Document EvYGrNM36K2pqMbpZvbnn99O4

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 5 77 WEST JACKSON BOULEVARD CHICAGO, ILLINOIS 60604 SUBJECT: FROM: THRU: TO: CLEAN AIR ACT INSPECTION REPORT Regis Technologies Inc., Morton Grove, Illinois Natalia Vazquez, Environmental Engineer AECAB (MI/WI) Sarah Marshall, Section Supervisor AECAB (MI/WI) File BASIC INFORMATION Facility Name: Regis Technologies, Inc. Facility Location: 8210 N Austin Avenue, Morton Grove, Illinois, 60053 Date of Inspection: March 23, 2023 EPA Inspector(s): 1. Natalia Vazquez, Environmental Engineer 2. Patrick Miller, Environmental Engineer Other Attendees: 1. Ron Pilli, Director of Engineering 2. Charvi Payghode, EHS Manager Contact Email Address: charvi.payghode@registech.com Purpose of Inspection: applicability of 40 C.F.R. Part 68 Facility Type: pharmaceutical manufacturing Regulations Central to Inspection: 40 C.F.R. Part 68 Arrival Time: 8:45 a.m. Departure Time: 10:00 a.m. Inspection Type: Unannounced Inspection Announced Inspection OPENING CONFERENCE Presented Credentials Stated authority and purpose of inspection Provided Small Business Resource Information Sheet Provided CBI warning to facility The following information was obtained verbally from Ron Pilli and Charvi Payghode unless otherwise noted. Process Description: Regis Technologies, Inc. (Regis) is a contract-based pharmaceutical manufacturing facility. Regis manufactures ingredients for other pharmaceutical manufacturing facilities. The Facility uses, handles and stores chloroform as part of one of its contract projects. Chloroform is used as a solvent in the production of an active ingredient for one of its customers. Regis stores around 30 to 40 55-gallon drums of chloroform. Staff Interview: The Facility has 100 employees. There are two shifts Monday through Friday, and one 12-hour shift Saturday and Sunday. The Facility has been in operation since 1972. Chloroform total quantity on site varies depending on customer's needs. It increases when its customer is planning a future shutdown. At the time of the inspection there were about 41 55-gallon drums of chloroform on site. Each batch uses about six to seven chloroform drums. Regis is regulated by the U.S. Food and Drug Administration. Each batch has an accompanying batch record. The batch record includes safety measures related to the chemical compounds used and a step-by-step description of the process. Regis has a warehouse where new inventory is stationed until is tested by quality control, a flammable room where it keeps class 1B and 1C solvents and a hazardous waste area. The flammable room includes an exhaust system and spill containment. Hazardous waste is picked up on Tuesdays. The clean rooms where different customer's products are produced have exhaust systems. In the past the Facility has taken samples to verify that employee exposure levels are below exposure thresholds within the clean rooms. The Facility stated that it follows National Fire Protection Association codes. Regis has a spill plan used for spills of chemicals such as chloroform. The Facility has about five or six employees that are trained to handle chemical spills on site. Page 2 of 4 Approximately three employees on the first weekday shift, two employees on the second weekday shift and one employee on the weekend shift. Regis also has an emergency action plan. Emergencies are communicated through a cellphone tree. All Regis employees are allowed to have their cellphones in the work areas. There is a fire alarm throughout the Facility. The Facility has showers and eyewash stations. TOUR INFORMATION EPA Tour of the Facility: Yes Data Collected and Observations: The Facility had about 35 chloroform drums in its warehouse and about six drums in its flammable room. The chloroform was behind a gate in the warehouse. There were showers and eyewash stations in the hallways of its manufacturing area. Photos and/or Videos: were not taken during the inspection. Field Measurements: were not taken during this inspection. CLOSING CONFERENCE Provided U.S. EPA point of contact to the facility Requested documents: 1. Safety data sheets for chloroform; 2. Current onsite inventory in pounds of chloroform; 3. Yearly usage of chloroform for the past 5 years; 4. A list of chemicals used, handled or stored on site that appear in Table 1 and Table 3 in 40 C.F.R. Part 68 (https://www.ecfr.gov/current/title-40/chapter-I/subchapter-C/part-68), its yearly usage for the past 5 years, current onsite inventory in pounds; 5. Spill Plan; 6. Emergency Action Plan; and 7. The safety section of the batch records for chloroform and any chemical listed as part of request no. 3. DIGITAL SIGNATURES NATALIA Digitally signed by NATALIA VAZQUEZ RIVERA Report Author: _V_A_Z_Q__U_E_Z__R_I_V_E_R_A__D_a_te_: 2_02_3._03_.2_3 _15_:2_2:0_1_-0_5'_00_' Page 3 of 4 Section Supervisor: SARAH Digitally signed by SARAH MARSHALL _M_A__R_S__H_A_L__L_______D_ate_: _20_23_.0_3._23_1_5:_43_:5_3 -_05_'0_0'_ Page 4 of 4