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01-2003-0124JudicialConcludedFY 2003· Region 01

EPA v. COSMED GROUP INC (NC) (Lead)

Final Order With Penalty

Case summary

REGION 1 IS THE LEAD REGION IN THIS CIVIL JUDICIAL ACTION AGAINST COSMED GROUP INC., HEADQUARTERED IN COVENTRY, RI. EPA REGIONS 1, 2, 3, 5, 6, AND 9 ARE INVOLVED IN THE CASE WHICH ALLEGES VIOLATIONS BY COSMED OF CLEAN AIR ACT MACT STANDARDS PERTAINING TO ETHYLENE OXIDE (EtO) STERILIZATION FACILITIES. 40 C.F.R. PART 63 SUBPART O. THE ALLEGATIONS COVER SIX OF COSMED'S EIGHT FACILITIES NATIONALLY AND INCLUDE THE RHODE ISLAND PLANT AS WELL AS FACILITIES IN CALIFORNIA, ILLINOIS, MARYLAND, NEW JERSEY, AND TEXAS. THE VIOLATIONS BY COSMED INCLUDE THE FAILURE TO INSTALL POLLUTION CONTROLS, MEET EtO EMISSION LIMITS, CONDUCT TIMELY COMPLIANCE TESTING, PROPERLY MONITOR CONTROLS, PROVIDE APPROPRIATE NOTIFICATIONS AND REPORTS TO EPA, AND MAINTAIN COMPLIANCE RECORDS. EXCESS EtO EMISSIONS AS A RESULT OF VIOLATIONS IS ESTIMATED AT 30 TONS. THIS IS EPA's FIRST MULTI-REGIONAL EtO MACT CASE EVER. BASED ON EPA's ESTIMATE OF THE # OF LARGE SUBJECT FACILITIES USING 10 TONS OF EtO OR MORE PER YEAR IN THE U.S., THIS ACTION COULD AFFECT ALMOST ONE-THIRD OF ALL SUCH SOURCES. EtO IS LISTED AS A HAZARDOUS AIR POLLUTANT UNDER SECTION 112 OF THE CLEAN AIR ACT AND IS CONSIDERED A PROBABLE CARCINOGEN TO WHICH THERE MAY BE NO SAFE LEVEL OF EXPOSURE. EtO IS ALSO A VOC ( A PRECURSOR TO GROUND LEVEL OZONE) SO THAT ANY EtO EMISSIONS ABOVE ALLOWABLE LIMITS WILL LEAD TO THE FURTHER DETERIORATION OF AIR QUALITY NEAR THE VIOLATING FACILITLIES, ALL OF WHICH ARE IN OZONE NON-ATTAINMENT AREAS AND/OR WITHIN THE OZONE TRANSPORT REGION.

Defendants (1)

  • COSMED GROUP INCNamed in complaintNamed in settlement

Facilities (3)

  • BOSTON SCIENTIFIC CORPORATION

    8 INDUSTRIAL DRIVE, COVENTRY, RI, 02816

    Registry ID: 110032604938

  • BOSTON SCIENTIFIC CORPORATION

    8 INDUSTRIAL DRIVE, COVENTRY, RI, 02816

    Registry ID: 110032604938

  • BOSTON SCIENTIFIC CORPORATION

    8 INDUSTRIAL DRIVE, COVENTRY, RI, 02816

    Registry ID: 110032604938

Statutes cited

  • CAA 112Hazardous Air Pollutants

Enforcement conclusions (1)

  • COSMED GROUP INC (NC)entered 2005-11-21

    Primary law: CAA

    Federal penalty: $130,000 · SEP: $260,000

Timeline (6 milestones)

  • 2003-09-22Referred To Dept Of Justice
  • 2003-09-25Enforcement Action Data Entered
  • 2005-08-18Final Order Lodged
  • 2005-08-18Complaint Filed With Court
  • 2005-11-21Concluded
  • 2005-11-21Final Order Entered

Case metadata

EPA activity ID
104411
Case number
01-2003-0124
Lead agency
EPA
EPA region
01
Voluntary self-disclosure
No
Primary statute
Hazardous Air Pollutants

Sourced verbatim from EPA ECHO Enforcement Case Report for case 01-2003-0124 . 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.