Document 3Nj3L4Qnjkb6Xe9mQqLD0X2kJ

EPA REGION 2 CARIBBEAN ENVIRONMENTAL PROTECTION DIVISION June 11, 2024 Via Email with Delivery and Read Receipt Requested: Ms. Milagros Hernandez EHS&S Manager Mcneil Healthcare LLC Bo. Montones Km 19.7 Carr 183 Las Piedras, Puerto Rico, 00771 lherna53@kenvue.com RE: RCRA 3008 - NOTICE OF VIOLATION Facility Name: Mcneil Healthcare LLC EPA ID: PRD980767974 CEPD-RCRA-24-0000-3008-011 Dear Ms. Hernandez: The U.S. Environmental Protection Agency (EPA) is charged with the protection of human health and the environment under the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901 et seq. Pursuant to RCRA, as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), EPA promulgated rules, regulations, and standards governing the handling and management of hazardous waste as set forth in 40 Code of Federal Regulations (C.F.R.) Parts 260-272. For the purposes of this Notice of Violation (NOV), (see Enclosure I), the hazardous waste regulations governing the generation of hazardous waste were promulgated in 1980 and amended by HSWA in 1984. The Commonwealth of Puerto Rico is not authorized by the EPA to conduct a hazardous waste program and to enforce RCRA under Section 3006 of RCRA, 42 U.S.C. 6926. On or about March 27, 2024, a duly authorized representative of the EPA conducted a Compliance Evaluation Inspection (CEI) of Mcneil Healthcare LLC, located in Las Piedras, Puerto Rico (the "Facility"), pursuant to Section 3007 of RCRA, 42 U.S.C. 6927. As a result of the CEI, EPA representative found the Facility in violation of Sections 262.17(a)(1)(ii), 262.263(d), 262.261(e), and 262.261(f) of the RCRA Regulations. This NOV is issued pursuant to Section 3008 of the Solid Waste Disposal Act, as amended by RCRA and HSWA, 42 U.S.C. 6901 and 6928. Issuance of this NOV and compliance with its terms does not preclude EPA from taking formal enforcement action against you and/or your company, including a monetary penalty, under Section 3008 of RCRA, 42 U.S.C. 6928, or any other applicable regulation or statute. CITY VIEW PLAZA II BUILDING, 7TH FLOOR ROUTE 165 GUAYNABO, PR 00968 If you have not already done so, you must take immediate action to correct the violations described in Enclosure I. Please submit, within thirty (30) days of the receipt of this letter, a response which includes (1) a description of the actions you have taken to correct the violations noted in Enclosure I, (2) documentation that the violations have been corrected, and (3) a description of the procedures that will be put into place to prevent such violations from occurring in the future. For consistency, please provide your answers in a format which is keyed to the sections as outlined in Enclosure I to this letter. Your response to this NOV can be sent through email to the following email address caballer.rosana@epa.gov and can also be mailed to the following address: Rosana Caballer-Cruz, Enforcement Officer RCRA & Revitalization Section U.S. Environmental Protection Agency - Region 2 Caribbean Environmental Protection Division City View Plaza II, Suite 7000 #48 PR-165 km 1.2 Guaynabo, PR 00968-8069 Failure to respond in full to the above requirements may result in federal enforcement action pursuant to Section 3008 of RCRA, 42 U.S.C. 6928, including the assessment of a monetary penalty. If you have any questions regarding this matter, please contact Ms. Rosana Caballer-Cruz, from my staff, at 787977-5880 or via e-mail at caballer.rosana@epa.gov. Sincerely, Digitally signed by CARMEN CARMEN GUERRERO PEREZ GUERRERO PEREZ Date: 2024.06.11 22:07:07 -04'00' Carmen R. Guerrero Prez Director Enclosures: I. Enclosure I - Notice of Violation cc: Lorna Rodrguez, Chief Hazardous Waste Enforcement Program Puerto Rico Department of Natural & Environmental Resources 8838 Street, Km 6.3, Sector El Cinco Rio Piedras, PR 00936 lornarodriguez@drna.pr.gov cc: Rafael Lopez, Environmental Technician Mcneil Healthcare LLC Bo. Montones Km 19.7 Carr 183 Las Piedras, Puerto Rico, 00771 rafaellopezrivera@me.com 2 CEPD-RCRA-24-0000-3008-011 Magali Loperena, PSM and Safety Specialist Mcneil Healthcare LLC Bo. Montones Km 19.7 Carr 183 Las Piedras, Puerto Rico, 00771 mloperen@kenvue.com Vicmari Santiago, Senior EHS Specialist Mcneil Healthcare LLC Bo. Montones Km 19.7 Carr 183 Las Piedras, Puerto Rico, 00771 vsanti02@kenvue.com 3 CEPD-RCRA-24-0000-3008-011 EPA REGION 2 CARIBBEAN ENVIRONMENTAL PROTECTION DIVISION ENCLOSURE I - RCRA 3008 NOTICE OF VIOLATION McNeil Healthcare LLC EPA ID: PRD980767974 CEPD-RCRA-24-0000-3008-011 On or about March 27, 2024, a duly authorized representative of EPA conducted a Resource Conservation and Recovery Act (RCRA) Hazardous Waste Compliance Evaluation Inspection (CEI) of the MCNEIL HEALTHCARE LLC (the Facility) located at Bo. Montones Km 19.7 Carr 183, Las Piedras, Puerto Rico, pursuant to Section 3007 of RCRA, 42 U.S.C. 6927. As a result of the CEI, EPA has identified the following violations of the RCRA regulations. i. 40 CFR 262.17(a)(1)(ii) At the time of the inspection, the Facility failed 40 CFR 262.17(a)(1)(ii) which required "If a container holding hazardous waste is not in good condition, or if it begins to leak, the large quantity generator must immediately transfer the hazardous waste from this container to a container that is in good condition, or immediately manage the waste in some other way that complies with the conditions for exemption of this section". The Facility failed to comply with this requirement in the 90-day HWAA. At this location, three (3) 15gallon containers were observed with their lids swollen. ii. 40 CFR 262.263(d) At the time of the inspection, the Facility failed 40 CFR 262.263(d), which required "The contingency plan must be reviewed, and immediately amended, if necessary, whenever: (d) The list of emergency coordinators changes." The Facility failed to comply with this requirement. Although the facility's contingency plan provided for evaluation has available the list of emergency coordinators, the latter was not updated. This information was confirmed with the facility personnel. CITY VIEW PLAZA II BUILDING, 7TH FLOOR ROUTE 165 GUAYNABO, PR 00968 RCRA 3008 - NOTICE OF VIOLATION Mcneil Healthcare LLC EPA ID No. PRD980767974 CEPD-RCRA-24-0000-3008-011 iii. 40 CFR 262.261(e) At the time of the inspection, the Facility failed 40 CFR 262.261(e), which required "The plan must include a list of all emergency equipment at the facility (such as fire extinguishing systems, spill control equipment, communications and alarm systems (internal and external), and decontamination equipment), where this equipment is required. This list must be kept up to date. In addition, the plan must include the location and a physical description of each item on the list, and a brief outline of its capabilities". The Facility failed to comply with this requirement. Although the facility's contingency plan provided for evaluation has available the emergency equipment list available at the facility, the document was not able to provide the physical description of each item on the list and a brief outline of its capabilities. iv. 40 CFR 262.261(f) At the time of the inspection, the Facility failed 40 CFR 262.261(f), which required "The plan must include an evacuation plan for generator personnel where there is a possibility that evacuation could be necessary. This plan must describe signal(s) to be used to begin evacuation, evacuation routes, and alternate evacuation routes (in cases where the primary routes could be blocked by releases of hazardous waste or fires)." The Facility failed to comply with this requirement. Although the facility's contingency plan provided for evaluation has available the facility's evacuation plan narrative, the emergency evacuation routes, and alternate evacuation routes were not found in the document. 2 CEPD-RCRA-24-0000-3008-011