Loading...
HomeMy WebLinkAboutDAQ-2025-001846 DAQE-AN116440010-25 {{$d1 }} Pedro Villarreal ICU Medical, Inc. 4455 South Atherton Drive Taylorsville, UT 84123 Pedro.Villarreal@icumed.com Dear Mr. Villarreal: Re: Approval Order: Modification to Approval Order DAQE-AN116440009-23 to Increase the VOC and HAP Emissions Limits for the Medical Device Manufacturing Process Project Number: N116440010 The attached Approval Order (AO) is issued pursuant to the Notice of Intent (NOI) received on October 3, 2024. ICU Medical, Inc. must comply with the requirements of this AO, all applicable state requirements (R307), and Federal Standards. The project engineer for this action is Mr. Tim DeJulis, who can be contacted at (385) 306-6523 or tdejulis@utah.gov. Future correspondence on this AO should include the engineer's name as well as the DAQE number shown on the upper right-hand corner of this letter. No public comments were received on this action. Sincerely, {{$s }} Bryce C. Bird Director BCB:TD:jg cc: Salt Lake County Health Department 195 North 1950 West • Salt Lake City, UT Mailing Address: P.O. Box 144820 • Salt Lake City, UT 84114-4820 Telephone (801) 536-4000 • Fax (801) 536-4099 • T.D.D. (801) 536-4414 www.deq.utah.gov Printed on 100% recycled paper State of Utah SPENCER J. COX Governor DEIDRE HENDERSON Lieutenant Governor Department of Environmental Quality Tim Davis Interim Executive Director DIVISION OF AIR QUALITY Bryce C. Bird Director April 3, 2025 STATE OF UTAH Department of Environmental Quality Division of Air Quality {{#s=Sig_es_:signer1:signature}} {{#d1=date1_es_:signer1:date:format(date, "mmmm d, yyyy")}} {{#d2=date1_es_:signer1:date:format(date, "mmmm d, yyyy"):align(center)}} APPROVAL ORDER DAQE-AN116440010-25 Modification to Approval Order DAQE-AN116440009-23 to Increase the VOC and HAP Emissions Limits for the Medical Device Manufacturing Process Prepared By Mr. Tim DeJulis, Engineer (385) 306-6523 tdejulis@utah.gov Issued to ICU Medical, Inc. - Salt Lake Medical Products Manufacturing Issued On {{$d2 }} Issued By {{$s }} Bryce C. Bird Director Division of Air Quality April 3, 2025 TABLE OF CONTENTS TITLE/SIGNATURE PAGE ....................................................................................................... 1 GENERAL INFORMATION ...................................................................................................... 3 CONTACT/LOCATION INFORMATION ............................................................................... 3 SOURCE INFORMATION ........................................................................................................ 3 General Description ................................................................................................................ 3 NSR Classification .................................................................................................................. 3 Source Classification .............................................................................................................. 3 Applicable Federal Standards ................................................................................................. 4 Project Description.................................................................................................................. 4 SUMMARY OF EMISSIONS .................................................................................................... 4 SECTION I: GENERAL PROVISIONS .................................................................................... 5 SECTION II: PERMITTED EQUIPMENT .............................................................................. 5 SECTION II: SPECIAL PROVISIONS ..................................................................................... 6 PERMIT HISTORY ..................................................................................................................... 8 ACRONYMS ................................................................................................................................. 9 DAQE-AN116440010-25 Page 3 GENERAL INFORMATION CONTACT/LOCATION INFORMATION Owner Name Source Name ICU Medical, Inc. ICU Medical, Inc. - Salt Lake Medical Products Manufacturing Mailing Address Physical Address 4455 South Atherton Drive 4455 South Atherton Drive Taylorsville, UT 84123 Taylorsville, UT 84123 Source Contact UTM Coordinates Name: Pedro Villarreal 422,045 m Easting Phone: (801) 284-1206 4,503,020 m Northing Email: Pedro.Villarreal@icumed.com Datum NAD83 UTM Zone 12 SIC code 3841 (Surgical & Medical Instruments & Apparatus) SOURCE INFORMATION General Description ICU Medical, Inc. (ICU) manufactures critical care medical products. Solvent bonding, cleaning, injection molding, and final assembly are used in the manufacturing processes. As parts are assembled, small amounts of solvent are used to bond pieces together. The solvent is stored and dispensed in small, vapor-tight containers that dispense small droplets of solvent onto the items to be bonded. Small amounts of VOC-containing solvent are used to clean various manufactured plastic products and equipment. Generally, solvents are applied to rags and wiped on the products or equipment. Raw plastic products are formed by injection molding. Plastic granules are stored in storage silos until they are pneumatically piped to an injection mold machine storage device. The raw products include polyvinyl chloride, polycarbonate, polypropylene, and other plastics. The VOC content of the plastic pellets is very small. The plastic pellets are heated in the injection-molding machine and extruded into molds. Once the parts are set and stable, they are pulled from the machine and allowed to cool before being transferred to another part of the facility or packaged. Many of the parts are assembled into ready-to-use systems and shipped to medical supply vendors for sale and further dispensing to hospitals. NSR Classification Minor Modification at Minor Source Source Classification Located in Northern Wasatch Front O3 NAA, Salt Lake City UT PM2.5 NAA, Salt Lake County SO2 NAA Salt Lake County Airs Source Size: B DAQE-AN116440010-25 Page 4 Applicable Federal Standards NSPS (Part 60), A: General Provisions NSPS (Part 60), IIII: Standards of Performance for Stationary Compression Ignition Internal Combustion Engines MACT (Part 63), A: General Provisions MACT (Part 63), ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines Project Description ICU requested a modification to Condition II.B.4.b of the AO DAQE-AN116440009-23, dated November 2, 2023, to increase the VOC emission limitations from 17.66 tpy to 26.02 tpy. ICU is also requesting to increase the HAPs emissions limitation from evaporative activities from 0.87 tpy to 7.36 tpy, with the overall HAPs emissions being 7.46 tpy. No other changes to the equipment list will result from this change in VOC and HAP production. SUMMARY OF EMISSIONS The emissions listed below are an estimate of the total potential emissions from the source. Some rounding of emissions is possible. Criteria Pollutant Change (TPY) Total (TPY) Ammonia 0 0.19 CO2 Equivalent 0 7041.00 Carbon Monoxide 0 4.98 Nitrogen Oxides 0 5.99 Particulate Matter - PM10 0 0.80 Particulate Matter - PM2.5 0 0.80 Sulfur Dioxide 0 0.06 Volatile Organic Compounds 8.36 26.35 Hazardous Air Pollutant Change (lbs/yr) Total (lbs/yr) Cyanide Compounds (CAS #143339) 5 11 Ethyl Benzene (CAS #100414) 0 4 Ethylene Glycol (CAS #107211) 17 26 Formaldehyde (CAS #50000) 0 9 Generic HAPs (CAS #GHAPS) 422 Glycol Ethers (CAS #EDF109) 0 47 Hexane (CAS #110543) 39 540 Methanol (CAS #67561) 12704 12756 Methylene Chloride (Dichloromethane) (CAS #75092) 47 707 Toluene (CAS #108883) 4 138 Xylenes (Isomers And Mixture) (CAS #1330207) 114 268 Change (TPY) Total (TPY) Total HAPs 6.46 7.46 DAQE-AN116440010-25 Page 5 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] SECTION II: PERMITTED EQUIPMENT II.A THE APPROVED EQUIPMENT II.A.1 ICU Medical, Inc. Salt Lake Medical Products Manufacturing II.A.2 Various Boilers Capacity: <5MMBtu/hr each Fuel: natural gas For informational purposes only II.A.3 Emergency Generator One (1) Emergency generator Capacity: 200 kW (268 hp) Fuel: diesel Manufactured: 2023 DAQE-AN116440010-25 Page 6 II.A.4 Various Comfort Heaters Comfort heaters, gas packs, sun units, or humidifiers Capacity: <5MMBtu/hr each Fuel: natural gas For information purposes only II.A.5 Mold Cleaning Equipment Resin Residual Removal Furnace Various solvent bonding, solvent cleaning, injection molding, and residual plastic resins removal chemicals used in the medical device manufacturing process. SECTION II: SPECIAL PROVISIONS II.B REQUIREMENTS AND LIMITATIONS II.B.1 Limitations and Requirements II.B.1.a Visible emissions from the following emission points shall not exceed the following values: A. Electric resin residual removal furnace - 10% opacity B. All natural gas-fired heater/boiler exhausts - 10% opacity C. Diesel engine exhaust - 20% opacity. [R307-401-8] II.B.1.a.1 Opacity observations of emissions from stationary sources shall be conducted according to 40 CFR 60, Appendix A, Method 9. [R307-401-8] II.B.1.b The owner/operator shall not burn more than five (5) pounds of resin per day in the resin residual removal furnace. [R307-401-8] II.B.1.b.1 To determine compliance, the owner/operator shall keep a record of the weight of resin remaining in each residual mold per day put into the resin residual removal furnace for all periods when the plant is in operation. Weight of the resin combusted in each mold shall be the total weight of the resin plus the mold minus the weight of each mold, measured with a mass balance. [R307-401-8] II.B.2 Fuel Requirements II.B.2.a The owner/operator shall use only natural gas as fuel in all the boilers and heaters. [R307-401-8] II.B.2.b The owner/operator shall only use diesel fuel (fuel oil #1, #2, or diesel fuel oil additives) in the emergency generator engine. All diesel burned shall meet the definition of ultra-low sulfur diesel (ULSD) and contain no more than 15 ppm sulfur. [R307-401-8] II.B.2.b.1 To demonstrate compliance with the diesel fuel requirements for any diesel fuel purchased, the owner/operator shall keep and maintain fuel purchase invoices. The fuel purchase invoices shall indicate that the diesel fuel meets the ULSD requirements, or the owner/operator shall obtain certification of sulfur content from the fuel supplier. [R307-401-8] II.B.3 Engine Requirements II.B.3.a The owner/operator shall not operate the emergency generator engine on-site for more than 100 hours per rolling 12-month period during non-emergency situations. There is no time limit on the use of the engines during emergencies. [40 CFR 60 Subpart IIII, 40 CFR 63 Subpart ZZZZ] DAQE-AN116440010-25 Page 7 II.B.3.a.1 To determine compliance with a rolling 12-month total, the owner/operator shall calculate a new 12-month total by the 20th day of each month using data from the previous 12 months. Records documenting the operation of each emergency engine shall be kept in a log and shall include the following: A. The date the emergency engine was used B. The duration of operation in hours C. The reason for the emergency engine usage. [R307-401-8] II.B.4 Volatile Organic Compound (VOC) Limitations II.B.4.a The VOC content of the solvent bonding, solvent cleaning, injection molding, and residual plastic resins removal chemicals as used shall not exceed the density limits established by R307-353. High solids (low VOC content) chemicals shall not be thinned or otherwise reduced beyond manufacturers recommendations. These parameters shall be tested by using the appropriate ASTM method or another method approved by the Director. [R307-353] II.B.4.b The owner/operator shall not emit more than the following from evaporative sources (solvent bonding, solvent cleaning, injection molding, residual plastic resin removal, etc.) on-site: 26.02 tons of VOC per rolling 12-month period 6.38 tons of methanol per rolling 12-month period 0.35 tons of methylene chloride per rolling 12-month period 0.16 tons of hexane per rolling 12-month period 0.13 tons of xylene per rolling 12-month period 0.34 tons of acrylic acid, benzene, cumene, cyanide compounds, diethanolamine, ethyl benzene, ethylene dichloride, ethylene glycol, formaldehyde, glycol ethers, isophorone, methyl methacrylate, naphthalene, nickel compounds, propylene oxide, toluene, and combined per rolling 12-month period This does not include the emissions from the natural gas and diesel combustion sources. [R307-401-8] II.B.4.b.1 The owner/operator shall calculate a new 12-month total by the 20th day of each month using data from the previous 12 months. The owner/operator shall use a mass-balance method to calculate emissions from evaporative sources. The owner/operator may use the following equations with applicable units to comply with the mass-balance method: VOCs = [% VOCs by Weight/100] x [Density] x [Volume Consumed] HAP = [% HAP by Weight/100] x [Density] x [Volume Consumed] [R307-401-8] II.B.4.b.2 The owner/operator shall use a mass-balance method to quantify any amount of VOCs and HAPs reclaimed. The owner/operator shall subtract the amount of VOCs and HAPs reclaimed from the quantities calculated above to provide the monthly total emissions of VOCs and HAPs. [R307-401-8] DAQE-AN116440010-25 Page 8 II.B.4.b.3 The owner/operator shall keep records each month of the following: A. The name (as per SDS) of the VOC- and HAP-emitting material B. The maximum percent by weight of VOCs and each HAP in each material used C. The density of each material used D. The volume of each VOC- and HAP-emitting material used E. The amount of VOCs and the amount of each HAP emitted from each material F. The amount of VOCs and the amount of each HAP reclaimed and/or controlled from each material G. The total amount of VOCs, the total amount of each HAP, and the total amount of all HAPs combined emitted from all materials (in tons). [R307-401-8] PERMIT HISTORY This Approval Order shall supersede (if a modification) or will be based on the following documents: Supersedes AO DAQE-AN116440009-23 dated November 2, 2023 Is Derived From NOI dated October 3, 2024 Incorporates Additional information dated December 11, 2024 DAQE-AN116440010-25 Page 9 ACRONYMS The following lists commonly used acronyms and associated translations as they apply to this document: 40 CFR Title 40 of the Code of Federal Regulations AO Approval Order BACT Best Available Control Technology CAA Clean Air Act CAAA Clean Air Act Amendments CDS Classification Data System (used by Environmental Protection Agency to classify sources by size/type) CEM Continuous emissions monitor CEMS Continuous emissions monitoring system CFR Code of Federal Regulations CMS Continuous monitoring system CO Carbon monoxide CO2 Carbon Dioxide CO2e Carbon Dioxide Equivalent - Title 40 of the Code of Federal Regulations Part 98, Subpart A, Table A-1 COM Continuous opacity monitor DAQ/UDAQ Division of Air Quality DAQE This is a document tracking code for internal Division of Air Quality use EPA Environmental Protection Agency FDCP Fugitive dust control plan GHG Greenhouse Gas(es) - Title 40 of the Code of Federal Regulations 52.21 (b)(49)(i) GWP Global Warming Potential - Title 40 of the Code of Federal Regulations Part 86.1818- 12(a) HAP or HAPs Hazardous air pollutant(s) ITA Intent to Approve LB/YR Pounds per year MACT Maximum Achievable Control Technology MMBTU Million British Thermal Units NAA Nonattainment Area NAAQS National Ambient Air Quality Standards NESHAP National Emission Standards for Hazardous Air Pollutants NOI Notice of Intent NOx Oxides of nitrogen NSPS New Source Performance Standard NSR New Source Review PM10 Particulate matter less than 10 microns in size PM2.5 Particulate matter less than 2.5 microns in size PSD Prevention of Significant Deterioration PTE Potential to Emit R307 Rules Series 307 R307-401 Rules Series 307 - Section 401 SO2 Sulfur dioxide Title IV Title IV of the Clean Air Act Title V Title V of the Clean Air Act TPY Tons per year UAC Utah Administrative Code VOC Volatile organic compounds The Salt Lake Tribune Publication Name: The Salt Lake Tribune Publication URL: Publication City and State: Salt Lake City, UT Publication County: Salt Lake Notice Popular Keyword Category: Notice Keywords: ICU medical Notice Authentication Number: 202502241044294957791 2892905420 Notice URL: Back Notice Publish Date: Sunday, February 23, 2025 Notice Content NOTICE A Notice of Intent for the following project submitted in accordance with R307-401-1, Utah Administrative Code (UAC), has been received for consideration by the Director: Company Name: ICU Medical, Inc. Location: ICU Medical, Inc. - Salt Lake Medical Products Manufacturing – 4455 South Atherton Drive, Taylorsville, UT Project Description: ICU Medical, Inc. (ICU) requested a modification to Condition II.B.4.b of the Approval Order DAQE-AN116440009-23, dated November 2, 2023, to increase the VOC emission limitations from 17.66 tpy to 26.02 tpy. ICU is also requesting to increase the HAPs emissions limitation from evaporative sources 0.88 tpy to 7.37 tpy with the overall HAPs emissions being 7.48 tpy. No other changes to the equipment list will result from this change in VOC and HAP production. The completed engineering evaluation and air quality impact analysis showed the proposed project meets the requirements of federal air quality regulations and the State air quality rules. The Director intends to issue an Approval Order pending a 30-day public comment period. The project proposal, estimate of the effect on local air quality, and draft Approval Order are available for public inspection and comment at the Utah Division of Air Quality, 195 North 1950 West, Salt Lake City, UT 84116. Written comments received by the Division at this same address on or before March 25, 2025, will be considered in making the final decision on the approval/disapproval of the proposed project. Email comments will also be accepted at tdejulis@utah.gov. If anyone so requests to the Director in writing within 15 days of publication of this notice, a hearing will be held in accordance with R307-401-7, UAC. Under Section 19-1-301.5, a person who wishes to challenge a Permit Order may only raise an issue or argument during an adjudicatory proceeding that was raised during the public comment period and was supported with sufficient information or documentation to enable the Director to fully consider the substance and significance of the issue. Date of Notice: February 23, 2025 SLT0031647 Back DAQE-IN116440010-25 February 20, 2025 Pedro Villarreal ICU Medical, Inc. 4455 South Atherton Drive Taylorsville, UT 84123 Pedro.Villarreal@icumed.com Dear Mr. Villarreal: Re: Intent to Approve: Modification to Approval Order DAQE-AN116440009-23 to Increase the VOC and HAP Emissions Limits for the Medical Device Manufacturing Process Project Number: N116440010 The attached document is the Intent to Approve (ITA) for the above-referenced project. The ITA is subject to public review. Any comments received shall be considered before an Approval Order (AO) is issued. The Division of Air Quality is authorized to charge a fee for reimbursement of the actual costs incurred in the issuance of an AO. An invoice will follow upon issuance of the final AO. Future correspondence on this ITA should include the engineer's name, Mr. Tim DeJulis, as well as the DAQE number as shown on the upper right-hand corner of this letter. Mr. Tim DeJulis, can be reached at (385) 306-6523 or tdejulis@utah.gov, if you have any questions. Sincerely, {{$s }} Alan D. Humpherys, Manager New Source Review Section ADH:TD:jg cc: Salt Lake County Health Department 195 North 1950 West • Salt Lake City, UT Mailing Address: P.O. Box 144820 • Salt Lake City, UT 84114-4820 Telephone (801) 536-4000 • Fax (801) 536-4099 • T.D.D. (801) 536-4414 www.deq.utah.gov Printed on 100% recycled paper State of Utah SPENCER J. COX Governor DEIDRE HENDERSON Lieutenant Governor Department of Environmental Quality Kimberly D. Shelley Executive Director DIVISION OF AIR QUALITY Bryce C. Bird Director STATE OF UTAH Department of Environmental Quality Division of Air Quality INTENT TO APPROVE DAQE-IN116440010-25 Modification to Approval Order DAQE-AN116440009-23 to Increase the VOC and HAP Emissions Limits for the Medical Device Manufacturing Process Prepared By Mr. Tim DeJulis, Engineer (385) 306-6523 tdejulis@utah.gov Issued to ICU Medical, Inc. - Salt Lake Medical Products Manufacturing Issued On February 20, 2025 {{$s }} New Source Review Section Manager Alan D. Humpherys {{#s=Sig_es_:signer1:signature}} TABLE OF CONTENTS TITLE/SIGNATURE PAGE ....................................................................................................... 1 GENERAL INFORMATION ...................................................................................................... 3 CONTACT/LOCATION INFORMATION ............................................................................... 3 SOURCE INFORMATION ........................................................................................................ 3 General Description ................................................................................................................ 3 NSR Classification .................................................................................................................. 3 Source Classification .............................................................................................................. 3 Applicable Federal Standards ................................................................................................. 4 Project Description.................................................................................................................. 4 SUMMARY OF EMISSIONS .................................................................................................... 4 PUBLIC NOTICE STATEMENT............................................................................................... 5 SECTION I: GENERAL PROVISIONS .................................................................................... 5 SECTION II: PERMITTED EQUIPMENT .............................................................................. 6 SECTION II: SPECIAL PROVISIONS ..................................................................................... 6 PERMIT HISTORY ..................................................................................................................... 9 ACRONYMS ............................................................................................................................... 10 DAQE-IN116440010-25 Page 3 GENERAL INFORMATION CONTACT/LOCATION INFORMATION Owner Name Source Name ICU Medical, Inc. ICU Medical, Inc. - Salt Lake Medical Products Manufacturing Mailing Address Physical Address 4455 South Atherton Drive 4455 South Atherton Drive Taylorsville, UT 84123 Taylorsville, UT 84123 Source Contact UTM Coordinates Name: Pedro Villarreal 422,045 m Easting Phone: (801) 284-1206 4,503,020 m Northing Email: Pedro.Villarreal@icumed.com Datum NAD83 UTM Zone 12 SIC code 3841 (Surgical & Medical Instruments & Apparatus) SOURCE INFORMATION General Description ICU Medical, Inc. (ICU) manufactures critical care medical products. Solvent bonding, cleaning, injection molding, and final assembly are used in the manufacturing processes. As parts are assembled, small amounts of solvent are used to bond pieces together. The solvent is stored and dispensed in small, vapor-tight containers that dispense small droplets of solvent onto the items to be bonded. Small amounts of VOC-containing solvent are used to clean various manufactured plastic products and equipment. Generally, solvents are applied to rags and wiped on the products or equipment. Raw plastic products are formed by injection molding. Plastic granules are stored in storage silos until they are pneumatically piped to an injection mold machine storage device. The raw products include polyvinyl chloride, polycarbonate, polypropylene, and other plastics. The VOC content of the plastic pellets is very small. The plastic pellets are heated in the injection-molding machine and extruded into molds. Once the parts are set and stable, they are pulled from the machine and allowed to cool before being transferred to another part of the facility or packaged. Many of the parts are assembled into ready-to-use systems and shipped to medical supply vendors for sale and further dispensing to hospitals. NSR Classification Minor Modification at Minor Source Source Classification Located in Northern Wasatch Front O3 NAA, Salt Lake City UT PM2.5 NAA, Salt Lake County SO2 NAA Salt Lake County Airs Source Size: B DAQE-IN116440010-25 Page 4 Applicable Federal Standards NSPS (Part 60), A: General Provisions NSPS (Part 60), IIII: Standards of Performance for Stationary Compression Ignition Internal Combustion Engines MACT (Part 63), A: General Provisions MACT (Part 63), ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines Project Description ICU requested a modification to Condition II.B.4.b of the AO DAQE-AN116440009-23, dated November 2, 2023, to increase the VOC emission limitations from 17.66 tpy to 26.02 tpy. ICU is also requesting to increase the HAPs emissions limitation from evaporative activities from 0.88 tpy to 7.37 tpy with the overall HAPs emissions being 7.48 tpy. No other changes to the equipment list will result from this change in VOC and HAP production. SUMMARY OF EMISSIONS The emissions listed below are an estimate of the total potential emissions from the source. Some rounding of emissions is possible. Criteria Pollutant Change (TPY) Total (TPY) Ammonia 0 0.19 CO2 Equivalent 0 7041.00 Carbon Monoxide 0 4.98 Nitrogen Oxides 0 5.99 Particulate Matter - PM10 0 0.80 Particulate Matter - PM2.5 0 0.80 Sulfur Dioxide 0 0.06 Volatile Organic Compounds 8.36 26.35 Hazardous Air Pollutant Change (lbs/yr) Total (lbs/yr) Cyanide Compounds (CAS #143339) 5 11 Ethyl Benzene (CAS #100414) 0 4 Ethylene Glycol (CAS #107211) 11 20 Formaldehyde (CAS #50000) 0 9 Generic HAPs (CAS #GHAPS) 480 Glycol Ethers (CAS #EDF109) 0 47 Hexane (CAS #110543) 39 540 Methanol (CAS #67561) 12708 12760 Methylene Chloride (Dichloromethane) (CAS #75092) 40 700 Toluene (CAS #108883) 6 140 Xylenes (Isomers And Mixture) (CAS #1330207) 106 260 Change (TPY) Total (TPY) Total HAPs 6.49 7.49 DAQE-IN116440010-25 Page 5 PUBLIC NOTICE STATEMENT The NOI for the above-referenced project has been evaluated and has been found to be consistent with the requirements of UAC R307. Air pollution producing sources and/or their air control facilities may not be constructed, installed, established, or modified prior to the issuance of an AO by the Director. A 30-day public comment period will be held in accordance with UAC R307-401-7. A notification of the intent to approve will be published in the Salt Lake Tribune and Deseret News on February 23, 2025. During the public comment period the proposal and the evaluation of its impact on air quality will be available for the public to review and provide comment. If anyone so requests a public hearing within 15 days of publication, it will be held in accordance with UAC R307-401-7. The hearing will be held as close as practicable to the location of the source. Any comments received during the public comment period and the hearing will be evaluated. The proposed conditions of the AO may be changed as a result of the comments received. SECTION I: GENERAL PROVISIONS The intent is to issue an air quality AO authorizing the project with the following recommended conditions and that failure to comply with any of the conditions may constitute a violation of the AO. 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] DAQE-IN116440010-25 Page 6 SECTION II: PERMITTED EQUIPMENT The intent is to issue an air quality AO authorizing the project with the following recommended conditions and that failure to comply with any of the conditions may constitute a violation of the AO. II.A THE APPROVED EQUIPMENT II.A.1 ICU Medical, Inc. Salt Lake Medical Products Manufacturing II.A.2 Various Boilers Capacity: <5MMBtu/hr each Fuel: natural gas For informational purposes only II.A.3 Emergency Generator One (1) Emergency generator Capacity: 200 kW (268 hp) Fuel: diesel Manufactured: 2023 II.A.4 Various Comfort Heaters Comfort heaters, gas packs, sun units, or humidifiers Capacity: <5MMBtu/hr each Fuel: natural gas For information purposes only II.A.5 Mold Cleaning Equipment Resin Residual Removal Furnace Various solvent bonding, solvent cleaning, injection molding, and residual plastic resins removal chemicals used in the medical device manufacturing process. SECTION II: SPECIAL PROVISIONS The intent is to issue an air quality AO authorizing the project with the following recommended conditions and that failure to comply with any of the conditions may constitute a violation of the AO. II.B REQUIREMENTS AND LIMITATIONS II.B.1 Limitations and Requirements II.B.1.a Visible emissions from the following emission points shall not exceed the following values: A. Electric resin residual removal furnace - 10% opacity B. All natural gas-fired heater/boiler exhausts - 10% opacity C. Diesel engine exhaust - 20% opacity. [R307-401-8] DAQE-IN116440010-25 Page 7 II.B.1.a.1 Opacity observations of emissions from stationary sources shall be conducted according to 40 CFR 60, Appendix A, Method 9. [R307-401-8] II.B.1.b The owner/operator shall not burn more than five (5) pounds of resin per day in the resin residual removal furnace. [R307-401-8] II.B.1.b.1 To determine compliance, the owner/operator shall keep a record of the weight of resin remaining in each residual mold per day put into the resin residual removal furnace, for all periods when the plant is in operation. Weight of the resin combusted in each mold shall be the total weight of the resin plus the mold minus the weight of each mold, measured with a mass balance. [R307-401-8] II.B.2 Fuel Requirements II.B.2.a The owner/operator shall use only natural gas as fuel in all the boilers and heaters. [R307-401-8] II.B.2.b The owner/operator shall only use diesel fuel (fuel oil #1, #2, or diesel fuel oil additives) in the emergency generator engine. All diesel burned shall meet the definition of ultra-low sulfur diesel (ULSD) and contain no more than 15 ppm sulfur. [R307-401-8] II.B.2.b.1 To demonstrate compliance with the diesel fuel requirements for any diesel fuel purchased, the owner/operator shall keep and maintain fuel purchase invoices. The fuel purchase invoices shall indicate that the diesel fuel meets the ULSD requirements, or the owner/operator shall obtain certification of sulfur content from the fuel supplier. [R307-401-8] II.B.3 Engine Requirements II.B.3.a The owner/operator shall not operate the emergency generator engine on site for more than 100 hours per rolling 12-month period during non-emergency situations. There is no time limit on the use of the engines during emergencies. [40 CFR 60 Subpart IIII, 40 CFR 63 Subpart ZZZZ] II.B.3.a.1 To determine compliance with a rolling 12-month total, the owner/operator shall calculate a new 12-month total by the 20th day of each month using data from the previous 12 months. Records documenting the operation of each emergency engine shall be kept in a log and shall include the following: A. The date the emergency engine was used B. The duration of operation in hours C. The reason for the emergency engine usage. [R307-401-8] II.B.4 Volatile Organic Compound (VOC) Limitations II.B.4.a The VOC content of the solvent bonding, solvent cleaning, injection molding, and residual plastic resins removal chemicals as used shall not exceed the density limits established by R307-353. High solids (low VOC content) chemicals shall not be thinned or otherwise reduced beyond manufacturers recommendations. These parameters shall be tested by using the appropriate ASTM method or another method approved by the Director. [R307-353] DAQE-IN116440010-25 Page 8 II.B.4.b The owner/operator shall not emit more than the following from evaporative sources (solvent bonding, solvent cleaning, injection molding, residual plastic resins removal, etc.) on site: 26.02 tons of VOC per rolling 12-month period 6.38 tons methanol per rolling 12-month period 0.35 tons of methylene chloride per rolling 12-month period 0.27 tons of hexane per rolling 12-month period 0.13 tons of xylene per rolling 12-month period 0.24 tons of chloride, cyanide compounds, ethyl benzene, ethylene dichloride, ethylene glycol, formaldehyde, glycol ethers, isophorone, methyl methacrylate, nickel compounds, propylene oxide, toluene, and xylene combined per rolling 12-month period. This does not include the emissions from the natural gas and diesel combustion sources. [R307-401-8] II.B.4.b.1 The owner/operator shall calculate a new 12-month total by the 20th day of each month using data from the previous 12 months. The owner/operator shall use a mass-balance method to calculate emissions from evaporative sources. The owner/operator may use the following equations with applicable units to comply with the mass-balance method: VOCs = [% VOCs by Weight/100] x [Density] x [Volume Consumed] HAP = [% HAP by Weight/100] x [Density] x [Volume Consumed] [R307-401-8] II.B.4.b.2 The owner/operator shall use a mass-balance method to quantify any amount of VOCs and HAPs reclaimed. The owner/operator shall subtract the amount of VOCs and HAPs reclaimed from the quantities calculated above to provide the monthly total emissions of VOCs and HAPs. [R307-401-8] II.B.4.b.3 The owner/operator shall keep records each month of the following: A. The name (as per SDS) of the VOC- and HAP-emitting material B. The maximum percent by weight of VOCs and each HAP in each material used C. The density of each material used D. The volume of each VOC- and HAP-emitting material used E. The amount of VOCs and the amount of each HAP emitted from each material F. The amount of VOCs and the amount of each HAP reclaimed and/or controlled from each material G. The total amount of VOCs, the total amount of each HAP, and the total amount of all HAPs combined emitted from all materials (in tons). [R307-401-8] DAQE-IN116440010-25 Page 9 PERMIT HISTORY This Approval Order shall supersede (if a modification) or will be based on the following documents: Supersedes AO DAQE-AN116440009-23 dated November 2, 2023 Is Derived From NOI dated October 3, 2024 Incorporates Additional information dated December 11, 2024 DAQE-IN116440010-25 Page 10 ACRONYMS The following lists commonly used acronyms and associated translations as they apply to this document: 40 CFR Title 40 of the Code of Federal Regulations AO Approval Order BACT Best Available Control Technology CAA Clean Air Act CAAA Clean Air Act Amendments CDS Classification Data System (used by Environmental Protection Agency to classify sources by size/type) CEM Continuous emissions monitor CEMS Continuous emissions monitoring system CFR Code of Federal Regulations CMS Continuous monitoring system CO Carbon monoxide CO2 Carbon Dioxide CO2e Carbon Dioxide Equivalent - Title 40 of the Code of Federal Regulations Part 98, Subpart A, Table A-1 COM Continuous opacity monitor DAQ/UDAQ Division of Air Quality DAQE This is a document tracking code for internal Division of Air Quality use EPA Environmental Protection Agency FDCP Fugitive dust control plan GHG Greenhouse Gas(es) - Title 40 of the Code of Federal Regulations 52.21 (b)(49)(i) GWP Global Warming Potential - Title 40 of the Code of Federal Regulations Part 86.1818- 12(a) HAP or HAPs Hazardous air pollutant(s) ITA Intent to Approve LB/YR Pounds per year MACT Maximum Achievable Control Technology MMBTU Million British Thermal Units NAA Nonattainment Area NAAQS National Ambient Air Quality Standards NESHAP National Emission Standards for Hazardous Air Pollutants NOI Notice of Intent NOx Oxides of nitrogen NSPS New Source Performance Standard NSR New Source Review PM10 Particulate matter less than 10 microns in size PM2.5 Particulate matter less than 2.5 microns in size PSD Prevention of Significant Deterioration PTE Potential to Emit R307 Rules Series 307 R307-401 Rules Series 307 - Section 401 SO2 Sulfur dioxide Title IV Title IV of the Clean Air Act Title V Title V of the Clean Air Act TPY Tons per year UAC Utah Administrative Code VOC Volatile organic compounds DAQE-NN116440010-25 February 20, 2025 Salt Lake Tribune and Deseret News Legal Advertising Dept. P.O. Box 704055 West Valley City, UT 84170 Acct #9001399880 RE: Legal Notice of Intent to Approve This letter will confirm the authorization to publish the attached NOTICE in the Salt Lake Tribune and Deseret News on February 23, 2025. Please mail the invoice and affidavit of publication to the Utah State Department of Environmental Quality, Division of Air Quality, P.O. Box 144820, Salt Lake City, Utah 84114-4820. If you have any questions, contact Jeree Greenwood, who may be reached at (385) 306-6514. Sincerely, {{$s }} Jeree Greenwood Office Technician Enclosure cc: Wasatch Front Regional Council cc: Salt Lake County 195 North 1950 West • Salt Lake City, UT Mailing Address: P.O. Box 144820 • Salt Lake City, UT 84114-4820 Telephone (801) 536-4000 • Fax (801) 536-4099 • T.D.D. (801) 903-3978 www.deq.utah.gov Printed on 100% recycled paper State of Utah SPENCER J. COX Governor DEIDRE HENDERSON Lieutenant Governor Department of Environmental Quality Kimberly D. Shelley Executive Director DIVISION OF AIR QUALITY Bryce C. Bird Director DAQE-NN116440010-25 Page 2 NOTICE A Notice of Intent for the following project submitted in accordance with R307-401-1, Utah Administrative Code (UAC), has been received for consideration by the Director: Company Name: ICU Medical, Inc. Location: ICU Medical, Inc. - Salt Lake Medical Products Manufacturing – 4455 South Atherton Drive, Taylorsville, UT Project Description: ICU Medical, Inc. (ICU) requested a modification to Condition II.B.4.b of the Approval Order DAQE-AN116440009-23, dated November 2, 2023, to increase the VOC emission limitations from 17.66 tpy to 26.02 tpy. ICU is also requesting to increase the HAPs emissions limitation from evaporative sources 0.88 tpy to 7.37 tpy with the overall HAPs emissions being 7.48 tpy. No other changes to the equipment list will result from this change in VOC and HAP production. The completed engineering evaluation and air quality impact analysis showed the proposed project meets the requirements of federal air quality regulations and the State air quality rules. The Director intends to issue an Approval Order pending a 30-day public comment period. The project proposal, estimate of the effect on local air quality, and draft Approval Order are available for public inspection and comment at the Utah Division of Air Quality, 195 North 1950 West, Salt Lake City, UT 84116. Written comments received by the Division at this same address on or before March 25, 2025, will be considered in making the final decision on the approval/disapproval of the proposed project. Email comments will also be accepted at tdejulis@utah.gov. If anyone so requests to the Director in writing within 15 days of publication of this notice, a hearing will be held in accordance with R307-401-7, UAC. Under Section 19-1-301.5, a person who wishes to challenge a Permit Order may only raise an issue or argument during an adjudicatory proceeding that was raised during the public comment period and was supported with sufficient information or documentation to enable the Director to fully consider the substance and significance of the issue. Date of Notice: February 23, 2025 {{#s=Sig_es_:signer1:signature}} DAQE- RN116440010 February 13, 2025 Pedro Villarreal ICU Medical, Inc. 4455 South Atherton Drive Taylorsville, UT 84123 Pedro.Villarreal@icumed.com Dear Pedro Villarreal, Re: Engineer Review: Modification to DAQE-AN116440009-23 to Increase the VOC and HAP Emissions Limits for the Medical Device Manufacturing Process Project Number: N116440010 The DAQ requests a company representative review and sign the attached Engineer Review (ER). This ER identifies all applicable elements of the New Source Review permitting program. ICU Medical, Inc. should complete this review within 10 business days of receipt. ICU Medical, Inc. should contact Mr. Tim DeJulis at (385) 306-6523 if there are questions or concerns with the review of the draft permit conditions. Upon resolution of your concerns, please email Mr. Tim DeJulis at tdejulis@utah.gov the signed cover letter. Upon receipt of the signed cover letter, the DAQ will prepare an ITA for a 30-day public comment period. At the completion of the comment period, the DAQ will address any comments and will prepare an Approval Order (AO) for signature by the DAQ Director. If ICU Medical, Inc. does not respond to this letter within 10 business days, the project will move forward without source concurrence. If ICU Medical, Inc. has concerns that cannot be resolved and the project becomes stagnant, the DAQ Director may issue an Order prohibiting construction. Approval Signature _____________________________________________________________ (Signature & Date) 195 North 1950 West • Salt Lake City, UT Mailing Address: P.O. Box 144820 • Salt Lake City, UT 84114-4820 Telephone (801) 536-4000 • Fax (801) 536-4099 • T.D.D. (801) 903-3978 www.deq.utah.gov Printed on 100% recycled paper Department of Environmental Quality Kimberly D. Shelley Executive Director DIVISION OF AIR QUALITY Bryce C. Bird Director State of Utah SPENCER J. COX Governor DEIDRE HENDERSON Lieutenant Governor Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 1 UTAH DIVISION OF AIR QUALITY ENGINEER REVIEW SOURCE INFORMATION Project Number N116440010 Owner Name ICU Medical, Inc. Mailing Address 4455 South Atherton Drive Taylorsville, UT, 84123 Source Name ICU Medical, Inc.- Salt Lake Medical Products Manufacturing Source Location 4455 South Atherton Drive Taylorsville, UT 84123 UTM Projection 422,045 m Easting, 4,503,020 m Northing UTM Datum NAD83 UTM Zone UTM Zone 12 SIC Code 3841 (Surgical & Medical Instruments & Apparatus) Source Contact Pedro Villarreal Phone Number (801) 284-1206 Email Pedro.Villarreal@icumed.com Billing Contact Pedro Villarreal Phone Number (801) 284-1206 Email Pedro.Villarreal@icumed.com Project Engineer Mr. Tim DeJulis, Engineer Phone Number (385) 306-6523 Email tdejulis@utah.gov Notice of Intent (NOI) Submitted October 3, 2024 Date of Accepted Application October 15, 2024 Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 2 SOURCE DESCRIPTION General Description ICU Medical, Inc. (ICU) manufactures critical care medical products. Solvent bonding, cleaning, injection molding, and final assembly are used in the manufacturing processes. As parts are assembled, small amounts of solvent are used to bond pieces together. The solvent is stored and dispensed in small vapor tight containers that dispense small droplets of solvent onto the items to be bonded. Small amounts of VOC-containing solvent are used to clean various manufactured plastic products and equipment. Generally, solvents are applied to rags and wiped on the products or equipment. Raw plastic products are formed by injection molding. Plastic granules are stored in storage silos until they are pneumatically piped to an injection mold machine storage device. The raw products include polyvinyl chloride, polycarbonate, polypropylene and other plastics. The VOC content of the plastic pellets is very small. The plastic pellets are heated in the injection-molding machine and extruded into molds. Once the parts are set and stable, they are pulled from the machine and allowed to cool before being transferred to another part of the facility or packaged. Many of the parts are assembled into ready-to-use systems and shipped to medical supply vendors for sale and further dispensing to hospitals. NSR Classification: Minor Modification at Minor Source Source Classification Located in Northern Wasatch Front O3 NAA, Salt Lake City UT PM2.5 NAA, Salt Lake County SO2 NAA Salt Lake County Airs Source Size: B Applicable Federal Standards NSPS (Part 60), A: General Provisions NSPS (Part 60), IIII: Standards of Performance for Stationary Compression Ignition Internal Combustion Engines MACT (Part 63), A: General Provisions MACT (Part 63), ZZZZ: National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines Project Proposal Modification to DAQE-AN116440009-23 to Increase the VOC and HAP Emissions Limits for the Medical Device Manufacturing Process Project Description ICU requested a modification to Condition II.B.4.b of the AO DAQE-AN116440009-23, dated November 2, 2023 to increase the VOC emission limitations from 17.66 tpy to 26.02 tpy. ICU is also requesting to increase the HAPs emissions limitation from evaporative activities from 0.88 tpy to 7.37 tpy with the overall HAPs emissions being 7.48 tpy. No other changes to the equipment list will result from this change in VOC and HAP production. EMISSION IMPACT ANALYSIS All criteria pollutants are below the modeling thresholds contained in R307-410-4. All HAP emissions are below their respective emission threshold values in R307-410-5. Therefore, no modeling is required from this source. [Last updated October 3, 2024] Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 3 SUMMARY OF EMISSIONS The emissions listed below are an estimate of the total potential emissions from the source. Some rounding of emissions is possible. Criteria Pollutant Change (TPY) Total (TPY) Ammonia 0 0.19 CO2 Equivalent 0 7041.00 Carbon Monoxide 0 4.98 Nitrogen Oxides 0 5.99 Particulate Matter - PM10 0 0.80 Particulate Matter - PM2.5 0 0.80 Sulfur Dioxide 0 0.06 Volatile Organic Compounds 8.36 26.35 Hazardous Air Pollutant Change (lbs/yr) Total (lbs/yr) Cyanide Compounds (CAS #143339) 5 11 Ethyl Benzene (CAS #100414) 0 4 Ethylene Glycol (CAS #107211) 11 20 Formaldehyde (CAS #50000) 0 9 Generic HAPs (CAS #GHAPS) 480 Glycol Ethers (CAS #EDF109) 0 47 Hexane (CAS #110543) 39 540 Methanol (CAS #67561) 12708 12760 Methylene Chloride (Dichloromethane) (CAS #75092) 40 700 Toluene (CAS #108883) 6 140 Xylenes (Isomers And Mixture) (CAS #1330207) 106 260 Change (TPY) Total (TPY) Total HAPs 6.49 7.49 Note: Change in emissions indicates the difference between previous AO and proposed modification. Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 4 Review of BACT for New/Modified Emission Units 1. BACT review regarding Process Equipment This BACT analysis is for the increase in VOC and HAP emissions from the production process. VOCs emissions will increase from 17.13 tpy to 26.02 tpy and HAPs will increase from 0.88 tpy to 7.37 tpy. The controls for this increase in emissions could be a thermal oxidizer, a regenerative thermal oxidizer, or a flare device. Use of these technologies are economically infeasible to implement. The process equipment will remain the same; therefore, maintaining visible emissions below 10% opacity and complying with all applicable requirements of R307-353 is BACT. [Last updated February 13, 2025] SECTION I: GENERAL PROVISIONS The intent is to issue an air quality AO authorizing the project with the following recommended conditions and that failure to comply with any of the conditions may constitute a violation of the AO. (New or Modified conditions are indicated as “New” in the Outline Label): 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] Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 5 I.7 The owner/operator shall comply with UAC R307-150 Series. Emission Inventories. [R307-150] SECTION II: PERMITTED EQUIPMENT The intent is to issue an air quality AO authorizing the project with the following recommended conditions and that failure to comply with any of the conditions may constitute a violation of the AO. (New or Modified conditions are indicated as “New” in the Outline Label): II.A THE APPROVED EQUIPMENT II.A.1 ICU Medical, Inc. Salt Lake Medical Products Manufacturing II.A.2 Various Boilers Capacity: <5MMBtu/hr each Fuel: natural gas For informational purposes only II.A.3 Emergency Generator One (1) Emergency generator Capacity: 200 kW (268 hp) Fuel: diesel Manufactured: 2023 II.A.4 Various Comfort Heaters Comfort heaters, gas packs, sun units, or humidifiers Capacity; <5MMBtu/hr each Fuel: natural gas For information purposes only II.A.5 Mold Cleaning Equipment Resin Residual Removal Furnace Various solvent bonding, solvent cleaning, injection molding, and residual plastic resins removal chemicals used in the medical device manufacturing process. Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 6 SECTION II: SPECIAL PROVISIONS The intent is to issue an air quality AO authorizing the project with the following recommended conditions and that failure to comply with any of the conditions may constitute a violation of the AO. (New or Modified conditions are indicated as “New” in the Outline Label): II.B REQUIREMENTS AND LIMITATIONS II.B.1 Limitations and Requirements II.B.1.a Visible emissions from the following emission points shall not exceed the following values: A. Electric resin residual removal furnace - 10% opacity B. All natural gas-fired heater/boiler exhausts - 10% opacity C. Diesel engine exhaust - 20% opacity. [R307-401-8] II.B.1.a.1 Opacity observations of emissions from stationary sources shall be conducted according to 40 CFR 60, Appendix A, Method 9. [R307-401-8] II.B.1.b The owner/operator shall not burn more than five (5) pounds of resin per day in the resin residual removal furnace. [R307-401-8] II.B.1.b.1 To determine compliance, the owner/operator shall keep a record of the weight of resin remaining in each residual mold per day put into the resin residual removal furnace, for all periods when the plant is in operation. Weight of the resin combusted in each mold shall be the total weight of the resin plus the mold minus the weight of each mold, measured with a mass balance. [R307-401-8] II.B.2 Fuel Requirements II.B.2.a The owner/operator shall use only natural gas as fuel in all the boilers and heaters. [R307-401-8] II.B.2.b The owner/operator shall only use diesel fuel (fuel oil #1, #2 or diesel fuel oil additives) in the emergency generator engine. All diesel burned shall meet the definition of ultra-low sulfur diesel (ULSD), and contain no more than 15 ppm sulfur. [R307-401-8] II.B.2.b.1 To demonstrate compliance with the diesel fuel requirements for any diesel fuel purchased, the owner/operator shall keep and maintain fuel purchase invoices. The fuel purchase invoices shall indicate that the diesel fuel meets the ULSD requirements, or the owner/operator shall obtain certification of sulfur content from the fuel supplier. [R307-401-8] II.B.3 Engine Requirements II.B.3.a The owner/operator shall not operate the emergency generator engine on site for more than 100 hours per rolling 12-month period during non-emergency situations. There is no time limit on the use of the engines during emergencies. [40 CFR 60 Subpart IIII, 40 CFR 63 Subpart ZZZZ] Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 7 II.B.3.a.1 To determine compliance with a rolling 12-month total, the owner/operator shall calculate a new 12-month total by the 20th day of each month using data from the previous 12 months. Records documenting the operation of each emergency engine shall be kept in a log and shall include the following: A. The date the emergency engine was used B. The duration of operation in hours C. The reason for the emergency engine usage. [R307-401-8] II.B.4 Volatile Organic Compound (VOC) Limitations II.B.4.a NEW The VOC content of the solvent bonding, solvent cleaning, injection molding, and residual plastic resins removal chemicals as used shall not exceed the density limits established by R307-353. High solids (low VOC content) chemicals shall not be thinned or otherwise reduced beyond manufacturers recommendations. These parameters shall be tested by using the appropriate ASTM method or another method approved by the Director. [R307-353] II.B.4.b NEW The owner/operator shall not emit more than the following from evaporative sources (solvent bonding, solvent cleaning, injection molding, residual plastic resins removal, etc.) on site: 26.02 tons of VOC per rolling 12-month period 6.38 tons methanol per rolling 12-month period 0.35 tons of methylene chloride per rolling 12-month period 0.27 tons of hexane per rolling 12-month period 0.13 tons of xylene per rolling 12-month period 0.24 tons of chloride, cyanide compounds, ethyl benzene, ethylene dichloride, ethylene glycol, formaldehyde, glycol ethers, isophorone, methyl methacrylate, nickel compounds, propylene oxide, toluene, and xylene combined per rolling 12-month period This does not include the emissions from the natural gas and diesel combustion sources. [R307-401-8] II.B.4.b.1 The owner/operator shall calculate a new 12-month total by the 20th day of each month using data from the previous 12 months. The owner/operator shall use a mass-balance method to calculate emissions from evaporative sources. The owner/operator may use the following equations with applicable units to comply with the mass-balance method: VOCs = [% VOCs by Weight/100] x [Density] x [Volume Consumed] HAP = [% HAP by Weight/100] x [Density] x [Volume Consumed]. [R307-401-8] II.B.4.b.2 The owner/operator shall use a mass-balance method to quantify any amount of VOCs and HAPs reclaimed. The owner/operator shall subtract the amount of VOCs and HAPs reclaimed from the quantities calculated above to provide the monthly total emissions of VOCs and HAPs. [R307-401-8] Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 8 II.B.4.b.3 The owner/operator shall keep records each month of the following: A. The name (as per SDS) of the VOC- and HAP-emitting material B. The maximum percent by weight of VOCs and each HAP in each material used C. The density of each material used D. The volume of each VOC- and HAP-emitting material used E. The amount of VOCs and the amount of each HAP emitted from each material F. The amount of VOCs and the amount of each HAP reclaimed and/or controlled from each material G. The total amount of VOCs, the total amount of each HAP, and the total amount of all HAPs combined emitted from all materials (in tons). [R307-401-8] PERMIT HISTORY When issued, the approval order shall supersede (if a modification) or will be based on the following documents: Supersedes AO DAQE-AN116440009-23 dated November 2, 2023 Is Derived From NOI dated October 3, 2024 Incorporates Additional information dated December 11, 2024 REVIEWER COMMENTS 1. Comment regarding Emissions Estimates: Based on a review of the VOC and HAP emissions by a mass balance methodology, the DAQ determined an increase in both VOC and HAP. [Last updated February 13, 2025] 2. Comment regarding NSPS and MACT Review: The plant is subject to 40 CFR 60 (NSPS) (Subpart A and Subpart IIII) and 40 CFR 63 (MACT) regulations (Subpart A and Subpart ZZZZ). 40 CFR 60 Subpart Dc applies to owners and operators of steam generating units (boilers) sized between 100 MMBtu/hr and 10 MMBtu/hr. All boilers are less than 5 MMBtu/hr on site, therefore this subpart doesn't apply to this plant. 40 CFR 60 Subpart IIII applies to owners and operators of stationary CI ICE that commence construction after July 11, 2005, where the stationary CI ICE are manufactured on or after July 11, 2005, for engines with a maximum engine power greater than 50 hp. The source has an emergency generator engine rated at 200 kW (268 hp). The engine was purchased after July 11, 2005 therefore, this subpart applies to this plant. 40 CFR 63 Subpart ZZZZ applies to owners and operators of stationary RICE at a major or area source of HAP emissions. Since this source will have a stationary RICE at an area source of HAP Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 9 emissions, Subpart ZZZZ applies to this plant. 40 CFR 63 Subpart JJJJJJ applies to owners and operators of boilers at an area source of HAPs emissions that use coal, biomass, or oil to fire them. Since this source will have boilers at an area source of HAP emissions, but use natural gas as fuel, this subpart will not apply to this plant . [Last updated February 13, 2025] 3. Comment regarding Title V Requirements: Title V of the 1990 Clean Air Act (Title V) applies to the following: 1. Any major source 2. Any source subject to a standard, limitation, or other requirement under Section 111 of the Act, Standards of Performance for New Stationary Sources; 3. Any source subject to a standard or other requirement under Section 112 of the Act, Hazardous Air Pollutants. 4. Any Title IV affected source. This facility is not a major source and is not a Title IV source. The facility is not subject to 40 CFR 61 (NESHAP) regulations. This facility is subject to 40 CFR 60 and 40 CFR 63 (MACT) regulations. However, Title V does not apply because NSPS Subpart IIII and MACT Subpart ZZZZ exempt sources from the obligation to obtain a permit under 40 CFR part 70 (Title V permit) if the source is not otherwise required by law to obtain a permit. There are no other reasons why this source would be required to obtain a part 70 permit; therefore, Title V does not apply to this facility. [Last updated November 6, 2024] Engineer Review N116440010: ICU Medical, Inc.- Salt Lake Medical Products Manufacturing February 13, 2025 Page 10 ACRONYMS The following lists commonly used acronyms and associated translations as they apply to this document: 40 CFR Title 40 of the Code of Federal Regulations AO Approval Order BACT Best Available Control Technology CAA Clean Air Act CAAA Clean Air Act Amendments CDS Classification Data System (used by EPA to classify sources by size/type) CEM Continuous emissions monitor CEMS Continuous emissions monitoring system CFR Code of Federal Regulations CMS Continuous monitoring system CO Carbon monoxide CO2 Carbon Dioxide CO2e Carbon Dioxide Equivalent - 40 CFR Part 98, Subpart A, Table A-1 COM Continuous opacity monitor DAQ/UDAQ Division of Air Quality DAQE This is a document tracking code for internal UDAQ use EPA Environmental Protection Agency FDCP Fugitive dust control plan GHG Greenhouse Gas(es) - 40 CFR 52.21 (b)(49)(i) GWP Global Warming Potential - 40 CFR Part 86.1818-12(a) HAP or HAPs Hazardous air pollutant(s) ITA Intent to Approve LB/HR Pounds per hour LB/YR Pounds per year MACT Maximum Achievable Control Technology MMBTU Million British Thermal Units NAA Nonattainment Area NAAQS National Ambient Air Quality Standards NESHAP National Emission Standards for Hazardous Air Pollutants NOI Notice of Intent NOx Oxides of nitrogen NSPS New Source Performance Standard NSR New Source Review PM10 Particulate matter less than 10 microns in size PM2.5 Particulate matter less than 2.5 microns in size PSD Prevention of Significant Deterioration PTE Potential to Emit R307 Rules Series 307 R307-401 Rules Series 307 - Section 401 SO2 Sulfur dioxide Title IV Title IV of the Clean Air Act Title V Title V of the Clean Air Act TPY Tons per year UAC Utah Administrative Code VOC Volatile organic compounds Tim Dejulis <tdejulis@utah.gov> ICU Medical's Engineering Review 18 messages Tim Dejulis <tdejulis@utah.gov>Mon, Jul 17, 2023 at 3:19 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Pedro, Here is ICU Medical's engineering review for your inspection. Please look this over carefully. If it is acceptable, sign the first page and return it to me by email. Otherwise, we can discuss anything. Thank you. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov RN116440009-23.v 7.ICU Medical.docx 150K Pedro Villarreal <Pedro.Villarreal@icumed.com>Wed, Aug 16, 2023 at 2:45 PM To: Tim Dejulis <tdejulis@utah.gov> Hi Tim- Just wanted to follow up, the engineer review was sent to Riley Jenkins (AECOM consultant) and suggested some changes. I wanted to ensure they got to you. I believe it was 7/27/2023 when they sent me a copy and hope they sent it to you as well. Below are the changes as a reference: Currently, the source contact is Steve Stauffer. We’d like to ask them to update that to be you. On Page 3, it erroneously lists the horsepower of the replaced engine as 264hp , it should be 268hp. It is correct in the rest of the document. On page 6, under Section II: Permitted Equipment, II.A.3: it states that the manufacture year for the 200 kW emergency generator as 2023. I don’t believe this is the correct manufacture date since the engine was installed in 2020. Double check the year that engine was manufactured and we’d like to ask them to update that section as well. Page Update Type Information to be updated 1 Source Contact Update Update information to be Pedro Villarreal (currently Steve Stauffer) 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…1/15 3 200 kW (268 hp) emergency generator Lists the generator hp as 264, should be 268hp 6 200 kW emergency generator manufacture year Provide the updated date of manufacture (currently listed as 2023) Best Regards, Pedro Villarreal EHS Manager 4455 Atherton Drive Salt Lake City, UT 84123 Phone: 801-284-1206 www.icumed.com From: Tim Dejulis <tdejulis@utah.gov> Sent: Monday, July 17, 2023 3:20 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Subject: ICU Medical's Engineering Review CAUTION: This message has originated from an EXTERNAL SOURCE. Please use proper judgment and caution when opening attachments, clicking links, or responding to this email. [Quoted text hidden] RN116440009-23.v 7.ICU Medical_AECOM changes.docx 161K Tim Dejulis <tdejulis@utah.gov>Fri, Aug 25, 2023 at 10:49 AM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Pedro, Here is the updated engineering review for ICU Medical. Let me know if there are any other changes. Again, sign the first page and return this to me by email if possible. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…2/15 Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] RN116440009-23.v 8.ICU Medical.docx 150K Tim Dejulis <tdejulis@utah.gov>Thu, Sep 7, 2023 at 10:45 AM To: Pedro Villarreal <Pedro.Villarreal@icumed.com>, "Steve Stauffer (sstauffer@icumed.com)" <sstauffer@icumed.com> Pedro, Did you have any questions for me regarding the engineering review? If not, please have Steve Stauffer sign the front page and return it to my attention. Thank you. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] Mail Delivery Subsystem <MAILER-DAEMON@mx0b-00291401.pphosted.com>Thu, Sep 7, 2023 at 10:46 AM To: tdejulis@utah.gov The original message was received at Thu, 7 Sep 2023 16:46:28 GMT from m0113504.ppops.net [127.0.0.1] ----- The following addresses had permanent fatal errors ----- <sstauffer@icumed.com> (reason: 550 5.4.1 Recipient address rejected: Access denied. [CY4PEPF0000E9D9.namprd05.prod.outlook.com 2023-09-07T16:46:29.316Z 08DBACEA4A42B397]) ----- Transcript of session follows ----- ... while talking to icumed-com.mail.protection.outlook.com.: >>> DATA <<< 550 5.4.1 Recipient address rejected: Access denied. [CY4PEPF0000E9D9.namprd05.prod.outlook.com 2023-09- 07T16:46:29.316Z 08DBACEA4A42B397] 550 5.1.1 <sstauffer@icumed.com>... User unknown <<< 503 5.5.2 Need rcpt command [CY4PEPF0000E9D9.namprd05.prod.outlook.com 2023-09-07T16:46:29.316Z 08DBACEA4A42B397] Final-Recipient: RFC822; sstauffer@icumed.com X-Actual-Recipient: rfc822; sstauffer@icumed.com Action: failed Status: 5.4.1 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…3/15 Remote-MTA: DNS; icumed-com.mail.protection.outlook.com Diagnostic-Code: SMTP; 550 5.4.1 Recipient address rejected: Access denied. [CY4PEPF0000E9D9.namprd05. prod.outlook.com 2023-09-07T16:46:29.316Z 08DBACEA4A42B397] Last-Attempt-Date: Thu, 7 Sep 2023 16:46:29 GMT ---------- Forwarded message ---------- From: Tim Dejulis <tdejulis@utah.gov> To: Pedro Villarreal <Pedro.Villarreal@icumed.com>, "Steve Stauffer (sstauffer@icumed.com)" <sstauffer@icumed.com> Cc: Bcc: Date: Thu, 7 Sep 2023 10:45:42 -0600 Subject: Re: ICU Medical's Engineering Review CAUTION: This message has originated from an EXTERNAL SOURCE. Please use proper judgment and cauon when opening aachments, clicking links, or responding to this email. Pedro, Did you have any questions for me regarding the engineering review? If not, please have Steve Stauffer sign the front page and return it to my attention. Thank you. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov On Fri, Aug 25, 2023 at 10:49 AM Tim Dejulis <tdejulis@utah.gov> wrote: Pedro, Here is the updated engineering review for ICU Medical. Let me know if there are any other changes. Again, sign the first page and return this to me by email if possible. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov On Wed, Aug 16, 2023 at 2:46 PM Pedro Villarreal <Pedro.Villarreal@icumed.com> wrote: Hi Tim- Just wanted to follow up, the engineer review was sent to Riley Jenkins (AECOM consultant) and suggested some changes. I wanted to ensure they got to you. I believe it was 7/27/2023 when they sent me a copy and hope they sent it to you as well. Below are the changes as a reference: 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…4/15 Currently, the source contact is Steve Stauffer. We’d like to ask them to update that to be you. On Page 3, it erroneously lists the horsepower of the replaced engine as 264hp , it should be 268hp. It is correct in the rest of the document. On page 6, under Section II: Permitted Equipment, II.A.3: it states that the manufacture year for the 200 kW emergency generator as 2023. I don’t believe this is the correct manufacture date since the engine was installed in 2020. Double check the year that engine was manufactured and we’d like to ask them to update that section as well. Page Update Type Information to be updated 1 Source Contact Update Update information to be Pedro Villarreal (currently Steve Stauffer) 3 200 kW (268 hp) emergency generator Lists the generator hp as 264, should be 268hp 6 200 kW emergency generator manufacture year Provide the updated date of manufacture (currently listed as 2023) Best Regards, Pedro Villarreal EHS Manager 4455 Atherton Drive Salt Lake City, UT 84123 Phone: 801-284-1206 www.icumed.com From: Tim Dejulis <tdejulis@utah.gov> Sent: Monday, July 17, 2023 3:20 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Subject: ICU Medical's Engineering Review CAUTION: This message has originated from an EXTERNAL SOURCE. Please use proper judgment and caution when opening attachments, clicking links, or responding to this email. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…5/15 Pedro, Here is ICU Medical's engineering review for your inspection. Please look this over carefully. If it is acceptable, sign the first page and return it to me by email. Otherwise, we can discuss anything. Thank you. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov Pedro Villarreal <Pedro.Villarreal@icumed.com>Thu, Sep 7, 2023 at 10:51 AM To: Tim Dejulis <tdejulis@utah.gov> Cc: "Jenkins, Riley" <riley.jenkins@aecom.com> Good Morning-, Tim- I am having our consultant review the engineering review. I will reach out to them to see if they have any questions. Also, Steve Stauffer is not longer with the company, ICU Medical, I replaced him. [Quoted text hidden] Jenkins, Riley <riley.jenkins@aecom.com>Thu, Sep 7, 2023 at 11:00 AM To: Pedro Villarreal <Pedro.Villarreal@icumed.com>, Tim Dejulis <tdejulis@utah.gov> Hi Pedro, I’ve attached the document with ‘Track Changes’ with the updates that are still requested for the AO. These are the following items we suggest be updated before we sign the cover letter and get it into the comment period. Currently, the source contact is Steve Stauffer. We’d like to ask them to update that to be you. See attached document for changes. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…6/15 On Page 3, it erroneously lists the horsepower of the replaced engine as 264hp , it should be 268hp. It is correct in the rest of the document. Thanks. Riley J. Jenkins, EIT Environmental Engineer Central Region Air Permitting and Measurements D +1-801-904-4142 riley.jenkins@aecom.com AECOM 756 E Winchester Street, Suite 400 Salt Lake City, Utah 84107, USA T +1-801-904-4000 aecom.com Imagine it. Delivered. LinkedIn Twitter Facebook Instagram From: Pedro Villarreal <Pedro.Villarreal@icumed.com> Sent: Thursday, September 7, 2023 10:51 AM To: Tim Dejulis <tdejulis@utah.gov> Cc: Jenkins, Riley <riley.jenkins@aecom.com> Subject: RE: ICU Medical's Engineering Review Good Morning-, Tim- I am having our consultant review the engineering review. I will reach out to them to see if they have any questions. Also, Steve Stauffer is not longer with the company, ICU Medical, I replaced him. Best Regards, Pedro [Quoted text hidden] RN116440009-23.v 8.ICU Medical_AECOM changes.docx 158K Tim Dejulis <tdejulis@utah.gov>Fri, Sep 22, 2023 at 11:39 AM To: "Jenkins, Riley" <riley.jenkins@aecom.com> Cc: Pedro Villarreal <Pedro.Villarreal@icumed.com> Pedro, The engineering review for ICU Medical was changed, as you requested. Please sign this and we will prepare it for the public comment period, lasting 30-days. I will let ICU Medical know if any comments are received. Thank you. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…7/15 Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] 3 attachments image001.png 19K image001.png 19K image001.png 19K Pedro Villarreal <Pedro.Villarreal@icumed.com>Fri, Sep 22, 2023 at 1:07 PM To: Tim Dejulis <tdejulis@utah.gov>, "Jenkins, Riley" <riley.jenkins@aecom.com> Hi Tim- I didn’t see an attachment for me to sign. [Quoted text hidden] Tim Dejulis <tdejulis@utah.gov>Fri, Sep 22, 2023 at 3:15 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Cc: "Jenkins, Riley" <riley.jenkins@aecom.com> First page, near the bottom. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] 2 attachments image001.png 19K 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…8/15 image001.png 19K Jenkins, Riley <riley.jenkins@aecom.com>Mon, Sep 25, 2023 at 12:20 PM To: Tim Dejulis <tdejulis@utah.gov>, Pedro Villarreal <Pedro.Villarreal@icumed.com> Hi Tim, Would you mind please resending the engineering review document attachment? It wasn’t attached to the email sent at 11:39am on 9/22/2023 or the follow-up at 3:15pm the same day. Thanks! Riley J. Jenkins, EIT Environmental Engineer Central Region Air Permitting and Measurements D +1-801-904-4142 riley.jenkins@aecom.com AECOM 756 E Winchester Street, Suite 400 Salt Lake City, Utah 84107, USA T +1-801-904-4000 aecom.com Imagine it. Delivered. LinkedIn Twitter Facebook Instagram From: Tim Dejulis <tdejulis@utah.gov> Sent: Friday, September 22, 2023 3:15 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Cc: Jenkins, Riley <riley.jenkins@aecom.com> Subject: Re: ICU Medical's Engineering Review First page, near the bottom. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality. utah. gov On Fri, Sep 22, 2023 at 1: 07 PM Pedro Villarreal <Pedro. Villarreal@ icumed. com> wrote: Hi Tim- I didn’t see [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] Pedro Villarreal 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-8204317799754…9/15 [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] Pedro Villarreal [Quoted text hidden] Tim Dejulis <tdejulis@utah.gov>Tue, Sep 26, 2023 at 9:12 AM To: "Jenkins, Riley" <riley.jenkins@aecom.com> Cc: Pedro Villarreal <Pedro.Villarreal@icumed.com> Just sent. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] RN116440009-23.v 9.ICU Medical.docx 146K Jenkins, Riley <riley.jenkins@aecom.com>Tue, Sep 26, 2023 at 9:27 AM To: Pedro Villarreal <Pedro.Villarreal@icumed.com>, Tim Dejulis <tdejulis@utah.gov> Hi Pedro and Tim, I just looked through the engineering review that Tim sent over. There is still one update that needs to be made. The horsepower of the diesel-fuel engine still needs to be updated from 264 to 268. I’ve taken a screenshot of the change need and attached it below. I’ve also included the word document with this change. The paragraph is located, on page 4 of the word document. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-820431779975…10/15 Please let me know if you have any questions. Thanks. Riley J. Jenkins, EIT Environmental Engineer Central Region Air Permitting and Measurements D +1-801-904-4142 riley.jenkins@aecom.com AECOM 756 E Winchester Street, Suite 400 Salt Lake City, Utah 84107, USA T +1-801-904-4000 aecom.com Imagine it. Delivered. LinkedIn Twitter Facebook Instagram From: Tim Dejulis <tdejulis@utah.gov> Sent: Tuesday, September 26, 2023 9:13 AM To: Jenkins, Riley <riley.jenkins@aecom.com> Cc: Pedro Villarreal <Pedro.Villarreal@icumed.com> Subject: Re: ICU Medical's Engineering Review Just sent. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality. utah. gov On Mon, Sep 25, 2023 at 12: 20 PM Jenkins, Riley <riley. jenkins@ aecom. com> wrote: Hi Tim, Would you mind please resending the [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-820431779975…11/15 [Quoted text hidden] [Quoted text hidden] Pedro Villarreal [Quoted text hidden] RN116440009-23.v 9.ICU Medical_AECOM Changes.docx 155K Tim Dejulis <tdejulis@utah.gov>Tue, Sep 26, 2023 at 9:36 AM To: "Jenkins, Riley" <riley.jenkins@aecom.com> Cc: Pedro Villarreal <Pedro.Villarreal@icumed.com> I've made the change indicated. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] 3 attachments image001.png 30K image001.png 30K RN116440009-23.v 9.ICU Medical.docx 148K Pedro Villarreal <Pedro.Villarreal@icumed.com>Tue, Sep 26, 2023 at 10:00 AM To: Tim Dejulis <tdejulis@utah.gov>, "Jenkins, Riley" <riley.jenkins@aecom.com> Hi Tim- Attached is the signed document. Best Regards, 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-820431779975…12/15 [Quoted text hidden] [Untitled].pdf 318K Tim Dejulis <tdejulis@utah.gov>Tue, Nov 19, 2024 at 1:15 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Cc: "Jenkins, Riley" <riley.jenkins@aecom.com>, "West, Emily" <emily.west@aecom.com> Bcc: Christine Bodell <cbodell@utah.gov> Pedro, I have ICU Medical's engineering review reviewed by the peer engineer. She has brought one question for me that ICU Medical must answer. In the NOI, the increase in VOC emissions was 17.99 tpy with an increase in emissions of 8.36 tpy leading to a total of 26.35 tpy. We should be increasing the solvent use VOC and HAPs accordingly. The VOC emissions should be 17.13 tpy changing to 26.02 tpy as described in the project description on page 7 of the NOI. The difference in the VOC emissions in this calculation is 8.89 tpy, not 8.36 tpy. This 0.52 tpy difference needs to be explained to us. Please explain this difference in the emissions of the VOC to us. Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] Jenkins, Riley <riley.jenkins@aecom.com>Mon, Dec 9, 2024 at 8:51 AM To: Tim Dejulis <tdejulis@utah.gov>, Pedro Villarreal <Pedro.Villarreal@icumed.com> Cc: "West, Emily" <emily.west@aecom.com> Hi Tim, On behalf of ICU Medical, please find the response below. During the 2023 AO Modification the overall facility emissions were increased from 17.49 tpy VOC to 17.99 tpy VOC. During the 2023 modification, condition II.B.4.b should have also been updated to reflect the new emission limits from 17.13 tpy non-combustion VOC to 17.66 tpy non-combustion VOC (increased by 0.53 tpy VOC). Therefore, the non-combustion emission increase difference of 0.53 tpy VOC is not reflected in the overall facility total increase for the 2024 modification because it had already been accounted for in the 2023 modification. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-820431779975…13/15 Thanks. Riley J. Jenkins, EIT Environmental Engineer Central Region Air Permitting and Measurements D +1-801-904-4142 riley.jenkins@aecom.com AECOM 756 E Winchester Street, Suite 400 Salt Lake City, Utah 84107, USA T +1-801-904-4000 aecom.com Imagine it. Delivered. LinkedIn Twitter Facebook Instagram From: Tim Dejulis <tdejulis@utah.gov> Sent: Tuesday, November 19, 2024 1:16 PM To: Pedro Villarreal <Pedro.Villarreal@icumed.com> Cc: Jenkins, Riley <riley.jenkins@aecom.com>; West, Emily <emily.west@aecom.com> Subject: Re: ICU Medical's Engineering Review Pedro, I have ICU Medical's engineering review reviewed by the peer engineer. She has brought one question for me that ICU Medical must answer. In the NOI, the increase in VOC emissions was 17. 99 tpy with an increase in emissions of 8. 36 [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] [Quoted text hidden] Please let me know if you have any questions. [Quoted text hidden] Tim Dejulis <tdejulis@utah.gov>Tue, Dec 10, 2024 at 2:04 PM To: Pedro Villarreal <pedro.villarreal@icumed.com> Cc: "West, Emily" <emily.west@aecom.com>, "Jenkins, Riley" <riley.jenkins@aecom.com> Pedro, I will make the change to the engineering review document based on this email. Thank you. 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-820431779975…14/15 Timothy DeJulis, PE Environmental Engineer | Minor NSR Section P: (385) 306-6523 airquality.utah.gov [Quoted text hidden] 12/30/24, 11:44 AM State of Utah Mail - ICU Medical's Engineering Review https://mail.google.com/mail/u/0/?ik=67721adfe9&view=pt&search=all&permthid=thread-a:r-1746650635288213335&simpl=msg-a:r-820431779975…15/15