New Regulations for Hospital Ethylene Oxide Sterilizers: Affected Facilities Must Submit Initial Notifications to DNR by June 27

Hospitals in Iowa that continue to use ethylene oxide to sterilize equipment may be subject to new federal air toxics regulations impacting these operations. The new regulations are the National Emission Standards for Hospital Ethylene Oxide Sterilizers and were published in the Federal Register December 28, 2007, under 40 CFR Part 63, Subpart WWWWW.

The Iowa Department of Natural Resources (DNR) took delegation of these federal standards several months ago. However, the DNR was given information that hospitals in Iowa were no longer using ethylene oxide. Recently, the DNR received information that this may not be the case.

The DNR is reminding Iowa hospitals that they may be subject to these regulations. Affected facilities are required to submit an Initial Notification to the DNR no later than June 27, 2009. Completed notifications should be sent to: NESHAP Coordinator, Iowa DNR Air Quality Bureau, 7900 Hickman Road, Suite 1, Urbandale, Iowa, 50322. The notification is not required to be sent to EPA.

A sample EPA notification that may be used is available on EPA’s website at:

www.epa.gov/ttn/atw/area/compilation.html

A copy of the federal regulations and other implementation materials are also available at this website.

In short, all hospitals that use ethylene oxide sterilization are affected by the new federal regulations. There is no de minimus level. However, the regulations basically require best management practicing consisting of sterilizing full loads except for medical emergencies. Hospitals that operate an air pollution control device (APCD) are considered to be in compliance with the regulations and do not need to follow the management practices. Initial Notification is required in all cases.

Facilities that have questions or concerns should contact Christine Paulson at the address above, by e-mail at christine.paulson@dnr.iowa.gov, or by phone at 515-242-5154.