WTO notification · TBT
United StatesUpdated: check whether it is now adopted or in force
Official title
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration
The United States issued an addendum on 4 May 2026 to the earlier TBT notification G/TBT/N/USA/1554. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 19 December 2019. The comment period closed on 15 May 2026.
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Ethylene oxide emissions; Environmental protection; Cleanrooms and associated controlled environments; Occupational safety. Industrial hygiene; Oxides
The comment period closed on 15 May 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/USA/1554/Rev.1/Add.1; it can take them up with the United States.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/USA/1554/Rev.1/Add.1, 4 May 2026)
The latest notice extends the comment period.
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration; Extension of Comment Period
On 17 March 2026, the U.S. Environmental Protection Agency (EPA) proposed a rule titled 'National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration' (notified in G/TBT/N/USA/1554/Rev.1). The EPA is extending the comment period on this proposed rule, which is scheduled to close on 1 May 2026. The comment period will now end on 15 May 2026, to allow additional time for stakeholders to review and comment on the proposal. The EPA is extending the comment period for the proposed rule that published in the Federal Register (FR) on 17 March 2026, at 91 FR 12700. The EPA must receive written comments on or before 15 May 2026. 91 Federal Register (FR) 23382, 1 May 2026; Title 40 Code of Federal Regulations (CFR) Part 63: This action and previous actions notified under the symbol G/TBT/N/USA/1554 are identified by Docket Numbers EPA-HQ-OAR-2019-0178. The Docket Folder is available from Regulations.gov at 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 15 May 2026. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with EPA and will also be submitted to the Docket on…
Proposed rule; reconsideration of final rule - On 5 April 2024, the U.S. Environmental Protection Agency (EPA) published the National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review (2024 Final Rule) (notified as G/TBT/N/USA/1554/Add.2). The 2024 Final Rule revised the Commercial Sterilization Facilities NESHAP based on a residual risk and technology review (RTR) pursuant to the Clean Air Act (CAA) sections. On 12 March 2025, the EPA announced that it was reconsidering the 2024 Final Rule. Based on its reconsideration of the RTR in the 2024 Final Rule, the EPA is proposing to amend the Commercial Sterilization Facilities NESHAP. The amendments would rescind the risk based standards, revise the standard for new aeration room vents that resulted from the technology review, revise the compliance demonstration requirements, and rescind a requirement related to permanent total enclosure (PTE). This proposal also includes technical corrections and clarifications to the Commercial Sterilization Facilities NESHAP and Performance Specification 19 to address erroneous cross-references, omissions of text, and typographical errors in the regulatory text that the EPA has identified after publication of the 2024 Final Rule. The EPA will hold a virtual public hearing on 1 April 2026. The EPA will announce further details at Please refer to the SUPPLEMENTARY INFORMATION section for…
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1554/Rev.1/Add.1
Comment deadline: Closed on 15 May 2026
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration; Extension of Comment Period
On 17 March 2026, the U.S. Environmental Protection Agency (EPA) proposed a rule titled 'National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration' (notified in G/TBT/N/USA/1554/Rev.1). The EPA is extending the comment period on this proposed rule, which is scheduled to close on 1 May 2026. The comment period will now end on 15 May 2026, to allow additional time for stakeholders to review and comment on the proposal. The EPA is extending the comment period for the proposed rule that published in the Federal Register (FR) on 17 March 2026, at 91 FR 12700. The EPA must receive written comments on or before 15 May 2026. 91 Federal Register (FR) 23382, 1 May 2026; Title 40 Code of Federal Regulations (CFR) Part 63: This action and previous actions notified under the symbol G/TBT/N/USA/1554 are identified by Docket Numbers EPA-HQ-OAR-2019-0178. The Docket Folder is available from Regulations.gov at 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 15 May 2026. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with EPA and will also be submitted to the Docket on…
RevisionG/TBT/N/USA/1554/Rev.1
Comment deadline: Closed on 1 May 2026
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration
Proposed rule; reconsideration of final rule - On 5 April 2024, the U.S. Environmental Protection Agency (EPA) published the National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review (2024 Final Rule) (notified as G/TBT/N/USA/1554/Add.2). The 2024 Final Rule revised the Commercial Sterilization Facilities NESHAP based on a residual risk and technology review (RTR) pursuant to the Clean Air Act (CAA) sections. On 12 March 2025, the EPA announced that it was reconsidering the 2024 Final Rule. Based on its reconsideration of the RTR in the 2024 Final Rule, the EPA is proposing to amend the Commercial Sterilization Facilities NESHAP. The amendments would rescind the risk based standards, revise the standard for new aeration room vents that resulted from the technology review, revise the compliance demonstration requirements, and rescind a requirement related to permanent total enclosure (PTE). This proposal also includes technical corrections and clarifications to the Commercial Sterilization Facilities NESHAP and Performance Specification 19 to address erroneous cross-references, omissions of text, and typographical errors in the regulatory text that the EPA has identified after publication of the 2024 Final Rule. The EPA will hold a virtual public hearing on 1 April 2026. The EPA will announce further details at Please refer to the SUPPLEMENTARY INFORMATION section for…
AddendumG/TBT/N/USA/1554/Add.2
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review
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 unregulated 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 amendments pursuant to 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 periods 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…
AddendumG/TBT/N/USA/1554/Add.1
Comment deadline: Closed on 27 June 2023
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations
TITLE: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review 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 Hazardous 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 review 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 during periods of startup, shutdown, and malfunction (SSM), including…
Regular notificationG/TBT/N/USA/1554
Comment deadline: Closed on 10 February 2020
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations
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 soliciting 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 is 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.
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