Document qdJd0YJ0E6YLzLM40KmargRRj

US Environmental Protection Agency - Region 2 Caribbean Environmental Protection Division Response and Remediation Branch Resource Conservation and Recovery Act (RCRA) Compliance Evaluation Inspection Facility Name: Neolpharma, Inc. - Caguas EPA ID Number: PRD090378225 Date of Inspection: August 9, 2023 Generator Status in Record: Large Quantity Generator (LQG) Generator Status at the time LQG of inspection: RCRA Permitted: No Basis for Inspection: Core Program Corrective Action: No Project ID CEPD-RCRA-23-0433 Potential EJ Concern Yes. 8 EJ Indexes above the 80% USA Percentile. (See Appendix C) Potential Flood Prone Area Yes. The Facility boundaries are within the 100-Year Flood Zone layer (See Appendix D) Facility Physical Location: 99 Jardines St (Municipality, PR, zip Caguas, PR 00725 code) Geographical Coordinates: 18.240619, -66.017865 Facility Owner: Neolpharma Inc 787-286-4000 99 Jardines St Caguas, PR 00725 Facility Operator: Neolpharma Inc 787-286-4000 99 Jardines St Caguas, PR 00725 NAICS: 325412; Pharmaceutical Preparation Manufacturing SIC: 2834; Pharmaceutical Preparations Area: ~30 acres Number Employees: ~200 Personnel participating in the inspection: Name Affiliation Title Contact Information Carlos J. Colombani EPA Region 2 Enforcement Officer 787-977-5862; CEPD colombani.carlos@epa.gov Vanessa Rodriguez Status: Record Schedule: Neolpharma, Inc. Manager, EHS Final 1044(c) 787-286-4159 vanessa.rodriguez@neolpharm a.com 1 EPA Inspector Signature/Date Supervisor Signature/Date Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 X Carlos Josue Colombani Enforcement Officer Digitally signed by CARLOS COLOMBANI DN: c=US, o=U.S. Government, ou=Environmental Protection Agency, cn=CARLOS COLOMBANI, 0.9.2342.19200300.100.1.1=68001003667785 Date: 2023.08.23 12:23:31 -04'00' Adobe Acrobat version: 2023.003.20284 Digitally signed by DAVID DAVID CUEVAS- CUEVAS-MIRANDA X MIRANDA Date: 2023.08.23 12:49:31 -04'00' David N. Cuevas Miranda, Ph.D. Status: Final 2 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 CONTENTS 1 INTRODUCTION .......................................................................................................................... 4 2 OPENING CONFERENCE............................................................................................................ 4 2.1 Facility Background And Operation ......................................................................................... 5 2.2 Solid And Hazardous Waste Generation .................................................................................. 5 3 FACILITY WALKTHROUGH...................................................................................................... 6 3.1 Satellite Accumulation Areas (SAAs) ...................................................................................... 6 3.2 Central Accumulation Areas (CAAs) ....................................................................................... 7 3.3 Used Oil Storage ....................................................................................................................... 7 3.4 Universal Waste Storage Area .................................................................................................. 7 4 DOCUMENT REVIEW ................................................................................................................. 7 5 CLOSING CONFERENCE .......................................................................................................... 10 6 POTENTIAL AREAS OF CONCERN ........................................................................................ 10 7 ENVIRONMENTAL ASSISTANCE........................................................................................... 12 8 APPENDICES .............................................................................................................................. 13 Status: Final 3 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 1 INTRODUCTION On August 9, 2023, a Resource Conservation and Recovery Act (RCRA) Subtitle C Compliance Evaluation Inspection (CEI) was conducted at Neolpharma, Inc. (the Facility), pursuant to Section 3007 of RCRA. As part of the inspection, an opening conference, walkthrough, document review and closing conference were conducted to evaluate the Facility's compliance with the requirements that govern hazardous waste generators, universal waste handlers and used oil generators, as applicable. The Facility is located at 99 Jardines Street, Caguas, Puerto Rico, 00725. See aerial photograph (Figure 1) below for reference. Figure 1: Neolpharma, Inc. Aerial Photograph The purpose of this inspection was to evaluate the Facility's compliance with the RCRA requirements for hazardous waste management. Based on EPA's RCRAInfo database, the Facility is listed as a large quantity generator (LQG) of hazardous waste and was last inspected by EPA on July 27, 2018. Under EPA Policy, LQGs are required to be inspected every five (5) years and thus, an inspection was due in July of 2023. The inspection was unannounced. 2 OPENING CONFERENCE I met with Ms. Vanessa Rodriguez, Manager of Environmental Health and Safety for the opening conference. I identified myself as an EPA RCRA enforcement officer, told the Facility representative the Status: Final 4 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 purpose of the inspection, and offered Ms. Rodriguez an opportunity to claim confidential business information (CBI). I then proceeded to request documents that would be needed to complete the compliance evaluation. These were the following: Hazardous waste manifests; Land disposal restrictions; RCRA personnel training; Contingency Plan; Quick reference guide; Biennial report; and Weekly inspections. I also explained the areas that required a visit to ensure compliance with the regulations. A plan was put in place to ensure these areas were inspected during the walkthrough. 2.1 FACILITY BACKGROUND AND OPERATION Neolpharma Group, a Mexican pharmaceutical, has more than 40 (forty) years of experience in the production of prescription and over-the-counter drugs. It is dedicated to research, development, manufacturing, marketing and distribution of pharmaceutical drugs. Neolpharma, Inc. in Caguas, PR consists of state-of-the art technology to produce liquid and solid forms, tablets, capsules and beads. The Facility acquired the plant from Pfizer in January of 2013. In 2017, a 35-million investment was announced that resulted in the expansion of the Facility, additional laboratory equipment for research and development, and created over a hundred jobs. Neolpharma, Inc. manufactures and packages levothyroxine (Levo-T), a drug used to treat an underactive thyroid (hypothyroidism). The PR plant has easy access to maritime and air transportation, which benefits the transportation for import and export of raw materials as finished products to the United States. The Facility representative reported that the plant currently employs approximately 200 (two hundred) full-time employees. Neolpharma, Inc. covers an area of about 30 (thirty) acres of land. 2.2 SOLID AND HAZARDOUS WASTE GENERATION Neolpharma, Inc. generates and stores hazardous and nonhazardous wastes from their research and development (R&D) laboratories, and the manufacturing area and stores them in two (2) central accumulation areas (CAAs), 5 (five) satellite accumulation areas (SAAs), and an assigned area for its universal waste. The CAAs are identified as CAA #1 and CAA #2. The SAAs are located in the Analytical Laboratory #1, the Analytical Laboratory #2, the Raw Material Laboratory #4, the Analytical Laboratory #6, and the Manufacturing area. Hazardous waste is generated daily throughout the Facility and Veolia is their dedicated hauler. Majority of the hazardous waste generated is shipped under waste codes D001 (ignitable), D002 (corrosive), F-listed spent solvents and F-listed spent nonhalogenated solvents, P-listed acute hazardous Status: Final 5 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 waste from discarded commercial chemical products, U-listed hazardous waste from discarded commercial chemical products, benzene, pyridine, and chromium. Its P-listed waste are mainly P030 (soluble cyanides salts) and P098 (potassium cyanide). 3 FACILITY WALKTHROUGH Ms. Rodriguez accompanied me during the facility walkthrough. The following areas were inspected for compliance: Analytical Laboratory #1 SAA; Analytical Laboratory #2 SAA; Raw Material Laboratory #4 SAA; Analytical Laboratory #6 SAA; Manufacturing SAA; CAA #1; CAA #2; and Universal Waste Storage Area. The observations for each area are described below. 3.1 SATELLITE ACCUMULATION AREAS (SAAS) As mentioned above, the Analytical Laboratories #1, #2, and #6, the Raw Material Laboratory #4, and the Manufacturing SAAs were visited to evaluate compliance with the RCRA regulations. At the time of the inspection, the Analytical Laboratory #1 SAA had 2 (two) 5-gallon hazardous waste containers of acetonitrile and 2 (two) 5-gallon hazardous waste containers of methanol. One (1) of the containers' storing acetonitrile was found open (See Appendix A, Photograph 1). At that time, laboratory representatives were not adding or removing waste from the container. The Analytical Laboratory #2 SAA had a 5-gallon hazardous waste container of acetonitrile, a 5-gallon hazardous waste container of methanol and a bucket of waste vials generated from high performance liquid chromatography (HPLC) (See Appendix A, Photograph 2). At the Raw Material Laboratory #4 SAA, there was a hazardous waste container of pyridine dated August 3, 2023 (See Appendix A, Photograph 3). Under RCRA, a generator must remove the excess from the SAA within three consecutive calendar days to a CAA or to an off-site designated facility. The SAA was also storing a 5-gallon hazardous waste container of acetonitrile and a 5-gallon hazardous waste container of methanol. The Analytical Laboratory #6 SAA had 3 (three) 5-gallon hazardous waste containers of acetonitrile and 3 (three) 5-gallon hazardous waste containers of methanol. At the Manufacturing SAA, there was a 55-gallon drum of adhesive solution and contaminated isopropyl alcohol (IPA) (See Appendix A, Photograph 4). Status: Final 6 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 The hazardous waste containers at the SAAs that I visited were properly labeled with the words "hazardous waste", with an indication of the nature of the hazard being stored, and at or near the point of generation. 3.2 CENTRAL ACCUMULATION AREAS (CAAS) CAA #1 No hazardous waste was being stored due to a pickup several days prior to the inspection (See Appendix A, Photograph 5). CAA #2 No hazardous waste was being stored due to a pickup several days prior to the inspection (See Appendix A, Photograph 6). At the time of the inspection, both CAAs had emergency spill kits and an eye washing station readily available, a telephone at reach in case emergency protocols had to be activated, fire extinguishers present, the emergency contact information signage posted, and adequate aisle space to conduct a thorough inspection of the hazardous waste storage drums/containers. 3.3 USED OIL STORAGE According to Ms. Rodriguez, the Facility does not generate used oil. 3.4 UNIVERSAL WASTE STORAGE AREA The Facility has a dedicated area solely for universal waste, specifically used fluorescent bulbs and batteries located within the premises in a shipping-type metal container (See Appendix A, Photograph 7). At the time of the inspection, 3 (three) batteries were being stored (See Appendix A, Photograph 8). 4 DOCUMENT REVIEW During the inspection, I requested the documents listed under Section 2 of this report. Below are the observations noted after the document review was completed. Weekly Inspections CAA #1 The weekly inspection records for CAA #1 were audited on-site from January 2020 through August 2021 since they were readily available. The records from September 2021 through July 2023 were requested electronically given they were not readily available the day of the inspection. Ms. Rodriguez provided weekly inspection records via email on August 18, 2023. The Facility keeps a binder for the weekly inspection records, and the inspection checklist includes checking for leaking containers and for deterioration of containers caused by corrosion or other factors, and for proper hazardous waste labels and accumulation start dates. Status: Final 7 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 The following table summarizes the number of weekly inspections by month and calendar year that were not recorded in the checklist. Calendar Year 2020 March August Number of Missing Weekly Inspections from Checklist 1 week 2 weeks Calendar Year 2021 September October November December Number of Missing Weekly Inspections from Checklist 1 week 1 week 1 week 4 weeks Calendar Year 2022 January February March April May June July August September October November December Number of Missing Weekly Inspections from Checklist 4 weeks 2 weeks 4 weeks 2 weeks 3 weeks 4 weeks 2 weeks 3 weeks 3 weeks 3 weeks 3 weeks 3 weeks As of August 22, 2023, no records have been provided for calendar year 2023. CAA #2 The Facility was not able to produce any weekly inspection records pertaining the CAA #2. Contingency Plan Ms. Rodriguez provided a copy of the Contingency Plan the day of the inspection since it must include specific information and it would require a more in-depth review. I verified that the plan was submitted to local emergency response agencies and that the Facility made arrangements with local responders, that it describes the actions needed to respond to explosions, fires and/or releases of hazardous waste, that it identifies an emergency coordinator alongside a 24/7 emergency telephone number, that it lists emergency equipment with its location and capabilities, and that it includes an evacuation plan. The plan is dated October 2022. Status: Final 8 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Quick reference guide The Facility does not have a quick reference guide. For facilities that began operations prior to May 30, 2017, a quick reference guide needs to be prepared and submitted to emergency response agencies as soon as the contingency plan is revised after that date. The Facility's latest contingency plan is from calendar year 2022. Personnel Training Annual personnel training was provided on-site for staff associated with the hazardous waste operations of the Facility for calendar year 2022. Participant rosters were provided alongside the training material slides. Ms. Rodriguez stated that RCRA annual refreshers were not conducted for calendar years 2020 and 2021. The job title and duty documents did not include a written description of type and amount of introductory and continuing training needed for personnel associated with the Facility's hazardous waste management. Manifests All the hazardous waste manifests listed in Appendix B had proper land disposal restriction notification forms based on the shipped waste codes, were dated, and signed by the designated facility, and were processed into EPA's Hazardous Waste Electronic Manifest System (e-Manifest). In 2020, the Facility shipped approximately 18,531 kilograms of hazardous waste, and 7 kilograms of acute hazardous waste. In 2021, it shipped approximately 12,357 kilograms of hazardous waste, and 16 kilograms of acute hazardous waste. In 2022, the Facility shipped approximately 12,592 kilograms of hazardous waste, and 2 kilograms of acute hazardous waste. So far, in 2023, the Facility has shipped approximately 1,996 kilograms of hazardous waste (from January through April of 2023). Thus, based on the manifests reviewed for the past three years, and conversations with the Facility representative, it appears that the Facility routinely generated more than 1,000 kg per month of hazardous waste. Consequently, the Facility appears to be correctly classified as a LQG. The following table summarizes the amount of non-acute and acute hazardous waste shipped by calendar year. Manifest Year 2020 2020 2021 2021 2022 2022 2023 Acute? Acute Non-Acute Acute Non-Acute Acute Non-Acute Non-Acute Amount of Waste (kg) 7 18,531 16 12,357 2 12,592 1996 Status: Final 9 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Neolpharma, Inc. ships its hazardous waste typically every 2 (two) or 3 (three) months but often sooner given the amount that is being generated. Biennial Report The Facility provided proof of its Biennial Report submission. This was verified in RCRAInfo for the reporting cycle of calendar year 2021. The report was received on February 28, 2022. 5 CLOSING CONFERENCE On August 9, 2023, after completion of the walkthrough and onsite document review, I met with Ms. Rodriguez to conduct a closing conference. I indicated that the purpose of the closing conference was to inform the Facility about the CEI observations and the opportunity to clarify any questions or doubts the representative might have pertaining the RCRA inspection. I also communicated that a CEI report would be emailed once finalized. 6 POTENTIAL AREAS OF CONCERN Based on observations made during the walkthrough of the Facility and/or a review of records provided to EPA by the Facility on-site and/or afterwards, the following potential areas of concern were identified. REGULATORY, STATUTORY OR PERMIT REFERENCE FIELD OBSERVATION RCRA Subtitle C - Hazardous Waste 40 CFR Part 262.15(a)(4): A container holding hazardous waste must be closed at all times during accumulation, except: when adding, removing, or consolidating waste; or when temporary venting of a container is necessary. At the time of the inspection, the Analytical Laboratory #1 SAA had an open container of acetonitrile. See Appendix A, Photograph 1. 40 CFR Part 262.15(a)(6)(ii): A generator must remove the excess from the satellite accumulation area within three consecutive calendar days. At the time of the inspection, the Raw Material Laboratory #4 SAA had a pyridine container dated August 3, 2023. The inspection was conducted on August 9, 2023. See Appendix A, Photograph 3. 40 CFR Part 262.17(a)(1)(v): At least weekly, the large quantity generator must inspect central accumulation areas. CAA #1 The following table summarizes weekly inspections that were not recorded in the checklist for calendar years Status: Final 10 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 REGULATORY, STATUTORY OR PERMIT REFERENCE FIELD OBSERVATION 2020 through 2022. For calendar year 2023, no records were provided. Calendar Year 2020 March August Number of Missing Weekly Inspections from Checklist 1 week 2 weeks Calendar Year 2021 September October November December Number of Missing Weekly Inspections from Checklist 1 week 1 week 1 week 4 weeks Calendar Year 2022 January February March April May June July August September October November December Number of Missing Weekly Inspections from Checklist 4 weeks 2 weeks 4 weeks 2 weeks 3 weeks 4 weeks 2 weeks 3 weeks 3 weeks 3 weeks 3 weeks 3 weeks CAA #2 The Facility was not able to produce weekly inspections for the past 3 (three) years. Status: Final 11 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 REGULATORY, STATUTORY OR PERMIT REFERENCE FIELD OBSERVATION 40 CFR Part 262.262(b): Prepares a quick reference guide and submits it to emergency response agencies. The Facility was not able to produce a Quick Reference Guide. 40 CFR Part 262.17(a)(7)(iii): Facility personnel must take part in an annual review of the initial training. The Facility was not able to produce RCRA personnel training records for calendar year 2020 and 2021. 40 CFR Part 262.17(a)(7)(iv)(C): The LQG must maintain the following documents and records at the facility: a written description of the type and amount of both introductory and continuing training that will be given to each person. The job title and duty documents provided for "Environmental Support Services Technician", "Sr. Pharmaceutical Services Operator", "Quality Operations Clerk", and "Environmental, Health and Safety Manager" did not include a written description of the type and amount of both introductory and continuing training that needs to be given to each person in and/or filling the position. 7 ENVIRONMENTAL ASSISTANCE Based on the observations made during the inspection, the Facility should consider the following resources to increase their understanding and compliance with applicable environmental requirements and/or go `beyond compliance' to reduce its overall environmental footprint: Final Rule: Hazardous Waste Generator Improvements (2017), https://www.epa.gov/hwgenerators/final-rule-hazardous-waste-generator-improvements Compliance Assistance Centers, https://www.complianceassistance.net/ Hazardous Waste Portal, and https://www.hazwasteportal.org/ Fact Sheet on Requirements for Large Quantity Generators of Hazardous Waste, https://www.epa.gov/sites/default/files/2020-07/documents/10635_lqg-factsheet_508.pdf Status: Final 12 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 8 APPENDICES A. Inspection Photographs B. Hazardous Waste Manifests C. EJScreen Report D. Flood Zone Map Status: Final 13 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Appendix A: Inspection Photos Photograph 1: Open container of acetonitrile at the Analytical Laboratory #1 SAA. Photograph 2: Waste vials of HPLC at the Analytical Laboratory #2 SAA. Status: Final 14 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Photograph 3: Container of pyridine dated August 3, 2023 at the Raw Material Laboratory #4 SAA. Photograph 4: 55-gallon drum of adhesive and contaminated IPA at the Manufacturing SAA. Status: Final 15 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Photograph 5: Overview of CAA #1 with no hazardous waste. Photograph 6: Overview of CAA #2 with no hazardous waste. Status: Final 16 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Photograph 7: UW Storage Area metal container. Photograph 8: UW batteries at the UW Storage Area. Status: Final 17 CEPD-RCRA-23-0433 Status: Final Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Appendix B: Hazardous Waste Manifests Manifest Date 4/27/2023 4/27/2023 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 12/30/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/13/2022 9/12/2022 9/12/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 Waste (kg) 363 1,633 601 11 1 7 20 2,177 95 1 45 318 1 3 2 5 352 20 5 39 363 50 5 57 5 5 5 7 392 1,814 54 18 11 57 2 2 3 18 Manifest Tracking Number 002066173VES 002066173VES 002066182VES 002066184VES 002066184VES 002066184VES 002066184VES 002066182VES 002066183VES 002066184VES 002066184VES 002066183VES 002066184VES 002066184VES 002066184VES 002066184VES 002064276VES 002064276VES 002064276VES 002064276VES 002064275VES 002064276VES 002064276VES 002064276VES 002064276VES 002064276VES 002064276VES 002064276VES 002067048VES 002067048VES 002069862VES 002069863VES 002069863VES 002069863VES 002069863VES 002069863VES 002069863VES CEPD-RCRA-23-0433 Status: Final Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 6/14/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 2/25/2022 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 11/29/2021 2 2,722 84 2 26 2 2 18 2 803 6 9 4 11 5 2,177 27 1 50 70 2 5 5 2 2 1 363 68 30 2 1 13 2,540 66 2 12 59 15 1 002069863VES 002069862VES 002069863VES 002069863VES 002069863VES 002069863VES 002069863VES 002069863VES 002069863VES 002064131VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002064131VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002064115VES 002069503VES 002069504VES 002069505VES 002069505VES 002069505VES 002069505VES 002069503VES 002069505VES 002069505VES 002069505VES 002069505VES 002069505VES 002069505VES 19 CEPD-RCRA-23-0433 Status: Final Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 11/29/2021 11/29/2021 11/29/2021 11/29/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 8/23/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 6/7/2021 1 1 2 1 441 143 20 5 5 79 1,814 73 29 20 18 41 5 5 5 20 5 18 220 132 5 1 14 2,354 74 3 3 21 1 15 41 10 2 1 1 002069505VES 002069505VES 002069505VES 002069505VES 001659979VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659979VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001659978VES 001656993VES 001656994VES 001656994VES 001656994VES 001656994VES 001656993VES 001656995VES 001656994VES 001656994VES 001656994VES 001656994VES 001656994VES 001656995VES 001656994VES 001656994VES 001656994VES 001656995VES 20 CEPD-RCRA-23-0433 Status: Final Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 3/12/2021 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 12/15/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 771 14 11 57 5 4 5 10 2,359 122 5 54 4 109 7 5 5 8 1 567 8 19 1 1 2,173 66 1 8 19 61 1 1 436 3 25 15 1 3,280 125 001849102VES 001849101VES 001849103VES 001849104VES 001849101VES 001849101VES 001849101VES 001849101VES 001849102VES 001849101VES 001849101VES 001849101VES 001849101VES 001849101VES 001849101VES 001849101VES 001849101VES 001849101VES 001849101VES 001513441VES 001513440VES 001513440VES 001513440VES 001513440VES 001513441VES 001513442VES 001513440VES 001513440VES 001513440VES 001513442VES 001513442VES 001513442VES 001659877VES 001659875VES 001659875VES 001659875VES 001659875VES 001659877VES 001659876VES 21 CEPD-RCRA-23-0433 Status: Final Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 9/28/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 7/9/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 4/27/2020 2/17/2020 20 1 2 234 3 13 2 15 57 2 1 1 9 3,050 147 4 86 9 176 8 1 1 9 4 760 342 20 3,084 181 20 54 181 20 5 5 5 7 5 71 001659875VES 001659875VES 001659875VES 001659876VES 001659876VES 001659875VES 001659875VES 001659876VES 001849949VES 001849951VES 001849951VES 001849951VES 001849951VES 001849949VES 001849950VES 001849951VES 001849952VES 001849951VES 001849950VES 001849951VES 001849951VES 001849951VES 001849951VES 001849950VES 001513219VES 001513221VES 001513221VES 001513219VES 001513220VES 001513221VES 001513221VES 001513220VES 001513221VES 001513221VES 001513221VES 001513221VES 001513220VES 001513221VES 001513329VES 22 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 2/17/2020 90 3 8 19 7 2 2,711 46 2 173 10 22 2 10 7 1 001513330VES 001513331VES 001513331VES 001513331VES 001513331VES 001513331VES 001513329VES 001513331VES 001513331VES 001513331VES 001513329VES 001513331VES 001513329VES 001513331VES 001513329VES 001513331VES Status: Final 23 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Appendix C: EJScreen Report Status: Final 24 CEPD-RCRA-23-0433 EJScreen Community Report This report provides environmental and socioeconomic information for user-defined areas, and combines that data into environmental justice and supplemental indexes. Caguas, PR 1 mile Ring Centered at 18.240619,-66.017865 Population: 17,099 Area in square miles: 3.14 COMMUNITY INFORMATION LANGUAGES SPOKEN AT HOME LANGUAGE English Spanish Total Non-English PERCENT 7% 93% 93% www.epa.gov/ejscreen Low income: 72 percent People of color: 98 percent Less than high school education: 13 percent Limited English households: 68 percent Unemployment: 21 percent Persons with disabilities: 32 percent Male: 43 percent Female: 57 percent 0 years Average life expectancy $14,028 Per capita income Number of households: 7,019 BREAKDOWN BY RACE Owner occupied: 60 percent White: 56% Black: 9% Asian: 0% Hispanic: 97% American Indian: 0% Hawaiian/Pacific Islander: 0% Other race: 22% BREAKDOWN BY AGE Two or more races: 13% From Ages 1 to 4 4% From Ages 1 to 18 17% From Ages 18 and up 83% From Ages 65 and up 23% LIMITED ENGLISH SPEAKING BREAKDOWN Speak Spanish 100% Speak Other Indo-European Languages 0% Speak Asian-Pacific Island Languages 0% Speak Other Languages 0% Notes: Numbers may not sum to totals due to rounding. Hispanic popultion can be of any race. Source: U.S. Census Bureau, American Community Survey (ACS) 2017 -2021. Life expectancy data comes from the Centers for Disease Control. Environmental Justice & Supplemental Indexes The environmental justice and supplemental indexes are a combination of environmental and socioeconomic information. There are thirteen EJ indexes and supplemental indexes in EJScreen reflecting the 13 environmental indicators. The indexes for a selected area are compared to those for all other locations in the state or nation. For more information and calculation details on the EJ and supplemental indexes, please visit the EJScreen website. PERCENTILE EJ INDEXES The EJ indexes help users screen for potential EJ concerns. To do this, the EJ index combines data on low income and people of color populations with a single environmental indicator. EJ INDEXES FOR THE SELECTED LOCATION 100 NaNNaN NaNNaN 90 80 70 66 60 50 40 30 25 20 10 0 Particulate Matter Ozone Diesel Particulate Matter 95 86 74 52 36 35 30 0 Air Toxics Cancer Risk* Air Toxics Respiratory HI* Toxic Releases To Air Traffic Proximity 77 47 Lead Paint 95 92 90 92 81 82 76 52 41 25 Superfund Proximity RMP Facility Proximity Hazardous Underground Wastewater Waste Storage Discharge Proximity Tanks State Percentile National Percentile PERCENTILE SUPPLEMENTAL INDEXES The supplemental indexes offer a different perspective on community-level vulnerability. They combine data on percent low-income, percent linguistically isolated, percent less than high school education, percent unemployed, and low life expectancy with a single environmental indicator. SUPPLEMENTAL INDEXES FOR THE SELECTED LOCATION 100 NaNNaN NaNNaN 90 80 70 70 98 97 99 97 93 91 89 87 84 75 76 60 52 53 50 48 45 40 34 34 33 30 27 22 20 10 0 Particulate Matter Ozone Diesel Particulate Matter 0 Air Toxics Cancer Risk* www.epa.gov/ejscreen Air Toxics Respiratory HI* Toxic Releases To Air Traffic Proximity Lead Paint Superfund Proximity RMP Facility Proximity Hazardous Underground Wastewater Waste Storage Discharge Proximity Tanks State Percentile National Percentile These percentiles provide perspective on how the selected block group or buffer area compares to the entire state or nation. Report for 1 mile Ring Centered at 18.240619,-66.017865 EJScreen Environmental and Socioeconomic Indicators Data SELECTED VARIABLES VALUE STATE AVERAGE PERCENTILE IN STATE USA AVERAGE PERCENTILE IN USA POLLUTION AND SOURCES Particulate Matter (g/m3) Ozone (ppb) N/A N/A N/A 8.08 N/A N/A N/A N/A 61.6 N/A Diesel Particulate Matter (g/m3) Air Toxics Cancer Risk* (lifetime risk per million) Air Toxics Respiratory HI* Toxic Releases to Air Traffic Proximity (daily traffic count/distance to road) Lead Paint (% Pre-1960 Housing) Superfund Proximity (site count/km distance) RMP Facility Proximity (facility count/km distance) Hazardous Waste Proximity (facility count/km distance) 0.0583 0.0667 64 0.261 5 20 23 0 28 3 0.2 0.19 17 0.31 4 430 4,300 27 4,600 44 250 180 76 210 80 0.11 0.16 56 0.3 37 0.084 0.15 52 0.13 60 0.14 0.47 40 0.43 41 1.9 0.76 89 1.9 73 Underground Storage Tanks (count/km2) 3.8 1.7 83 3.9 71 Wastewater Discharge (toxicity-weighted concentration/m distance) 0.00083 2.3 31 22 47 SOCIOECONOMIC INDICATORS Demographic Index Supplemental Demographic Index People of Color Low Income Unemployment Rate Limited English Speaking Households Less Than High School Education Under Age 5 Over Age 64 Low Life Expectancy 85% 83% 42 35% 97 43% 43% 43 14% 99 98% 96% 19 39% 95 72% 70% 43 31% 94 21% 15% 72 6% 96 68% 67% 45 5% 99 13% 21% 30 12% 68 4% 4% 67 6% 46 23% 22% 58 17% 77 N/A N/A% N/A 20% N/A *Diesel particulate matter, air toxics cancer risk, and air toxics respiratory hazard index are from the EPA's Air Toxics Data Update, which is the Agency's ongoing, comprehensive evaluation of air toxics in the United States. This effort aims to prioritize air toxics, emission sources, and locations of interest for further study. It is important to remember that the air toxics data presented here provide broad estimates of health risks over geographic areas of the country, not definitive risks to specific individuals or locations. Cancer risks and hazard indices from the Air Toxics Data Update are reported to one significant figure and any additional significant figures here are due to rounding. More information on the Air Toxics Data Update can be found at: https://www.epa.gov/haps/air-toxics-data-update. Sites reporting to EPA within defined area: Superfund . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 Hazardous Waste, Treatment, Storage, and Disposal Facilities . . . . . . . . . . . . . . . . . . . . . . . . . 1 Water Dischargers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Air Pollution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Brownfields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 Toxic Release Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Other community features within defined area: Schools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Hospitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Places of Worship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 Other environmental data: Air Non-attainment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No Impaired Waters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Selected location contains American Indian Reservation Lands* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No Selected location contains a "Justice40 (CEJST)" disadvantaged community . . . . . . . . . . . . . . . . . . . Yes Selected location contains an EPA IRA disadvantaged community . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Report for 1 mile Ring Centered at 18.240619,-66.017865 www.epa.gov/ejscreen EJScreen Environmental and Socioeconomic Indicators Data INDICATOR Low Life Expectancy Heart Disease Asthma Cancer Persons with Disabilities HEALTH VALUE N/A N/A N/A N/A 29.7% HEALTH INDICATORS STATE AVERAGE STATE PERCENTILE -99999900% N/A -999999 N/A -999999 N/A -999999 N/A 21.6% 86 US AVERAGE 20% 6.1 10 6.1 13.4% INDICATOR Flood Risk Wildfire Risk HEALTH VALUE N/A N/A CLIMATE INDICATORS STATE AVERAGE STATE PERCENTILE -99999900% N/A -99999900% N/A US AVERAGE 12% 14% INDICATOR Broadband Internet Lack of Health Insurance Housing Burden Transportation Access Food Desert HEALTH VALUE 21% 7% Yes No No CRITICAL SERVICE GAPS STATE AVERAGE STATE PERCENTILE 32% 31 7% 60 N/A N/A N/A N/A N/A N/A US AVERAGE 14% 9% N/A N/A N/A Footnotes Report for 1 mile Ring Centered at 18.240619,-66.017865 US PERCENTILE N/A N/A N/A N/A 98 US PERCENTILE N/A N/A US PERCENTILE 76 52 N/A N/A N/A www.epa.gov/ejscreen Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 Appendix D: Flood Zone Map Federal Emergency Management Agency (FEMA) 100 Year Flood Zones and EPA's Region 2 Composite Flood Risk Layer Facility Name: Neolpharma, Inc. - Caguas The Facility boundaries are within the 100-Year Flood Zones FEMA Layer. Status: Final 29 CEPD-RCRA-23-0433 Resource Conservation and Recovery Act Neolpharma, Inc. - Caguas PRD090378225 The Facility boundaries are within a high composite potential risk area based on EPA's Region 2 Composite Flood Risk layer. Status: Final 30 CEPD-RCRA-23-0433