Document 0J3m9w4ap6Y6BVVx7N960Xo4b

NPDES Pretreatment Categorical Industrial User Inspection Pharmaceutical Manufacturing Point Source Category 40 CFR Part 439 National Database Information Inspection Type Pretreatment Categorical Industrial User (CIU) NPDES ID Number COPF-000106 Inspection ID 202304_COPF00106 Inspection Date 04/13/2023 Entry Time 04/13/2023 @ 0915 Exit Time 04/13/2023 @ 1300 General Inspector Name Al Garcia Telephone 303.312.6382 Inspector Type Inspector Name Telephone Inspector Type EPA Region 8 Stephanie Passarelli 303.312.6803 EPA Region 8 Facility Location Information Business Name Tolmar Inc. Facility Location 1201 Cornerstone Drive, Windsor CO 80550 Mailing Address same Type of Business/Operations Average Production Rate Pharmaceutical Manufacturing NA Number of Employees 300 Days of Operation Type/Number of Shifts 365 days per year, 24 hours per day; except for holiday schedules and planned shutdowns Production Days/Shifts: x A shift (5:30 am through 5:30 pm), B shift (5:30 pm through 5:30 am) - Monday through Wednesday x C shift (5:30 am through 5:30 pm), D shift (5:30 pm through 5:30 am) - Wednesday through Saturday Facility Representatives Name Title Contact Information Tony Backo Environmental Health and Safety Specialist Tony.Backo@tolmar.com; 720.442.1016 Mike Ricks Associate Director - Maintenance and Facilities 970.212.4515 Charles Mays VP-Engineering and Facilities 970.212.4515 Chris Banfield Environmental Health and Safety Manager 970.212.4515 R8FQPForm-2020 R0 1 of 17 POTW/Receiving Water Publicly Owned Treatment Works (POTW) and Permit Number Town of Windsor, CO-0020320 Ultimate Receiving Water(s) Cache la Poudre 2 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 General Inspection and Facility Information Inspection Description The U.S. Environmental Protection Agency (EPA) and the Town of Windsor (Town) conducted a facility inspection at Tolmar Inc. (the facility) on April 13, 2023 at 0915. The facility inspection consisted of an opening interview facility walk-through tour, and a closing conference. Digital photos were taken during the facility tour to document laboratory wastewater sources, purified supply water treatment, the wastewater collection lift stations and the wastewater treatment system/discharge point to the Town. EPA reviewed relevant Pretreatment records provided by the facility electronically prior to the facility inspection. Al Garcia and Stephanie Passarelli, EPA inspectors, and Mr. Ryne Oniecinski from the Town of Windsor (jointly referred to as inspectors) provided credentials and introductions to all attendees. The inspectors interviewed the facility representatives consisting of Mr. Tony Backo, Mr. Mike Ricks, Mr. Charles May and Mr. Chris Banfield about the facility and the associated unit operations/processes, including raw materials/chemicals and management or treatment of discharged and non-discharged wastestreams. A facility walk-through was performed to visually observe the unit operations, chemical storage/transfer/handling for slug discharge potential, wastewater generation/management/treatment and the discharge/compliance monitoring point. A closing conference was held to discuss the findings and observations of the facility inspection. During the facility inspection, EPA provided outreach regarding the applicable Pretreatment Regulations and projections of the control mechanism that will be issued by the EPA. The EPA and Town inspectors signed out of the facility at 1300. Chemical/Raw Material Flammables: (isopropyl alcohol, acetonitrile, acetone, ethanol, methanol) Cleaner: (sporacide, hydrogen peroxide, para-acetic acid, Vesphene, lysol) Sulfuric acid Caustic Soda Defoamer Chemicals/ Raw Materials Overview Volume/Mass Storage Location Various sizes (5-gallon, 55-gallon, 250-gallon} Raw Materials Waterhouse Various sizes Raw Materials warehouse Two 55-gallons drums Two 55-gallons drums 10-gallons Wastewater treatment skids in spill containment Wastewater treatment skids in spill containment Wastewater treatment skids in spill containment 3 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Process Use Pharmaceutical manufacturing Pharmaceutical manufacturing Wastewater treatment - pH neutralization Wastewater treatment - pH neutralization Wastewater treatment Boiler treatment chemicals (descalant, oxygen scavengers) Lab pack chemicals Solvents (halogenated and non-halogenated) 35 gallons Various sizes various Boilers Room- in spill containment QC labs Labs Boiler treatment Laboratory Pharmaceutical manufacturing Description of Chemical Handling/Transfer to Process Operations: The raw materials, active pharmaceutical ingredients (API) and chemicals are received in shipping docks located on the south side of the facility and stored in the Raw Materials warehouse. The boiler treatment and wastewater treatment chemicals are moved to the in-use areas. The raw materials are stored in the warehouse either on the floor or on shelves of large industrial storage racks. When requested by the various manufacturing areas or labs within the facility, the raw materials are staged in a pickup storage rack and issued to that area or lab. Certain raw materials may be sampled to ensure quality control. An aliquot is taken from the raw material container and analyzed in the QA area, located in the Raw Materials warehouse. Note: the facility is decommissioning the dermatological products manufacturing (Derms East and Derms West areas and will be moving large manufacturing equipment (mixing/bulking) and quantities of chemicals used in this larger scale manufacturing out of the facility. Potential for Spills or Slug Discharges from Chemical Storage/Handling/Transfer to reach Sanitary Sewer? yes no Describe Spill or Slug Discharge Potential: Minimal, the facility is transitioning to smaller quantities of mixing, compounding and formulating of API and pharmaceutical products. The current slug discharge control plan adequately addresses slug discharge potential and measures, equipment and procedures to eliminate or minimize slug discharges to the sanitary sewer. Process/Unit Operations Describe the facility industrial process. The facility organizes its pharmaceutical manufacturing of products into areas or labs within its building. As mentioned in the previous section, the raw materials, chemicals, and API are stored in the Raw Materials warehouse and are issued to the different pharmaceutical product areas when requested. The current pharmaceutical products manufactured at the facility includes the following: x Eligard 4 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 x Fen-Solvi x EPSS - Eligard with improved packaging. x Polymer Manufacturing Suites x Polymer R&D x Note: The facility no longer manufactures dermatological products in the Derms East and West areas. The Derms East area is currently vacant, and the Derms West area is under construction for the EPSS product line. Pharmaceutical Manufacturing - The raw materials and APIs that are issued from the Raw Materials warehouse are received in the centralized mixing or bulking lab. The bulking process occurs in one centralized area or lab within the facility. The mixing/compounding/formulating operations for each pharmaceutical product (Eligard, EPSS and Fen-Solvi) are the same, but the volumes change depending on the pharmaceutical product manufactured. The volumes for each pharmaceutical product will be identified in the narrative of the bulking operations. The raw materials and APIs are mixed and compounded in carboys (Eligard - 10L, EPSS - 20L) using a magnetic stir plate. The mixed product is sent through an oven and then pumped through a series of filters to a media bag. The filters used during this process are single use and are collected as non-hazardous waste for disposal. The media bag is used in the filling machine designed to create dosage forms in syringe vials. The filling machine has a 5-station manifold and silicone tubing to fill syringes. The silicone tubing is single use and is disposed after every product filling run. The stainless-steel fill nozzles are rinsed in a lab sink, sterilized and reused. The facility manufactures 100 syringes per tub. The typical production runs for each pharmaceutical product are identified below: x Eligard - 120 tubs x EPSS - 60 to 210 tubs x Fen-Solvi - 60 tubs The dosage form products are freeze-dried (lyophilization) to stabilize the product in either final dosage form (EPSS) or ready for combining with the polymer syringe component. Polymer Manufacturing - The polymer is manufactured in two suites. The raw materials issued from the warehouse are received and mixed in an 8L helicone mixing vessel, the facility currently manufactures about two to three batches per week. The mixture is heated to dry and are extruded out of the containers into milling machines. The helicone vessel is cleaned with solvents to dissolve the residual polymer. The bottom of the container is opened to aid in cleaning. The waste solvent is collected and hauled off-site as hazardous waste. The milled polymer powder is contained and sealed in a Syringe A bulking area/lab. According to facility representatives, the facility manufactures about 5 batches of polymer per week. Polymer Development - The polymer research and development are conducted in the Polymer Lab, located east of the Derms East area in the facility. The polymers developed and tested in this lab are produced in 10L batches. Acetone is 5 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 used for cleaning and dissolving polymer in this lab. The waste acetone is collected and shipped off-site as hazardous waste. Specialty Injectables - The APIs used in specialty injectables is in powder form and are mixed in a 20L vessel, transferred to a 20L tank and are milled in a 200 machine. The milled product is contained in a carrier container and are transferred to a 30L tank and then moved to the filling room for dosage form in vials. These products do not undergo lyophilization. The vessels used in this manufacturing operation are washed in the washrooms. Purified Water - The facility uses supply water that has undergone reverse osmosis (RO) for use in its manufacturing operations. Approximately 1 gallon of reject water or brine is generated for every 3 gallons of RO-treated water. The RO brine generated from the process is discharged directly to the City sewer. The RO water is first contained in a 5,400-gallon tank for facility use, with the exception of the Eligard manufacturing process. The water undergoes an additional treatment process and contained in a separate 5,400-gallon tank for use in the Specialty Injectables and Eligard manufacturing processes. Boiler Room - The facility boilers are blown down daily, based on conductivity and are annually evacuated for maintenance/inspection. The boilers wastewaters are discharged directly to the City sewer. Ancillary Wastestreams - According to the facility representatives, a certain volume (about 250 to 450 gallons per day) of steam condensate is discharged to the Eligard and South lift stations and to the wastewater treatment system. In addition, the facility performs cleaning of the production areas/labs and this wastewater is discharged to the wastewater treatment system. Describe any substantial changes in manufacturing processes (or planned changes): The facility is currently performing construction to increase its manufacturing EPSS production in the old Derms West area. The old Derms East area is currently vacant, but the facility may add new manufacturing processes in this space. The Derms pharmaceutical products areas were discontinued since 2019 and as a result, the wastewater generated decreased significantly. In addition, the generation of waste acetone is tightly controlled. As a result of acetone exceedances in the past two years, the facility has tightly controlled the use of acetone in the Polymer Development lab. The facility collects this wastewater and hauls off-site as hazardous waste. Did these changes result in substantial change in wastewater? yes no Were these substantial changes reported, as required in 40 CFR 403.12(j)? yes no 6 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Wastewater Treatment/Managment Describe the wastewater treatment system or wastewater management: Wastewater Collection and lift stations - The south lift station (photo log # 271) collects regulated process wastewater from the Specialty Injectables, EPSS and old Derms East labs. The north lift station (photo log # 270) collects regulated process wastewater from the H2 area within the Derms East lab. The facility does not allow the north lift station to pump to wastewater treatment but instead, the north lift station pumps to a 12,000-gallon collection tank. The valves on the pipes leading to wastewater treatment are locked. The 12,000-gallon collection tank has alarms that are triggered at about 3,500 and 6,000 gallons. The wastewater within this tank is hauled off-site and is tested for pH and flashpoint to ensure they are within the characteristic pH hazardous waste levels and a flashpoint below 140 C. The regulated process wastewaters generated in the pharmaceutical products bulking lab are collected in the 75-gallon Eligard lift station (photo log # 269) located on the west side of the Raw Materials warehouse. Wastewater Treatment - The wastewater pumped from the Eligard and South lift stations are collected in the 2,800-gallon equalization tank (photo log # 262). The facility has a larger backup overflow, in case this is needed. The contents in the 2,800-gallon equalization tank are pumped to the 2 waste treatment skids at about 37% capacity (photo log # 263). The 2 wastewater treatment skids are identical in functionality for pH neutralization and capacity. The wastewater enters Stage 1 (450-gallon capacity) of the pH neutralization skid and is treated for pH and defoaming agent is added if needed. The pH treatment acid/base and defoaming agent is adequately contained in spill containment equipment (photo log #268). The treatment pH meter is set for 5.0 to 10.3. If Stage 1 wastewater is outside this range, the appropriate volume of either H2SO4 acid or caustic soda is added to adjust the pH within the set criteria. The wastewater is moved across a weir to Stage 2 within the system and is monitored for a pH range of 7.0 to 9.0. If the pH of the Stage 2 wastewater is outside this range, then the wastewater is rerouted back to Stage 1 for additional treatment (photo log #264). If the Stage 2 wastewater is within range, then the contents are discharged through the discharge pipe from the treatment skid (photo log # 265). The discharge pipes from the two treatment skids combine into one common discharge pipe. This is defined as outfall 001 and the facility continuously monitors for pH and flow. A monitoring point valve is also located on this discharge pipe (photo log # 267). Are all treatment units functioning? yes no Bypasses or emergency overflows from the treatment system? yes no 7 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Applicable Regulated Operation(s) Pharmaceutical - 40 CFR 439 Does the Facility fall in the SIC Codes 2833, 2834 or 2836? yes Are products considered to be pharmaceutically active ingredients yes Multiple end use products such as components of formulation, chemical intermediates or final products derived from pharm manufacturing operations yes and to be used for use primarily in pharmaceutical applications Which pharmaceutical manufacturing operations are performed? Subpart A - Fermentation Subpart B - Extraction Subpart C - Chemical Synthesis Subpart D - Mixing/Compounding and Formulation Subpart E - Research Based on information gathered during the facility inspection, the facility does not perform fermentation or extraction unit operations. The facility performs mixing, compounding, and formulating to manufacture its products in dosage form. The wastewater generated from these unit operations are subject to Subpart D which contains the following definitions in 40 C.F.R. 439.41(a) and (b): (a) Mixing, compounding, and formulating operations means processes that put pharmaceutical products in dosage forms. (b) Product means any pharmaceutical product manufactured by blending, mixing, compounding, and formulating pharmaceutical ingredients. The term includes pharmaceutical preparations for both human and veterinary use such as ampules, tablets, capsules, vials, ointments, medicinal powders, solutions, and suspensions. Do all process wastes flow through a monitoring point before being diluted? If no, can an internal monitoring point be established (423.17(b)) Do the monitoring location and selfmonitoring sampling days appear to produce results that are representative of the discharge? (403.12(g)(3)) Is the monitoring location free from dilution? (403.6(d) and 403.12(g)(c)) Yes, all regulated process wastes flow to either the Eligard or South Lift Stations, and then to the waste treatment system. The facility also discharges an estimated 250 to 450 gallons of steam condensate to the waste treatment. The steam condensate is considered unregulated. yes No, the facility discharges steam condensate, an unregulated wastestream. 8 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Sampling and Reporting Where DMRs submitted on time in June and December of the previous calendar year? (403.12(e)) Where all parameters monitored? (403.12(e) and 467.16 and 465.35) Notes yes yes Where all parameters reported correctly? yes Does the DMR include measured or estimated average and maximum daily flows? (403.12(e)) yes Are appropriate sample types collected? x Grab - pH, cyanide, total phenols, oil and grease, sulfide, and volatile organic compounds (some may be lab or field composited) x All other pollutants - 24-hour composite samples through flow-proportional yes composite sampling techniques, unless time-proportional composite sampling or grab sampling is authorized by the EPA (403.12(g)(3)) Do sample collection and analysis meet requirements in 40 CFR 136 (hold time, preservation, container type, method)? (403.12(g)(5)) Where DMRs signed and certified by required personnel? (403.12(l)) Is the IU sampling at the required frequency (min 2/year)? (403.12(e)) If the IU is sampling more frequently than required, are the results included in the report? (403.12(g)(6)) Do sampling records contain: x The date, exact place, method, and time of sampling and the names of the person or persons taking the samples; x The dates analyses were performed; x Who performed the analyses; x The analytical techniques/methods use; and x The results of such analyses. x Record keeping requirements (403.12(o)(1)) yes yes yes Acetone sampled monthly yes 9 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Sampling and Reporting Notes Are records kept for at least 3 years? (403.12(o)(2)) yes If IU sampling indicates a violation, was the EPA notified within 24 hours of the IU becoming aware of the violation? NA (403.12(g)(2)) If IU sampling indicates a violation, did the IU repeat the sampling and analysis becoming aware of the violation? and submit the results of the repeat analysis to the EPA within 30 days after NA (403.12(g)(2)) Was POTW notified immediately of all discharges that could cause problems to the POTW, including any slug loadings, as defined by 403.5(b)? If no, were there such instances where the POTW should have been notified? NA (403.12(f)) Is the facility required to have a slug discharge control plan? If yes, it must contain to following: x Description of discharge practices, including non-routine batch Discharges; x Description of stored chemicals; x Procedures for immediately notifying the POTW of Slug Discharges, including any Discharge that would violate a prohibition under 403.5(b) with procedures for follow-up written notification within five days; and x If necessary, procedures to prevent adverse impact from accidental spills, including inspection and maintenance of storage areas, handling and transfer of materials, loading and unloading operations, control of plant site run-off, worker training, building of containment structures or equipment, measures for containing toxic organic pollutants (including solvents), and/or measures and equipment for emergency response. (403.8(f)(2)(vi)) Describe any Deficiencies: Based on the facility inspection, the slug discharge control plan adequately addresses the conditions at the facility. Did the IU promptly notify the EPA and the POTW in advance of any substantial change in the volume or character of pollutants in their discharge? NA (403.12(j)) Did the IU submit notification of hazardous waste discharge? If no, should they have? NA (403.12(j) and (p)) Did the IU submit notification of bypass? If no, should they have? (403.17) NA Did the IU submit a complete baseline monitoring report (180 days before discharge) and a 90-day compliance report? NA (403.12(b) and (d)) 10 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Significant Noncompliance Evaluation (403.8(f)(2)(viii)) If effluent violations have occurred, is the IU in significant non-compliance (SNC) for chronic or technical review criteria? Has the IU caused or contributed to pass through or interference? If yes, evaluate for SNC. Has any discharge from the IU resulted in imminent endangerment to human health, welfare or to the environment? If yes, evaluate for SNC. Has the IU failed to meet a compliance milestone contained in an Order within 90 days? If yes, evaluate for SNC. Has the IU failed to provide, within 45 days after the due date, required reports such as baseline monitoring reports, 90-day compliance reports, periodic selfmonitoring reports, and reports on compliance with compliance schedules? If yes, evaluate for SNC. Notes NA NA NA NA NA Has the IU failed to accurately report noncompliance? If yes, evaluate for SNC. NA Records Reviewed x 2022 and 2023 Waste Disposal Tracking spreadsheets (hazardous and non-hazardous wastes) x 2021 Slug Discharge Control Plan x SOP 01029 - Acetone Spill SOP x SOP 00669 - Chemical Spill Response x Sample Data Sheets - 07/2022 to 03/2023 Miscellaneous Information As discussed during the facility inspection, the EPA will issue a Notice of Discharge Requirements to replace the control mechanism issued by the Colorado Department of Public Health and Environment. The CDPHE has not been delegated the Pretreatment Program and the EPA is the Approval Authority and is collaborating with the town of Windsor to issue control mechanisms for categorical industrial users in the Town. The EPA will provide Tolmar a permit application to complete and submit to the EPA by May 30, 2023. 11 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Report Review and Signature Drafter Name Address/Phone Number Al Garcia U.S. EPA Region 8 1595 Wynkoop Street 8WP-CWW Denver, Colorado 80202 303-312-6382 Reviewer Name Address/Phone Number Stephanie Passarelli U.S. EPA Region 8 1595 Wynkoop Street 8ENF-W-NP Denver, Colorado 80202 303-312-6803 Supervisor Signature/Name Address/Phone Number MICHAEL BOEGLIN Digitally signed by MICHAEL BOEGLIN Date: 2023.05.04 11:21:54 -06'00' U.S. EPA Region 8 1595 Wynkoop Street 8WP-CWW Denver, Colorado 80202 Mike Boeglin 303-312-6133 Date 04/20/2023 Date 04/24/2023 Date 12 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Summary of Findings Tolmar, Inc. NPDES ID# COPF-000106 Pretreatment Inspection Findings Follow up Action Items 1. The Pretreatment Regulations at 40 C.F.R. 403.6(d) states the following: "Except where expressly authorized to do so by an applicable Pretreatment Standard or Requirement, no Pretreatment Requirement 40 C.F.R. 403.6(d) Industrial User shall ever increase the use of process water, or in any other way attempt to dilute a Discharge as a partial or complete substitute for 40 C.F.R. 439.47 Corrective Actions adequate treatment to achieve compliance with a Pretreatment Standard or Requirement." The Pharmaceutical PSNS standards at 40 C.F.R. 439.47 do not authorize dilution. The facility needs to provide accurate volume measurements of the steam condensate discharged to the waste treatment system in the permit application to EPA. Tolmar, Inc. currently discharges approximately 250 to 450 gallons of steam condensate to the waste treatment system. Steam condensate is determined to be an unregulated wastestream to the Pharmaceutical PSNS at 40 C.F.R. 439.47. EPA recommends Tolmar evaluate the feasibility of rerouting the steam condensate to avoid discharging it to the waste treatment system to eliminate or minimize the dilution of regulated wastestreams. 13 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 Photo # (RIMG0258.jpg) (RIMG0259.jpg) (RIMG0260.jpg) (RIMG0261.jpg) Photolog #1 (RIMG0262.jpg) Photolog #2 (RIMG0263.jpg) Photolog #3 (RIMG0264.jpg) Photolog #4 (RIMG0265.jpg) Photolog #5 (RIMG0266.jpg) Photolog #6 (RIMG0267.jpg) Photolog #7 (RIMG0268.jpg) Photolog #8 (RIMG0269.jpg) Photolog #9 (RIMG0270.jpg) Photolog #10 (RIMG0271.jpg) Attachment 1 - Photo Log Description QC lab dishwasher (Room 806) - photo unrecoverable from memory card QC lab two-compartment sink (Room 806) - photo unrecoverable from memory card QC Lab-lab waste satellite collection room (Room 807) - photo unrecoverable from memory card Water purification System-Filters and brine tank - photo unrecoverable from memory card Wastewater treatment system - 2,800-gallon equalization tank Wastewater treatment system - overview of 2,800-gallon equalization tank and pH neutralization skids pH neutralization skid -recirculation loop between stage 1 and stage 2 pH neutralization skid -discharge pipe from stage 2 pH neutralization skid -discharge pipe from stage 2(duplicate) pH neutralization skid -combined discharge pipe from both pH neutralizations skids and monitoring point, pH meter and flow meter pH neutralization skids -caustic/acid and defoamer treatment chemicals Eligard lift station (75 gallons) North lift station South lift station 14 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 DMR DATA REVIEW FORM - Pharmaceuticals, Subpart D (439.47) PSNS Facility Name: Tolmar Inc. Inspector(s): DMR Date: -07/18/22 @ 0730 NPDES ID Number: Inspection Date: Parameter Daily Maximum (avg limit) - mg/L Monthly Average - mg/L Reported Value (mg/L) Actual Value Acetone 20.7 n-Amyl acetate 20.7 Ethyl acetate 20.7 Isopropyl 20.7 acetate Methylene 3.0 chloride 8.2 0.025 8.2 <0.01 8.2 <0.02 8.2 <0.02 0.7 <0.005 Limits Exceeded? Required Monitoring Frequency (403.12(e)) 1 / 6 months 1 / 6 months 1 / 6 months 1 / 6 months Actual Monitoring Frequency Required Holding Time, Preservation, Container, and Method Met? (Part 136 Tables IA-G and II) 1 / 6 months Required Sample Type Met? (403.12(g)( 3)) pH OLPLW n/a (403.5(b)( 2)1, 2 1. 403.12(e) does not require CIUs to monitor for pH, but the CIU is required to comply with the Specific Prohibition requiring GLVFKDUJHVZLWKS+LILWLVDWWKHRXWIDOOWRWKH327: 2. 1RWHS+RULVKD]DUGRXVZDVWHDQGmay be subject to hazardous waste reporting (403.12(p)) Acetone sampling date 08/09/22 09/19/22 Result (mg/L) 1.6 0.0011 15 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 DMR DATA REVIEW FORM - Pharmaceuticals, Subpart D (439.47) PSNS Facility Name: Tolmar Inspector(s): DMR Date:10/11/22 NPDES ID Number: Inspection Date: Parameter Daily Maximum (avg limit) - mg/L Monthly Average - mg/L Reported Value (mg/L) Actual Value Acetone 20.7 n-Amyl acetate 20.7 Ethyl acetate 20.7 Isopropyl 20.7 acetate Methylene 3.0 chloride 8.2 0.33 8.2 <2.001 8.2 <0.002 8.2 <0.0037 0.7 <0.000 Limits Exceeded? Required Monitoring Frequency (403.12(e)) 1 / 6 months 1 / 6 months 1 / 6 months 1 / 6 months Actual Monitoring Frequency Required Holding Time, Preservation, Container, and Method Met? (Part 136 Tables IA-G and II) 1 / 6 months Required Sample Type Met? (403.12(g)( 3)) pH OLPLW n/a (403.5(b)( 2)1, 2 1. 403.12(e) does not require CIUs to monitor for pH, but the CIU is required to comply with the Specific Prohibition requiring GLVFKDUJHVZLWKS+LILWLVDWWKHRXWIDOOWRWKH327: 2. 1RWHS+RULVKD]DUGRXVZDVWHDQGmay be subject to hazardous waste reporting (403.12(p)) Acetone sampling date 11/14/22 12/07/22 Result (mg/L) <0.10 1.1 16 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106 DMR DATA REVIEW FORM - Pharmaceuticals, Subpart D (439.47) PSNS Facility Name: Tolmar Inspector(s): DMR Date: 01/09/23 NPDES ID Number: Inspection Date: Parameter Daily Maximum (avg limit) - mg/L Monthly Average - mg/L Reported Value )mg/L) Actual Value Acetone 20.7 n-Amyl acetate 20.7 Ethyl acetate 20.7 Isopropyl 20.7 acetate Methylene 3.0 chloride 8.2 0.75 8.2 <0.001 8.2 <0.002 8.2 <0.0087 0.7 0.0002 Limits Exceeded? Required Monitoring Frequency (403.12(e)) 1 / 6 months 1 / 6 months 1 / 6 months 1 / 6 months Actual Monitoring Frequency Required Holding Time, Preservation, Container, and Method Met? (Part 136 Tables IA-G and II) 1 / 6 months Required Sample Type Met? (403.12(g)( 3)) pH OLPLW n/a (403.5(b)( 2)1, 2 1. 403.12(e) does not require CIUs to monitor for pH, but the CIU is required to comply with the Specific Prohibition requiring discharges with pH LILWLVDWWKHRXWIDOOWRWKH327: 2. 1RWHS+RULVKD]DUGRXVZDVWHDQGmay be subject to hazardous waste reporting (403.12(p)) Acetone sampling date 02/07/23 03/01/23 Result (mg/L) 1.70 <0.0055 17 of 17 Tolmar Inc. Pretreatment Inspection - April 13, 2023 COPF-000106