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HomeMy WebLinkAboutDAQ-2024-0051301 DAQC-CI104350001-23 Site ID 10435 (B1) MEMORANDUM TO: FILE – STERIGENICS US, LLC – Ethylene Oxide Commercial Sterilization Plant THROUGH: Chad Gilgen, Minor Source Compliance Section Manager FROM: Susan Weisenberg, Environmental Scientist DATE: September 22, 2023 SUBJECT: FULL COMPLIANCE EVALUATION, Minor, Salt Lake County INSPECTION DATE: August 23, 2023 SOURCE LOCATION: 5725 West Harold Gatty Drive International Center Salt Lake City, UT 84116 DIRECTIONS: From I-80 West bound, take exit 113, 5600 West. Take west bound Amelia Earhart Drive to Harold Gatty Drive. SOURCE CONTACTS: Joe Jeppson, General Manager, Salt Lake City 801-328-9901 OPERATING STATUS: Operating normally PROCESS DESCRIPTION: Disposable medical devices are stored in a warm and humid environment. After temperature and humidity stabilization the products are moved to one of ten sterilizer chambers for sterilization with ethylene oxide (EtO). A source tank scale controls the volume of EtO pumped into the chambers. After a prescribed resident time the chambers are purged with nitrogen or air through the sterilization chamber vacuum exhaust to the Ceilcote acid water high volume scrubber. The sterilized product is then moved to one of 14 aeration rooms and is stored to release the remaining EtO. Emissions from the aeration rooms are vented through the Advanced Air Technologies (AAT) scrubber. It is reported that aeration room emissions can be held if the AAT system malfunctions or requires maintenance. The AAT adsorber which consists of seven adsorbent dry beds controls the vacuum vent emissions during breakdowns and emergency events. The chamber back vents to the AAT. The Ceilcote scrubber consists of a packed tower scrubber, two acid-water reaction glycol storage tanks (17,000 gallons each), dual recycling plumbing, heat exchanger, and control panel. Acidified (sulfuric) water/glycol is sprayed from the top of the tower and the EtO is vented to the bottom. The acidified water reacts with the EtO to form ethylene glycol. The acidified water 2 circulates until the solution reaches a designated glycol concentration. All or part of the glycol solution is then pumped to a tank for reuse. Fresh water and sulfuric acid is added as needed to the system and the process continues The AAT scrubber system consists of a packed scrubber tower, three acid water-reaction glycol storage tanks (18,500 gallons each), seven adsorbent dry beds and a countercurrent flow running acid-water. This system can use one or two components to meet the 99% reduction requirement; the acid scrubber (SC1) and dry beds (SC2). The first component (SC1) is a high air flow (up to 13,000 cfm), large volume (55,000 gallons) acid water scrubber capable of handling all the aeration room vents. Due to the high evaporative water losses the control tank liquid level is held constant by frequent water addition. The first component, like the Ceilcote scrubber, uses acid-water that reacts with the EtO to produce ethylene glycol. The second component (SC2) consists of seven adsorbent dry beds. Each dry bed is a pair of drawers filled with dry adsorbent media. The SRI GC is used to monitor the dry beds when used as a backup system. The acid scrubber and dry beds are under negative pressure created by a stack fan drawing up to 13,000 cfm. APPLICABLE REGULATIONS: Approval Order (AO) DAQE-AN104350030-21, dated March 25, 2021 NSPS (Part 60) JJJJ: Standards of Performance for Stationary Spark Ignition Internal Combustion Engines, MACT (Part 63) -O: Ethylene Oxide Emissions Standards for Sterilization Facilities, MACT (Part 63) - ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines, SOURCE EVALUATION: Name of Permittee: Permitted Location: Sterigenics US, LLC - Ethylene Oxide Commercial Sterilization Plant 2015 Spring Road, Suite 650 Oak Brook, IL 60523 5725 West Harold Gatty Drive International Center Salt Lake City, UT 84116 SIC Code: 7389: (Business Services, NEC) Section I: GENERAL PROVISIONS I.1 All definitions, terms, abbreviations, and references used in this AO conform to those used in the UAC R307 and 40 CFR. Unless noted otherwise, references cited in these AO conditions refer to those rules. [R307-101] I.2 The limits set forth in this AO shall not be exceeded without prior approval. [R307-401] 3 I.3 Modifications to the equipment or processes approved by this AO that could affect the emissions covered by this AO must be reviewed and approved. [R307-401-1] I.4 All records referenced in this AO or in other applicable rules, which are required to be kept by the owner/operator, shall be made available to the Director or Director's representative upon request, and the records shall include the two-year period prior to the date of the request. Unless otherwise specified in this AO or in other applicable state and federal rules, records shall be kept for a minimum of two (2) years. [R307-401-8] I.5 At all times, including periods of startup, shutdown, and malfunction, owners and operators shall, to the extent practicable, maintain and operate any equipment approved under this AO, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions. Determination of whether acceptable operating and maintenance procedures are being used will be based on information available to the Director which may include, but is not limited to, monitoring results, opacity observations, review of operating and maintenance procedures, and inspection of the source. All maintenance performed on equipment authorized by this AO shall be recorded. [R307-401-4] I.6 The owner/operator shall comply with UAC R307-107. General Requirements: Breakdowns. [R307-107] I.7 The owner/operator shall comply with UAC R307-150 Series. Emission Inventories. [R307-150] I.8 The owner/operator shall submit documentation of the status of construction or modification to the Director within 18 months from the date of this AO. This AO may become invalid if construction is not commenced within 18 months from the date of this AO or if construction is discontinued for 18 months or more. To ensure proper credit when notifying the Director, send the documentation to the Director, attn.: NSR Section. [R307-401-18] Status: In Compliance. No AO limits appeared to have been exceeded based on the site observations and the submitted documents. No equipment additions or changes to the process were noted during the inspection. No UAC R307-107 applicable breakdowns are on record. This site is not subject to Emission Inventory requirements. A startup notification for Chamber 11 (item II.A.12) was submitted on August 25, 2023. See the attached email statement. Chambers 12 -17 (items II.A.13 through II.A.18) have not yet been completed. Section II: SPECIAL PROVISIONS II.A The approved installations shall consist of the following equipment: II.A.1 Sterigenics US, LLC Commercial medical equipment ethylene oxide sterilization facility. II.A.2 EtO Sterilizer Chamber 1 Capacity: 1,087 cu. ft. (8-pallet) Manufacture Date: 2004 II.A.3 EtO Sterilizer Chamber 2 Capacity: 1,087 cu. ft. (8-pallet) Manufacture Date: 2000 II.A.4 EtO Sterilizer Chamber 3 Capacity: 1,087 cu. ft. (8-pallet) Manufacture Date: 2004 II.A.5 EtO Sterilizer Chamber 4 Capacity: 1,087 cu. ft. (8-pallet) Manufacture Date: 2003 4 II.A.6 EtO Sterilizer Chamber 5 Capacity: 35 cu. ft. (1-pallet) Manufacture Date: 1990 II.A.7 EtO Sterilizer Chamber 6 Capacity: 1,080 cu. ft. (8-pallet) Manufacture Date: 1999 II.A.8 EtO Sterilizer Chamber 7 Capacity: 1,087 cu. ft. (8-pallet) Manufacture Date: 2002 II.A.9 EtO Sterilizer Chamber 8 Capacity: 1,133 cu. ft. (8-pallet) Manufacture Date: 1990 II.A.10 EtO Sterilizer Chamber 9 Capacity: 283 cu. ft. (2-pallet) Manufacture Date: 1992 II.A.11 EtO Sterilizer Chamber 10 Capacity: 3,600 cu. ft. (24-pallet) Manufacture Date: 1997 II.A.12 EtO Sterilizer Chamber 11 Capacity: 198 cu. ft. (1-pallet) Manufacture Date: 1999 II.A.13 EtO Sterilizer Chamber 12 Capacity: 20 cu. ft. (R&D) II.A.14 EtO Sterilizer Chamber 13 Capacity: 20 Cu. Ft. (R&D) II.A.15 EtO Sterilizer Chamber 14 Capacity: 6 cu ft. (R&D) II.A.16 EtO Sterilizer Chamber 15 Capacity: 12 cu. ft. (R&D) II.A.17 EtO Sterilizer Chamber 16 Capacity: 20 cu. ft. (R&D) II.A.18 EtO Sterilizer Chamber 17 Capacity: 20 cu. ft. (R&D) II.A.19 Ceilcote Scrubber One scrubber equipped with a packed tower, reaction tanks, dual recycle piping, heat exchanger and a control panel II.A.20 Advanced Air Technologies Scrubber One scrubber equipped with packed tower with a countercurrent flow running acid-water Maximum air-flow rate: 13,000 cubic feet/minute II.A.21 Advanced Air Technologies Adsorber Seven adsorbers consisting of dry beds II.A.22 Nitrogen Dioxide Sterilizer Control: Scrubber-Adsorber Cartridges 5 II.A.23 Various Water Tube Boilers Maximum Rated Capacity: Less than 5.0 MMBtu/hr each Fuel: Natural Gas II.A.24 Comfort Heaters Maximum Rated Capacity: Less than 5.0 MMBtu/hr each Fuel: Natural Gas II.A.25 Five Non-Volatile Liquid Organic Storage Tanks Two 17,000 gallon and three 18,500 gallon tanks, for information purposes. Status: In Compliance. No unapproved equipment was observed operating at the source location. Additional equipment and process information gathered at the time of inspection: • II.A.13 through II.A.18 - EtO Sterilizer Chambers 12 through 17 - have not yet been installed. • II.A.22 - Nitrogen Dioxide Sterilizer - Has been permanently removed. • II.A.23 - Various Water Tube Boilers - The source currently operates two Cleaver-Brooks FLX Watertube Boilers rated at 4.5 MMBtu/hr each. • The source operates a maintenance shop which contains an enclosed abrasive unit used to sporadically remove calcium deposits. • The source operates a natural-gas fired emergency generator that was installed in 2019 with a manufacture date of February 2019. Sterigenics appears to have submitted the required information to Minor Source NSR. The issuance of the Modified AO adding this generator to the permit is pending a complete review of a submitted Reduction in Air Contaminants request. II.B Requirements and Limitations II.B.1 Requirements and Limitations II.B.1.a The owner/operator shall not use more than 210.2 tons of ethylene oxide gas per rolling 12- month period. [R307-401-8] Status: In Compliance. The 12-month rolling total ethylene oxide gas used for the period of August 2022 through July 2023, was reported as 123.784 tons (247,568 pounds). See the attached spreadsheet. II.B.1.a.1 The owner/operator shall: A. Determine usage with purchase and usage records. B. Record usage on a daily basis C. Use the usage data to calculate a new rolling 12-month total by the 28th day of each month using data from the previous 12 months. [R307-401-8] Status: In Compliance. The records were provided during the inspection. Totals are determined by daily usage and purchase data. The data is tabulated into a spreadsheet by at least the 28th day of each month. 6 II.B.1.b The owner/operator shall use ethylene oxide monitoring devices in the dispensing and sterilization areas. [R307-401-8] Status: Not Applicable. In compliance/not applicable as these monitoring devices are in place but used solely to measure the ethylene oxide in the indoor air. II.B.1.c Visible emissions from the following emission points shall not exceed the following values: A. AAT scrubber and dry bed system - 0% opacity B. Storage Tanks - 0% opacity C. All other points - 20% opacity. [R307-201-3] Status: In Compliance. No emissions were observed from any scrubber stack, vent, or other point. See the attached VEO form. II.B.1.c.1 Opacity observations of emissions from stationary sources shall be conducted according to 40 CFR 60, Appendix A, Method 9. [R307-401-8] Status: In Compliance. Observations were made in a manner consistent with Method 9. II.B.2 Scrubber Requirement II.B.2.a The Ceilcote scrubber shall be used to control all process streams from the sterilization chamber vacuum pumps. The Advanced Air Technologies (AAT) scrubber and adsorber system shall control all process streams from the aeration vents. [R307-401-8] Status: In Compliance. The Ceilcote and AAT scrubbers were observed to be properly installed to control process streams at the points required. II.B.2.b Emissions from the Ceilcote scrubber shall be routed to the AAT scrubber and adsorber system. [R307-401-8] Status: In Compliance. The Ceilcote scrubber was observed to be routed to the AAT scrubber and adsorber system. II.B.2.c The owner/operator shall route all ethylene oxide sterilizer back vent emissions through the AAT scrubber and adsorber system. [R307-401-8] Status: In Compliance. All ethylene oxide sterilizer back vent emissions were observed to be routed through the AAT scrubber and adsorber system. II.B.2.d In case of an AAT adsorber system breakdown, the Ceilcote scrubber can be rerouted to the Ceilcote stack to control sterilization chamber vacuum pump emissions. [R307-401-8] Status: In Compliance. The source contact stated that the Ceilcote scrubber can be properly rerouted through the Ceilcote stack during the event of the AAT adsorber breakdown. II.B.2.e In case of Ceilcote breakdown, the AAT adsorber system shall be used to control the sterilization chamber vacuum pumps, back vent and aeration emissions. [R307-401-8] Status: In Compliance. The General Manager confirmed that the AAT adsorber system will be used as described in the event of a breakdown for the Ceilcote system breakdown. 7 II.B.2.e.1 The owner/operator shall not allow the ethylene oxide concentration in the AAT adsorber exhaust to exceed 5.415 ppmv (24-hour average) in the event of the Ceilcote scrubber breaking down. This represents a 99% reduction as required by MACT Subpart O. [40 CFR 63 Subpart O, R307-401-8] Status: Not Applicable. The Ceilcote scrubber did not experience any breakdown during the previous rolling 12-month period. Sterigenics EHS Manager, Daniel May, stated that an "Interlock System" prevents any operation of the system in the event of a Ceilcote scrubber breakdown. II.B.2.f The owner/operator shall keep and maintain records of any scrubber breakdowns. [R307-401-8] Status: In Compliance. This requirement was reviewed during the on-site observations. The General Manager is aware of the record requirements of any scrubber breakdowns. No applicable breakdowns had occurred during the previous 12-month period. II.B.2.f.1 The scrubber breakdown records shall include the following items: A. Date of breakdown B. Cause of breakdown C. Duration of breakdown D. Any corrective actions taken. [R307-401-8] Status: Not Applicable. No applicable scrubber breakdowns occurred during the previous 12-month period. The specific items of the required records were reviewed during the on-site interview. II.B.2.g The following liquid flow rates in the scrubbers shall be maintained within the indicated ranges: A. The Ceilcote scrubber average liquid flow rate shall be greater than 80 gallons per minute B. The AAT scrubber average liquid flow rate shall be greater than 1,500 gallons per minute. [R307-401-8] Status: In Compliance. The scrubbers are equipped with sensors and alarms to ensure the flow rates are compliant with the established ranges. Site personnel are also trained to understand the operating requirements. All records reviewed on site were within the limits. See the attached AAT and Ceilcote Daily record checks as recent examples. II.B.2.g.1 The owner/operator shall record daily the liquid flow rates. The records shall be kept as long as the scrubbers are in operation and shall include the following items: A. Date B. Scrubber Type C. Liquid flow rate. [R307-401-8] Status: In Compliance. The required records indicating the date, time, liquid flow rate, and the monitoring site personnel are kept. See the attached example of daily AAT and Ceilcote systems check. 8 II.B.2.h The pH of the ethylene glycol solutions in the Ceilcote scrubber shall not exceed 2.0. [R307-401-8] Status: In Compliance. Standard operating procedures for the scrubber maintains the pH of scrubber liquid at 1.0 or less. Weekly Preventive Maintenance is performed for the scrubber. Each aspect of the maintenance is recorded on a Sterigenics Work Order. Sequence #50 checks the pH of the scrubber liquid and records the value. All reviewed records indicated pH values that were under 1.0. II.B.2.h.1 The owner/operator shall record weekly the pH of the ethylene glycol solutions. The records shall be maintained for all periods when the Ceilcote scrubber is in operation and shall include the following items: A. Date B. pH. [R307-401-8] Status: In Compliance. See the attached recent Weekly Preventive Work Orders as example record keeping. "Seq" 50 records the date, the equipment number, the site personnel, and the pH measurement. II.B.2.i The AAT heat exchanger temperature difference between inlet and outlet (delta T) shall be greater than 5 degrees Fahrenheit. The outlet temperature shall be greater than the inlet temperature. [R307-401-8] Status: In Compliance. The AAT heat exchanger temperatures are measured each minute for all hours of operation and are recorded on graph line charts. Graphs were presented for several months of operation on site. The reviewed graph recordings indicated that the temperature differences between inlet and outlet measurements were consistently greater than 5 degrees Fahrenheit. An alarm system has been installed to ensure that the AAT temperatures are compliant with the permitted limits and that the outlet temperature is consistently greater than the inlet temperature. II.B.2.i.1 The owner/operator shall record daily the delta T and shall keep and maintain a logbook for all periods when the AAT heat exchanger is in operation. The records shall include the following items: A. Date B. Delta T C. Any corrective actions taken. [R307-401-8] Status: In Compliance. A continuous minute to minute temperature graph is recorded and can be reviewed on site. The recordings provide the date, time, the temperature differential between the outlet and inlet (Delta T) measurement. The system includes a warning system that reportedly alerts the operators to noncompliance with the temperature limits and shuts down as required. Corrective actions are recorded on Work Orders. No applicable breakdowns occurred within the last 12-months. II.B.2.j The owner/operator shall sample the AAT scrubber liquor and analyze and record once per week the ethylene glycol concentration of the scrubber using the test methods and procedures in 40 CFR 63, MACT Subpart O Section 63.365(e)(1). The source shall monitor and record once per week the liquor level of the Ceilcote scrubber. Monitoring is not required during a week in which the scrubber unit has not been operated. [40 CFR 63 Subpart O] Status: In Compliance. Weekly Preventative Maintenance for the acid scrubbers are conducted for all periods that the system is in operation. The ethylene glycol concentrations are addressed by "Seq" 100 and 110. 9 II.B.2.j.1 The operating parameters for scrubber-liquor in the indicated scrubber shall not exceed the following: A. Ceilcote scrubber liquor level 181.5 inches in tank #2 when tank #1 is completely full B. Ethylene glycol concentration in AAT scrubber 26.7%. [40 CFR 63 Subpart O] Status: In Compliance. The Weekly Preventative Work Order addresses the scrubber liquor storage tank level on "Seq 30". The glycol concentration is addressed on "Seq 100". The reviewed weekly orders indicated that the liquor levels and ethylene glycol concentrations remained within the limits required by this Condition. Also see the attached submitted Semi-Annual Subpart O Reports submitted for the applicable time periods. II.B.2.k The owner/operator shall monitor and record the ethylene oxide concentration according to Subpart O Section 63.364(e). [40 CFR 63 Subpart O, R307-401-8] Status: In Compliance. See the applicable portions of the Weekly Preventative Work Orders and the submitted Subpart O Reports II.B.2.k.1 In the event of a breakdown of the instrumentation for the hourly monitoring of ethylene oxide concentrations at the AAT adsorber exhaust, the facility shall take a daily reading at the dry bed sampling port using a portable Photo Ionization Detector (PID) analyzer, Draeger tube, or equivalent technology. [R307-401-8] Status: Not Applicable. There were no breakdowns for the instrumentation used to monitor the ethylene oxide concentrations during the last 12-month. II.B.2.l The stack heights shall be as follows: A. Chamber Room ventilation vents: 27 feet from ground surface B. AAT and dry bed system stack: 45 feet from ground surface C. Ceilcote scrubber stack: 40 feet from ground surface. [R307-401-8] Status: In Compliance. The previous inspection memo DAQC-1543-21 provided information indicating that the stack heights had met this requirement. The SLC Facility Manager, Joseph Jeppson, states that both A. - the Chamber Room ventilation and C. the Ceilcote scrubber, have been rerouted to B., the AAT and dry bed system stack, which is now 60 feet from the ground surface. II.B.3 Stack Requirement II.B.3.a The owner/operator shall monitor and record ethylene oxide concentration according to MACT Subpart O, Section 63.362(c), Section 63.362(d), and 63.364(e). The AAT scrubber shall not have less than a 99% reduction in ethylene oxide. [40 CFR 63 Subpart O, R307-401-8] II.B.3.a.1 Compliance Demonstration To demonstrate compliance with the emissions limitations above, the owner/operator shall perform stack testing on the AAT Scrubber according to the stack testing conditions contained in this permit. [R307-165] II.B.3.b The owner/operator shall conduct any stack testing required by this AO according to the following conditions. [R307-401-8] II.B.3.b.1 Initial Test The owner/operator shall conduct an initial stack test within 180 days after start up of combined scrubber system. [R307-165-2] Status: In Compliance. The initial stack test was conducted on August 25, 2021. 10 II.B.3.b.2 Test Frequency The owner/operator shall conduct subsequent emission tests within five years after the date of the most recent emission test. The Director may require the owner/operator to perform an emission test at any time. [R307-165-2, R307-401-8] II.B.3.b.3 Notification At least 60 days prior to conducting an emission test, the owner/operator shall submit a source test protocol to the Director. The source test protocol shall include: A. The date, time, and place of the proposed test B. The proposed test methodologies C. The stack to be tested D. The procedures to be used E. Any deviation from an EPA-approved test method F. Explanation of any deviation from an EPA-approved test method If directed by the Director, the owner/operator shall attend a pretest conference. [40 CFR 63, R307-165-3, R307-401-8] II.B.3.b.4 Access The owner/operator shall provide Occupational Safety and Health Administration (OSHA)- or Mine Safety and Health Administration (MSHA)-approved access to the test location. [R307- 401-8] II.B.3.b.5 Testing The owner/operator shall conduct testing according to the approved source test protocol. The Director may reject emission test data if the test did not follow the approved source test protocol or if Director was not provided an opportunity to have an observer present at the test. [R307-165- 5, R307-401-8] II.B.3.b.6 Test Conditions The owner/operator shall conduct all tests while the source is operating at the maximum production at which the source will be operated unless otherwise specified in the approved source test protocol. During the tests, the owner/operator shall burn fuels or combinations of fuels, use raw materials, and maintain process conditions representative of normal operations. In addition, the owner/operator shall operate under any other relevant conditions that the Director specifies. [R307-165-4, R307-401-8] II.B.3.b.7 Reporting Within 60 days after completing an emission test, the owner/operator shall submit a copy of the test results to the Director. [40 CFR 63, R307-401-8] II.B.3.b.8 Possible Rejection of Test Results The Director may reject emissions test data if they are determined to be incomplete, inadequate, not representative of operating conditions specified for the test, or if the Director was not provided an opportunity to have an observer present at the test. [R307-165-5] II.B.3.c Test Methods When performing emission testing, the owner/operator shall use the appropriate EPA-approved test methods as acceptable to the Director. Acceptable test methods for pollutants are listed below. [R307-401-8] II.B.3.c.1 Sample Location The emission point shall be designed to conform to the requirements of 40 CFR 60, Appendix A, Method 1, or other methods if approved by the Director. [R307-165] 11 II.B.3.c.2 Ethylene Oxide 40 CFR 63.7 of Subpart A according to applicability in Table 1 of Subpart O, the procedure listed in Subpart O, 63.360 through 63.367, and the test methods listed in 63.365 of Subpart O. Temperature, flow rate, and efficiency of control device shall be determined. [R307-401] II.B.3.c.3 Volumetric Flow Rate 40 CFR 60, Appendix A, Method 2 or other testing methods approved by the Director. [R307- 165] II.B.3.c.4 Calculation To determine mass emission rates (lb/hr, etc.) the pollutant concentration as determined by the appropriate methods above shall be multiplied by the volumetric flow rate and any necessary conversion factors determined by the Director, to give the results in the specified units of the emission limitation. [R307-165, R307-401] II.B.3.c.5 Source Operation The production rate during all compliance testing shall be no less than 90% of the maximum production achieved in the previous three (3) years. Maximum production rate in this AO shall mean the production rate in one day (24 hours) at which amount of ethylene oxide is consumed. [R307-165] Status: In Compliance. A review of the initial stack test report indicates the requirements of all applicable conditions were met during the stack test with EtO emissions being reduced more than 99% from inlet to outlet for both the Ceilcote Scrubber and Ceilcote Scrubber in series with the AAT Scrubber. See the stack test memo (DAQC-486-22) in the source file for additional information. Stack testing will next be due in 2026. Section III: APPLICABLE FEDERAL REQUIREMENTS In addition to the requirements of this AO, all applicable provisions of the following federal programs have been found to apply to this installation. This AO in no way releases the owner or operator from any liability for compliance with all other applicable federal, state, and local regulations including UAC R307. NSPS (Part 60) JJJJ: Standards of Performance for Stationary Spark Ignition Internal Combustion Engines Status: In Compliance. 40 CFR 60.4243 requires operating and maintaining the engine as per the manufacturer's specifications. A contract with the manufacturer for routine maintenance is in place. Records of the Cummins engine maintenance were available and will be kept for the life of the engine. Any initial testing requirements should be determined by the DAQ Minor Source Engineering Section when the pending modified AO that will add this engine to the pending permit. MACT (Part 63) - O: Ethylene Oxide Emissions Standards for Sterilization Facilities Status: In Compliance. The applicable requirements of this subpart have been incorporated into the AO as conditions II.B.2.e.l, II.B.2.j, II.B.2.k, II.B.3.a, and II.B.3.c.2. In addition, see the attached submitted Semi Annual Subpart O Reports. 12 MACT (Part 63) - ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines Status: In Compliance. The operation of the 2019 Cummins C150N6 natural gas fired emergency generator appears to currently meets the requirements of MACT Subpart ZZZZ for standard maintenance and operation hours. Maintenance has been contracted with the manufacturer of the engine. The generator has been installed with a non-resettable meter. An operation log that includes the date, duration of time, purpose of operation, and the employee initials, was initiated on June 9, 2023. The generator operated for 6.3 hours from June 9 through August 23, 2023, which would average to 25.2 hours if extended for a 12-month period. A 2021 Cummins EPA Exhaust Emission Compliance Statement has been submitted and will remain on site for the life of the generator. See the attached generator documents. It is expected that this generator will be added to a modified AO following the completion of the current NOI review. AREA SOURCE RULES EVALUATION: The following Area Source Rules were evaluated during this inspection: National Emission Standards for Hazardous Air Pollutants [R307-214] Status: In Compliance. This area source rule is applicable per R307-214-2. Sources Subject to Part 63. (11) 40 CFR Part 63, Subpart O, National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations. Nonattainment and Maintenance Areas for PM10: Emission Standards [R307-305] Status: In Compliance. This area source rule is satisfied by compliance with AO condition II.B.1.c. EMISSION INVENTORY: The emissions listed below are an estimate of the total potential emissions (PTE) from Sterigenics US, LLC - Ethylene Oxide Commercial Sterilization Plant on the Approval Order (AO) DAQE-AN104350030-21, dated March 25, 2021. PTE are supplied for supplemental purposes only. Criteria Pollutant PTE tons/yr CO2 Equivalent 3927.00 Carbon Monoxide 1.20 Nitrogen Oxides 3.16 Particulate Matter - PM10 0.39 Particulate Matter - PM2.5 0.39 Sulfur Dioxide 0.02 Volatile Organic Compounds 2.16 Hazardous Air Pollutant PTE lbs/yr Ethylene Oxide (CAS #75218) 4200 Generic HAPs (CAS #GHAPS) 120 13 PREVIOUS ENFORCEMENT ACTIONS: No enforcement actions within the past five years. COMPLIANCE STATUS & RECOMMENDATIONS: Sterigenics was not in compliance with the permitting requirements of AN104350030-21 dated March 25, 2021 Section II.A due to the installation of a 2019 Cummins natural gas generator. Sterigenics, has however, submitted the required forms to the NSR Minor Source Section to modify the AO. No additional compliance actions are currently recommended. This facility was compliant with the other conditions of their AO, MACT O, and applicable UACR at the time of this inspection. MACT ZZZZ and NSPS JJJJ provisions for the unpermitted generator were evaluated. No non-compliant issues were discovered during the review; however, a complete review of these federal subparts should be performed after the engine has been added to the pending modified permit. HPV STATUS: Not Applicable. RECOMMENDATION FOR NEXT INSPECTION: Check for a new Modified AO that addresses the Reduction in Air Contaminants request and that adds the natural gas emergency generator. NSR RECOMMENDATIONS: 40 CFR 63 Subpart ZZZZ and 40 CFR 60 Subpart JJJJ requirements need to be added to the pending modified AO for the emergency natural gas generator. Remove II.A.22 – Nitrogen Dioxide Sterilizer as the equipment has been permanently removed. Evaluate the removal of Condition II.B.1.b, as the referenced monitors are used solely to monitor indoor air for worker safety. ATTACHMENTS: VEO, ETO gas consumption spreadsheet, Chamber 11 installation notification, AAT and Ceilcote Daily Systems Check example records, Weekly Preventative Maintenance – Acid Scrubbers Work Order example records, CWM Environmental AAT Total Glycol analysis example records, Cummins natural gas emergency generator records, and Subpart O Semi-Annual Reports. 9/22/23, 7:15 PM State of Utah Mail - Sterigenics SLC - Chamber 11 https://mail.google.com/mail/u/0/?ik=bffac613d3&view=pt&search=all&permthid=thread-f:1775233804761466823%7Cmsg-f:1775233804761466823&…1/1 Susan Weisenberg <sweisenberg@utah.gov> Sterigenics SLC - Chamber 11 1 message Jeppson, Joseph <JJeppson@sterigenics.com>Fri, Aug 25, 2023 at 2:21 PM To: Susan Weisenberg <sweisenberg@utah.gov> Cc: "May, Daniel" <DMay2@sterigenics.com>, "Grady, Don" <DGrady@sterigenics.com> Hello Susan, The Sterigenics Salt Lake City site has completed the construction and testing of EtO sterilizer Chamber 11, identified in paragraph II.A.12. We are now preparing to commence utilizing the chamber. Please let me know if you have any questions or need further information. Respectfully, Joe Jeppson General Manager, Salt Lake City Sterigenics, A Sotera Health Company 5725 Harold Gatty Dr. Salt Lake City, UT 84116 O: 801-328-9901 C: 801-698-9961 jjeppson@sterigenics.com This e-mail and any files transmitted with it may contain privileged and/or confidential information. If you believe this e- mail or any of its attachments were not intended for you, you must not use, distribute, forward, print or copy this e-mail or any attached files. If you have received this e-mail in error, please notify the sender by reply e-mail and then immediately delete the email and all attachments.