EPA delays ethylene oxide sterilizer rule timeline amid industry pushback

Read the full story from Medtech Dive.

New draft regulations on ethylene oxide do not appear imminent after an Environmental Protection Agency announcement it will not issue a proposed rule on commercial sterilizers immediately, instead opting to issue an Advance Notice of Proposed Rulemaking and request for information in October.

Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published. An FDA official told MedTech Dive at The MedTech Conference while EPA and FDA are in frequent communication, no formal interagency consultation on EtO regulations has occurred yet. EPA is under court order to issue the rule by March 13, 2020.

The proposed rule on ethylene production will now likely come out mid-October, but an eventual proposed rule on commercial sterilizers will come out in December or January at the earliest, Greg Crist, AdvaMed’s executive vice president of public affairs, told MedTech Dive.

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