Document 4vEMXm7yQgbE554Z8w94onzb1

Report Prepared by: Report Approved by: RCRA COMPLIANCE EVALUATION INSPECTION Medisca Inc. 661 Route 3 Plattsburgh, New York NYR000128934 July 17, 2024 ROBERT Digitally signed by ROBERT MORRELL _M_O__R_R__E_L_L________D_at_e:_20_24_.0_9._05_1_6:_23_:0_8 -_04_'0_0' Robert Morrell, Geologist Monitoring Operations Section Date: ________________ Digitally signed by PHILIP PHILIP COCUZZA COCUZZA _________________D_at_e:_20_2_4.0_9_.10_0_6:_54_:4_7 _-0_4'0_0' Philip Cocuzza, Supervisor Monitoring Operations Section Date: ________________ Medisca Inc. NYR000128934 Inspection Date: July 17, 2024 Page 2 of 6 Medisca Inc. NYR000128934 Inspection Date: July 17, 2024 Objective A RCRA Compliance Evaluation Inspection (CEI) was conducted at Medisca Incorporated on July 17, 2024. The purpose of the inspection was to obtain information on the facility's hazardous waste management program. This information will be used to determine compliance with regulations pertaining to the Resource Conservation and Recovery Act (RCRA). Survey Participants Medisca Incorporated Benjamin Arts, Quality Manager barts@medisca.com, 518-563-4636 Sean Martin, Quality Investigator smartin@medisca.com, 518-563-4636 U.S. Environmental Protection Agency Robert Morrell, Geologist morrell.robert@epa.gov, 732-906-6804 Molly Hillenbrand, Life Scientist Hillenbrand.molly@epa.gov, 732-321-4452 Facility Description Medisca is located at 661 Route 3 in Plattsburgh, New York. The facility is a bulk repackager of pharmaceutical compounds. The company has been operating at this location since 1992. The 12,000 square-foot facility conducts its business operations from 7:00 am to 7:00 pm, five days per week. There are 65 employees that work on one of two teams. The production team works a 7:00 am to 3:30 pm shift, and the shipping team works a 10:00 am to 7:00 pm shift. Bulk pharmaceutical compounds arrive at the receiving area in containers that range in size from 1 kilogram to 50 kilograms. A quality check is performed here. Each container is tested for U.S. pharmaceutical standards and European pharmaceutical standards. Once approved, each container is transferred to one of six laboratories. In the laboratory, the contents of the bulk container are transferred to smaller containers ranging in size from 1 mg to 50 kilograms. Employees wear fully encapsulated suits with supplied air during the repackaging process. There are approximately 200 different pharmaceutical compounds, consisting of powders or liquids, that are repackaged at this facility. After the repackaging is completed, the smaller packages are conveyed to the shipping area, where the packages are prepared for shipping to the compound pharmacies. Page 3 of 6 Medisca Inc. NYR000128934 Inspection Date: July 17, 2024 Water and Wastewater Water for the facility is provided by the Town of Plattsburgh. Sanitary wastewater is discharged to the local POTW. There is no process wastewater discharged from the facility. Solid and Hazardous Waste Management Leftover, expired, or non-usable products are transferred to the Rejection Cage. The product containers can range in size from 1 gram to 500 grams for powders, and 1 milliliter to 4 liters for liquids. The containers are placed in separate bins on shelves according to their hazard class. For example, containers with flammable liquids are segregated from containers with corrosive liquids. A rejection log is maintained for all containers in the cage. Approximately every four months, a hazardous waste pickup is scheduled with Advanced Waste Solutions of Lockport, New York. The containers are placed in 55-gallon lab pack containers according to their EPA hazardous waste numbers. The hazardous waste labels, DOT shipping labels, and hazardous waste manifests are prepared by Advanced Waste Solutions personnel. Most of the hazardous waste lab pack containers are D001 (ignitable) hazardous waste and D002 (corrosive) hazardous waste. The hazardous waste lab pack containers are shipped to one of two treatment, storage, and disposal facilities (TSDFs): EQ Detroit in Detroit, Michigan, or Spring Grove Resource Recovery in Cincinnati, Ohio. Containers of non-hazardous raw products are shipped to American Recyclers Company in Tonawanda, New York. Observations A review of the hazardous waste manifests indicates that Medisca is a small quantity generator of hazardous waste. In the last 12 months, the facility generated 3802 pounds of hazardous waste. The most recent shipment of hazardous waste was on April 17, 2024. The facility maintains daily inspection logs of the containers in the Rejection Cage. Hazardous materials safety training is provided annually to employees that handle hazardous materials. DOT/IATA training is provided for employees in the shipping department. Hazardous waste determinations are based on generator knowledge, safety data sheets, and product literature. Findings There were no violations or compliance issues found on the day of the inspection. Page 4 of 6 Medisca Inc. NYR000128934 Attachments Photograph #1 Inspection Date: July 17, 2024 Page 5 of 6 Medisca Inc. NYR000128934 Photo #1: View of the Rejection Cage. Inspection Date: July 17, 2024 Page 6 of 6