EPA v. REGIS TECHNOLOGIES INC - 112R7 ACO

Case summary

Regis Technologies Inc. operates a process that uses chloroform as part of its pharmaceutical manufacturing operations. On March 23, 2023, EPA inspectors observed chloroform being stored on site above the CAPP threshold amount of 20,000 pounds. Based on data provided by Regis, the Facility violated the CAPP by handling and storing chloroform above the CAPP threshold of 20,000 pounds on 87 days between February 4, 2019, and August 16, 2023. 40 C.F.R. ? 68.10(a) provides, in part, that the owner or operator of a stationary source that has more than a threshold quantity of a regulated substance in a process, as determined under 40 C.F.R. ? 68.115, shall comply with the requirements of the CAPP, 40 C.F.R. Part 68, Subparts A to H, no later than the date on which a regulated substance is first present above a threshold quantity in a process. Pursuant to 40 C.F.R. ? 68.12(a), the owner or operator of a stationary source subject to the requirements of the CAPP is required to submit an RMP to EPA, as provided in 40 C.F.R. ? 68.150. The RMP documents compliance with the CAPP in a summary format and, for a Program 3 process such as the covered process at the Facility, must document compliance with the elements of the Program 3 Risk Management Program including, but not limited to: 40 C.F.R. Part 68.12 (General Requirements); 40 C.F.R. Part 68.15 (Management Requirements); 40 C.F.R. Part 68.20 through 68.42 (Hazard Assessment); 40 C.F.R. Part 68.65 through 68.87 (Program 3 Prevention Program); and 40 C.F.R. Part 68.90 to 96 (Emergency Response Program). EPA Region 5 (R5) found that for Regis Technologies Inc. violated 40 CFR Part 68 Chemical Accident Prevention Provisions (CAPP) by failing to submit a Risk Management Plan for periods when chloroform was present above the RMP threshold of 20,000 pounds, and by failing to analyze and report a worst-case release scenario. This ACO requires Regis Technologies Inc. to update their inventory standard operating procedure to monitor regulated substances under the CAPP and write a safety program that follows Guidelines for Process Safety in Outsourced Manufacturing Operations, and addresses the violations set forth in the FOV issued to Regis Technologies Inc. on July 9, 2024.

Defendants (1)

• REGIS TECHNOLOGIES INCNamed in complaintNamed in settlement

Facilities (1)

• REGIS TECHNOLOGIES INC

  8210 AUSTIN AVE, MORTON GROVE, IL, 60053-3205

  Registry ID: 110000429661

Statutes cited

• CAA 112[R][7] — Prevention of Accidental Release/Risk Management Plans (RMPs)

Enforcement conclusions (1)

• REGIS TECHNOLOGIES INC - 112R7 ACOentered 2026-07-01

  Primary law: CAA

Timeline (2 milestones)

• 2026-07-01Final Order Issued
• 2026-07-17Enforcement Action Data Entered