Document baGrpVG8k3XL6JBYKgw4OEvLo

EPA REGION 2 CARIBBEAN ENVIRONMENTAL PROTECTION DIVISION February 5, 2024 VIA ELECTRONIC MAIL Ms. Wanda Marrero EHS1 Manager at San Lorenzo Facility Ethicon LLC Carr. #183 Km. 8.3 Hato Industrial San Lorenzo, Puerto Rico, 00754 wmarrer2@its.jnj.com lrodr274@its.jnj.com creyes35@its.jnj.com RE: RCRA 3008 - NOTICE OF VIOLATION Facility Name: Ethicon LLC EPA ID: PRD982542219 CEPD-RCRA-24-0000-3008-007 Dear Ms. Marrero: 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), 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 November 29, 2023, a duly authorized representative of the EPA conducted a Compliance Evaluation Inspection (CEI) of Ethicon LLC, located in San Lorenzo, 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 262.42(a)(2) and 262.261(f) of the RCRA Regulations. CITY VIEW PLAZA II BUILDING, 7TH FLOOR ROUTE 165 GUAYNABO, PR 00968 This Notice of Violation (Enclosure I) 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. 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 Response and Remediation Branch 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, HECTOR Digitally signed by HECTOR VELEZ-CRUZ VELEZ-CRUZ 12:57:51 -04'00' Date: 2024.02.05 Hctor L. Vlez Cruz, Esq, Acting 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 CEPD-RCRA-24-0000-3008-007