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RCRA Inspection Report 1) Inspector and Author of Report Tarin Tischler Life Scientist Phone: 404-562-9702 Tischler.Tarin@epa.gov Brooke York Environmental Engineer Phone: 404-562-8025 York.Brooke@epa.gov U.S. Environmental Protection Agency, Region 4 Enforcement and Compliance Assurance Division Chemical Safety and Land Enforcement Branch RCRA Enforcement Section 61 Forsyth Street, S.W. Atlanta, Georgia 30303 Kayla Acosta Physical Scientist Phone: 404-562-8451 Acosta.Kayla@epa.gov 2) Facility Information Janssen Pharmaceuticals, Inc. 1440 Olympic Drive Athens, GA 30601-1645 3) Responsible Officials Cannon Mauldin Staff Environmental Engineer Cmauldin@its.jnj.com 4) Inspection Participants Brandon Van Laar, Janssen Environmental Health and Safety Manager Cannon Mauldin, Janssen Staff Environmental Engineer 5) Date of Inspection April 18, 2023 9:46 AM EPA ID#: GAD980726491 NAICS #: 325411 - Medicinal and Botanical Manufacturing 325199 - All Other Basic Chemical Manufacturing Brandon Van Laar Environmental Health and Safety Manager Bvanlaar@its.jnj.com Tarin Tischler, USEPA Brooke York, USEPA Kayla Acosta, USEPA Sara Porter, GAEPD EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 1 of 27 6) Applicable Regulations1 Resource Conservation and Recovery Act (RCRA) Sections 3002 (42 U.S. Code - Annotated U.S.C.A. 6925 and 6927), and 40 Code of Federal Regulation (C.F.R.) Parts 260 - 270, 273, 278, & 279; Georgia Hazardous Waste Management Act, Ga. Code Ann. 12-8-60 et seq., and Georgia Hazardous Waste Management Rules, Ga. Comp. R. and Regs. 391-3-11.01 to 391-311.18 (2016 and 2018). Pursuant to Ga. Comp. R. and Regs. 391-3-11-.02(1) [40 C.F.R. 260.10], a large quantity generator of hazardous waste (LQG) is a generator who generates greater than or equal to 1,000 kilograms (2,200 pounds) of non-acute hazardous waste in a calendar month. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.18 [40 C.F.R. 273.9], a small quantity handler of universal waste (SQHUW) is a universal waste handler who does not accumulate 5,000 kilograms or more of universal waste (batteries, pesticides, mercury-containing equipment, lamps, or aerosol cans, calculated collectively) at any time. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.15(a)], a generator may accumulate as much as 55 gallons of non-acute hazardous waste in containers at or near any point of generation where wastes initially accumulate, which is under the control of the operator of the process generating the waste, without a permit or without having interim status, as required by Section 12-8-66 of the GHWMA, Ga. Code Ann. 12-8-66 [Section 3005 of RCRA, 42 U.S.C. 6925], and without complying with Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.16(b) or 262.17(a)], except as required in Ga. Comp. R. and Regs. 391-3-11.08(1) [40 C.F.R. 262.15(a)(7) and (8)], provided that the generator complies with the satellite accumulation area conditions listed in Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.15(a)] (hereinafter referred to as the "SAA Permit Exemption"). Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17], an LQG may accumulate hazardous waste on-site for 90 days or less without a permit or without having interim status, as required by Section 12-8-66 of the GHWMA, Ga. Code Ann. 12-8-66 [Section 3005 of RCRA, 42 U.S.C. 6925], provided that the generator complies with the conditions listed in Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17] (hereinafter referred to as the "LQG Permit Exemption"). Pursuant to Ga. Comp. R. and Regs 391-3-11-.07(1) [40 C.F.R. 261.4(a)(8)], secondary materials that are reclaimed and returned to the original process or processes in which they were generated where they are reused in the production process are not solid wastes provided that the conditions listed in Ga. Comp. R. and Regs 391-3-11-.07(1) [40 C.F.R. 261.4(a)(8)] (hereinafter referred to as the "Closed-Loop Recycling Exemption") are met. 1 As the State's authorized hazardous waste program operates in lieu of the federal RCRA program, the citations of those authorized provisions will be to the authorized State program. However, for ease of reference, the federal citations will follow in brackets. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 2 of 27 7) Purpose of Inspection The purpose of this inspection was to conduct an unannounced compliance evaluation inspection to determine Janssen Pharmaceuticals, Inc.'s compliance with the applicable requirements of RCRA and the corresponding Georgia regulations. This was an EPA lead inspection. 8) Facility Description Janssen Pharmaceuticals, Inc. (hereinafter "Janssen" or the "facility") has been operating at its current location since 1983. Janssen is a subsidiary of Johnson & Johnson and originally notified the EPA as a Large Quantity Generator (LQG) of hazardous waste under the name Noramco, Inc. on February 19, 1990. The facility re-notified under the name Janssen Pharmaceuticals, Inc. on May 17, 2016, and Janssen most recently notified via submittal of the 2021 Biennial Report and EPA 8700-12 form on February 3, 2022. The 2021 Biennial report demonstrated that the facility generated wastes which include the following EPA waste Codes: D001, D002, D003, D008, D019, D021, D022, D035, D038, D039, D040, F002, F003, F005, U056, and U188. The facility has also notified under Ga. Comp. R. and Regs. 391-3-11-.04(5) [40 C.F.R. 260.42] as managing an estimated 352 tons of hazardous secondary material exhibiting the hazardous characteristic of ignitibility (EPA Waste Code: D001). The facility is connected to both city water and a private wastewater treatment plant and operates under an Athens-Clake County Public Utilities Industrial Pretreatment Permit, permit number NO-006. The facility operates under primary NAICS code 325411 for Medicinal and Botanical Manufacturing and NAICS code 325199 for All Other Basic Chemical Manufacturing. Janssen manufactures active pharmaceutical ingredients (API) to be used in pharmaceutical manufacturing. The facility receives raw material, solubilizes, synthesizes, and crystalizes the material, before centrifuging and drying the material. The finished product is in the form of a dry powder, which is stored in drums and shipped to a separate manufacturing location. The manufacturing process is broken into batches, with different active pharmaceutical ingredients produced in each batch. The facility's parent company, Johnson & Johnson, is headquartered in New Brunswick, New Jersey. The APIs produced at the subject facility are used in the manufacturing of medications and medical devices produced in other Johnson & Johnson subsidiaries, including Ortho-McNeil Pharmaceutical, Janssen, Ethicon, and other third-party companies. Janssen employs 212 people when fully staffed and operates 24 hours a day, seven days a week. Employees operate in two 12-hour shifts. The facility is located on approximately 100 acres, 40 acres of which are occupied by multiple manufacturing buildings. The buildings adjacent to the facility are also owned by Janssen, but this section operates under a separate EPA Identification number. Janssen is currently constructing an additional facility to manufacture pharmaceutical oxidizing agents, but this facility is not currently in service. Access to the facility is controlled by a gated entrance manned by 24/7 security. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 3 of 27 9) Previous Inspection History GAEPD has conducted two RCRA CEIs at the subject facility between 2015 and 2017 found 0 violations during those inspections. On April 14, 2016, EPA and GAEPD conducted a RCRA Focused Compliance Inspection (FCI) for RCRA organic air emissions standards at the subject facility and found 3 apparent violations of RCRA's requirements for failure to keep an emergency relief valve on Tank T-81 closed unless it is required for safety purposes, failure to operate a pressure relief valve on tank T-81 with no detectable emissions, and failure to return pressure relief valves to no detectable emissions no later than 5 calendar days after each pressure release. As a result, GAEPD later verified that the facility had returned to compliance during a follow up inspection on April 20, 2017. 10) Opening Conference On April 18, 2023, EPA inspectors Tarin Tischler, Brooke York, and Kayla Acosta, accompanied by GAEPD inspector Sara Porter, arrived at the facility at approximately 9:46 AM. Cannon Mauldin, Staff Environmental Engineer, immediately received the inspectors. Robert Mauldin and the inspectors were joined by Brandon Van Laar, Environmental Health and Safety Manager, for the opening conference. The inspectors introduced themselves, showed their credentials to the facility representatives, and explained the purpose of the visit. The inspectors described the anticipated use of equipment (digital camera) during the inspection and provided a request for records. Facility representatives explained that the digital camera was not permitted for use within the tank farm, but Janssen could provide an intrinsically safe iPad to use for photographs within the tank farm. The EPA inspector explained that the Small Business Regulatory Enforcement Fairness Act's classification of a "small business" is generally set by the Small Business Administration using the business' SIC/NAICS code and annual receipts or number of employees. A copy of the EPA's information sheet for small businesses can be found at https://www.epa.gov/sites/production/files/2017-06/documents/smallbusinessinfo.pdf. The EPA inspector also discussed the company's ability, pursuant to 40 C.F.R. 2.203, to assert a business confidentiality claim for information submitted to EPA. The company did not assert a business confidentiality claim. Brandon Van Laar provided an overview of the facility's history and current operations during the opening conference. The inspection participants also discussed health and safety protocols and required personal protective equipment before facility representative led the inspectors on a tour of the facility operations. 11) Inspection Observations Building 1- Tank Farm: The facility's tank farm consists of 8 tanks including the following waste tanks (Photo 8): - T-81, a 28,000-gallon mixed solvent hazardous waste tank. This tank is in light liquid service and is subject to Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265 Subpart BB and EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 4 of 27 Subpart CC] RCRA organic air emission standards. This tank was labeled "Mixed Solvent Hazardous Waste" and marked with a chemical hazard label consistent with the National Fire Protection Association code 704. - T-80, a 23,000-gallon toluene distillates tank. The facility informed inspectors that material in this tank was hazardous secondary material (HSM) under Ga. Comp. R. and Regs 391-311-.07(1) [40 C.F.R. 261.4(a)(24)] and was excluded from RCRA hazardous waste requirements. This tank was labeled "Toluene Distillate" and marked with a chemical hazard label consistent with the National Fire Protection Association code 704. - T-91, a 10,000-gallon isopropyl alcohol (IPA) solvent tank. The facility informed inspectors that material in this tank was HSM under Ga. Comp. R. and Regs 391-3-11-.07(1) [40 C.F.R. 261.4(a)(24)] and was excluded from RCRA hazardous waste requirements. This tank was labeled "Recoverable Solvents, IPA/ISOPAR-E" and marked with a chemical hazard label consistent with the National Fire Protection Association code 704. - T-92, a 10,000-gallon recoverable ethyl acetate tank. The facility informed inspectors that material in this tank was HSM under Ga. Comp. R. and Regs 391-3-11-.07(1) [40 C.F.R. 261.4(a)(24)] and was excluded from RCRA hazardous waste requirements. This tank was labeled "Recoverable Ethyl Acetate" and marked with a chemical hazard label consistent with the National Fire Protection Association code 704. Inspectors observed several missing tags on connections, valves, and pump equipment that contains or comes in contact with hazardous waste stored in the T-81 hazardous waste tank. Specifically, two flanges and one valve were missing a tag on the T-81 equipment (Photos 1-3). Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(2)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [ [40 C.F.R. Part 265, Subpart BB], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must comply with the RCRA Subpart BB organic air emission standards for equipment leaks, including, but not limited to, the tank requirements in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1050(c)]: Each piece of equipment to which this subpart applies shall be marked in such a manner that it can be distinguished readily from other pieces of equipment. Inspectors requested a written description of how the HSM in tanks T-80, T-91, and T-92 are managed. This information was submitted via EPA file transfer site by Cannon Mauldin on May 10, 2023. The description stated that the facility is currently trying to find a recycling facility interested in accepting the toluene distillate material, and in the meantime toluene distillate is sent to hazardous waste tank T-81 and the toluene is managed as hazardous waste. On July 20, 2023, facility representatives informed inspectors that "At the time of the inspection, tank T-80 was partially full of toluene distillate. Toluene distillate is not transferred from T-80 to T-81." Therefore, it appears the facility has accumulated hazardous waste in tank T-80. In addition, equipment transferring/managing hazardous waste toluene is subject to RCRA Subpart BB Organic Air Emission Standards and T-80 appears to be subject to the RCRA Subpart CC Organic Air Emission Standards for Tanks. Further assessment on Janssen's management of HSMs is currently under US EPA review. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.11], a person who generates a solid waste, as defined in Ga. Comp. R. and Regs. 391-3-11-.07(1) [40 C.F.R. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 5 of 27  261.2], must determine if that waste is a hazardous waste following the methods articulated in Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.11]. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10 (1) [40 C.F.R. Part 265, Subpart BB], a condition of the LQG Permit Exemption, equipment that contains or contacts hazardous waste with organic concentration of at least ten (10) percent by weight for greater than 300 hours per year must comply with the RCRA Subpart BB Organic Air Emission Standards for equipment leaks. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10 (1) [40 C.F.R. Part 265, Subpart CC], a condition of the LQG Permit Exemption, a generator accumulating hazardous waste containing an average volatile organic concentration of great than 500 ppm at the point of waste generation in tanks must comply with the RCRA Subpart CC Organic Air Emission Standards for tanks. At the time of the CEI, the facility's third-party contractors for leak detection and Repair (LDAR) requirements were present to conduct the quarterly leak detection monitoring required under RCRA Organic Air Emission Standards. The EPA inspectors observed two contractors from BrandSafway conducting leak detection monitoring using a handheld TVA2020 device. BrandSafway representatives calibrate the device prior to monitoring by turning it on 30 minutes prior to monitoring. After the device has been on for 30 minutes, BrandSafway representatives use methane at 500, 1,000, and 10,000 ppm, as well as an oxygen, and nitrogen mixture for 0 ppm calibration. When using the handheld device, all pumps, valves, and connections that require monitoring are already in the computer system. The unique identification number on the tags on the regulated equipment are displayed on the device and include instructions for monitoring each specific point. The device provides instruction on the time and distance from the valve to hold the wand, depending on the size and type of component being tested. BrandSafway representative Mike Williams, Supervisor, informed inspectors that different components in the tank farm require different monitoring timeline, with some testing conducted monthly and some conducted quarterly. At the time of the CEI, Janssen had identified 184 components/equipment subject to leak detection monitoring. If a missing tag (unique identification) is observed, a note is made in the handheld device to reattach a tag on the next visit. If a leak is detected, Janssen representatives are notified immediately to conduct repairs. BrandSafway representatives informed inspectors that the overhead piping that requires additional equipment to reach is not within their monitoring responsibilities, an LDAR monitoring on these areas is performed by the facility (Photo 4). Facility representatives informed inspectors that this piping is monitored by the contractor. Inspectors have informed the facility that difficult to monitor equipment must monitored within 5 days if evidence of a potential leak is found by visual, audible, olfactory, or any other detection method. Inspectors observed a closed 55-gallon drum of used oil labeled "Used Oil" in the tank farm secondary containment. Inspectors also observed an open and unlabeled 5-gallon bucket of liquid in the secondary containment (Photo 5). Facility representatives informed inspectors that this bucket was used to clear out leftover liquid in the hose used to pump waste from tank T-81 into a EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 6 of 27 tanker for transportation and disposal. The hose is cleared out after loading or unloading material into the tanker to clear the hose, and the bucket is dumped into hazardous waste tank T-81. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(1)(iv)], which is a condition of the LQG Permit Exemption, a container holding hazardous waste must always be closed during accumulation, except when it is necessary to add or remove waste. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(5)(i)], which is a condition of the LQG Permit Exemption, a generator must mark or label its containers with the following: the words "Hazardous Waste"; an indication of the hazards of the contents; and the date upon which each period of accumulation begins clearly visible for inspection on each container. Building 1 - Pharmaceutical Plant The Pharmaceutical Plant in Building 1 contains numerous reactors to process raw material and API intermediates. Reactors charge chemicals and solvent to solubilize, crystalize, and place material in a centrifuge to yield the dry product. The dry product is discharged to an intermediate bulk container. Inspectors observed a strong solvent-like smell upon entering the first floor of the Pharmaceutical Plant. All areas except for the monomer production areas are multipurpose and are used to create a variety of active pharmaceutical ingredients. Products are manufactured in batches, with about ten batches in a single campaign. Different campaigns yield different APIs, and the production areas are cleaned between each campaign. Facility representatives informed inspectors that 10-20 batches are completed every 4-6 weeks. The inspectors observed one 10-gallon metal container of used solvent contaminated reusable wipes near the reactors in Building 1. The container was closed and labeled "excluded solvent contaminated wipes." Inspectors observed four 30-gallon containers of product glyceride. Floor one of Building 1 is part of the prefiltration process and contains reactors 1, 3, 5, and 7. Floor two of Building 1 is part of the post-filtration process. Inspectors observed a black diaphragm pump connected to the reactors in the pharmaceutical plant. Inspectors were informed that color coded hoses are used to clear out material from this area at the end of each batch. A black hose is used for hazardous waste material, blue for nonhazardous, and white for water. These hoses were color-coded but not marked or labeled. Following the inspection, facility representatives informed inspectors that diaphragm pumps and hoses are frequently used in various process transfers: from solvent manifolds to vessels, from vessel to vessel, and from vessel to waste manifolds. Following the use, the pumps and hoses are typically allowed to run dry and then purged with nitrogen. Following the completion of the campaign, the pumps and hoses are flushed with water to the onsite wastewater treatment facility prior to being disconnected. Although this equipment may be in service for less than 300 hours during a calendar year, the facility did not provide a log of service hours in the operating record. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(2)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [ [40 C.F.R. Part 265, Subpart BB], EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 7 of 27 and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must comply with the RCRA Subpart BB organic air emission standards for equipment leaks, including, but not limited to, the tank requirements in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1050(c)]: Each piece of equipment to which this subpart applies shall be marked in such a manner that it can be distinguished readily from other pieces of equipment. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(1)(i)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [subparts AA, BB, and CC of 40 C.F.R. Part 265], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste with organic concentrations of at least 10 percent by weight in tanks must comply with the RCRA Subpart BB Organic Air Emission Standards for Equipment Leaks, including the requirement to monitor each pump in light liquid service monthly to detect leaks in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1052(a)(1)], by methods specified in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1063(b)]. Facility representatives informed inspectors that tetrahydrofuran (THF) distillate travels from the T-27 process vessel (Photo 6) into the hazardous waste tank T-81. Facility representatives informed inspectors that this vessel undergoes the same RCRA air emission monitoring as T-81, however no tagging was observed on the equipment connected to the process tank. When asked by inspectors about organic air emission monitoring on this vessel as no tagging was visible in this area (Photo 7), facility representatives informed inspectors that this vessel may not contain hazardous waste. Inspectors requested a written description of T-27 operations. On May 10, 2023, Cannon Mauldin provided the following explanation: "T-27 is used as a distillate receiver (vacuum) in two API processes. Distillate is typically transferred to T-81 and managed as a hazardous waste. P&IDs for each vessel are included in this folder. Each of these vessels is also included in the Subpart BB program and monitored routinely. Each vessel is pumped empty following completion of each batch process." Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(2)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [ [40 C.F.R. Part 265, Subpart BB], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must comply with the RCRA Subpart BB organic air emission standards for equipment leaks, including, but not limited to, the tank requirements in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1050(c)]: Each piece of equipment to which this subpart applies shall be marked in such a manner that it can be distinguished readily from other pieces of equipment. Quality Control (QC) Laboratory: The QC laboratory conducts testing on raw material prior to production. The facility manages several SAAs in the QC laboratory. Each satellite was connected to a separate chromotography machine and was labeled "Hazardous Waste, UPLC Waste, ACN/MEC-1/H2O, Ignitable, EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 8 of 27 Toxic." Facility representatives informed inspectors following the inspection that mobile phase aqueous waste containers storing UPLC waste are emptied to the lab sinks, which are directed to the onsite wastewater treatment facility. Inspectors observed eight 5-gallon UPLC SAA containers within the QC laboratory and one 5gallon container labeled "IPA/ Isopar-G, Ignitable, Toxic, Malvern Waste." The container of malvern waste had a hose in the hood and could therefore not be completely closed (Photo 9). Inspectors requested the container be closed when not adding or removing waste. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.15(a)(4)], which is a condition of the SAA Permit Exemption, a generator is required to keep containers of hazardous waste closed at all times during accumulation, except when adding, removing, or consolidating waste; or when temporary venting of a container is necessary for the proper operation of equipment, or to prevent dangerous situations, such as build-up of extreme pressure. Other satellite containers were managed inside two chemical fume hoods within the QC laboratory. Inspectors observed the following containers: One 5-gallon container labeled "Hazardous Waste, Halogenated, Ignitable, Toxic, Corrosive." Four 20-liter containers labeled "Hazardous Waste, Non-Halogenated, Ignitable, Toxic, Corrosive." One 5-gallon container labeled "Hazardous Waste, LC/GC Vials, Ignitable, Reactive" (Photo 11). One 30-gallon container labeled "Hazardous Waste, Solid Samples, Corrosive, Toxic, Reactive." One 5-gallon container labeled "Hazardous Waste, Malvern Waste." This container was not marked with an indication of the hazards of its contents. This was corrected and labeled "Ignitable, Toxic" on site. One 5-gallon vacuum (Photo 10). Facility representatives informed inspectors that the vacuum was used to collect dry powder from around the laser diffraction device and it was emptied into the solid sample containers when full. Therefore, the vacuum acted as a hazardous waste satellite accumulation container. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.15(a)(5)], which is a condition of the SAA Permit Exemption, a generator is required to mark or label its containers (i) with the words "Hazardous Waste" and (ii) with an indication of the hazards of the contents. QC 90-Day Storage Area Janssen manages a small CAA outside of the QC Laboratory in a yellow flame cabinet within secondary containment (Photo 12). At the time of the CEI, inspectors observed the following two containers in the QC 90-Day Storage Area: - One (1) 55-gallon drum labeled "Hazardous Waste, Nonhalogenated Solvents, Ignitable, Accumulation Date: 4/4/2023." EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 9 of 27 - One (1) 55-gallon drum labeled "Hazardous Waste, Halogenated Solvents, Ignitable, Accumulation Date: 4/4/2023." Building 3 - Environmental Services Building 3 is located next to the waste treatment plant. A tank of product ammonium hydroxide product sat outside the building, as well as the 50,000-gallon neutralization basin. Behind Building 3, inspectors observed two pallets of drums marked "Empty drum for return, This drum has been rinsed, Drum is completely drained, Bungs are intact and secure." Inspectors observed a tank of ammonium hydroxide product and the 50,000-gallon neutralization basin outside of Building 3. Inside of Building 3, inspectors observed an open hopper accumulating hazardous waste sludge (EPA Waste Codes: F003, F005) from the rotary fan press. This hazardous waste sludge had spilled onto the floor (Photo 13). Although the hopper was not storing hazardous waste at the time of the inspection, it should be closed and labeled when it does accumulate hazardous waste (Photo 14). Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(6)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.251], and is a condition of the LQG Permit Exemption, a generator is required to maintain and operate its facility to minimize the possibility of a fire, explosion, or any unplanned sudden or nonsudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water which could threaten human health or the environment. Three 20-yard roll off containers were stored directly outside of the Building 3 SAA. Two roll off containers were empty, and one was partially full. Facility representatives explained that the hazardous waste sludge was moved from the smaller hopper inside Building 3 to one the roll off containers. The hazardous waste sludge separates and dewaters while stored in the roll offs, which are then shipped for disposal. The water collected during the dewatering process is pumped back into the wastewater treatment plant. One of the roll off containers in this area is used to accumulate foreign material collected from the on-site wastewater treatment system. The roll off containers of hazardous waste sludge were labeled with a Class 9: Miscellaneous DOT regulated placard (Photo 15). Facility representatives claimed that these containers were not considered hazardous waste containers because they were still considered "in process" during dewatering. Inspectors informed facility representatives that the hazardous waste sludge will not be reused and is destined for disposal as soon as it collects in the Building 3 SAA, therefore the roll off containers are hazardous waste containers and must be labeled as such. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(5)(i)], which is a condition of the LQG Permit Exemption, a generator must mark or label its containers with the following: the words "Hazardous Waste"; an indication of the hazards of the contents; and the date upon which each period of accumulation begins clearly visible for inspection on each container. Janssen manages a universal waste storage area at the entrance of Building 3 (Photo 16). The inspectors observed the following containers in this area: EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 10 of 27  One (1) 55-gallon drum labeled "Universal Waste, Used Batteries, 1/5/2023." One (1) 15-gallon drum labeled "Universal Waste, Used Batteries, 1/25/2023." One (1) 15-gallon drum labeled "Universal Waste, Compressed Cylinders, 1/25/2023." One (1) 30-gallon container labeled "Universal Waste, Used Lamps, 1/24/2023." Two (2) 4-ft boxes labeled "Universal Waste, Used Lamps, 1/5/2023." One (1) 4-ft boxes labeled "Universal Waste, Used Lamps, 1/24/2023." One (1) 8-ft box labeled "Universal Waste, Used Lamps, 1/5/2023." One (1) 55-gallon drum labeled "Universal Waste, Used Aerosol Cans, 1/5/2023." One (1) 30-gallon container labeled "Nonhazardous Waste." One (1) 10-gallon container labeled "Nonhazardous Waste." Janssen manages a CAA outside of Building 3 near the waste treatment area. The CAA consists of two trailers, one for hazardous waste and one for nonhazardous waste. At the time of the inspection, the hazardous waste trailer contained one 55-gallon drum labeled "Hazardous Waste, Solid Samples, Ignitable, Toxic, Accumulation Date: 4/18/2023." Inspectors observed several pallets holding 44 empty drums near the CAA. These drums were marked with labels that read "Empty" and were marked with the name of the chemical that drums originally contained. Nine of these drums were marked "Empty, Pyridine" and had dates 3/28/2023, 4/6/2023, 4/11/2023, and 4/13/2023 (Photo 17). Inspectors informed facility representatives that Pyridine is acutely toxic and carries EPA waste code P075. Containers holding P-listed material must be triple rinsed before being considered RCRA empty and must otherwise be managed as hazardous waste. Facility representatives informed inspectors on May 10, 2023, that these drums originally contained pure, unused commercial chemical product, and therefore carried EPA waste code U196 (CAS 110-86-1), not P075 (CAS 54-11-51), and did not require triple rinsing before being considered empty. On July 20, 2023, the facility submitted the safety data sheet (SDS) for the product pyridine via email. The SDS identified the product as CAS 110-86-1. Building 7 - Oxidized Regenerated Cellulose (ORC) Facility Building 7 serves as a utility area which holds temperature-controlled units for the reactors. This area adjusts the pH in the reactors and catches tank ruptures in the event of an emergency. Vessels in this area are normally empty except in the event of tank upsets. All waste generated in this building is sent to the wastewater treatment plant, except for an IPA and waste mixture which is sent to the tank farm and then sent to recycling. Inspectors observed a container of excluded solvent wipes in this area. 12) Records Review Contingency Plan and Quick Reference Guide (QRG): The actions that facility personnel should take in response to an emergency are described in the facility's Integrated Contingency Plan, which was last updated on April 3, 2023. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 11 of 27 The plan describes actions facility personnel must take in response to explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water at the facility, but not a response to a fire. The plan describes arrangements agreed to with the local police department, fire department, other emergency response teams, emergency response contractors, equipment suppliers, local hospitals or the Local Emergency Planning Committee. The plan lists the names and emergency telephone numbers for persons identified as emergency coordinators. Brandon Van Laar is listed as the primary emergency coordinator, and the other individuals are listed in the order in which they will assume responsibility as alternates. The plan includes a list of all emergency equipment at the facility. The list includes fire extinguishing systems, spill control equipment, communications and alarm systems, and decontamination equipment. The list appears up to date. The plan includes a detailed physical description and location of each item on the list, and a brief outline of its capabilities. The plan does not include an evacuation plan for personnel. This plan describes signals to be used to begin evacuation, evacuation routes, and alternate evacuation routes. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(6)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.261(e)], and is a condition of the LQG Permit Exemption, the contingency plan must describe the actions facility personnel must take in response to fires and an evacuation plan for generator personnel where there is a possibility that evacuation could be necessary. The facility could not provide a quick reference guide to the Integrated Contingency Plan. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(6)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.262(b)], and is a condition of the LQG Permit Exemption, a generator must submit a quick reference guide of the contingency plan to the local emergency responders. Please note that Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.262(b)] requires an LQG that is amending its contingency plan to submit a quick reference guide of the contingency plan to the local emergency responders. The required contents of the contingency plan are specified in Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.261], and the required contents of the quick reference guide are specified in Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.262(b)]. Training Records: The facility was not able to provide records of personnel training during the inspection. This documentation was provided via file upload following the inspection on May 10, 2023. The facility was not able to provide a written job description of each position at the facility related to hazardous waste management, and the name of the employee filling each job. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 12 of 27 Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(7)], which is a condition of the LQG Permit Exemption, the generator must maintain training records that include, among others: the job title for each position at the facility related to hazardous waste management, and the name of the employee filling each job; a written job description for each position; a written description of the type and amount of both introductory and continuing training that will be given to each person filling a position; and records documenting that the training required has been given to and completed by Facility personnel. Waste Manifest and Land Disposal Restriction (LDR) Records: The inspectors reviewed available hazardous waste manifest records and land disposal restriction forms for shipments of hazardous waste sent since 2021. Several of the facility's records did not include a signed designated facility to generator return copy of hazardous waste manifest number, including manifest tracking numbers 024967009JJK, 024798274JJK, and 024967008JJK. No records were provided to show that Janssen contacted the transporter or the owner or operator of the designated facility to determine the status of this waste, and Janssen did not submit exception reports for these missing manifests. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.40(a)], a generator must keep a copy of each manifest signed in accordance with 40 C.F.R. 262.23(a) for three years or until he receives a signed copy from the designated facility which received the waste. This signed copy must be retained as a record for at least three years from the date the waste was accepted by the initial transporter. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.42(a)], a LQG (1) who does not receive a copy of the manifest with the handwritten signature of the owner or operator of the designated facility within 35 days of the date the waste was accepted by the initial transporter must contact the transporter and/or the owner or operator of the designated facility to determine the status of the hazardous waste. (2) must submit an Exception Report to the EPA Regional Administrator for the Region in which the generator is located if he has not received a copy of the manifest with the handwritten signature of the owner or operator of the designated facility within 45 days of the date the waste was accepted by the initial transporter. Following the inspection, a review of the facility's e-manifests indicated an increase in waste generated in certain months out of the year. For example, manifests tracking numbers 020830819JJK, 020830818JJK, 021732566JJK, 021732567JJK, 014978936JJK, 020830705JJK, 020830708JJK, 021732569JJK, and 020830709JJK demonstrate that Janssen shipped 88,042 lbs of waste ethyl acetate and 267,094 lbs of waste toluene and methanol in April 2020. Facility representatives informed inspectors that waste generation rates during a given time frame are determined by the production schedule and product portfolio. Some products within the portfolio generate primarily aqueous waste streams containing readily biodegradable solvents which are managed through the onsite wastewater treatment facility. Other products utilize solvents we prefer not to manage through the wastewater treatment, for a multitude of reasons, and are managed exclusively via off-site recycle/energy recovery. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 13 of 27 All wastes are managed in their designated tank. There is no excess waste per se; greater generation requires greater frequency of shipment to maintain adequate tank space. Weekly Inspection Records: The inspectors reviewed Janssen's available records of inspections of the hazardous waste central accumulation area (CAA) since January 2022. The inspection log includes a checklist to record observations about leaking containers and for deterioration of containers caused by corrosion or other factors. The inspection log includes a checklist to record observations about condition of containers, accumulation dates, labeling, spill debris, and environment for the wastewater Treatment Plant Storage Area, the Raw Material Drum Storage Area, and the QC Lab 90-day area. The records include the date and time of the inspection and the name, signature and initials of the employee conducting the inspection. Each week, the employee records notations of observations and necessary follow-up actions for the inspected areas. Inspectors requested weekly inspection records for 2021 following the inspection. These records were provided via email on May 10, 2023. The inspectors requested all Organic Air Emission records required under 40 CFR Part 265 Subpart AA, BB and CC be submitted following the inspection. These records were provided on May 10, 2023, including Piping and Instrumentation Diagrams, Leak Detection and Repair monitoring reports, and inspection records. 13) Closing Conference The inspectors conducted the exit meeting at 6:00 PM with Brandon Van Laar and Cannon Mauldin, as well as Mary Beth Desper, Senior EHS Engineer, and Tim Smith, EHS Southeast Director. During this meeting, the inspectors stated their preliminary conclusions of the inspection. Janssen agreed to provide all requested records, and on May 10, 2023, Cannon Mauldin transferred the requested files to Tarin Tischler. 14) Summary of Observations Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(2)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. Part 265, Subpart BB], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must comply with the RCRA Subpart BB organic air emission standards for equipment leaks, including, but not limited to, the tank requirements in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1050(c)]: Each piece of equipment to which this subpart applies shall be marked in such a manner that it can be distinguished readily from other pieces of equipment. At the time of the CEI, two connections and one valve were missing a tag on the equipment connected to tank T-81. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 14 of 27 Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.11], a person who generates a solid waste, as defined in Ga. Comp. R. and Regs. 391-3-11-.07(1) [40 C.F.R. 261.2], must determine if that waste is a hazardous waste following the methods articulated in Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.11]. At the time of the CEI, toluene distillate was stored in tank T-80 while the facility searched for a recycling facility to accept the material. The facility therefore failed to make a proper waste determination on this material. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10 (1) [40 C.F.R. Part 265, Subpart BB], a condition of the LQG Permit Exemption, equipment that contains or contacts hazardous waste with organic concentration of at least ten (10) percent by weight for greater than 300 hours per year must comply with the RCRA Subpart BB Organic Air Emission Standards for equipment leaks. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10 (1) [40 C.F.R. Part 265, Subpart CC], a condition of the LQG Permit Exemption, a generator accumulation hazardous waste containing an average volatile organic concentration of great than 500 ppm at the point of waste generation in tanks must comply with the RCRA Subpart CC Organic Air Emission Standards for tanks. At the time of the CEI, toluene distillate was being stored in tank T-80. At the time of the inspection, toluene distillate was managed at the facility as hazardous waste, and tank T-80 appears to be subject to the RCRA Subpart CC Organic Air Emission Standards for Tanks. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(1)(iv)], which is a condition of the LQG Permit Exemption, a container holding hazardous waste must always be closed during accumulation, except when it is necessary to add or remove waste. At the time of the CEI, inspectors observed an open 5-gallon container in the tank farm secondary containment holding hazardous waste liquid solvent from tank T-81. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(5)(i)], which is a condition of the LQG Permit Exemption, a generator must mark or label its containers with the following: the words "Hazardous Waste"; an indication of the hazards of the contents; and the date upon which each period of accumulation begins clearly visible for inspection on each container. At the time of the CEI, inspectors observed an unlabeled 5-gallon container in the tank farm secondary containment holding hazardous waste liquid solvent from tank T-81. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(2)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. Part 265, Subpart BB], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must comply with the RCRA Subpart BB organic air emission standards for equipment leaks, including, but not limited to, the tank requirements in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1050(c)]: Each piece of equipment to which this EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 15 of 27 subpart applies shall be marked in such a manner that it can be distinguished readily from other pieces of equipment. At the time of the inspection, inspectors observed a black diaphragm pump used to transfer hazardous waste into containers in the Pharmaceutical Plant that was not marked in a manner that it can be readily distinguished from other pieces of equipment. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(1)(i)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [subparts AA, BB, and CC of 40 C.F.R. Part 265], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste with organic concentrations of at least 10 percent by weight in tanks must comply with the RCRA Subpart BB Organic Air Emission Standards for Equipment Leaks, including the requirement to monitor each pump in light liquid service monthly to detect leaks in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1052(a)(1)], by methods specified in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1063(b)]. At the time of the inspection, the black diaphragm pump in the Pharmaceutical Plant was not being monitored for leaks under the facility LDAR procedures. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(2)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.10(1) [ [40 C.F.R. Part 265, Subpart BB], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must comply with the RCRA Subpart BB organic air emission standards for equipment leaks, including, but not limited to, the tank requirements in Ga. Comp. R. and Regs. 391-3-11-.10(1) [40 C.F.R. 265.1050(c)]: Each piece of equipment to which this subpart applies shall be marked in such a manner that it can be distinguished readily from other pieces of equipment. At the time of the inspection, equipment used to transfer hazardous waste solvent from T-27 to T-81 was not marked in a manner that it can be readily distinguished from other pieces of equipment. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.15(a)(4)], which is a condition of the SAA Permit Exemption, a generator is required to keep containers of hazardous waste closed at all times during accumulation, except when adding, removing, or consolidating waste; or when temporary venting of a container is necessary for the proper operation of equipment, or to prevent dangerous situations, such as build-up of extreme pressure. At the time of the CEI, the container of malvern waste in the QC Laboratory had a hose in the hood and could therefore not be completely closed. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.15(a)(5)], which is a condition of the SAA Permit Exemption, a generator is required to mark or label its containers (i) with the words "Hazardous Waste" and (ii) with an indication of the hazards of the contents. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 16 of 27 At the time of the CEI, inspectors observed a vacuum used to collect dry powder hazardous waste in the SAA that was not labeled. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(6)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.251], and is a condition of the LQG Permit Exemption, a generator is required to maintain and operate its facility to minimize the possibility of a fire, explosion, or any unplanned sudden or nonsudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water which could threaten human health or the environment. At the time of the CEI, sludge generated from the rotary fan press was spilled on the floor surrounding the hopper container in Building 3 with no attempt to contain the spill and manage the released material. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(5)(i)], which is a condition of the LQG Permit Exemption, a generator must mark or label its containers with the following: the words "Hazardous Waste"; an indication of the hazards of the contents; and the date upon which each period of accumulation begins clearly visible for inspection on each container. At the time of the CEI, roll off containers storing sludge generated in the rotary fan press were marked with only a Class 9: Miscellaneous DOT regulated placard and not labeled with the words "Hazardous waste," an indication of the hazards of the contents, or an accumulation date. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(6)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.261(e)], and is a condition of the LQG Permit Exemption, the contingency plan must describe the actions facility personnel must take in response to fires and an evacuation plan for generator personnel where there is a possibility that evacuation could be necessary. At the time of the CEI, the facility's Integrated Contingency Plan did not include an emergency response to fire or facility evacuation routes. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(6)], which incorporates Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.262(b)], and is a condition of the LQG Permit Exemption, a generator must submit a quick reference guide of the contingency plan to the local emergency responders. At the time of the CEI, the facility could not demonstrate it had submitted a quick reference guide of the Integrated Contingency Plan to local emergency responders. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.17(a)(7)], which is a condition of the LQG Permit Exemption, the generator must maintain training records that include, among others: the job title for each position at the facility related to hazardous waste management, and the name of the employee filling each job; a written job description for each position; a written description of the type and amount of both introductory and continuing training that will be given to each person filling a position; EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 17 of 27 and records documenting that the training required has been given to and completed by Facility personnel. At the time of the CEI, the facility could not provide a written job description of each position at the facility related to hazardous waste management, and the name of the employee filling each job. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.40(a)], a generator must keep a copy of each manifest signed in accordance with [40 C.F.R. 262.23(a) for three years or until he receives a signed copy from the designated facility which received the waste. This signed copy must be retained as a record for at least three years from the date the waste was accepted by the initial transporter. At the time of the CEI, the facility could not provide final signed copies of several uniform hazardous waste manifests. Pursuant to Ga. Comp. R. and Regs. 391-3-11-.08(1) [40 C.F.R. 262.42(a)], a LQG (1) who does not receive a copy of the manifest with the handwritten signature of the owner or operator of the designated facility within 35 days of the date the waste was accepted by the initial transporter must contact the transporter and/or the owner or operator of the designated facility to determine the status of the hazardous waste. (2) must submit an Exception Report to the EPA Regional Administrator for the Region in which the generator is located if he has not received a copy of the manifest with the handwritten signature of the owner or operator of the designated facility within 45 days of the date the waste was accepted by the initial transporter. At the time of the CEI, the facility could not provide final signed copies of several uniform hazardous waste manifests and had not submitted any exception reports to the applicable EPA Regional Administrator. 15) List of Appendices Appendix 1 - Photo Log: Janssen iPad Photos Appendix 2 - Photo Log: EPA Camera Photos EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 18 of 27 16) Signed Digitally signed by TARIN TARIN TISCHLER TISCHLER Date: 2023.08.07 14:09:45 -04'00' Tarin Tischler Life Scientist BROOKE YORK Digitally signed by BROOKE YORK Date: 2023.08.07 14:19:25 -04'00' Brooke York Environmental Engineer Digitally signed by KAYLA KAYLA ACOSTA ACOSTA Date: 2023.08.07 15:53:48 -04'00' Kayla Acosta Physical Scientist 17) Concurrence Digitally signed by ARACELI ARACELI CHAVEZ CHAVEZ Date: 2023.08.07 17:32:53 -04'00' Araceli B. Chavez Chief RCRA Enforcement Section EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 19 of 27 Appendix 1 - Photo Log 7 Photos taken Photos taken by: Tarin Tischler and Kayla Acosta Photos taken with: iPad Photo 1: Missing tag on a connection in a pipe attached to T-81. Photo 2: Missing tag on a valve attached to T-81. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 20 of 27 Photo 3: Missing tag on a connection in a pipe attached to T-81. Photo 4: Overhead piping connected to tanks in tank farm, including hazardous waste tank T-81. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 21 of 27 Photo 5: Open, unlabeled drum of hazardous waste solvent material in secondary containment of tank farm. Photo 6: T-27 distillate receiver in Building 1. Photo 7: Components of receiver T-27 missing Subpart BB tagging. EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 22 of 27 Appendix 2 - Photo Log 2 10 Photos taken Photos taken by: Kayla Acosta Photos taken with: Olympus Tough EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Photo 8: Janssen Pharmaceutical s, Inc. Tank Farm Photo 9: SAA in QC Laboratory with hose stuck in the lid preventing it from closing completely. Page 23 of 27 EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Photo 10: Vacuum in QC Lab SAA Photo 11: LC/GC Vials in QC Lab SAA Page 24 of 27 EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Photo 12: QC Laboratory 90day Storage Area Photo 13: Sludge accumulating on floor outside of dumpster in Building 3. Photo 14: unlabeled dumpster accumulating sludge from the rotary fan press Page 25 of 27 Photo 15: Roll off containers to accumulate, dewater, and dispose of hazardous waste sludge Photo 16: Universal Waste Storage Area in Building 3 EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 26 of 27 Photo 17: Empty Pyridine container destined for return EPA-RCRA CEI Report Janssen Pharmaceuticals, Inc. EPA ID# GAD980726491 April 18, 2023 Page 27 of 27