Document YjeXekp2gGRvKwxQraE0RXbVO

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 2 CARIBBEAN ENVIRONMENTAL PROTECTION DIVISION CITY VIEW PLAZA II BUILDING, 7TH FLOOR ROUTE 165 GUAYNABO, PUERTO RICO 00968 SENT VIA EMAIL: faustino_cintron@baxter.com; carlos_r_torres@baxter.com; julia_vazquez@baxter.com; diana_santiago@baxter.com; erick_rocher@baxter.com Baxter Healthcare of Puerto Rico-Guayama RD 3 KM 144.2 GUAYAMA, PUERTO RICO 00785 C/O: Mr. Faustino Cintrn RE: RCRA 3008 - NOTICE OF VIOLATION Baxter Healthcare of Puerto Rico-Guayama EPA ID: PRD000692525 CEPD-RCRA-23-0000-3008-011 Dear Mr. Faustino Cintrn 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 June 1st, 2023, a duly authorized representative of the EPA conducted a Compliance Evaluation Inspection (CEI) of Baxter Healthcare of Puerto Rico, located in Guayama, 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 40 CFR 262.17(a)(1)(vii)(C), 40 CFR 262.261(d), 40 CFR 262.261(f), and 40 CFR 262.262(b), of the RCRA Regulations. 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. Internet Address (URL) http://www.epa.gov CEPD-RCRA-10-0162 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 send 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, Carmen R. Guerrero-Prez, Director Enclosures: Enclosure I - Notice of Violation cc: Ms. Lorna Rodrguez, RCRA Enforcement Section Chief Puerto Rico Dept. Natural & Environmental Resources CEPD-RCRA-10-0162 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 2 CARIBBEAN ENVIRONMENTAL PROTECTION DIVISION CITY VIEW PLAZA II BUILDING, 7TH FLOOR ROUTE 165 GUAYNABO, PUERTO RICO 00968 ENCLOSURE I - RCRA 3008 NOTICE OF VIOLATION Baxter Healthcare of Puerto Rico-Guayama EPA ID: PRD000692525 CEPD-RCRA-23-0000-3008-011 On or about June 1st, 2023, a duly authorized representative of EPA conducted a Resource Conservation and Recovery Act (RCRA) Hazardous Waste Compliance Evaluation Inspection (CEI) of the BAXTER HEALTHCARE OF PUERTO RICO (BAXTER) located at RD 3 KM 144.2, GUAYAMA, 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)(vii)(C) At the time of the inspection, BAXTER failed 262.17(a)(1)(vii)(C) which required "A container holding a hazardous waste that is incompatible with any waste or other materials accumulated or stored nearby in other containers, piles, open tanks, or surface impoundments must be separated from the other materials or protected from them by means of a dike, berm, wall, or other device." The facility failed to comply with this requirement in the 90-day Hazardous Waste Accumulation Area (HWAA). In the Flammables Subarea, corrosive containers were observed between flammables containers. Hence, the facility representatives did not separate the corrosive containers from the flammable containers. ii. 40 CFR 262.261(d) At the time of the inspection, BAXTER failed 262.261(d) which required "The plan must list names and emergency telephone numbers of all persons qualified to act as emergency coordinator (see 262.264), and this list must be kept up to date..." The facility failed to comply with this requirement. During the documents review section, one of the facility's emergency response phone numbers was not up to date. iii. 40 CFR 262.261(f) At the time of the inspection, BAXTER failed 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 Internet Address (URL) http://www.epa.gov RCRA 3008 - NOTICE OF VIOLATION Baxter Healthcare of Puerto Rico-Guayama EPA ID No. PRD000692525 CEPD-RCRA-23-0000-3008-011 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. Evacuation routes, and alternate evacuation routes were not available in the document evaluated. iv. 40 CFR 262.262(b) At the time of the inspection, BAXTER failed 262.262(b) which required "A large quantity generator that first becomes subject to these provisions after May 30, 2017 or a large quantity generator that is otherwise amending its contingency plan must at that time submit a quick reference guide of the contingency plan to the local emergency responders identified at paragraph (a) of this section or, as appropriate, the Local Emergency Planning Committee..." The facility failed to comply with this requirement. As discussed during the documents review section, the quick reference guide needs to be reviewed, in order to comply with the regulation requirements. CEPD-RCRA-10-0162