EPA v. SIGMPHARM LABORATORIES LLC

Case summary

On May 3, 2023, EPA entered into an Expedited Settlement Agreement (ESA) with Sigmapharm Laboratories LLC for violations of RCRA Subtitle C (Hazardous Waste Program). Theranostix manufactures generic pharmaceuticals and performs research and development. The compliance issues addressed in the ESA involve operating a hazardous waste storage facility without a permit or valid exemption to the permitting requirements by failing to label or mark containers both in the hazardous waste and satellite accumulation areas with the words ?Hazardous Waste?. Containers were also observed to be open while being stored in these areas. The other violations were failing ot ensure ?Excluded Solvent-Contaminated Wipes? were free of liquid before discarding, failing to maintain a manifest form signed by the designated facility, Failure to specify locations of emergency spill equipment and evacuation routes in the contingency plan, failure to train two employees, and failure to manage universal waste lamps and batteries.. The company has agreed to pay a civil penalty of $11,250 and has corrected the violations cited in the ESA.

Defendants (1)

• SIGMPHARM LABORATORIES LLCNamed in complaintNamed in settlement

Facilities (2)

• SIGMPHARM LABORATORIES LLC

  3375 PROGRESS DR, BENSALEM, PA, 19020

  Registry ID: 110060129855

• SIGMPHARM LABORATORIES LLC

  3375 PROGRESS DRIVE, BENSALEM, PA, 19020

  Registry ID: 110060129855

Statutes cited

• RCRA 3002 — Standards Applicable to Generators of Hazardous Waste

Enforcement conclusions (1)

• SIGMPHARM LABORATORIES LLCentered 2023-05-03

  Primary law: RCRA

  Federal penalty: $11,250

Timeline (4 milestones)

• 2023-05-03Complaint Filed/Proposed Order
• 2023-05-03Final Order Issued
• 2023-05-08Enforcement Action Closed
• 2023-06-15Enforcement Action Data Entered