National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations

Protection of the environment (TBT)

Ethylene oxide emissions

Link to ePing

13.020 - Environmental protection; 13.020 - Environmental protection; 13.040.35 - Cleanrooms and associated controlled environments; 13.040.35 - Cleanrooms and associated controlled environments; 71.060.20 - Oxides; 71.060.20 - Oxides

TITLE: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology ReviewAGENCY: 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 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 testing 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 source 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.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. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point by or before 4pmEastern 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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