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Commercial Sterilizers

Air Toxics Notebook

Commercial Sterilizers

Applicability

eCFR Subpart O [ecfr.gov]

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;
Rules apply to small, area sources?
Yes
Known Sources in NDEE Jurisdiction
Facility IDNameCity
73007Becton DickinsonColumbus
Date of Original Final Rule
Amendments Dates

05/10/2021 - Proposed Informatoin Collection Request, 2nd Notice
06/05/2020 - Proposed Informatoin Collection Request
12/12/2019 - Advanced Notice of Proposed Rulemaking
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, Chapter 13, Section 001.10

Previously: 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 [ecfr.gov]

 

206 KB1O - Fed. Reg. 2021-05-10 Proposed Information Collection Request 2nd Notice.pdf
271 KB1O - Fed. Reg. 2020-06-05 Proposed Informatoin Collection Request.pdf
317 KB1O - Fed. Reg. 2019-12-12 ANPRM.pdf
311 KB1O - Fed. Reg. 2005-12-19 - Final Rule.pdf
193 KB1O - Fed. Reg. 2001-11-02 - Final Rule; amendments.pdf
FAQ's, Fact Sheets, and Rules Summaries

Texas CEQ - Rule Flowchart [tceq.texas.gov]

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

 

293 KB1O - EPA Guide 2004.pdf
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