals-for-epa/
- Published: 2023-01-24T12:00:00.000Z
- Updated: 2026-09-14T18:12:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153605

AdvaMed says it appreciates a proposed update to the EPA emissions standards for facilities using ethylene oxide (EtO) to sterilize medical devices and offers points for the Biden Administration to consider as it finalizes the regulation. In a [letter](https://www.advamed.org/wp-content/uploads/2023/01/2023-01-18-letter-to-the-President-on-EtO-January-2023-final.pdf?ref=fdaweb.com) to President **Joseph Biden**, AdvaMed asks the administration to:

- consider the potential threat to patient care if any sterilization facilities shut down;
- encourage EPA to embrace technology-neutral solutions to meet new emissions targets; and
- ask EPA to consider background EtO levels in ambient air and the tiny proportion of that represented by medical device sterilization EtO use.

Last year, CDRH director **Jeffrey Shuren** [said](https://www.fdaweb.com/fda-working-to-cut-ethylene-oxide-emissions/) that as EPA working to finalize the regulation, FDA was working with the industry on steps to reduce emissions and also to maintain sufficient sterilizing capacity. Shuren’s statement discussed the EtO Sterilization Master File Pilot Program for PMA holders of high-risk devices that enables certain changes between sterilization processes and facilities that reduce the amount of EtO concentrations used to sterilize without compromising safety and effectiveness. He also discussed the Innovation Challenges that he said showed encouraging progress with new strategies to reduce EtO emissions.