Document B8nXpNVDkVjO1k1kV1jX7zRok

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: nvalles@aliviahealth.com August 10, 2023 Farmacias Plaza/Alivia Home Delivery Alivia Health Network 18 Calle Diana, Guaynabo, Puerto Rico C/O: Ms. Nabila Valls RE: RCRA 3007 - REQUEST FOR INFORMATION Farmacias Plaza #4 EPA ID: PRN008031015 CEPD-RCRA-23-3007-0000-007 Farmacias Plaza #2 EPA ID: PRN008031031 CEPD-RCRA-23-3007-0000-007 Dear Ms. Valls: The U.S. Environmental Protection Agency (EPA) is charged with the protection of human health and the environment under Section 3008 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (RCRA) of 1976 and the Hazardous and Solid Waste Amendments (HWSA) of 1984, 42 U.S.C. 6901, 6928. This request for information is made pursuant to the provisions of 3007 of RCRA, 42 U.S.C. 6927, which requires that you provide the information requested in Enclosure I to this letter using the instructions and definitions included in Enclosure II. This information is required to evaluate the full regulatory and compliance status of the facility. The information requested in Enclosure I must be submitted no later than thirty (30) calendar days from receipt of this letter. Requests for additional time to provide the information requested in Enclosure I must be justified and must be made in writing within ten (10) calendar days of receipt of this letter. The response must be signed by a responsible official or agent of your facility, using the form in Enclosure III to this letter. Failure to respond to this letter truthfully and accurately within the time provided may subject you to sanctions authorized by federal law, including but not limited to a potential enforcement action pursuant to Section 3008 of RCRA, 42 U.S.C. 6928, including the assessment of a monetary penalty. Please also note that all information you provide may be used in an administrative, civil judicial or criminal Internet Address (URL) http://www.epa.gov RCRA 3007 REQUEST FOR INFORMATION Farmacias Plaza #4 (PRN008031015) Farmacias Plaza #2 (PRN008031031) CEPD-RCRA-23-3007-0000-007 action. This information is not subject to the requirements of the Paperwork Reduction Act as amended, 44 U.S.C. 3501 et seq. You may, if you desire, assert a business confidentiality claim covering all or part of the information herein requested. This claim may be asserted by placing on (or attaching to) the information at the time it is submitted, a cover sheet, stamped or typed legend, or other suitable form of notice employing language such as "trade secret", "proprietary", or "company confidential". The claim should set forth the information requested in 40 C.F.R. 2.204(e)(4). Information covered by such a claim will be disclosed by EPA only to the extent permitted by, and by means of procedures set forth in 40 C.F.R. Part 2. EPA will review the information to determine the extent of confidentiality of the information, and may, at its discretion challenge the confidentiality claim pursuant the procedures set forth at 40 C.F.R. Part 2. If no such claim accompanies the information when it is received by EPA, it may be available to the public by EPA without further notice you. The responses to the information request in Enclosure I must be provided by email or 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, Puerto Rico 00968 Email: caballer.rosana@epa.gov If you have any questions regarding this matter, please contact Rosana Caballer-Cruz, from my staff, at 787-977-5880 or via e-mail at caballer.rosana@epa.gov. Sincerely yours, CARMEN GUERRERO PEREZ Digitally signed by CARMEN GUERRERO PEREZ Date: 2023.08.10 12:12:50 -04'00' Carmen R. Guerrero Prez, Director Caribbean Environmental Protection Division Enclosures: cc: Ms. Lorna Rodrguez, RCRA Enforcement Section Chief Puerto Rico Dept. Natural & Environmental Resources CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2) 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 3007 Request for Information Farmacias Plaza #4 EPA ID No. PRN008031015 Farmacias Plaza #2 EPA ID No. PRN008031031 On or about February 9, 2023, a duly authorized representative of EPA conducted a RCRA Hazardous Waste Compliance Evaluation Inspection of the Farmacias Plaza #4 (PLAZA #4) at RIVERVIEW II BLOQUE L2 CALLE 10 - BAYAMON, PUERTO RICO, pursuant to Section 3007 of RCRA, 42 U.S.C. 6927. On or about March 2, 2023, a duly authorized representative of EPA conducted a RCRA Hazardous Waste Compliance Evaluation Inspection of the Farmacias Plaza #2 (PLAZA #2) at MARGINAL D-32 EXT FORREST HILLS - BAYAMON, PUERTO RICO, pursuant to Section 3007 of RCRA, 42 U.S.C. 6927. Based on the information obtained during both inspections, EPA determined that the following information is required to determine the compliance status of PLAZA #4 and PLAZA #2, respectively. 1. General Information a. Provide the full legal name of PLAZA #4 and PLAZA #2, respectively. If the company has used any other names, please provide them. b. Provide the management structure of the company (President/Owner, Partners, General Manager, etc.). If the company is a subsidiary, indicate the parent company. c. Provide the type of company (corporation, partnership, etc.), employer identification number, Department of State certificate number, DUNS number, and business licenses, if any. d. Besides the EPA inspection performed on February 9, 2023, and March 2, 2023, respectively, please provide information about any other inspection conducted by any other state or federal agency, since 2019-2023. e. Do you have any knowledge of any state or federal agency (EPA, Department of Justice, Puerto Rico Department of Natural and Environmental Resources, etc.) actions (complaints, suits, investigations, etc.) against PLAZA #4 and PLAZA #2, respectively? If yes, explain and elaborate your answers. CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2) RCRA 3007 REQUEST FOR INFORMATION Farmacias Plaza #4 (PRN008031015) Farmacias Plaza #2 (PRN008031031) CEPD-RCRA-23-3007-0000-007 f. Please certify if PLAZA #4 and PLAZA #2 have filed for bankruptcy at any time under their current or any previous name. 2. Specific Information a. Non-notifier i. Those facilities identified as Non-notifiers, such as PLAZA #4 and PLAZA #2, respectively, are facilities that EPA has a reason to believe that is a generator of hazardous waste, based on EPA's review of eManifests(s). As generators of hazardous waste, PLAZA #4, and PLAZA #2, are subject to Sections 3002 and 3010 of RCRA, 42 U.S.C. 6922 and 6930, and the regulations set forth at 40 C.F.R. Parts 262 and/or 270, or the authorized State equivalent. ii. On August 21st, 2019, the final rule, Hazardous Waste Pharmaceuticals, was effective. Part 266 subpart P only applies to the management of hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. The Regulation citation of Subpart P - Hazardous Waste Pharmaceuticals can be found at 40 CFR part 266 subpart P: healthcare facilities and reverse distributors. Here, 40 CFR 266.500(2) defines Healthcare facility as "means any person that is lawfully authorized to Distribute, sell, or dispense pharmaceuticals, including over-thecounter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This definition includes but is not limited to... pharmacies..." The rule also established that "healthcare facilities that generate above VSQGs amounts of hazardous waste (i.e., SQG or LQG) must manage their hazardous waste pharmaceuticals under 40 CFR part 266 subpart P. Healthcare facilities that generate VSQG amounts of hazardous waste are subject to the hazardous waste generator regulations for VSQGs in 40 CFR section 262.14, as well as three sections of part 266 subpart P: 40 CFR section 266.505, 266.507, and 266.504", respectively, in order to comply with Hazardous waste pharmaceutical requirements. PLAZA #4 and PLAZA #2 fulfill the definition of a healthcare facility; hence, the facility is subject to the Subpart P - Hazardous Waste Pharmaceuticals rule. b. Waste Generation i. Please describe and provide information related to how PLAZA #4 properly evaluated their hazardous waste generation at the facility. ii. PLAZA #4 has to identify and establish if their generation of hazardous waste is above VSQG amounts of or if they are currently generating VSQG amounts of hazardous waste in order to comply with the Subpart P - Hazardous Waste Pharmaceuticals 266.500 - SUBPART P - HAZARDOUS WASTE PHARMACEUTICALS. Please describe and provide information related to how PLAZA #4 properly established its generation of hazardous waste in order to identify its generation classification. CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2) RCRA 3007 REQUEST FOR INFORMATION Farmacias Plaza #4 (PRN008031015) Farmacias Plaza #2 (PRN008031031) CEPD-RCRA-23-3007-0000-007 iii. As a healthcare facility, PLAZA #4 must notify the EPA Regional Administrator, using the Site Identification Form (EPA Form 8700-12), that it is a healthcare facility operating under this subpart. At a minimum, EPA has reason to believe that PLAZA #4 failed to comply with RCRA notification requirements set forth in Subpart P - Hazardous Waste Pharmaceuticals. Please provide documentation nor evidence that the mentioned notification was, indeed, submitted to the EPA Regional Administrator. In case the mentioned notification was not done, please explain the reason for not conducting such notification. iv. Please describe and provide information related to how PLAZA #2 properly evaluated their hazardous waste generation at the facility. v. PLAZA #2 has to identify and establish if their generation of hazardous waste is above VSQG amounts of or if they are currently generating VSQG amounts of hazardous waste in order to comply with the Subpart P - Hazardous Waste Pharmaceuticals 266.500 - SUBPART P - HAZARDOUS WASTE PHARMACEUTICALS. Please describe and provide information related to how PLAZA #2 properly established its generation of hazardous waste in order to identify its generation classification. vi. As a healthcare facility, PLAZA #2 must notify the EPA Regional Administrator, using the Site Identification Form (EPA Form 8700-12), that it is a healthcare facility operating under this subpart. At a minimum, EPA has reason to believe that PLAZA #2 failed to comply with RCRA notification requirements set forth in Subpart P - Hazardous Waste Pharmaceuticals. Please provide documentation nor evidence that the mentioned notification was, indeed, submitted to the EPA Regional Administrator. In case the mentioned notification was not done, please explain the reason for not conducting such notification. CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2) RCRA 3007 REQUEST FOR INFORMATION Farmacias Plaza #4 (PRN008031015) Farmacias Plaza #2 (PRN008031031) CEPD-RCRA-23-3007-0000-007 ENCLOSURE II - Instructions and Definitions In responding to this Request for Information, apply the following instructions and definitions: 1. The signatory should be an officer or agent who is authorized to respond on behalf of the company or facility. The signatory must complete and return the attached Certification of Answers to Responses (ENCLOSURE III). 2. A complete response must be made to each individual question in this Request for Information. Identify each answer with the number of the question to which it is addressed. 3. In preparing your response to each question, consult with all present and former employees and agents of the company or facility who you have reason to believe may be familiar with the matter to which the question pertains. 4. In answering each question, identify all contributing sources of information. 5. If you are unable to answer a question in a detailed and complete manner or if you are unable to provide any of the information or documents requested, indicate the reason for your inability to do so. If you have reason to believe that there is an individual who may be able to provide more detail or documentation in response to any question, state that person's name and last known address and phone number and the reasons for your belief. 6. If you cannot provide a precise answer to any violation, please approximate and state the reason for your inability to be specific. 7. For each document produced in response to this Request for Information, indicate on the document or in some other reasonable manner, the number of the question to which it applies. 8. If anything is deleted from a document produced in response to this Request for Information, state the reason for and the subject matter of the deletion. 9. If a document is requested but is not available, state the reason for its unavailability. In addition, identify any such document by author, date, subject matter, number of pages, and all recipients and their addresses. 10. The company and/or facilities for the purposes of this Request for Information are Farmacias Plaza #4, at RIVERVIEW II BLOQUE L2 CALLE 10 - BAYAMON, PUERTO RICO, and Farmacias Plaza #2, at MARGINAL D-32 EXT FORREST HILLS - BAYAMON, PUERTO RICO. 11. A generator of hazardous waste for the purposes of this Request for Information shall be defined as any person (which includes this facility), by site, whose act or process produces hazardous waste or whose act first causes a hazardous waste to become subject to regulation. 12. Solid waste shall be defined for the purposes of this Request for Information as that term is defined in Section 1004(27) of RCRA, as amended, 42 U.S.C. Part 6903(27). CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2) RCRA 3007 REQUEST FOR INFORMATION Farmacias Plaza #4 (PRN008031015) Farmacias Plaza #2 (PRN008031031) CEPD-RCRA-23-3007-0000-007 13. Hazardous waste shall be defined for the purposes of this Request for Information as that term is defined in Section 1004(5) of RCRA, as amended, 42 U.S.C. Part 6903(5). 14. Manage shall be defined for the purposes of this Request for Information as to market, generate, treat, store, dispose, or otherwise handle. 15. Used oil shall be defined for the purposes of this Request for Information as any oil that has been refined from crude oil, or any synthetic oil, that has been used and as a result of such use is contaminated by physical or chemical impurities. CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2) RCRA 3007 REQUEST FOR INFORMATION Farmacias Plaza #4 (PRN008031015) Farmacias Plaza #2 (PRN008031031) CEPD-RCRA-23-3007-0000-007 ENCLOSURE III - Certification of Answers to Responses I certify, under penalty of law, that I have personally examined and am familiar with the information submitted in this document (response to EPA Request for Information CEPD-RCRA-23-3007-0000007) and all documents submitted herewith, that the submitted information is true, accurate, and complete, and that all documents submitted herewith are complete and authentic unless otherwise indicated. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment. Name (Print or Type) Title (Print or Type) Signature Date (Print or Type) FARMACIAS PLAZA #4 EPA ID: PRN008031015 FARMACIAS PLAZA #2 EPA ID: PRN008031031 CEPD-RCRA-23-0429 (Farmacias Plaza #4) CEPD-RCRA-23-0430 (Farmacias Plaza #2)