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08-2021-0003Administrative - FormalClosedFY 2021· Region 08

EPA v. Tolmar

Final Order No Penalty

Case summary

On October 8, 2020, NPDES Enforcement finalized an administrative order on consent (AOC) with Tolmar to resolve the facility?s violations of the pretreatment regulations. On April 14, 2020, NPDES Enforcement sent a Letter of Violation (LOV) to Tolmar outlining the facility?s violations. Violations cited in the AOC and outlined in the LOV were identified during an EPA inspection conducted 12/13/2019 and include the following: ? Exceedances of the facility?s acetone monthly average limit of 8.2 milligrams per liter (mg/L); and ? Failure to notify and resample within 24 hours of becoming aware of acetone exceedances. Tolmar is a pharmaceutical manufacturer of dermatological and injectable products. Wastewater discharges from Tolmar to the City of Windsor?s collection and treatment system are subject to New Source Pretreatment Standards (NSPS) for Pharmaceutical Manufacturing in 40 C.F.R. ? 439.47. EPA directly implements the pretreatment regulations in Colorado and serves as the control authority for Tolmar because Windsor does not have an approved pretreatment program. The AOC requires Tolmar to submit to the EPA a comprehensive written plan and schedule for achieving compliance with the monthly average acetone limitation. The AOC also requires Tolmar to submit quarterly reports to the EPA describing the actions it has taken to comply with the terms of the AOC. These reports should include, at a minimum, a detailed update on the progress of the compliance plan, including a description of activities completed, milestones met during the reporting period, potential setbacks, new information which may result in changes to the compliance plan or schedule, and those activities scheduled for the next reporting period. The quarterly reports shall also describe the disposal method and include a copy of the manifest(s) for any wastewater disposed offsite during the quarter. The AOC also requires Tolmar to notify the EPA within 24 hours of becoming aware of any acetone effluent violations, and to submit analytical results of re-sampling to the EPA within 30 days of becoming aware of the acetone effluent violation.

Defendants (1)

  • Tolmar, Inc.Named in complaintNamed in settlement

Facilities (1)

  • TOLMAR INC. - WINDSOR FACILITY

    1201 CORNERSTONE DR, WINDSOR, CO, 80550

    Registry ID: 110064520308

Statutes cited

  • CWA 301/402NPDES Permit Violations

Enforcement conclusions (1)

  • Tolmarentered 2020-10-08

    Primary law: CWA

Timeline (4 milestones)

  • 2020-10-08Final Order Issued
  • 2020-10-30Enforcement Action Data Entered
  • 2021-11-17NPDES Closed
  • 2021-11-17Enforcement Action Closed

Case metadata

EPA activity ID
3602321876
Case number
08-2021-0003
Lead agency
EPA
EPA region
08
Voluntary self-disclosure
No
Primary statute
NPDES Permit Violations

Sourced verbatim from EPA ECHO Enforcement Case Report for case 08-2021-0003 . Bulk data: ICIS-FEC download summary.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.