G/TBT/N/USA/1554/Add.2  
 
8 April 2024  
(24-2950) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  8 April 2024, is being circulated at the request of the delegation 
of the United States of America . 
 
_______________  
 
 
Title:  National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions 
Standards for Sterilization Facilities Residual Risk and Technology Review  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 5 April 2024;  
[X] Notified measure enters into force - date: 5 April 2024  
[X] Text of final measure available from1:  
89 Federal Register (FR) 24090; Title 40 Code of Federal Regulations (CFR) Part 60 and 
Part 63:  
https://www.govinfo.gov/content/pkg/FR -2024-04-05/html/2024 -05905.htm  
https://www.govinfo.gov/content/pkg/FR -2024-04-05/pdf/2024 -05905.pdf  
https://members.wto.org/crnattachments/2024/TBT/USA/final_measure/24_02484_00
_e.pdf  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[ ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  Final rule from the Environmental Protection Agency (EPA) - This action finalizes the 
residual risk and technology review  (RTR) conducted for the Commercial Sterilization Facilities  
source category regulated under national emission standards for hazardous air pollutants (NESHAP) 
under the Clean Air Act. The EPA is finalizing decisions concerning the RTR, including definitions for 
affected sources, emission standards for previously un regulated sources, amendments pursuant to 
the risk review to address ethylene oxide (EtO) emissions from certain sterilization chamber vents 
(SCVs), aeration room vents (ARVs), chamber exhaust vents (CEVs), and room air emissions, and 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1554/Add.2  
 
- 2 - 
 
  amendments pursuant t o the technology review for certain SCVs and ARVs. In addition, we are 
taking final action to correct and clarify regulatory provisions related to emissions during periods of 
startup, shutdown, and malfunction (SSM), including removing exemptions for perio ds of SSM. We 
are also taking final action to require owners and operators to demonstrate compliance through the 
use of EtO continuous emissions monitoring systems (CEMS), with exceptions for very small users 
of EtO; add provisions for electronic reporting  of performance test results and other reports; and 
include other technical revisions to improve consistency and clarity. We estimate that these final 
amendments will reduce EtO emissions from this source category by approximately 21 tons per year 
(tpy).  
This action is identified by Docket Number EPA -HQ-OAR-2019-0178. The Docket Folder is available 
on Regulations.gov  at https://www.regulations.gov/docket/EPA -HQ-OAR-2019-0178/document  and 
provides access to primary and supporting documents as well as comments received. Documents 
are also accessible from Regulations.gov  by searching the Docket Number.  
See also 40 CFR 60  and 40 CFR 63 . 
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