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02-2023-1210Administrative - FormalClosedFY 2023· Region 02

EPA v. Medtronic Puerto Rico, Inc.

Final Order With Penalty

Case summary

EPA Region 2 reached a settlement with Respondent involving violations of the National Emissions Standards for Hazardous Air Pollutants (NESHAPs) for: Ethylene Oxide Emissions Standards for Sterilization Facilities, 40 C.F.R. Part 63, Subpart O (NESHAP Subpart O) at a facility located at Villalba, Puerto Rico that emits ethylene oxide. EPA found that Respondent failed to submit the semi-annual excess emissions and continuous monitoring system performance report and/or summary report for the reporting periods of January 1-June 30, 2016, July 1-December 31, 2016, January 1-June 30, 2017, July 1-December 31, 2017, January 1- June 30, 2018, July 1-December 31, 2018, January 1-June 30, 2019, and July 1-December 31, 2019, in violation of 40 C.F.R. ?? 63.360 and 63.10(e)(3). Respondent corrected the violation and agreed to pay a civil penalty of $117,998.

Defendants (1)

  • Medtronic Puerto Rico, Inc.Named in complaintNamed in settlement

Facilities (1)

  • MEDTRONIC MEDREL

    CARR. 149 KM. 56, VILLALBA, PR, 00766

    Registry ID: 110007805107

Statutes cited

  • CAA 112Hazardous Air Pollutants

Enforcement conclusions (1)

  • Medtronic Puerto Rico, Inc.entered 2023-04-13

    Primary law: CAA

    Federal penalty: $117,998

Timeline (5 milestones)

  • 2023-04-13Complaint Filed/Proposed Order
  • 2023-04-13Final Order Issued
  • 2023-04-13Air Resolved
  • 2023-04-13Enforcement Action Closed
  • 2023-05-15Enforcement Action Data Entered

Case metadata

EPA activity ID
3603598903
Case number
02-2023-1210
Lead agency
EPA
EPA region
02
Voluntary self-disclosure
No
Primary statute
Hazardous Air Pollutants

Sourced verbatim from EPA ECHO Enforcement Case Report for case 02-2023-1210 . 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.