Document 6RrbYvqQzaqJBR7kV17LwqN81

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 8 RESOURCE CONSERVATION AND RECOVERY ACT GENERAL INFORMATION Facility Name: bioMrieux, Inc. RCRA ID: UTR000014001 Facility Location: 515 Colorow Drive, Salt Lake City, Utah Facility Contact: Wade Veselka, 801-834-8881, wade.veselka@biomereiux.com Notification Status: Large Quantity Generator Date of Inspection: August 23, 2023 Arrival Time: 9:15 a.m. Departure Time: 4:55 p.m. Lead Inspector & Report Author: Annette Maxwell, U.S. EPA Inspector Inspection Attendees: 1. Kristin McNeill, U.S. EPA 2. Erika Greenwell, Utah DEQ DWMRC 3. Craig Jorgensen, Utah DEQ DWMRC 4. Wade Veselka, bioMrieux, Inc. 5. Todd Robinson, bioMrieux, Inc. 6. Adam Nelson, bioMrieux, Inc. 7. Bill Phifer, bioMrieux, Inc. Type and Purpose of Inspection: Compliance Evaluation Inspection Compliance with RCRA Subtitle C Facility Type: NAICS 334516 - Analytical Laboratory Instrument Manufacturing Applicable Regulations: R315-260 to R315-273 of the Utah Administrative Code (UAC) and R315-15 of the UAC Inspection Type: Unannounced Inspection EPA inspection with DWMRC accompanying Disclaimer This report is a summary of observations and information gathered from the facility at the time of the inspection. The information provided does not constitute a final decision on compliance with RCRA regulations, nor is it meant to be a comprehensive summary of all activities and processes conducted at the facility. OPENING CONFERENCE Upon arrival at the facility, an opening conference was conducted with the above-listed facility personnel. Kristin McNeill and I presented our federal inspector credentials and explained the purpose of the inspection. We were not denied access to the facility and were allowed to inspect all areas that we selected for inspection. Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 The following information was obtained verbally during the inspection from the above-listed facility personnel unless otherwise noted. FACILITY OVERVIEW Regulatory Status According to RCRAInfo, the bioMrieux, Inc. Salt Lake City facility located at 515 Colorow Drive (bioMrieux) is a large quantity generator (LQG) of hazardous waste. During the inspection, Mr. Veselka confirmed this generator status. Facility and Process Description BioMrieux is a manufacturer of molecular infectious disease diagnostic testing instrumentation capable of detecting and identifying pathogens. The facility was previously Biofire Diagnostics, LLC, but had recently been purchased prior to the inspection. The instrumentation remains marketed under the Biofire name. The facility began occupancy at this location in 2015 or 2016, and at the time of the inspection, the site had approximately 500 to 600 employees with 24/7 production. The building is leased from the University of Utah. Processes include pouch manufacturing on the first floor, instrument manufacturing and engineering on the second floor, and research and development labs, office space, and manufacturing support on the third floor. HVAC equipment is located above the third floor. The facility comprises 288,000 square feet, with an approximate total of up to 140,000 square feet of manufacturing and laboratory space. Hazardous waste is accumulated in two central accumulation areas and four satellite accumulation areas. The facility did not have pretreatment or Clean Air Act permits at the time of the inspection. Outdoor storage includes dumpsters, a bulk diesel fuel tank, and recycling of glass, cardboard and compost. Based upon the facility's 2023 Biennial Report, commonly generated hazardous waste includes: Waste organic liquid, D001, F003, F005 Lab pack waste, D001, D002, D022, and U-listed waste Waste rags and debris, D001, F005 TOUR INFORMATION All photographs collected during the inspection and referenced below are included in Attachment 1 - Photograph Log. Areas of the Facility included in the site tour: PCR Lab (viewed through window) Main Lab BSL Lab HCT Lab Engineering Lab Instrument assembly (viewed through window) 1011 Storage waste closet central accumulation area 1010 Storage e-waste closet Page 2 of 6 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Outdoor dock Reagent manufacturing 1220 Tank Room 3 Tank Room 2 Tank Room 1 Biochemistry Room Array Manufacturing R&D Project Shop The following narrative includes areas listed above in which conditions of interest or potential deficiencies were noted. The information included below was obtained by my observation or by explanation provided by the accompanying facility personnel unless otherwise noted. In the Main Lab, I observed a 5-gallon satellite accumulation area (SAA) container that was not marked with the words "hazardous waste" or with an indication of the hazards but was empty. At a PCR Lab SAA, I observed a 5-gallon SAA container that was not labeled with the words "hazardous waste" or with an indication of the hazards. At the Engineering Lab, I observed a 5-gallon SAA container that was marked with the words "hazardous waste" but not with an indication of the hazards, see Attachment 1, photo 1. At the 1011 Storage waste closet 90-day central accumulation area (see Attachment 1, photos 2-4), Mr. Veselka explained that SAA containers are brought to this location, and that this is also where the hazardous waste transporter, AET, performs lab packing and pickups. The hazardous waste stored in this area was separated by hazard, and I observed three yellow bins labeled with indications of the hazards such as "corrosive" and with an accumulation start date of 3/17/2023. An additional clear bin was not marked with an accumulation start date. Mr. Veselka said that AET had recently been having trouble finding a designated facility to receive certain wastes due to the hazardous waste incinerator backlog. Ms. Greenwell told him that DWMRC has a process for requesting, on a case-by-case basis, an extension to accumulation deadlines that may be applicable, and that any such request submitted should include as much detail as possible. When asked by the inspection team about weekly inspections, Mr. Veselka said they had not been doing weekly inspections of this area. Also at this 1011 Storage waste closet, I observed that the area was marked "Satellite Accumulation Area." However, this area was not at or near the point of generation and under the control of the operator. Following the inspection, Mr. Veselka provided a photograph of this area showing that signage had been revised to indicate the area was a central accumulation area (see Attachment 2 - Facility Correspondence: Photos of Changes and Improvements). In addition, small individual containers of hazardous waste in the 1011 Storage waste closet that were stored in open-top bins, plastic bags containing smaller containers, and a plastic tote, were not marked with the words Hazardous Waste, an indication of the hazard, and an accumulation start date. In the 1220 Tank Room 3, I observed a 55-gallon white poly drum labeled to contain hazardous waste and marked "synthesizer with THF," flammable, with accumulation start date 8/23/2023. See Attachment 1, photos 5 and 6. I observed that tubing led from the drum to overhead ducting, and that the container was also equipped with a pressure relief valve marked RVD025V-PV. Page 3 of 6 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Near the R&D Project Shop, a flammable cabinet contained an approximately 5-gallon can that was marked "IPA Waste" but was not marked with the words "Hazardous Waste" or with an indication of the hazards. See Attachment 1, photo 8. ON-SITE RECORD REVIEW: During review of hazardous waste manifests, the inspection team noted that manifests 016047771FLE, 016047772FLE, and 016047773FLE exceeded 45 days in transport (transport times based on generator and first transporter signature dates were 59 days, 56 days, and 54 days, respectively). During review of accumulation area weekly inspection logs, the inspection team noted that, of the logs reviewed in the conference room, log entries were missing for the weeks of 12/5/2022, each week of July 2022, 12/20/2021, 2/20/2023, 2/6/2023, 2/1/2023, 3/1/2023, and 5/15/2023. Additional documentation was requested for post-inspection review as described below. CLOSING CONFERENCE During the closing conference, I requested copies of the contingency plan, quick reference guide, and training records. I said I would follow up with an email requesting copies of specified designated facility-signed manifests. I also stated concern regarding the 1011 Storage waste closet central accumulation area for a period longer than 90 days missing weekly inspection logs. Some containers stored in the area that were not marked with the words hazardous waste, with an indication of the hazard and with an accumulation start date, and concern regarding certain satellite accumulation area containers not marked with the words hazardous waste and with an indication of the hazard. POST-INSPECTION DOCUMENTATION RECEIVED After the inspection, I requested by email designated facility-signed copies of the following manifests (list compiled during the inspection as a spot-check that the signed copies have been received): 017110807FLE, 017110844FLE, 017110655FLE, 017110798FLE, 017110641FLE, 017110637FLE, 017109546FLE, 017109542FLE, 017109409FLE, 017109404FLE, 017109399FLE, 017109475FLE, 017109364FLE, 017109367FLE, 017109355FLE, 017109354FLE, 017109240FLE, 017109285FLE, 016050748FLE, 016050734FLE, 016050723FLE, 016050712FLE, 015375960FLE, 016050576FLE, 017102685FLE, 016050462FLE, 016050392FLE, 015376286FLE, 015376292FLE, 015376188FLE, and 015376298FLE. The following documentation was provided to me by email following the inspection: 9/6/2023: o Hazardous waste manifests: 015375960FLE, 015376188FLE, 015376286FLE, 015376292FLE, 015376298FLE, 016050392FLE, 016050462FLE, 016050576FLE, 016050712FLE, 016050723FLE, 016050734FLE, 016050748FLE, 017102685FLE, 017109240FLE, 017109285FLE, 017109354FLE, 017109355FLE, 017109364FLE, 017109367FLE, 017109399FLE, 017109404FLE, 017109409FLE, 017109542FLE, 017109546FLE, 017110637FLE, 017110641FLE, 017110655FLE, and 017110798FLE. o An explanation that manifests 017110807FLE and 017110844FLE would be provided when the designated facility-signed copy was received, and an explanation that the shipment associated Page 4 of 6 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 with manifest 017109475FLE was still in transport, that UDEQ had been notified about the delay, and that the transporter had explained that the delay was due to the incinerator disposal facility cancelling the scheduled delivery. o A copy of a 30-day hazardous waste storage extension request submitted to Utah DEQ. o A spreadsheet tracking system to be used for hazardous waste manifests for internally identifying when exception report notifications are to be submitted. o Training tracker spreadsheets and training records. o Copies of the QRG and EAP/Contingency Plan. o Photographs with narratives describing changes implemented following the inspection related to the 1011 Storage waste closet central accumulation area, certain satellite accumulation areas, and a screenshot of the updated facility name in the RCRAInfo database, see Attachment 2 - Facility Correspondence: Photos of Changes and Improvements. This documentation appears to demonstrate that hazardous waste stored in the 1011 Storage waste closet central accumulation area is segregated into containers that are marked with the words "Hazardous Waste," an indication of the hazards, and marked with an accumulation start date. The documentation also shows new satellite accumulation area labels that are marked with the words "Hazardous Waste" and with a pre-printed selection of indications of the hazards for users to circle the applicable hazard classification. o An explanation regarding aerosol can disposal. o Facility maps with fire extinguishers, spill stations, emergency exits, and other safety related equipment identified. 2/15/2024: o Hazardous waste manifests: 017110807FLE and 017110844FLE. ADDITIONAL POST-INSPECTION RECORD REVIEW Based on a post-inspection review of RCRAInfo e-Manifest data, it appears that waste documented on 1) hazardous waste manifest 017109475FLE was in transit from 3/10/2023 to 10/9/2023, a total transportation time of 213 days, 2) hazardous waste manifest 017109476FLE was in transit from 3/10/2023 until 10/10/2023, a total transportation time of 214 days, and 3) hazardous waste manifest 016050355FLE was in transit from 12/22/2021 until 5/2/2022, a total transportation time of 134 days (Attachment 3 - Manifests 017109475FLE, 017109476FLE, and 016050355FLE). Hazardous waste generators that operate in LQG status are required to submit exception reports within 45 days of shipment for manifests for which they have not received the designated facility-signed copy, and bioMrieux has submitted to the EPA documentation, including a hazardous waste manifest tracker spreadsheet, indicating that a procedure to flag such manifests has been implemented. As discussed in the Federal Register at 45 FR 12728, the generator of hazardous waste is responsible for determining where the waste will be disposed of and ensuring that it gets there. INSPECTION FOLLOW-UP Details regarding requested follow-up will be included in correspondence to the facility, as appropriate. Page 5 of 6 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 SIGNATURES __________________________________________________________ Annette Maxwell, Inspector __________________________________________________________ Kristin McNeill, Supervisor RCRA Enforcement Section Enforcement and Compliance Assurance Division ATTACHMENT LIST Attachment 1 - Photograph Log Attachment 2 - Facility Correspondence: Photos of Changes and Improvements Attachment 3 - Manifests 017109475FLE, 017109476FLE, and 016050355FLE Page 6 of 6 Attachment 1 - Photograph Log Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 ATTACHMENT 1 - PHOTO LOG Photographer: Annette Maxwell Camera Model and ID: Nikon Coolpix S7000, B00228 Photo 1: DSCN2152.jpg - photo of an SAA in the engineering lab. The 5-gallon container was marked with the words "Hazardous Waste" but not with an indication of the hazards. Page 1 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 2: DSCN2153.jpg - photo of hazardous waste stored in the 1011 Storage waste closet 90day central accumulation area. The three yellow bins were marked with accumulation start date 3/17/2023. The clear bin at left-center was not marked with an accumulation start date. Page 2 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 3: DSCN2154.jpg - photo of hazardous waste in the same area as that shown in photo 2, panned left from photo 2. Page 3 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 4: DSCN2155.jpg - photo of the same area as that shown in photos 2 and 3. Page 4 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 5: DSCN2156.jpg - photo of a 55-gallon drum of hazardous waste in 1220 Tank Room 3, equipped with tubing leading to overhead ducting, and to a PRD marked RVD025V-PV. Page 5 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 6: DSCN2157.jpg - photo of labels on the drum shown in photo 5. Page 6 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 8: DSCN2159.jpg - photo of an approximately 5-gallon can located inside a flammable cabinet near the R&D Project Shop. Page 8 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 9: DSCN2160.jpg - photo of a service request-waste disposal order for manifest 017109240FLE. Page 9 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 10: DSCN2161.jpg - photo of hazardous waste manifest 015376125FLE. Page 10 of 11 Facility Name: bioMrieux, Inc. (UTR000014001) Facility Location: 515 Colorow Drive, Salt Lake City, Utah Date of Inspection: August 23, 2023 Photo 11: DSCN2162.jpg - photo of the same hazardous waste manifest shown in photo 10 after a second transporter was added. Page 11 of 11 Attachment 2 - Facility Correspondence: Photos of Changes and Improvements Changes/Improvements related to 8/23/2023 EPA Inspection bioMerieux 515 Colorow Drive Salt Lake City, UT 2nd Floor waste closet labeled "Central Accumulation Area" (CAA) Addition of weekly inspection logs of 2nd floor waste closet CAA Hazardous chemicals in 2nd floor SAA moved to waste bins and properly labeled with the words "hazardous waste" and its chemical hazard type Satellite Accumulation Area (SAA) properly labeled to include the words "hazardous waste" and the corresponding waste hazard classification Satellite Accumulation Area (SAA) properly labeled to include the words "hazardous waste" and the corresponding waste hazard classification Satellite Accumulation Area (SAA) properly labeled to include the words "hazardous waste" and the corresponding waste hazard classification IPA waste container with proper labeling EPA ID Site Name change from BioFire Diagnostics to bioMerieux Attachment 3 Manifests 017109475FLE, 017109476FLE, and 016050355FLE  n,uYl- '2)'31::A Ip olllUC\ vRM HAZARDOUS 1.lffi27 WASTE MANIFEST r-- ---LlalaniLMailioo.Address ....,,,, -- SIOSOUlH 5lOO WEST Form Approved. 0MB No. 2050-0039 Generator's Site Add!ess (if diflereol than mailing address) T LAKE QTY, UT 8'10' GeneratOf's Pnone: 6 TranSJ)Ol1er 1 Name Ei'IVl,o,wrIIII, Inc. UT 7 Tlll/'ISprter 2 Company Name A t,'\.V r'"d /'\n'IO \.:ia..l . m. -- --'---.NCAraoonlla 11800 NORTH APTUS ru:w> ,.,..,.-.;LLE. UT84029 Faoli!y's Phone 801-323-6100 9a 9b US. DOT (indudklg Proper Shipp,ng Name, Hazard Class, ID Numbef, HM and Pactdng Group (if any)) 1.- -.. n--.-1 ,....,...., , rv NI, ERG 171 4. 10. Containers Type OF OF I I ' OF US. EPA ID Numbef I l1TR0000005 U.S. EPA ID Number I RC60odj'16'C. U.S. EPA 10 Number uroga 15521 n I 11. Total Quantity 12 Unit Wt.NrJ. 13. Waste Codes 5 1...... 5 G -- 5 G 14 s HSJl.dlltructions and Addioonal lnformabon 01. (Lt.U<U)021323-0S DF 5 G /Y:,f/J/Z 02: (LCCRD) 02132!-04- CC79550- Of G //" )/JfZ" Emergency Contact: INFOTRAC 72952 15 GENERATOR'SIOFFEROR'S CERTIFICATION: I hereby declare that lhe contents of tllis coosignment are fully and aa:urately desaibed above by the proper shopping name, ard are dasslfoed. packaged. marked and labeled/placarded and are in all respects in proper condibon for transpor according 10 applicable intematiooaland national governmental regulaboos If export shipment and I am lhe Pmay Exporter, I that lhe contents otthrs consignment conform lo the t8ffl\S of Ille atlaChed EPAAcknowledgmenlof senl I certify that the wasle minimization statement idenilfied Kl 40 CFR 262 27(a) [d I am a large quantity geoeralo) or (b) (11\'\m a small qua!!)IIY generalOI) Is true. Montll Day Yea., D ...J 16. lntematlOOal Sl\ipments i;... lmpontoU.S. Transporter signature (fol' eXJ)O(ts only): ffi 17 TranS!)OrterAGknow4egment of Receil)I of Material Ix Trans..,- 1 Pmted/Typed Name 0 I/ I I g, Ill. ... .. .... ..... z Transporter2 PnntecJ1Jr<' Name _ g / , J J.h Ju+l, l 18. Discrepancy - D 1811 llscrepa lndtCabon Space Quantity D c........,...,..1.1u..,.u. US. 131Jo IB -, 1 P:j/ l'of entry'exit: ____ _ ___________ OIta leaving US. I Type Si9nature I J ISgi nat\J Residue ,, I Partial Re,ection Month Day Year I I 1.. Month Day Year I 3 Ida 1,3 Futt Rejection Manifest Reference Number: 18b. Altamate Facility (or Generator) U.S. EPAID Number ::; i I @ 18c Signature otAltemale Facility (or Generator) Monlh Day Year I I zt-_________________________________________.___._____._---t 19. Hazanlous Waste Report Management Melhod Codes (ie. codes fol' hazardous waste treatment. disposal, and recyclin systems) l. \-1 Dl\O 12' \--\540 r- \---H\L\[\ - ; l ::.::=7Q;:1;f\:;n--..PY\ '- m 09 EPAForm8700-22(Rev.12-17) Previousedi{Jonsareobsolete. ' ' r,.,. c:.. per\ I I 0ESIGNMe0 MCILITY TO EPA's e-MANIFEST SYSTEM I