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HomeMy WebLinkAboutDAQ-2024-0105401 DAQC-CI104350002-24 Site ID 10435 (B1) MEMORANDUM TO: FILE – STERIGENICS US, LLC – Ethylene Oxide Commercial Sterilization Plant THROUGH: Chad Gilgen, Minor Source Compliance Section Manager FROM: Connor Kijowski, Environmental Scientist DATE: June 21, 2024 SUBJECT: FULL COMPLIANCE EVALUATION, Minor, Salt Lake County INSPECTION DATE: April 25, 2024 SOURCE LOCATION: 5725 West Harold Gatty Drive 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: Joseph Jeppson, General Manager, Salt Lake City 801-328-9901 OPERATING STATUS: Operating normally at the time of inspection 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 eleven sterilizer chambers for sterilization with Ethylene Oxide (EtO). A source tank scale controls the volume of EtO pumped into the chambers. After a proscribed 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. ) 1 2 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 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 5725 West Harold Gatty Drive Oak Brook, IL 60523 Salt Lake City, UT 84116 SIC Code: 7389: (Business Services, NEC) 3 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] 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. Each condition of Section I was reviewed with source at the time of inspection and appeared to be in compliance. This site has not been directed to submit an Emission Inventory at this time. The AAT wet scrubber broke down and was reported as required. No excess emissions occurred as the process emissions were routed to the dry bed scrubber. A startup notification for Chamber 11 (item II.A.12) was submitted on August 25, 2023. A new AO was issued on April 30, 2024, after the inspection occurred (DAQE-AN104350031-24). While some equipment and requirements from the new AO were reviewed with the source during the site visit, the source was evaluated based on AO DAQE-AN104350030-21, dated March 25, 2021. Section II: SPECIAL PROVISIONS II.A The approved installations shall consist of the following equipment: 4 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 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) 5 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 (AAT) 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 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.14 through II.A.17 - EtO Sterilizer Chambers 13 through 16 - have not yet been installed. II.A.22 - Nitrogen Dioxide Sterilizer - has been permanently removed. 6 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. This equipment is included on the recently issued AO. 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 April 2023 through March 2024 was reported as 124.6815 tons (249,363 pounds). 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. 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. 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. Monitoring devices are in place but used solely to measure ethylene oxide for 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. 7 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 stated that the Ceilcote scrubber can be properly rerouted through the Ceilcote stack during an 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 source stated that the AAT adsorber system will be used as described in the event of a breakdown of the Ceilcote system. 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. No Ceilcote scrubber breakdowns occurred during the previous 12 months. The source 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. The source is aware of the record requirements of any scrubber breakdowns. The AAT wet scrubber broke down during the previous 12 months and was recorded. Records of breakdowns are kept indefinitely. Refer to the Semi-Annual Subpart O Report in the attachments for more details. 8 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: In Compliance. The AAT wet scrubber broke down and was reported according to this condition. No excess emissions occurred as the process emissions were routed to the dry bed scrubber. 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 Sterigenics Work Order, Sequence 10, as an example. 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 Sterigenics Work Order record as an example. 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 2.0 or less with a target pH less than 1.0. Weekly preventive maintenance is performed for the scrubber. Each aspect of maintenance is recorded on a Sterigenics Work Order. Sequence 50 checks the pH of the scrubber solution and records the value. All reviewed records indicated pH values were under 2.0. 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 9 the following items: A. Date B. pH. [R307-401-8] Status: In Compliance. See the attached Sterigenics Work Order as an example of record keeping. Sequence 50 records the date, the equipment number, the site personnel, and the pH value. 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 delta T was consistently greater than 5 degrees Fahrenheit. The delta T at the time of inspection was 15 degrees Fahrenheit. An alarm system has been installed to ensure 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 was reviewed on site. The recordings provide the date, time, and delta T. 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. 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 scrubbers are conducted for all periods that the systems are in operation. The glycol concentrations are addressed by Sequence 100 and 110. II.B.2.j.1 The operating parameters for scrubber-liquor in the indicated scrubber shall not exceed the following: 10 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 Sterigenics Work Order addresses the scrubber liquor storage tank level on Sequence 30. The glycol concentration is addressed on Sequence 100. The reviewed weekly orders indicated that the liquor levels and ethylene glycol concentrations remained within the limits required by this condition. 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 attached Sterigenics Work Order; see also the Semi- Annual Subpart O Report submitted for the applicable time periods, submitted January 26, 2024. 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 previous 12-months. 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. A previous inspection memo (DAQC-1543-21) provided information indicating that the stack heights had met this requirement. The SLC Facility Manager, Joseph Jeppson, stated that both A. (the Chamber Room ventilation) and C. (the Ceilcote scrubber) has been rerouted to B. (the AAT and dry bed system stack), which is now 60 feet from the ground surface. This condition has been updated in the newly issued AO. 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 11 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 startup of combined scrubber system. [R307-165-2] Status: In Compliance. The initial stack test was conducted August 25, 2021. 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] 12 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] 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] Status: In Compliance. 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. The most recent stack test was performed October 5, 2023, and reviewed and approved on March 6, 2024. The stack test report indicates a 99.9% reduction efficiency for EtO emissions (DAQC-222-24). 13 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. This generator engine is included on the recently issued AO. 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 report. 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. 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. This generator engine is included on the recently issued AO. AREA SOURCE RULES EVALUATION: The following Area Source Rules were evaluated during this inspection: Stationary Sources [R307-210] Status: In Compliance. This area source rule is satisfied through compliance with NSPS Subpart JJJJ listed above. Refer to the Federal Requirements section for more details. National Emission Standards for Hazardous Air Pollutants [R307-214] Status: In Compliance. This area source rule is satisfied through compliance with MACT Subpart ZZZZ and Subpart O. Refer to the Federal Requirements section for more details. 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. 14 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 PREVIOUS ENFORCEMENT ACTIONS: No enforcement actions within the past five years. COMPLIANCE STATUS & RECOMMENDATIONS: In regards to Approval Order (AO) DAQE-AN104350030-21, dated March 25, 2021: 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. After the inspection, a new AO was issued (DAQE-AN104350031-24) addressing this issue. No additional compliance actions are currently recommended. This facility is compliant with the other conditions of the AO at the time of inspection. HPV STATUS: Not Applicable. RECOMMENDATION FOR NEXT INSPECTION: Schedule inspection as this is a secured site. NSR RECOMMENDATIONS: None at this time. ATTACHMENTS: VEO Form, EtO Emission Totals, Sterigenics Work Orders, Semi-Annual Subpart O Report STATE OF UTAH, DEPARTMENT OF ENVIRONMENTAL QUALITY DIVISION OF AIR QUALITY Page_of_ EPA METHOD 9-VISIBLE EMISSION OBSERVATION FORM ~ource Name: SJ~ie,,s US I UC,. Street Address: S'1'2-5 IJ,} \:\aold Gt\:\_j ~r City/County: c-, ,. / C' ~11...-l ✓ 00 I:\: Ll\\C.C., Phone: <gt:)\_ 3 Z-€" _ a.qo\ Site ID: \04~ Facility: E6 O S::\er,,,:24\;o/\ Equipment/Process: 5': 'I ,,:: ,- s.J.U' !W'S, vfV\"3et<:j 91"(,, Control Equipment: cS'Cru~CS' Emission Point: "~-1, c-\ u C..C.,J , kcls Sky Conditions: Clear [ ) Partly Cloudy [ ] Overcast [ ] Precipitation: No [ ) Yes [ ) Wind: Direction: ___ Speed: __ _ mph Ambient Temp: °F RH: % --- Height Relative to Observer: --- Distance From Observer: --- Condensed Water Vapor Present: No [ ] Yes [ ] Attached [ ] Detached [ ] Length of Condensed Water Vapor Plume: _____ _ Background: -------------- Sketch process unit: indicate observer position relative to source; indicate potential emission points and/or actual emission points. 0 DIJIN ,-,..1r1h Jfffi~ • observer Sun ♦ Wind ► Emission Point with Plume (_)_ Observer Position x Observer's Signature: ~ ~~--- Distrib: white-file; ca~, p=w~er/operator oasERVATION DATE: ~ Jis I z.~ Start time: ___ Stop time: __ _ ~ c min 0 15 30 45 1 A I J.'c .... 2 /') ,LL / V 'J ii;;, I I . , 3 4 ~M1S~ ~) , 5 6 7 8 9 10 11 12 iolt1"" \v nil\-\1.A Per-,o~ ', A~r; I z,oz,:~-Mart:'1 202.t.! COMMENTS: /:tt:.&.1-a •, JC?f'\,S GW 5as. , ,sed ~,B2-f3 ', Suvl:br \1tp1d £\ow rgk& -b~t , Sicu!,hcL l:i ?' 1 Row Rak /:tt 6 2.b : (.e~l Gt•L '-~Jitrt 9 1~'-ul ,, H ~.~1., ~ AAT bv1ta. T \/11:e.i-J ·, ScN\btr t◄fvcr 'M,\ +: ~VD< J1¥"c.l (c<t:. v1fe,2.1,: t:60 Co/\C<•1trnM.t I have received a copy of these observations: SIGNATURE: 2-¥----- Printed Name: Jo -c., ~:::f f SA'"' R5S4119 Version STEROOO I Location Item Number UOM -- CHAMBER II EO LB CHAMBER! EO LB CHAMBER2 EO LB CHAMBER3 EO LB CHAMBER4 EO LB CHAMBERS EO LB CHAMBER6 EO LB CHAMBER7 EO LB CHAMBERS EO LB CHAMBER9 EO LB CHAMBER_I0 EO LB Sterigenics International, lnc Gas Usage Report Business Unit 129 Salt Lake City Date From 3/28/2023 Date Thru 3/28/2024 Unit Of Measure Description Pounds Pounds Pounds Pounds Pounds Pounds Pounds Pounds Pounds Pounds Pounds Total Usace Pr0"}-<--c) '?'f Quantity 87- 20,224- 22,739- 22,454- 21,626- JSS- 24,490- 21,762- 27.223- 4,695- 83•908• 249.,)_~ f ~AyrZOZY 4/23/2024 Page- 22:55:02 GMT of I ~ Sterigenics. A Sotera Health company Sterigenics Work Order ~ Sterigenics. A Sotera Health company Work Order Work Order: 852370 (SLCEO) WEEKLY PM-ACID SCRUBBER-NO DOWNTIME REQ'D Status: PM Closed Date Completed: 17/APR/2024 21:56 Completed By: OGRADY WO Type: Preventive Maintenance Department: MAINTENANCE PM Code: PM-NAEO-1245 Standard WO: Route: Downtime Hours: Equipment: AS001 (SLCEO) AA T Acid Scrubber Equipment Activities Task Plan Task Plan Description Scheduled Start Date: 13/APR/2024 Scheduled End Date: 19/APR/2024 Date Started: 17/APR/2024 Date/Time Performed: 17/APR/2024 21:56 Performed By: KCOLAIZZI Date/Time Reviewed: 24/APR/2024 17:08 Reviewed By: OGRADY Parent Work Order: Class: SCHMAINT Priority: Problem Code: PM Assigned To: Manufacturer: Model: Serial Number: Activity 10 G-F-EO-MNT -048-WEEKLY PREVENTIVE MAINTENANCE -ACID SCRUBBERS (ALL Trade MAINT NA TYPES) Checklist Seq Description Date Updated Equipment Result Note Follow- Updated By up WO 10 Check and record flow rate to Absorption 17/APR/ Tower 2024 21 :56 20 Perform alarm light test. 17/APR/ I KCOLAIZZI I AS001 I I I KCOLAIZZI [ AS001 Value: 1500 GPM .J. Finding: Ok j"---1-'--J I J 2024 21:56 30 Check the scrubber liquor and record the 17/APR/ KCOLAIZZI AS001 I Storage Tank level 2024 21:56 40 If liquor is shipped for recycling, record 17/APR/ KCOLAIZZI AS001 amount shipped. 2024 21:56 50 Check the scrubber liquor and record the pH 17/APR/ KCOLAIZZI AS001 (TAR GET pH 1.0 or less) 2024 21:56 ----- 60 Record Inlet Temperature if the system 17/APR/ KCOLAIZZI AS001 I monitors this parameter 2024 I 21:56 Sterigenics Work Order Run On: Apr 24, 2024 5:09:13 PM Value: 154 INH I I Value: 0 GAL j Value: .12 pH Value: 80 DEGF l -l Page: 1 of 2 .ti#WSf '<f/j Sterigenics. Sterigenics Work Order ~ Sterigenics® ~ A Sotera Health company A Sotera Health company Seq Description Date Updated Equipment Result Note 70 Record oulet Temperature if the sys I em monitors this parameter 80 Check all pumps, pipes, seals, and rings for leaks. 90 Check pressure relief valve for leaks or discharge. 100 Record Glycol concentration 110 1 Ensure concentration does NOT exce;d permit conditions 120 (Line inserted for translation requirements) 130 Record Wet scrubber outleVdry bed inlet EO Levels (High flow system only) 140 Record Dry bed outlet EO Levels 150 Record static pressure drop across Scrubber 160 Deoxx only, validate reactor emptying cycle, insp. correct open/close of valves Updated By 17/APR/ 2024 21:56 17/APR/ 2024 21:56 17/APR/ 2024 21:56 I 17/APR/ 2024 I 21:56 17/APR/ 1 2024 21:56 1 17/APR/ 2024 21:56 17/APR/ 2024 I 21:56 T I 17/APR/ 2024 21:56 17/APR/ 2024 21:56 17/APR/ 2024 21:56 KCOLAIZZI AS001 I KCOLAIZZI / AS001 I I KCOLAIZZI I AS001 KCOLAIZZI I AS001 I KCOLAIZZI I AS001 KCOLAIZZI I AS001 KCOLAIZZI AS001 I t KCOLAIZZI AS001 I KCOLAIZZI AS001 KCOLAIZZI AS001 Print Booked Hours Labels Sterigenics Work Order /Employee / Date / Total Time / KCOLAIZZI 17/APR/2024 Run On: Apr 24, 2024 5:09:13 PM I Value: 95 DEGF ' Finding: Ok T Finding: Not 1 applicable to equipment -- I Value: 26 pct l Finding: Ok I T Completed Value: 0 ppm Value: 0 ppm Value: 4 lnH20 Finding: Not applicable to equipment Page: 2 of 2 t Follow- up WO I ~ Sterigenicse A Setera Health company Sterigenics Work Order Work Order Work Order: 816635 (SLCEO) WEEKLY PM-ACID SCRUBBER-NO DOWNTIME REC'D Status: PM Closed Date Completed: 10/JAN/2024 22:53 Completed By: OGRADY WO Type: Preventive Maintenance Department: MAINTENANCE PM Code: PM-NAEO-1245 Standard WO: Route: Downtime Hours: Equipment: AS002 (SLCEO) Ceilcote Scrubber Equipment Activities Task Plan Task Plan Description ~ Sterigenics® Y:(/ A Sotera Health company Scheduled Start Date: 06/JAN/2024 Scheduled End Date: 12/JAN/2024 Date Started: 10/JAN/2024 Date/Time Performed: 10/JAN/2024 22:53 Performed By: KCOLAIZZI Date/Time Reviewed: 16/JAN/2024 14:26 Reviewed By: OGRADY Parent Work Order: Class: SCHMAINT Priority: Problem Code: PM Assigned To: Manufacturer: CEILCOTE Model: SPT-48-240 Serial Number: N/A Activity 10 G-F-EO-MNT --048-WEEKLY PREVENTIVE MAINTENANCE -ACID SCRUBBERS (ALL Trade MAINT NA TYPES) Checklist Seq Description Date Updated Equipment Updated By 10 Check and record flow rate to Absorption 110/JAN/ I KCOLAIZZI I AS002 Tower 2024 22:53 20 Perform alarm light test. 10/JAN/ KCOLAIZZI AS002 2024 22:53 30 Check the scrubber liquor and record the 10/JAN/ KCOLAIZZI AS002 Storage Tank level 2024 22:53 40 If liquor is shipped for recycling, record amount 10/JAN/ KCOLAIZZI AS002 shipped. 2024 22:53 50 Check the scrubber liquor and record the pH 10/JAN/ KCOLAIZZI AS002 (TAR GET pH 1.0 or less) 2024 22:53 60 Record Inlet Temperature if the system 10/JAN/ KCOLAIZZI I AS002 monitors this parameter 2024 22:53 1 Sterigenics Work Order Run On: Apr 24, 2024 5:21 :53 PM Result Note Follow- up WO Value: 131.7 GPM Finding: Ok Value: 76 INH Value: 5000 GAL ----Value: 1.4 pH I 1 - I Value: 68 DEGF I 1 Page: 1 of 2 'fl) Sterigenics~ A Setera Health company Sterigenics Work Order 1f/) Sterigenics~ A Setera Health company Description Date Updated Equipment Result Note Follow- 70 Record oulet Temperature if the system monitors this parameter 80 Check all pumps, pipes, seals, and rings for leaks. 90 Check pressure relief valve for leaks or discharge. 100 Record Glycol concentration 110 Ensure concentration does NOT exceed permit conditions 120 (line inserted for translation requirements) 130 Record Wet scrubber outlet/dry bed inlet EO Levels (High flow system only) 140 Record Dry bed outlet EO Levels 150 Record static pressure drop across Scrubber 160 Deoxx only, validate reactor emptying cycle, insp. correct open/close of valves Updated 10/JAN/ 2024 22:53 10/JAN/ 2024 22:53 10/JAN/ 2024 I 22:53 10/JAN/ 2024 22:53 10/JAN/ 2024 22:53 10/JAN/ 12024 22:53 10/JAN/ 2024 I 22:53 1 10/JAN/ 2024 22:53 10/JAN/ 2024 I 22:53 10/JAN/ 2024 22:53 By KCOLAIZZI AS002 1 KCOLAIZZI AS002 KCOLAIZZI AS002 I KCOlAIUI 1 AS002 KCOlAIUI l AS002 KCOlAIUI j AS002 KCOLAIZZI AS002 KCOLAIZZI l AS002 I KCOlAIZZI I AS002 KCOLAIZZI AS002 1 Print Booked Hours Labels Sterigenics Work Order Employee I Date I Total Time j KCOLAIZZI 10/JAN/2024 1 Run On: Apr 24, 2024 5:21:53 PM Value: 66 DEGF Finding: Ok =~~~i~~~,~~~ t j equipment I --f Value: 50 pct I I l Finding: Ok - j_ Completed J --I Value: 0 ppm Value: 0 ppm Value: 2.4 lnH20 Finding: Not applicable to equipment Page: 2 of 2 up WO vlHHgli"f; January 26,2024 Director, Air and Toxics Technical Enforcement program Office of Enforcement, Compliance and Environmentat Justice EPA Region Vlll MailCode SENF-AT 1595 Wynkoop Sheet Denver, CO 80202-1129 RE: 9-ummary Report- Gaseous and Opacity Excess Emission and Continuoua f,lonitoring System Perforrnarre Sterigenics Salt Lake City Facility - tftah Permit # DAeE-AN-i0{t50030.21 For the Period: July 1 - December g1,2D2g Dear Director: Per the requirements of 40 CFR $ 63. 10(eX3[vi), please accept this semi-annual Summary Report for our Salt Lake City, Utah facility. As provided in 40 CFR S 63.10(eX3[vii), we are submitting only the Summary Report for our Salt Lake City facility because: a) The total duration of excess emissions, or process or control system parameter exceedances during the reporting period was less than 1 perc6nt of tire total operating time, and b) CMS downtime during the reporting period was tess than 5'percent of the totat operating time. In this reporting period, the Salt Lake City facility experienced a breakdown of its Advanced Air Technologies (AAT) wet scrubber control device system. However, during the breakdown, Process emissions were treated with the facility's dry bed conbol device Jystem as alowedbythefacility's operating permit. Sterigenics US, LLC has reviewed applicable prwisions of the operating permit. The following information is submitted as required in g63.10(eX3Xvi): A) Qgmpanv Name and Address of the Affected Source: Sterigenics US, LLC UTAH DEPABTMENT OF E}wl RONMENTAL OI..I,AUTY FEB - 1 2024 DIVISION OF AIR QUAUTY REVIEWED Initiats: CG o^,,7' -27-?4 compriancc r,^u*fr-5ffi1 rt t ql r?/o/ ? 5725 West Harold Getty Dr. Salt Lake City, UT 84116-3763 B) ldentificatlon of Hazardous Air pollutant: Ethylene Oxide 2015 Spring Rd., Oak Brook, tL 50523 63G928'170O I sterigenics.com 0,,,u (cTJ.; f '^) C) Reoortino Period Dates: Beginning: July 01 ,2023 Ending: December 31, 2A23 D) Descriotion of Process Units:.,@ionchambersofvarioussizestosterilizemedicaldevicesand other products'using ethylene oxide in gaseous form. Process emissions are exhausted from tire sterilizatiori chambers through vacuum pumps to a Ceilcote acid-water scrubber system for treatment. Process emissions from chamber backvents and aeration rooms for dlgassing ethylene oxide from products following sterilization are treated in an AAT wet scrubber with a dry bed catalyst system. 1E1 Emission and Ooeratino Parameter Limitations Soecified in Relevant Standards: Control Unit Control Parameter LimitationsrSta ndards Ceilote Scrubber Glycol liquor leveltank #2 Scrubber liquid flow rate avg.) Scrubber qlycol solution PH Level<181.5 inches 80 GPM pH < 2.0 AAT Wet Scrubber/ Dry Bed System Glycol concentration Scrubber liquid flow rate avg.) Heat exchanger temp differential EO conc. in dry bed exhaust Concentration < 26.7 o/o 1500 GPM 50F 5.415 ppmv during normal operation Monitorino Eouipment Manufacturer and Model Number SRI Gas Chromatograph ; Model 8610C Date of Latest CMS Certification or Audit: Calibrations occur weekly TotalOoeratinq Time of Affected Source durino Reoortino Period: 4344 hours F) G) H) t) J) CMS Performance Summarv: 2015 Spring Rd., Oak Brook, lL 60523 630-928.f700 | ,t*rigcnrcs.cor. Emission Data Summarv: Control Unit Total Duration of Excess Emissions Excess Emission Duration as o/o of Total Hours Excess Emission Duration bY Cause Startupl Shutdown Control Equipmen t Problems Process Problems Other Known Causes Other Unknown Causes AAT 0hr 0o/o 0 0 0 0 0 Ceilcote 0hr 0o/o 0 0 0 0 0 There were no CMS outages of the emission oontrolsystems during the period' K) Descfiption of chanqes in cMS. Process€s or contrcls since Last Reoortino Period: No changes to rePort. L) ResDonsibleOfficid qertificali:on:i Based on the information and belief formed after reasonable inquiry, the statements and information in this report are tue, accurate, and complete' Wagner Vice President - Environmentral Health & Safety M) Pate of Reoort: January 2A,2024 lf you have any questions regarding this repor! please contract me at (310) 706 9600 or soeorgacoo@Sterioenics. com Sincerely, Stelgia GeorgacoPoulos Maniger, Environmental Health & Safety Cc: Mr. BrYce Bird, Director UDEQ Division of AirQualitY 195 North 1950West P.O. Box'1448120 Salt Lake CitY, UT 84.114-48,20 Joseph Jeppson - SLC Facility General Manager 2015 Spring Rd.. Oak Brook, lL 60523 63&928-1700 | sterig€nics.com