National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Parts 60 and 63</CFR> <DEPDOC>[EPA-HQ-OAR-2019-0178; FRL-7055-02-OAR]</DEPDOC> <RIN>RIN 2060-AU37</RIN> <SUBJECT>National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective on April 5, 2024. The incorporation by reference (IBR) of certain material listed in the rule is approved by the Director of the Federal Register April 5, 2024. The incorporation by reference (IBR) of certain other material listed in the rule was approved by the Director of the Federal Register before February 27, 2021. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The U.S. Environmental Protection Agency (EPA) has established a docket for this action under Docket ID No. EPA-HQ-OAR-2019-0178. All documents in the docket are listed on the <E T="03">https://www.regulations.gov/</E> website. Although listed, some information is not publicly available, <E T="03">e.g.,</E> Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through <E T="03">https://www.regulations.gov/,</E> or in hard copy at the EPA Docket Center, WJC West Building, Room Number 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST), Monday through Friday. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For questions about this final action, contact U.S. EPA, Attn: Jonathan Witt, Mail Drop: E143-05, 109 T.W. Alexander Drive, P.O. Box 12055, RTP, North Carolina 27711; telephone number: (919) 541-5645; and email address: <E T="03">witt.jon@epa.gov.</E> For specific information regarding the risk modeling methodology, contact U.S. EPA, Attn: Matthew Woody, Mail Drop: C539-02, 109 T.W. Alexander Drive, P.O. Box 12055, RTP, North Carolina 27711; telephone number: (919) 541-1535; and email address: <E T="03">woody.matt@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Preamble acronyms and abbreviations.</E> We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here: <EXTRACT> <FP SOURCE="FP-2">ADAF age-dependent adjustment factor</FP> <FP SOURCE="FP-2">AEGL acute exposure guideline level</FP> <FP SOURCE="FP-2">APCD air pollution control device</FP> <FP SOURCE="FP-2">ARV aeration room vent</FP> <FP SOURCE="FP-2">ASME American Society of Mechanical Engineers</FP> <FP SOURCE="FP-2">BTF Beyond-the-Floor</FP> <FP SOURCE="FP-2">BMP best management practice</FP> <FP SOURCE="FP-2">CAA Clean Air Act</FP> <FP SOURCE="FP-2">CDX Central Data Exchange</FP> <FP SOURCE="FP-2">CEDRI Compliance and Emissions Data Reporting Interface</FP> <FP SOURCE="FP-2">CEMS continuous emission monitoring system</FP> <FP SOURCE="FP-2">CEV chamber exhaust vent</FP> <FP SOURCE="FP-2">CFR Code of Federal Regulations</FP> <FP SOURCE="FP-2">cfs cubic feet per second</FP> <FP SOURCE="FP-2">dscfm dry standard cubic feet per minute</FP> <FP SOURCE="FP-2">EJ environmental justice</FP> <FP SOURCE="FP-2">EPA Environmental Protection Agency</FP> <FP SOURCE="FP-2">ERT Electronic Reporting Tool</FP> <FP SOURCE="FP-2">EtO ethylene oxide</FP> <FP SOURCE="FP-2">FDA Food and Drug Administration</FP> <FP SOURCE="FP-2">FIFRA Federal Insecticide, Fungicide, and Rodenticide Act</FP> <FP SOURCE="FP-2">FR Federal Register</FP> <FP SOURCE="FP-2">FRFA final regulatory flexibility analysis</FP> <FP SOURCE="FP-2">FTIR Fourier Transform Infrared Spectroscopy</FP> <FP SOURCE="FP-2">GACT generally available control technology</FP> <FP SOURCE="FP-2">HAP hazardous air pollutants(s)</FP> <FP SOURCE="FP-2">HEM Human Exposure Model</FP> <FP SOURCE="FP-2">HQ hazard quotient</FP> <FP SOURCE="FP-2">ICR Information Collection Request</FP> <FP SOURCE="FP-2">ID Interim Decision</FP> <FP SOURCE="FP-2">IFU instructions for use</FP> <FP SOURCE="FP-2">IRFA initial regulatory flexibility analysis</FP> <FP SOURCE="FP-2">IRIS Integrated Risk Information System</FP> <FP SOURCE="FP-2">ISO International Organization for Standardization</FP> <FP SOURCE="FP-2">km kilometer</FP> <FP SOURCE="FP-2">lb pound</FP> <FP SOURCE="FP-2">lb/h pounds per hour</FP> <FP SOURCE="FP-2">LEL lower explosive limit</FP> <FP SOURCE="FP-2">LPL lower prediction limit</FP> <FP SOURCE="FP-2">MACT maximum achievable control technology</FP> <FP SOURCE="FP-2">MIR maximum individual risk</FP> <FP SOURCE="FP-2">mg/L milligrams per liter</FP> <FP SOURCE="FP-2">NAICS North American Industry Classification System</FP> <FP SOURCE="FP-2">NDO natural draft opening</FP> <FP SOURCE="FP-2">NESHAP national emission standards for hazardous air pollutants</FP> <FP SOURCE="FP-2">OMB Office of Management and Budget</FP> <FP SOURCE="FP-2">OPP Office of Pesticide Programs</FP> <FP SOURCE="FP-2">OSHA Occupational Safety and Health Administration</FP> <FP SOURCE="FP-2">PID Proposed Interim Decision</FP> <FP SOURCE="FP-2">ppbv parts per billion by volume</FP> <FP SOURCE="FP-2">ppm parts per million</FP> <FP SOURCE="FP-2">ppmv parts per million by volume</FP> <FP SOURCE="FP-2">PTE permanent total enclosure</FP> <FP SOURCE="FP-2">REL reference exposure level</FP> <FP SOURCE="FP-2">RDL Representative detection level</FP> <FP SOURCE="FP-2">RFA Regulatory Flexibility Act</FP> <FP SOURCE="FP-2">RIA regulatory impact assessment</FP> <FP SOURCE="FP-2">RTR risk and technology review</FP> <FP SOURCE="FP-2">SAB Science Advisory Board</FP> <FP SOURCE="FP-2">SBA Small Business Administration</FP> <FP SOURCE="FP-2">SBAR Small Business Advocacy Review</FP> <FP SOURCE="FP-2">SCV sterilization chamber vent</FP> <FP SOURCE="FP-2">SER small entity representative</FP> <FP SOURCE="FP-2">SSM startup, shutdown, and malfunction</FP> <FP SOURCE="FP-2">TOSHI target organ-specific hazard index</FP> <FP SOURCE="FP-2">tpy tons per year</FP> <FP SOURCE="FP-2">UPL upper prediction limit</FP> <FP SOURCE="FP-2"> µg/m <SU>3</SU>  micrograms per cubic meter </FP> <FP SOURCE="FP-2">UMRA Unfunded Mandates Reform Act</FP> <FP SOURCE="FP-2">URE unit risk estimate</FP> <FP SOURCE="FP-2">VCS voluntary consensus standards</FP> </EXTRACT> <E T="03">Background information.</E> On April 13, 2023, the EPA proposed revisions to the Commercial Sterilization Facilities NESHAP based on our RTR. In this action, we are finalizing decisions and revisions for the rule. We summarize some of the more significant comments we timely received regarding the proposed rule and provide our responses in this preamble. A summary of all other public comments on the proposal and the EPA's responses to those comments is available in <E T="03">Summary of Public Comments and Responses for the Risk and Technology Review for Commercial Sterilization Facilities,</E> Docket ID No. EPA-HQ-OAR-2019-0178. A “track changes” version of the regulatory language that incorporates the changes in this action is available in the docket. <E T="03">Organization of this document.</E> The information in this preamble is organized as follows: <EXTRACT> <FP SOURCE="FP-2">I. General Information</FP> <FP SOURCE="FP1-2">A. Executive Summary</FP> <FP SOURCE="FP1-2">B. Does this action apply to me?</FP> <FP SOURCE="FP1-2">C. Where can I get a copy of this document and other related information?</FP> <FP SOURCE="FP1-2">D. Judicial Review and Administrative Reconsideration</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP1-2">A. What is the statutory authority for this action?</FP> <FP SOURCE="FP1-2">B. What is the Commercial Sterilization Facilities source category and how does the NESHAP regulate HAP emissions from the source category?</FP> <FP SOURCE="FP1-2">C. What changes did we propose f ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 784k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━