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Skip Navigation LinksDNREC : Division of Waste & Hazardous Substances : Info : Regulations : ETOSterilizer


Regulation  1138 - Emission Standards for Hazardous Air Pollutants for Source Categories


Section 9.0:"Emission Standards for Hazardous Air Pollutants for Hospital Ethylene Oxide Sterilizers" 


Congress sought to reduce cancer and non-cancer health risks due to the exposure to hazardous air pollutants (HAPs) in the 1990 Amendments to the Clean Air Act.  Under Section 112(k) – Area Source Program, Congress mandated that the EPA identify 30 or more HAPs that posed the greatest threat to public health in urban areas, and to identify the small (i.e., area) sources that emit any of those pollutants.

In 1999, the EPA identified 33 HAPs that posed the greatest threat to public health and has, since that time, identified over 60 area source categories for which standards are to be promulgated.  The EPA promulgated its first of these area source standards in 2006, and they are under Court ordered deadlines to complete all promulgations by June 2009.  Air Quality Management (AQM) has estimated that approximately 28 of the area source standards could affect Delaware sources.

In December 2007, the EPA promulgated the second of these federal area source standards affecting a Delaware facility. This standard, found at 40 CFR Part 63 Subpart WWWWW, is applicable to new and existing area source hospital ethylene oxide sterilizers.

This federal standard addresses the emissions of ethylene oxide or ETO. ETO is classified as a probable human carcinogen, and long-term exposures to ETO are linked to irritation of the eyes, skin, and mucous membranes, and problems in the functioning of the brain and nerves.  The EPA reports that some cancer data show an increase in the incidence of leukemia, stomach cancer, cancer of the pancreas, and Hodgkin’s disease in workers exposed to ethylene oxide.


Delaware’s anticipated schedule for adopting the hospital ethylene oxide sterilizer requirements into Regulation 1138 is:

  • Start Action Notice Approved – Completed on May 14, 2008
  • Draft Regulatory Language Available – Completed on July 20, 2008
  • Proposed Regulatory Language Published in Delaware Register  – Completed on November 1, 2008
  • Public Hearings Held – Completed on December 3, 2008
  • Secretary's Order Issued - January 14, 2009
  • Effective Date – February 11, 2009


The owner or operator of a hospital ethylene oxide sterilizer is required to submit an initial notification of compliance status, pursuant to 9.7 of this regulation.  The owner or operator shall provide the Department (with copies to the EPA) with information provided in 9.7.1 or 9.7.2, whichever is applicable.  The Delaware Notification of Compliance Status Form may be used to meet this requirement.


Final Amendment of Section 9.0   NEW!

On Jan. 14, 2009 DNREC Secretary John A Hughes approved this proposed amendment to regulation 1138.

Public Hearing held on December 3, 2008

Initially Proposed Regulation and Public Hearing    

The public hearing notice and proposed regulation as they appeared in the November 1, 2008 Delaware Register of Regulations.

The proposed Section 9.0 addition to Regulation 1138 and the Public Hearing Notice submitted for publication in the November 1, 2008 Delaware Register of Regulations.

Draft Regulatory Language

State Action Notice

Reference Information

  • The General Provisions of Regulation 1138 that are applicable to owners or operators of hospital ethylene oxide sterilizers, as provided in Table 9-1 of Section 9.0, can be found in Section 3 of Regulation 1138.
  • Potential Adverse Health Effects Associted with Ethylene Oxide

EPA provides fact sheets describing the effects on human health of substances that were identified as hazardous air pollutants in the 1990 amendments of the Clean Air Act.  These substances include certain volatile organic chemicals, heavy metals, pesticides, herbicides, and radionuclides that present tangible hazards, based on scientific studies of exposure to humans and other mammals. Ethylene Oxide or ETO is classified as a hazardous air pollutant.

Links to EPA's Health Effects Fact Sheets are provided below:

 Federal Rules and Amendments

For information regarding Regulation No. 1138 in Delaware contact:

Jim Snead
715 Grantham Lane 
New Castle, DE 19720

Main line – (302) 323-4542
Fax line – (302) 323-4598


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