Air Toxics Notebook
Commercial Sterilizers -  Subpart O

Applicability: eCFR Subpart O []

This subpart applies to:
  1. Sterilization sources that use ethylene oxide in sterilization or fumigation operations.

Not subject to this subpart:
  1. Beehive fumigators;
  2. Research or laboratory facilities as defined in Section 112(c)(7) of Title III of the Clean Air Act Amendment of 1990;
  3. Ethylene oxide sterilization operations at hospitals, doctors offices, clinics, or other facilities whose primary purpose is to provide medical services to humans or animals;

Partial Exemptions:
  1. Sterilization sources using less than 1 ton of ethylene oxide within any 12-month consecutive period are not subject to emission standards, however other subpart requirements still apply.
Rules apply to small, area sources? Yes
Known Sources in NDEQ Jurisdiction:

Facility ID

Becton Dickinson

Date of Original Final Rule: 12/6/94
Amendments Dates: 12/19/2005 - Final Rule (Title V operating permit deferrals for area sources)
11/02/2001 - Amendments to chamber exhaust vent requirements
12/14/1999 - Title V operating permit deferral
06/03/1996 - Title V operating permit deferral
State Regulations (Title 129): Title 129, Chapter 28, Section 001.24. Sources are also responsible for ensuring they are in compliance with current federal requirements found for this subpart in the CFR.
Federal Regulations: 40 CFR 63.360
Related Rules:

NESHAP - 40 CFR Part 63

Subpart WWWWW - Hospitals Ethylene Oxide Sterilizers
Regulations and Federal Registers:
eCFR Subpart O []

(See attached file: 1O - Fed. Reg. 2005-12-19 - Final Rule.pdf)

(See attached file: 1O - Fed. Reg. 2001-11-02 - Final Rule; amendments.pdf)

SizeFile Name
311 KB 1O - Fed. Reg. 2005-12-19 - Final Rule.pdf
193 KB 1O - Fed. Reg. 2001-11-02 - Final Rule; amendments.pdf
Important Dates:
FAQs, Fact Sheets, and Rule Summaries: (See attached file: 1O - EPA Guide 2004.pdf)

Texas CEQ - Rule Flowchart []

EPA's Subpart O Website [] - Contains federal register notices and implementation tools

SizeFile Name
293 KB 1O - EPA Guide 2004.pdf
Presentations, Training and Articles:
Other Information and Resources:
Page Last Updated: 2/23/18