G/TBT/N/USA/1554  
19 December 2019  
(19-8874) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AME RICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Environmental Protection Agency (EPA) [1581]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applica ble):  Ethylene 
oxide emissions; Environmental protection (ICS 13.020), Cleanrooms and associated 
controlled environments (ICS 13.040.35), Oxides (ICS 71.060.20)  
5. Title, number of pages and language(s) of the notified document:  National 
Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization 
and Fumigation Operations (11 page(s), in English)  
6. Description of content:  In this advance notice of proposed rulemaking (ANPRM), the 
U.S. Environmental Protection Agency (EPA) is soliciting information that will aid in 
potential future revisions to the Ethylene Oxide Emission Standards for Sterilization 
Facilities. The EPA is s oliciting information and requesting comment on potential control 
measures for reducing ethylene oxide (EtO) emissions from commercial sterilization 
facilities. These control measures include controls for fugitive emissions of EtO, safety 
measures for the chamber exhaust vents (CEVs), process equipment improvements, and 
advances in add -on control technologies for point sources. In addition, the EPA is 
considering, and requesting comment on, how best to assess potential impacts on small 
businesses. The EPA i s also taking comment on the available EtO usage data for individual 
facilities and on additional data contained in the modeling file that will be used to evaluate 
the impact of emissions from commercial EtO sterilizers.  
7. Objective and rationale, includ ing the nature of urgent problems where 
applicable:  Protection of the environment  
8. Relevant documents:   
• 84 Federal Register (FR) 67889, 12 December 2019; Title 40 Code of Federal 
Regulations (CFR) Part 63:  
https://www.govinfo.gov/content/pkg/FR -2019-12-12/html/2019 -26804.htm  
https://www.govinfo.gov/content/pkg/FR -2019-12-12/pdf/2019 -26804.pdf  G/TBT/N/USA/1554  
 
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  • Supporting Documents:  
https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentD
ueDate&po=0&dct=SR%2BO&D=EPA -HQ-OAR-2019-0178 
9. Prop osed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  10 February 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2019/TBT/USA/19_7342_00_e.pdf