4 The record articles

40 CFR Part 63, Subpart O Comments and Information Request

Posted: January 14th, 2020

Authors: Christina L. 

On December 12, 2019, U.S. EPA issued an advance notice of proposed rulemaking (ANPRM) requesting information from the ethylene oxide (EtO) sterilization industry, including companies, trade associations, and control technology vendors.  In addition to the ANPRM, U.S. EPA is seeking additional information from facilities on several topics under the authority of Section 114 of the Clean Air Act (CAA) “Section 114 Request”.  These actions focus on potential amendments to 40 CFR Part 63, Subpart O (Ethylene Oxide Emissions Standards for Sterilization Facilities), which contains the standards for hazardous air pollutants (HAP) that apply to commercial EtO sterilization facilities.

Some background on the rule’s history and additional information about the ANPRM and Section 114 Request are provided below.

Rule Background

  • 1994: Original 40 CFR Part 63, Subpart O, Ethylene Oxide Emissions Standards for Sterilization Facilities rule finalized
  • 2001: Amendment to remove 40 CFR Part 63, Subpart O requirements (i.e., controls) from sterilization chamber exhaust vents due to a safety issue
  • 2005: Amendment to exempt area sources from Title V Operating Permit program
  • 2006: Risk and Technology Review (RTR) concluded no revisions to the standard were necessary
  • 2016: U.S. EPA updated the cancer risk value for EtO to reflect higher cancer risk in the Integrated Risk Information System (IRIS)
  • 2018: U.S. EPA incorporated new risk values into the National Air Toxics Assessment (NATA), showing higher cancer risks for areas near commercial sterilizers
  • 2016 – 2019:
    • Increased public scrutiny at EtO facilities since the IRIS value for EtO was updated
    • S. EPA and U.S. Food and Drug Association (FDA) acknowledge that EtO facility shutdowns are causing a shortage of sterilized medical devices
    • ANPRM published December 12, 2019 with comments due on February 10, 2020
    • Section 114 Information Collection Request (ICR) sent to select recipients


The ANPRM contained requests for comments on 20 items focusing on the following:

  • Corrections to a Modeling File and Annual EtO Usage Data that Evaluates the Impact of Emissions from Commercial EtO Sterilizers
  • Control of Fugitive Emissions
  • Chamber Exhaust Vent Control and Safety Considerations
  • Other Pont Source Control Options
  • Types of Sterilization Facilities

Section 114 Request

In addition to the ANPRM, U.S. EPA is seeking additional information from facilities on several topics under the authority of Section 114 of the Clean Air Act via an ICR.  The “Section 114 Request” is required to be completed by any facility that receives the Section 114 Request. The Section 114 Request contains a survey for information related to current operations, EtO emissions, air permitting, performance testing, and monitoring.

Here are links to the ANRPM published within the Federal Register and the Section 114 Request.

If your facility is looking for assistance in responding to the ANPRM or the Section 114 Request, please free to contact me at clynch@all4inc.com or 610-422-1135.



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