G/TBT/N/USA/1554/Add.1  
 
 
2 June 2023  
(23-3783) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  2 June 2023, 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 Commercial 
Sterilization and Fumigation Operations  
 
Reason for Addendum:  
[X] Comment period changed - date:  27 June 2023; 
https://www.govinfo.gov/content/pkg/FR -2023-06-01/html/2023 -11619.htm  
https://www.govinfo.gov/content/pkg/FR -2023-06-01/pdf/2023 -11619.pdf  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] Text of final measure available from1:  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[X] Content or scope of notified measure changed  and text available from1:  
12 June 2023, extended to 27 June 2023  
https://www.govinfo.gov/content/pkg/FR -2023-04-13/html/2023 -06676.htm  
https://www.govinfo.gov/content/pkg/FR -2023-04-13/pdf/2023 -06676.pdf  
https://members.wto.org/crnattachments/2023/TBT/USA/modification/23_1 0000_00_e
.pdf 
https://members.wto.org/crnattachments/2023/TBT/USA/modification/23_10000_01_e
.pdf 
New deadline for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  TITLE: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide 
Emissions Standards for Sterilization Facilities Residual Risk and Technology Review  
 
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.1  
 
- 2 - 
 
  AGENCY: Environmental Protection Agency (EPA)  
ACTION: Proposed rule; extension of public comment period.  
SUMMARY: On 13 April 2023, the U.S. Environmental Protection Agency (EPA) proposed a rule titled 
"National Emission Standards for Haz ardous Air Pollutants: Ethylene Oxide Emissions Standards for 
Sterilization Facilities Residual Risk and Technology Review." The EPA is extending the comment 
period on this proposed rule that currently closes on 12 June 2023, by 15 days. The comment period  
will now remain open until 27 June 2023, to allow additional time for stakeholders to review and 
comment on the proposal.  
EPA is proposing amendments to the National Emission Standards for Hazardous Air Pollutants 
(NESHAP) for the Commercial Sterilization  Facilities source category. The EPA is proposing decisions 
concerning the risk and technology review (RTR), including proposing amendments pursuant to the 
technology review for certain point source emissions and proposing amendments pursuant to the 
risk r eview to specifically address ethylene oxide (EtO) emissions from point source and room air 
emissions from all commercial sterilization facilities. The EPA is also proposing amendments to 
correct and clarify regulatory provisions related to emissions durin g periods of startup, shutdown, 
and malfunction (SSM), including removing general exemptions for periods of SSM and adding work 
practice standards for periods of SSM where appropriate. Lastly, the EPA is proposing to revise 
monitoring and performance testi ng requirements and to add provisions for electronic reporting of 
performance test results and reports, performance evaluation reports, and compliance reports. We 
estimate that, if finalized, these proposed amendments would reduce EtO emissions from this s ource 
category by 19 tons per year (tpy) and reduce risks to public health to acceptable levels.  
This proposed rule; extension of the public comment period is identified by Docket Number EPA -HQ-
OAR-2019-0178. The Docket Folder is available on Regulations.g ov 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. WTO Members and their stakeholders are 
asked to submit comments to the USA TBT Enquiry Point  by or before 4pm Eastern Time  on 27 June 
2023. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders 
will be shared with the regulator and will also be submitted to the Docket  on Regulations.gov if 
received within the comment period.  
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