Document Rjn9pmNmKaaQ0pKeMzJj0aQNX

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION III 1600 John F Kennedy Boulevard Four Penn Center Philadelphia, Pennsylvania 19103 Report Title: Inspection Date(s): Regulatory Program(s): Type of Activity: Facility Name: Permittee(s): Facility Operator: Facility Address: Lat/Long: County/Parish: Permit Number: NAICS & SIC Codes: Unique Project #: Clean Water Act Compliance Inspection Report 03/16/2023 National Pollutant Discharge Elimination System (NPDES) Pretreatment Industrial User Inspection Alcon Precision Device Manufacturing Alcon Research, Ltd. Alcon Research, Ltd. 714 Columbia Avenue Building A, Sinking Spring, PA, 19608 40.32222/-76.02463 Berks PAP128649 339112/3841 3E23WN041A Facility Representative(s): Point of Contact Ryan Johnson HSE Site Head Alcon Phone: 610-927-6047 Email: ryan-1.johnson@alcon.com EPA Inspectors: Aaron Thomson - EPA Inspector (3ED33) Phone: 215-814-2116 Email: Thomson.aaron@epa.gov Report Preparer Signature/Date Supervisor Signature/Date Aaron Thomson (3ED33) Four Penn Center Philadelphia, Pennsylvania 19103 JESSICA Digitally signed by JESSICA DUFFY DUFFY Date: 2023.06.06 07:56:25 -04'00' Jessica Duffy, NPDES Section 2 Chief (3ED33) Four Penn Center Philadelphia, Pennsylvania 19103 Date Date Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 Table of Contents I. Introduction ......................................................................................................................................................... 3 A. Inspection Opening Conference ............................................................................................................... 3 B. Weather and Precipitation Conditions...................................................................................................... 3 II. Facility Activity/Walkthrough ........................................................................................................................... 4 III. Observations ..................................................................................................................................................... 4 IV. Records Review .............................................................................................................................................. 11 V. Closing Conference.......................................................................................................................................... 11 VI. List of Attachments......................................................................................................................................... 11 Unique Project #: 3E23WN041A Page 2 of 11 I. Introduction Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 On March 16, 2022, Aaron Thomson (hereinafter, or ) an inspector from n on-site inspection of the Alcon Precision Device Manufacturing facility (hereinafter, Alcon , or Facility pretreatment program. Alcon is a surgical eye care manufacturing facility located at 714 Columbia Avenue Building A, Sinking Spring, PA 19608 and operates under the EPA pretreatment program identification number PAP12864. Alcon is permitted by the Borough of Sinking Spring to discharge to the local sewerage system leading to the Borough of Sinking Spring Wastewater Treatment Plant (Attachment 1). A. Inspection Opening Conference The EPA Inspector arrived at the facility at est. 11:00 AM for the on-site inspection. Inspector Thomson met with the following facility representatives: Name Aaron Thomson Ryan Johnson Table 1: Inspection Attendee List Affiliation Telephone Email EPA Region III Inspectors and Contractors EPA Region III 215-814-2116 Thomson.aaron@epa.gov Site/Facility Representatives Alcon 610-927-6047 ryan-1.johnson@alcon.com Inspector Thomson displayed their credentials to Mr. Johnson at the outset of the inspection, and explained the purpose of the inspection was to observe compliance with the Federal Pretreatment Regulations. The EPA Inspector informed Mr. Johnson that any information that the Facility deemed to be confidential business B. Weather and Precipitation Conditions During the inspection, the weather was sunny with a high of 62 degrees Fahrenheit. National Oceanic and Atmospheric Administration (NOAA) National Weather Service precipitation data for the date of the inspection and five days prior are provided in the Table 2 below: Table 2. Precipitation Data Station Name Date ADAMSTOWN 2.5 SSE, PA US US1PALN0003 ADAMSTOWN 2.5 SSE, PA US US1PALN0003 ADAMSTOWN 2.5 SSE, PA US US1PALN0003 ADAMSTOWN 2.5 SSE, PA US US1PALN0003 ADAMSTOWN 2.5 SSE, PA US US1PALN0003 ADAMSTOWN 2.5 SSE, PA US US1PALN0003 03/11/2023 03/12/2023 03/13/2023 03/14/2023 03/15/2023 03/16/2023 Precipitation Amount (inches)1 0.47 0.00 0.01 T2 T 0.00 1 Source: NOAA National Climatic Data Center (http://www.ncdc.noaa.gov/). 2 "T" values in the Precipitation or Snow category above indicate a "trace" value was recorded. Unique Project #: 3E23WN041A Page 3 of 11 Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 II. Facility Activity/Walkthrough Based on statements by Mr. Johnson and observations made on-site, the facility is classified as a metal finishing point source Categorical Industrial User (CIU), which is subject to the Federal Pretreatment Regulations 40 CFR Part 403 and Categorical Industrial User Regulations 40 CFR Part 433.15. The facility discharges to the Borough of Sinking Spring publicly owned treatment works (POTW). Because the facility discharges into a POTW without an approved pretreatment program, EPA is designated as the Control Authority, and as such is the authority for inspections per 40 CFR Part 403.3(f). Alcon is a surgical eye care manufacturing plant. es that contribute to the wastewater stream discharged to the sewage system includes process wastewater generated from two separate . The process is identical for both trains, and includes, in order, a degreasing bath, a rinse bath, a basket drain, a deburring (acid) bath, and a series of 3 cascading baths. Wastewater from the rinse bath (second) and the first cascading bath (fifth) contribute to the wastewater stream discharged to the local wastewater treatment facility. Wastewater from the first cascading bath (fifth) will enter a reservoir tank, which will enter a neutralization tank after the previous wastewater load is neutralized. Novalite 1 produces approximately 40 gallons per discharge 24 times a day (960 gallons per day) and has a neutralization tank with a capacity of 55 gallons. Novalite 2 produces approximately 116 gallons per discharge 6 times per day (696 gallons per day). Batch neutralization occurs in the neutralization tanks, which are monitored continuously by a pH probe. Once the pH is brought within permitted discharge limits, the wastewater is discharged to a sump tank where water from the rinse bath (second) is also directly received, before being discharged to the sewer system. Sampling points are located after the neutralization tank in each process train and do not include water from the rinse bath (second). Waste from the deburring bath (fourth) is stored as hazardous waste and hauled off-site and treated by Veolia Environmental Services as hazardous waste. Overflow from the second and third cascading baths are directed back into the first cascading bath. After the opening conference, Mr. Johnson led a tour of the processes that contribute to the wastewater discharge to the sewage system. first chemical bath process train (Novalite 1), equipped with troughs to collect any spillage. neutralization tank and the Novalite 1 sampling point. Next, Inspector Thomson was led to piping exiting the neutralization tank and leading to the ng discharged to the sewer. baths, the neutralization tank, and the continuous monitoring systems. At the request of Inspector Thomson, Mr. Johnson then described the lo III. Observations A checklist was utilized during the review and is provided below. The checklist is divided into sections, with Observations listed under each section. Photographs were taken during the inspection by Facility representative Ryan Johnson but were not provided to Inspector Thomson to include in this report. Visual Observations pertaining to each section are listed at the end of each section. Unique Project #: 3E23WN041A Page 4 of 11 Section 1. General Information General Description of Processes and Products Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 Yes No N/A Comments Surgical eye care manufacturing Are there any alternates to effluent monitoring conducted? (e.g., TTO/TOMP, Waiver requirements?) Describe in 2/13/18 Alcon will only need to submit semiannual data for the following Total Toxic Organic (TTO) compounds: benzene, 1,1,2-trichlorethane, chloroform (trichloromethane), methylene chloride (dichloromethane), napthalene, phenol, toluene and trichloroethylene included on the cover page of bi-annual self-monitoring reports for 2021, 2022 (not attached) Additionally, the selfmonitoring reports each include a signed letter from Alan Carl, General Manager for Alcon, of my knowledge and belief, no dumping of concentrated toxic organics into the wastewaters [h]as occurred since filing of the last discharge monitoring Provide production rates for all processes subject to production based standards and include: 1) Process 2) production rate used for calculating limits 3) production rate for last 12 months Any anticipated changes in processes or production rates? List the production rate listed on the approval letter Shift information, list 1) Shift # 2) No. of Employees Unique Project #: 3E23WN041A n/a Mon-fri shifts, discharge (batch) only when operating Page 5 of 11 3) Hours 4) Work Days Is production seasonal? If yes, describe List all visual observations pertaining to this section Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 Section 2. Categorical Industry Categorical Industry? Category(s): Subcategory(s): Regulatory New Source Date: New source? List of categorical processes List of other operations producing wastewater List all visual observations pertaining to this section Yes No N/A Comments 40 CFR Part 433.15, Subpart A: Metal Finishing. Cascading (rinse) bath for deburring (acid) bath Rinse/wash bath after degreasing bath Section 3. Characterization of Wastewater Discharges (CFR 433.15) Yes No N/A Comments Describe the time of day discharge to sewer occurs Are discharges seasonal (if yes, describe) The discharges occur in batches during the normal operating hours of 8 AM to 5 PM Attach a block flow diagram of manufacturing process in the Facility Activity section of the inspection report, including: chemical storage area, and wastewater generated. Identify all regulated, unregulated and dillution wastewater discharges. Include sample location, discharge flow rates and method of disposal*. Note any recent changes. *disposal method CD - Continuous discharge to sanitary ND - Not discharged or disposed BD - Batch discharge to sanitary sewer HH - Hauled as hazardous waste OD - Other disposal - not to sanitary sewer HW - Hauled as nonhazardous waste List all visual observations pertaining to this section Section 4. Pretreatment Facility Unique Project #: 3E23WN041A Page 6 of 11 Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 Yes No N/A Comments Consists of pH Pretreatment installed? neutralization, measuring pH as discharged Attach a schematic of the pretreatment facility in the Facility Activity section of the inspection report (include all units and sludge storage) Water from rinse bath (after acid bath) is Briefly describe treatment processes and operation. collected, neutralized/measured and discharged Describe sludge storage and disposal method 5 gal container 55 gal drum hauled as haz waste Describe appearance of effluent at time of inspection. n/a List all visual observations pertaining to this section Section 5. Self Monitoring Yes No N/A Comments According to Mr. Johnson, Does facility have a sampling plan or protocol including use of 40 C.F.R. Part 136 techniques (obtain copy)? sampling for selfmonitoring of Facility is Is sampling location (identified on block flow diagram) the same as in control mechanism? If no, explain. staff Outfall 1 (all wastewater streams) is labeled/sampled also includes individual Is this sampling location permanently identified by a sign, painted number, or other means? Is this sampling location appropriate? If no, Is this sampling location shown on the chain of custody form? Are any parameters monitored by approved methods more frequently than required at permitted sampling location?. If yes to previous question, are all results submitted to the control authority? Does facility resample and report within 30 days of discovering a violation? Are sampling records maintained on site? Describe for how long. Is flow determined as required by permit? Unique Project #: 3E23WN041A More locations that permit requires are sampled, all are reported If they were sampled above frequency, all would be reported 3 years+ Page 7 of 11 How is flow determined (i.e., estimated or measured)? Is flow measurement appropriate? Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 Calculated (based on known volume of full tank) Permit calls for Is flow measurement device calibrated? Does the facility have an operator's manual for its pH meters? Does the facility do a proper 2-point calibration of its pH meter in accordance with the operator's manual? Is other monitoring equipment (e.g. DO meter) calibrated? Describe how often if yes. Is sampling and analysis done in-house or by contract? If by contract, list company. Is QA/QC program for sampling and analysis adequate? Obtain copy of plan if available. List all visual observations pertaining to this section Monthly, in-house calibration Contract, M.J. Reider Associates, Inc. contract Section 6. Hazardous Waste Management Yes No N/A Comments Is IU aware of RCRA regulations? Does facility generate any hazardous waste? If yes, indicate type of waste, method of management on site and means of disposal on a separate sheet. Describe any spillage problems or any other releases that are observed. 5 gal container 55 gal drums Veolia environmental services Has facility notified POTW and EPA of any hazardous waste discharges to the sewer? List all visual observations pertaining to this section Section 7. Spill Prevention Yes No N/A Comments Has the facility had any spills or been responsible for slug loads? List dates of events in comments. If yes to previous question, was POTW notified? Does the facility have spill notification procedures posted? Has the facility evaluated its need for a spill prevention plan at least every two years? If yes to previous question, was it determined that they needed one? Yes, also required by permit Does the IU have a spill prevention (SP) plan to address spills to the POTW? Included in Integrated Contingency Plan, updated Unique Project #: 3E23WN041A Page 8 of 11 If spills occurred- Did the IU follow procedures outlined in the spill plan at the time of spills? If spills occurred- Were procedures effective in containing the spill? Is the facility keeping records of spill events? Have there been any changes in spill procedures recently. Describe if yes. List all visual observations pertaining to this section Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 in 2023 and includes description of discharge practices, description of stored chemicals, procedures to notify borough of sinking spring/epa in case of discharge, procedures to prevent slug discharge and a facility flow diagram (reviewed, not attached) Section 8. Recordkeeping Review. Yes No N/A Comments Current IU control mechanism (through EPA, not a permit) Attachment 2 Notices and correspondence with control authority including: a. Self monitoring report transmittals? Self monitoring reports (reviewed, not attached) received by facility from MJ Reider are sent control authority b. BMR if required? c. Other? Do sampling records include: a. Date of sampling event? Chain of Custody (CoC) b. Time of sampling event? CoC c. Name of sampling person and affiliation? CoC d. Sample collection method? CoC e. Method of sample preservation? CoC f. Description of sample location? CoC g. Name of person conduction analysis? CoC h. Date of analysis? CoC i. Time of analysis, if applicable (i.e., BOD, Cr?) CoC Unique Project #: 3E23WN041A Page 9 of 11 j. Sample analyses method? Is type of sample specified in control mechanism? Are all parameters monitored at the required frequency? Note any discrepancies in comments. Analytical results? Are all monitoring results sent to the Control Authority? Are copies sent to the POTW? Appropriate production records for production based standards? Documentation of flow rates and volumes? Are records maintained at least 3 years? List all visual observations pertaining to this section Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 CoC shows requested method, analysis results show method used CoC Analysis Section 9. EPA Sampling Were samples taken? Describe sampling location, method, and time: List all visual observations pertaining to this section Yes No N/A Comments Section 10. Stormwater Does facility have a stormwater permit? If yes, describe what type of permit along with issuance and expiration dates Does facility have a stormwater pollution prevention plan? Describe any BMPs that the facility is currently implementing. List all visual observations pertaining to this section Yes No N/A Comments According to Mr. Johnson, site is contained and does not require a stormwater permit Section 11. Current Compliance Status Indicate compliance with: a. effluent limits (indicate in comments the date range reviewed) b. monitoring (indicate in comments the date range reviewed) Yes No N/A Comments Unique Project #: 3E23WN041A Page 10 of 11 c. recordkeeping/reporting (indicate in comments the date range and records reviewed) List all visual observations pertaining to this section Alcon Precision Manufacturing Sinking Spring Pretreatment Industrial User Inspection 03/16/2023 IV. Records Review Prior to the inspection, Inspector Thomson requested the following documentation, via email, to be prepared for the inspection, or by email up to two weeks after the inspection: Control mechanism, categorical status, 2 years worth of compliance monitoring reports, slug/spill prevention plan and process flow diagrams relating to the pretreatment system. During the inspection, Mr. Johnson provided the following information/documents which were reviewed by Inspector Thomson; categorical status; compliance monitoring reports from Q1 & Q2 2021, Q3 & Q4 2021, Q1 & Q2 2022 and Q3 & Q4 2022; the integrated contingency plan (slug/spill prevention plan); and process diagrams. Mr. Johnson also provided a copy of their discharge permit granted by the Borough of Sinking Spring (Attachment 1). At the time of the inspection, and after the inspection via telephone and email, Inspector Thomson requested Mr. Johnson provide the photographs taken during the inspection, as of writing this report no photographs were supplied by the Facility. V. Closing Conference After the facility inspection, the EPA Inspection Team met with the facility representatives for a closing conference. The EPA Inspection Team shared preliminary observations with the facility. The EPA Inspection Team reiterated to the facility representatives that all preliminary observations discussed were not compliance determinations. Any and all preliminary observations shared were subject to further investigation by EPA upon the additional review of records and documentation. Additional observations may be contained in this inspection report that were not identified at the time of the closing conference after EPA reviewed additional materials following the inspection. The inspection concluded at 2:00 PM VI. List of Attachments Attachment 1. Alcon's Local Permit Unique Project #: 3E23WN041A Page 11 of 11