Ethylene Oxide Sterilizers

In relation to the 2007 rule on ethylene oxide sterilizers for hospitals, EPA has continued to receive information on the use and impacts of ethylene oxide. Ethylene oxide is a flammable, colorless gas used to make other chemicals that are used in making a range of products, including antifreeze, textiles, plastics, detergents and adhesives. Ethylene oxide also is used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. In recent years, there has been a growing body of evidence of the potential risks and EPA has been holding several public outreach workshops as they develop new rules relating to ethylene oxide. As this is a source category that is not commonly used in Tennessee, the TN Small Business Environmental Assistance Program would like to direct attention to the EPA website on ethylene oxide as it will have the most current information as well as links or recordings of public outreach webinars in relation to ethylene oxide: EPA Hazardous Air Pollutants: Ethylene Oxide.

In addition to the EPA website, TDEC has been reviewing businesses in Tennessee that may use ethylene oxide. For more information on these efforts and questions relating to ethylene oxide, please visit the Division of Air Pollution Control webpage on ethylene oxide.

Hospital Sterilizers (2007 rule)

On December 28, 2007, the Environmental Protection Agency (EPA) published a final rule regarding new emission standards for Ethylene Oxide (EO) Hospital Sterilizers. The rule implements new emission standards for ethylene oxide, an air toxic associated with hospital sterilizers. Hospitals, clinics and dental offices with sterilizers will be required to implement a management practice to reduce ethylene oxide emissions by sterilizing full loads to the extent practicable or have the sterilizer fitted with an air pollution control device. Therefore, sterilizer units will be required to run full loads or provide reasons why partial loads were needed. Facilities that currently route ethylene oxide emissions to an air pollution control device will be considered in compliance with this area source rule.

Affected sources are required to submit an Initial Notification of Compliance Status to notify regulatory programs that you are operating your sterilizer in accordance with rule requirements. This notification is due no later than June 25, 2009 for existing sources (constructed or reconstructed before November 6, 2006). The notification for new sources (constructed or reconstructed after November 6, 2006) is due 180 days after initial start-up. If your EO sterilizer is located within one of the state’s local air programs (Counties of Davidson, Hamilton, Knox and Shelby), you should contact them concerning an Initial Notification of Compliance Status submittal. All other sources should submit their Initial Notification of Compliance Status to Tennessee’s Division of Air Pollution Control (APC) and the EPA at the addresses on the sample notification response mentioned below.

To assist this service group SBEAP has prepared an EO Sterilizer Fact Sheet to help summarize main points of the rule, including compliance date(s), initial notification, keeping records plus regulatory contact information. SBEAP has also prepared a sample response that affected facilities may find helpful in complying with area source rule requirements. Additionally, EPA has developed a brochure to highlight details of the area source rule – See EPA’s brochure.