Ethylene Oxide Monitoring Experience in Colorado
Gordon Pierce Technical Services Program Manager [email protected]
Monitoring Steering Committee Meeting, 5/14/2019
Ethylene Oxide
Flammable, colorless gas used to make other chemicals that are used in making a range of products, including antifreeze, textiles, plastics, detergents and adhesives Also used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment
Non-cancer effects Eye and respiratory irritation Headache, nausea, memory loss, numbness Increased rate of miscarriage in female workers Cancer effects Increased risk of lymphoid (lymphoma, leukemia, myeloma) and breast cancer in workers 2
Issue On 8/22/2018, The US Environmental Protection Agency (EPA) released their 2014 National Air Toxics Assessment (NATA) EPA significantly lowered the IRIS health risk threshold for ethylene oxide (by 30x) in Dec. 2016 An increased potential cancer risk was noted for census tracts due to several facilities nationwide Terumo BCT in Lakewood, CO was one of the facilities 2014 NATA cancer risk for ethylene oxide ~500/million The Colorado Department of Health and Environment decided to perform ambient air monitoring in the area to determine actual ethylene oxide concentrations Community meeting held after risk assessment performed 3
2014 NATA ethylene oxide sources (>0.5 TPY)
State Locality Facility Name NAICS description Facility source description NEI_Emis_(tons) LA Hahnville Union Carbide Corp - St Charles Operations Petrochemical Manufacturing Chemical Plant 15.0324015 TX PORT NECHES PORT NECHES PLANT Petrochemical Manufacturing Chemical Plant 10.776 TX Laredo Midwest Sterilization Corp Surgical Appliance and Supplies Manufacturing 7.869 TX LONGVIEW TEXAS OPERATIONS Petrochemical Manufacturing Chemical Plant 7.4139 LA Geismar BASF Corp - Geismar Site All Other Basic Organic Chemical Manufacturing Chemical Plant 7.13912891 LA Westlake Sasol Chemicals (USA) LLC - Lake Charles Chemical Complex All Other Basic Organic Chemical Manufacturing Chemical Plant 6.3198945 TX PASADENA CLEAR LAKE PLANT Petrochemical Manufacturing Chemical Plant 5.9467 TX SEADRIFT SEADRIFT PLANT Petrochemical Manufacturing Chemical Plant 5.1958 LA Geismar Shell Chemical LP - Geismar Plant Petrochemical Manufacturing Chemical Plant 4.829033538 TX PASADENA BAYPORT UNDERWOOD PLANT Petrochemical Manufacturing Chemical Plant 4.0277 MO Jackson Midwest Sterilization Corp-Jackson Surgical Appliance and Supplies Manufacturing 3.491 PA ALLENTOWN B BRAUN MED INC/ALLENTOWN Offices of Physicians (except Mental Health Specialists) 3.3 GA Covington C R Bard Surgical and Medical Instrument Manufacturing 3.02355 WV INSTITUTE UNION CARBIDE CORPORATION-INSTITUTE All Other Basic Organic Chemical Manufacturing 2.9088 NM Santa Teresa STERIGENICS-SANTA TERESA FACILITY Packaging and Labeling Services 2.8805 IL Willowbrook Sterigenics US LLC Packaging and Labeling Services 2.78298184 TX CONROE CONROE FACILITY Petrochemical Manufacturing Chemical Plant 2.6693 LA New Hampton BCP Ingredients Inc Other Animal Food Manufacturing 2.501710002 KY Brandenburg Monument Chemical Kentucky LLC All Other Basic Organic Chemical Manufacturing Chemical Plant 1.875501 MO VERONA BCP INGREDIENTS VERONA PLANT Medicinal and Botanical Manufacturing Pharmaceutical 1.83265 LA Plaquemine The Dow Chemical Co - Louisiana Operations All Other Basic Organic Chemical Manufacturing Chemical Plant 1.8021955 LA Reserve Air Products Performance Manufacturing Inc - Reserve Plant Surface Active Agent Manufacturing 1.61095 GA Smyrna Griffith Micro Science Inc All Other Professional, Scientific, and Technical Services 1.5945 IL Waukegan Medline Industries Inc Northpoint Services Div Packaging and Labeling Services 1.5288 DE NEW CASTLE CRODA INC. Surface Active Agent Manufacturing 1.347147965 IA WEBSTER CITY VAN DIEST SUPPLY COMPANY Pesticide and Other Agricultural Chemical Manufacturing 1.27 UT Salt Lake City Ethylene Oxide Commercial Sterilization Surgical Appliance and Supplies Manufacturing 1.179 LA St. Gabriel Taminco US LLC All Other Basic Organic Chemical Manufacturing Chemical Plant 1.14947 CO LAKEWOOD TERUMO BCT STERILIZATION SERVICES, INC Surgical and Medical Instrument Manufacturing 1.11 SC CHARLESTON SOLVAY USA INC All Other Basic Organic Chemical Manufacturing Chemical Plant 0.962 TX CHANNELVIEW CHANNELVIEW PLANT Petrochemical Manufacturing Chemical Plant 0.9593 WV SOUTH UNION CARBIDE CORP -SO CHARLESTON FAC. All Other Basic Organic Chemical Manufacturing Chemical Plant 0.8282 TX CLUTE DOW TEXAS OPERATIONS FREEPORT Petrochemical Manufacturing Chemical Plant 0.7113 PR Anasco Edwards Lifesciences Corporation Surgical and Medical Instrument Manufacturing 0.69355 MI GRAND RAPIDS Vention Medical Inc. Surgical and Medical Instrument Manufacturing 0.585165 TX San Angelo Ethicon Inc Surgical and Medical Instrument Manufacturing 0.5485 TX FREEPORT PETROCHEMICAL REFINING All Other Miscellaneous Chemical Product and Preparation Manufacturing 4 0.5072 NJ WASHINGTON BASF Corporation Surface Active Agent Manufacturing 0.506445 SC Spatanburg BASF Chemical Corporation - White Stone Site Surface Active Agent Manufacturing 0.5 Colorado 2014 NEI ethylene oxide sources
FACILITY CITY EMISS. (lb) NAICS DESCRIPTION TERUMO BCT STERILIZATION SERVICES, INC LAKEWOOD 2220 SURGICAL AND MEDICAL INSTRUMENT MFG. COORSTEK, INC. - WEST TABLE MTN PLANT GOLDEN 329.222 ROCKY MOUNTAIN PRESTAIN, LLC COMMERCE CITY 164 WOOD PRESERVATION. COMMUNITY HOSPITAL GRAND JUNCTION 110 GENERAL MEDICAL AND SURGICAL HOSPITALS. NORTH COLORADO MEDICAL CENTER - MAIN GREELEY 100 GENERAL MEDICAL AND SURGICAL HOSPITALS. U.S. VETERANS AFFAIRS MEDICAL CENTER DENVER 98 GENERAL MEDICAL AND SURGICAL HOSPITALS. JORGENSEN LABORATORIES, INC. LOVELAND 40 MEDICAL LABORATORIES. SWEDISH MEDICAL CENTER ENGLEWOOD 38.9 GENERAL MEDICAL AND SURGICAL HOSPITALS. ST MARY CORWIN REGIONAL MEDICAL CENTER PUEBLO 8 GENERAL MEDICAL AND SURGICAL HOSPITALS. COORSTEK, INC. - 600 9TH STREET GOLDEN 2.462 ST. ANTHONY HOSPITAL - NORTH WESTMINSTER 0 GENERAL MEDICAL AND SURGICAL HOSPITALS. DENVER HEALTH & GENERAL HOSPITAL DENVER 0 GENERAL MEDICAL AND SURGICAL HOSPITALS. ST JOSEPH HOSP DENVER 0 GENERAL MEDICAL AND SURGICAL HOSPITALS.
5 Ethylene oxide sources in Denver area
6 Terumo BCT overview
Based in Lakewood, CO (suburb of Denver) Manufacturer of blood component, therapeutic apheresis and cellular technologies Uses ethylene oxide to sterilize medical equipment 3 emissions sources: Main chamber vents (6 chambers) – emissions controlled by wet acid scrubber Chamber back flush vents – not initially controlled as not required under MACT Aeration room – emissions controlled by dry sorbent scrubber Emitting ~1.1 TPY of EtO (permitted for 5 TPY) 7 Terumo BCT
8 2014 NATA
9 Sampling overview
Air sampling performed using whole-air stainless steel ‘Summa’ canisters 7 consecutive days of sampling Background samples 24-hour samples, approx. 7 a.m. – 7 a.m. Analyses performed by Eastern Research Group (ERG) Site locations determined by: Meteorology Topography Modeling 10
Monitoring overview 8/24/2018—8/30/2018 = “Pre-control” sampling Air sampling conducted at 4 sites around Terumo BCT sterilization facility 2 sites to west of the facility, 2 sites to the east 9/9/2018 – 9/10/2018 = Background sampling 2 sites Terumo BCT modified systems to control more of their ethylene oxide emissions Back vents routed to main vents wet acid scrubber system 10/17/2018—10/23/2018 = “Post-control” sampling Air sampling conducted at 8 sites around Terumo BCT sterilization facility 3 sites to west of the facility, 5 sites to the east 10/26/2018—10/29/2018 = Background sampling 4 sites 11
Sampling locations around Terumo BCT
12 Background sampling locations
13 Sampling photo examples
14 Monitoring Results
15 Cancer Risk
16 Post-control cancer risk perspective (based on monitoring data)
Largest calculated risk: 1,500 in one million excess risk of cancer Equivalent to 0.15% increased risk Lifetime risk (all causes) in US Non-Hodgkins lymphoma - 2.1% Breast cancer 12.4%
17 Cancer rates in the community
18 Co-elution issue Trans-2-butene identified as a co-eluting compound ERG made changes to add ions to the MS analysis to resolve the issue Data from pre-control samples potentially affected Post-control samples were analyzed after ERG made changes to analytical method From CDPHE ozone precursor sampling conducted in Denver around the same timeframe, trans-2-butene was detected only 1 time (in 12 samples) ERG determined that trans-2-butene was only detected in ~40% of the samples analyzed in 2018 with an average concentration of ~0.06 ppbv Result: Likely that there was very little or no impact to pre-control samples from trans-2-butene 19 Conclusions Post-control sample values were significantly lower (50-75%) than the pre-control values, indicating that the new back vent emissions controls are having an impact Concentrations decreased with distance from the Terumo BCT sterilization facility in both east and west directions Many of the post-control samples were in the same general range as some of the background samples, especially for the sites further away in residential neighborhoods Cancer risks at all sampling locations (including background) were elevated compared to the EPA’s acceptable risk range The rates of cancer in the community surrounding Terumo BCT were not statistically different than expected compared to the rest of Colorado Background concentrations have been found in other areas of the country as well https://www.colorado.gov/pacific/cdphe/ethylene-oxide 20