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Subpart O - Ethylene Oxide Commercial Sterilization Plant Explosions

July 29th, 1997

From:John Seitz, Director, OAQPS (MD-10)

As you know from our earlier discussions and my July 18, 1997, memorandum, we have recently learned of reports of explosions at ethylene oxide sterilization facilities. Attached is a summary of the recent events furnished by the Ethylene Oxide Sterilization Association. With your help, my office has been conducting a preliminary investigation to determine whether the emission control equipment mandated by 40 C.F.R. part 63, Subpart O has in any way been associated with the cause of the problems at these facilities.

In the July 18 memorandum, I asked you to inform all ethylene oxide facilities of the recent incidents and the potential safety problem. At that time I recommended you inform the facilities that if they have a safety concern, they may disconnect the control units immediately until we are able to examine the matter further, since Subpart O's December 1997 compliance date had not yet been triggered. EPA does not want matters associated with the December 1997 compliance date potentially compromising safety, so the Agency is taking steps to extend that date by one year until December 8, 1998, pursuant to Clean Air Act section 112(I)(3)(B). An interim final rule implementing that extension will be forthcoming. In the meantime, all ethylene oxide facilities should be notified that it would be prudent to cease the installation and operation of their emission control equipment while the Agency continues its investigation of this matter.

I am requesting the appropriate Regional Offices, in cooperation with the Office of Solid Waste and Emergency Response's Chemical Emergency Preparedness and Prevention (CEPP) Office, and the Regional CEPP program offices, to visit the facilities where the incidents have occurred to gather the relevant information. Additionally, all facilities subject to Subpart O should be notified about the extension of the compliance schedule.

The role of this Agency has been and continues to be one of protecting public health and the environment in a way that is compatible with safety concerns. I am hopeful that by taking these steps we can fulfill this responsibility.

If you have any questions regarding the emissions requirements please call David Markwordt, at 919-541-0837. If you have any questions about the accident investigations, please call Craig Matthiessen at 202-260-9781.

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