Neshap ethylene oxide • The proposed area source standards and practices to address EtO emissions include: o Fenceline monitoring and corrective action when a specified “action level” is Apr 13, 2023 · In 1994, the EPA promulgated the Ethylene Oxide Emissions Standards for Sterilization Facilities NESHAP, 40 CFR part 63, subpart O (referred to in this proposed rulemaking as the EtO Commercial Sterilization NESHAP) (59 FR 62589), which is codified at 40 CFR part 63, subpart O. The NESHAP established emission standards for both large and small commercial sterilizers that use at least 1 ton of ethylene oxide in sterilization or fumigation operations in any 12-month period. Exposure to these substances may cause adverse health effects such as irritation of the lung, eye, and mucous membranes, effects on the central nervous system, and cancer. Section 112(b) of the CAA identifies ethylene oxide (EO) as a HAP because it is suspected to cause cancer in humans, is highly mutagenic and teratogenic, and has significant acute and subchronic exposure health effects. Maximum ethylene glycol concentration means the concentration of ethylene glycol in the scrubber liquor of an acid-water scrubber control device established during a performance test when the scrubber achieves the appropriate control of EtO emissions. Jan 7, 2025 · Regulatory Impact Analysis for the Proposed NESHAP for Ethylene Oxide Commercial Sterilization and Fumigation Operations (pdf) (711. Accordingly, in this final action, we are also conducting a CAA section 112(d)(6) review of the current standards in this source category. According to the ruling, all owners and operators of sterilization facilities must use a CEMS to demonstrate compliance, with few exceptions. Mar 31, 2025 · Learn about the NESHAP for ethylene oxide emissions for sterilization facilities. The NESHAP for Ethylene Oxide Emissions Standards for Commercial Sterilization and Fumigation Operations found in 40 Code of Federal Regulations (CFR) Part 63, Subpart O establishes emission standards for major and area sources that use at least 1 ton of EtO in sterilization or fumigation operations in any 12-month period (59 FR 6289 1994). In addition to the current actions, EPA plans to publish a proposed rule covering hospitals with EtO sterilizers in February 2024 and a final rule in June 2025. EPA) is conducting its required periodic reviews of air rules, 2025 promises to bring additional changes to regulations for the chemical industry, including users of ethylene oxide (EtO). 5 to 3. Environmental Protection Agency Region 5, Library (PL-12J) 77 West Jackson May 30, 2024 · For years, the Environmental Protection Agency has been looking for ways to regulate the use of ethylene oxide (EtO) — a difficult-to-measure gas that is widely used to sterilize medical devices and some food products — as it’s been found to have carcinogenic properties. Ethylene oxide (EtO) is one of 188 hazardous air pollutants regulated by the EPA. CMAS NESHAP to address emissions of ethylene oxide (EtO) from CMAS. 71 KB, April 11, 2023) Hearing Registrants Mar 12, 2025 · On April 6, 2023, the U. Emission control standards are based on how much EtO a facility uses with the ability to use alternative compliance Sep 13, 2019 · For the NESHAP for Ethylene Oxide Commercial Sterilizers, EPA has been working over the past year to compile information on control technology options and costs for the more than 100 sterilizers that the rule would potentially cover. The EtO Commercial Sterilization NESHAP regulates EtO emitted from Apr 5, 2024 · We last completed this required technology review for the Ethylene Oxide Commercial Sterilization NESHAP (40 CFR 63, subpart O) in 2006. Since 2019, EPA has been gathering information about how to reduce people’s risk from exposure to ethylene oxide (EtO). Some of these pollutants are considered to be probable human carcinogens when inhaled, and all can cause toxic effects following exposure. Mar 15, 2024 · EPA’s final EtO NESHAP for Commercial Sterilization Facilities (CSF) has been released with significant changes from the proposal. To meet the requirements of the CAA, EPA promulgated NESHAP for ethylene oxide commercial sterilization and fumigation The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Ethylene Oxide Sterilization and Fumigation Operations apply to both new and existing commercial ethylene oxide (EO) sterilization and fumigation facilities using one ton of EO (as defined in 40 CFR section 63. ” 7 Mar 21, 2025 · The hazardous air pollutants (HAP) emitted by the facilities producing polyether polyols include ethylene oxide (EtO), propylene oxide (PO), hexane, toluene, and incidental emissions of several other HAP. Feb 3, 2025 · On March 14, 2024, EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers. Fact Sheet: Proposal to Strengthen Clean Air Act Standards for Ethylene Oxide Commercial Sterilizers (pdf) (200. 9 KB, 12/5/2019) Fact Sheet: Advance notice of proposed rulemaking for National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations ----- ETHYLENE OXIDE COMMERCIAL STERILIZATION AND FUMIGATION OPERATIONS NESHAP IMPLEMENTATION DOCUMENT Prepared for: Program Review Group Information Technology and Program Integration Division Office of Air Quality Planning and Standards U. Jan 27, 2025 · Continuing the momentum of the past several years as the United States Environmental Protection Agency (U. Dec 5, 2019 · Fact Sheet - Ethylene Oxide Sterilizers ANPRM (pdf) (176. These Maximum Achievable Control Technology or MACT standards are based on emissions levels that are already being achieved by the best-controlled and lowest-emitting sources in an industry. 361) after December 6, 1994. Mar 26, 2025 · In the first "technology-based" phase, EPA develops standards for controlling the emissions of air toxics from sources in an industry group. Apr 17, 2024 · This rule will set a variety of tougher limits for currently regulated emission from ethylene oxide sterilizers under National Emission Standards for Hazardous Air Pollutants (NESHAP) 40 CFR 63, Subpart O. Environmental Protection Agency (EPA) announced final amendments to Clean Air Act standards for ethylene oxide (EtO) emitted from commercial sterilization facilities, also called commercial sterilizers. Jan 22, 2025 · As such, we evaluated a Control Option to represent GACT for wastewater streams that are “in ethylene oxide service” that would require owners and operators at certain CMAS (those that would either become subject to the CMAS NESHAP if EtO is added to table 1 to 40 CFR part 63, subpart VVVVVV, as proposed, or are already subject to the CMAS Mar 13, 2024 · Ethylene Oxide (EtO, EO), a sterilant gas and a key ingredient in chemical feedstock, is being subjected to a major regulatory oversight revision to ensure industrial facilities limit fugitive emissions and worker exposure. Ethylene Oxide Emissions Standards for Sterilization Facilities, 40 CFR Part 63, Subpart O. Environmental Protection Agency Research Triangle Park, NC 27711 U. For facilities that use more than 100 pounds of ethylene oxide a year, the NESHAP ruling does not include an alternative to a National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilization and Fumigation Operations (40 CFR Part 63, Subpart O). S. Environmental Protection Agency (EPA) announced a proposal to significantly reduce emissions of toxic and other harmful air pollution from chemical plants, including the highly toxic chemicals ethylene oxide (EtO) and chloroprene Mar 21, 2025 · Ethylene Oxide Emission Standards for Sterilization Facilities (see also Hospital Ethylene Oxide Sterilizers) 40 CFR 63 Subpart O: Fabric Printing, Coating and Dyeing: 40 CFR 63 Subpart OOOO: Ferroalloys Production (major sources) 40 CFR 63 Subpart XXX: Ferroalloys Production (area sources) 40 CFR 63 Subpart YYYYYY (6Y) Mar 8, 2023 · Separately, on 8 October 2021, the EPA recognized that “despite recent monitoring efforts,” the agency does not “know what the background levels are for ethylene oxide,” and the “EPA’s current method for measuring ethylene oxide cannot detect it at all levels. size or operational use of ethylene oxide. 5 years to comply with EPA’s requirements instead of 18 months. This document presents the regulatory impact analysis (RIA) for this final rule. Aug 30, 2024 · One of these challenges is the short-term implementation of Continuous Emission Monitoring Systems (CEMS), which continuously track pollutant emissions in industrial facilities, specifically to monitor ethylene oxide (EtO) within a 2- to 3-year period based on your facility’s EtO usage and source type. • The EPA completed a risk assessment of CMAS and identified a need to propose EtO-specific standards. Who should use this guide? If you own or operate a commercial sterilization facility, then you should use this guide. S. Aug 21, 2023 · EPA’s EtO NESHAP Rule and EtO FIFRA Action are now in review, with both expected to be finalized by spring 2024. This rule is one of the most important measures EPA is taking to reduce emissions of EtO and will significantly reduce lifetime cancer risks for people living near commercial Mar 21, 2025 · The HAP emitted from MON manufacturing facilities include toluene, ethylene oxide, methanol, xylene, hydrogen chloride, and methylene chloride. • Originally issued in 1994, the NESHAP for ethylene oxide commercial sterilizers established emission limits for three parts of the facility. Mar 20, 2025 · On March 14, 2024, EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers. NESHAPs are meant to be revisited by USEPA on a periodic basis to incorporate new science on hazardous air pollutants. 55 KB) Rule History; Fact Sheet. Dec 18, 2024 · Learn about the NESHAP for hospital ethylene oxide sterilizers. CSFs will now have 2. Find the rule history information, federal register citations, legal authority, and related rules as well as a rule summary. The NESHAP for commercial sterilization plants was adopted in 1994, requiring control equipment to be added to commercial sterilizers reducing ethylene oxide emissions. Mar 14, 2024 · Ethylene Oxide Commercial Sterilization Facilities FACT SHEET • On March 14, 2024, the U. . trz iqxoo srugxgh bwu mtzj qdgm amvqtr xmnftks qlokx gvjam ypzf lvjym lklhv dxeec wdaj