ethylene oxide monitoring experience in colorado

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Ethylene Oxide Monitoring Experience in Colorado Gordon Pierce Technical Services Program Manager [email protected] Monitoring Steering Committee Meeting, 5/14/2019

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Page 1: Ethylene Oxide Monitoring Experience in Colorado

Ethylene Oxide Monitoring Experience

in Colorado Gordon Pierce

Technical Services Program Manager

[email protected]

Monitoring Steering Committee Meeting, 5/14/2019

Page 2: Ethylene Oxide Monitoring Experience in Colorado

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

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Page 3: Ethylene Oxide Monitoring Experience in Colorado

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

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Page 4: Ethylene Oxide Monitoring Experience in Colorado

2014 NATA ethylene oxide sources (>0.5 TPY)

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State Locality Facility Name NAICS description Facility source description NEI_Emis_(tons)LA Hahnville Union Carbide Corp - St Charles Operations Petrochemical Manufacturing Chemical Plant 15.0324015TX PORT NECHES PORT NECHES PLANT Petrochemical Manufacturing Chemical Plant 10.776TX Laredo Midwest Sterilization Corp Surgical Appliance and Supplies Manufacturing 7.869TX LONGVIEW TEXAS OPERATIONS Petrochemical Manufacturing Chemical Plant 7.4139LA Geismar BASF Corp - Geismar Site All Other Basic Organic Chemical Manufacturing Chemical Plant 7.13912891LA Westlake Sasol Chemicals (USA) LLC - Lake Charles Chemical Complex All Other Basic Organic Chemical Manufacturing Chemical Plant 6.3198945TX PASADENA CLEAR LAKE PLANT Petrochemical Manufacturing Chemical Plant 5.9467TX SEADRIFT SEADRIFT PLANT Petrochemical Manufacturing Chemical Plant 5.1958LA Geismar Shell Chemical LP - Geismar Plant Petrochemical Manufacturing Chemical Plant 4.829033538TX PASADENA BAYPORT UNDERWOOD PLANT Petrochemical Manufacturing Chemical Plant 4.0277MO Jackson Midwest Sterilization Corp-Jackson Surgical Appliance and Supplies Manufacturing 3.491PA ALLENTOWN B BRAUN MED INC/ALLENTOWN Offices of Physicians (except Mental Health Specialists) 3.3GA Covington C R Bard Surgical and Medical Instrument Manufacturing 3.02355WV INSTITUTE UNION CARBIDE CORPORATION-INSTITUTE All Other Basic Organic Chemical Manufacturing 2.9088NM Santa Teresa STERIGENICS-SANTA TERESA FACILITY Packaging and Labeling Services 2.8805IL Willowbrook Sterigenics US LLC Packaging and Labeling Services 2.78298184TX CONROE CONROE FACILITY Petrochemical Manufacturing Chemical Plant 2.6693LA New Hampton BCP Ingredients Inc Other Animal Food Manufacturing 2.501710002KY Brandenburg Monument Chemical Kentucky LLC All Other Basic Organic Chemical Manufacturing Chemical Plant 1.875501MO VERONA BCP INGREDIENTS VERONA PLANT Medicinal and Botanical Manufacturing Pharmaceutical 1.83265LA Plaquemine The Dow Chemical Co - Louisiana Operations All Other Basic Organic Chemical Manufacturing Chemical Plant 1.8021955LA Reserve Air Products Performance Manufacturing Inc - Reserve Plant Surface Active Agent Manufacturing 1.61095GA Smyrna Griffith Micro Science Inc All Other Professional, Scientific, and Technical Services 1.5945IL Waukegan Medline Industries Inc Northpoint Services Div Packaging and Labeling Services 1.5288DE NEW CASTLE CRODA INC. Surface Active Agent Manufacturing 1.347147965IA WEBSTER CITY VAN DIEST SUPPLY COMPANY Pesticide and Other Agricultural Chemical Manufacturing 1.27UT Salt Lake City Ethylene Oxide Commercial Sterilization Surgical Appliance and Supplies Manufacturing 1.179LA St. Gabriel Taminco US LLC All Other Basic Organic Chemical Manufacturing Chemical Plant 1.14947CO LAKEWOOD TERUMO BCT STERILIZATION SERVICES, INC Surgical and Medical Instrument Manufacturing 1.11SC CHARLESTON SOLVAY USA INC All Other Basic Organic Chemical Manufacturing Chemical Plant 0.962TX CHANNELVIEW CHANNELVIEW PLANT Petrochemical Manufacturing Chemical Plant 0.9593WV SOUTH UNION CARBIDE CORP -SO CHARLESTON FAC. All Other Basic Organic Chemical Manufacturing Chemical Plant 0.8282TX CLUTE DOW TEXAS OPERATIONS FREEPORT Petrochemical Manufacturing Chemical Plant 0.7113PR Anasco Edwards Lifesciences Corporation Surgical and Medical Instrument Manufacturing 0.69355MI GRAND RAPIDS Vention Medical Inc. Surgical and Medical Instrument Manufacturing 0.585165TX San Angelo Ethicon Inc Surgical and Medical Instrument Manufacturing 0.5485TX FREEPORT PETROCHEMICAL REFINING All Other Miscellaneous Chemical Product and Preparation Manufacturing 0.5072NJ WASHINGTON BASF Corporation Surface Active Agent Manufacturing 0.506445SC Spatanburg BASF Chemical Corporation - White Stone Site Surface Active Agent Manufacturing 0.5

Page 5: Ethylene Oxide Monitoring Experience in Colorado

Colorado 2014 NEI ethylene oxide sources

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FACILITY CITY EMISS. (lb) NAICS DESCRIPTIONTERUMO BCT STERILIZATION SERVICES, INC LAKEWOOD 2220 SURGICAL AND MEDICAL INSTRUMENT MFG.COORSTEK, INC. - WEST TABLE MTN PLANT GOLDEN 329.222ROCKY 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 2.462ST. 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.

Page 6: Ethylene Oxide Monitoring Experience in Colorado

Ethylene oxide sources in Denver area

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Page 7: Ethylene Oxide Monitoring Experience in Colorado

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

Page 8: Ethylene Oxide Monitoring Experience in Colorado

Terumo BCT

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Page 9: Ethylene Oxide Monitoring Experience in Colorado

2014 NATA

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Page 10: Ethylene Oxide Monitoring Experience in Colorado

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

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Page 11: Ethylene Oxide Monitoring Experience in Colorado

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

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Page 12: Ethylene Oxide Monitoring Experience in Colorado

Sampling locations around Terumo

BCT

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Page 13: Ethylene Oxide Monitoring Experience in Colorado

Background sampling locations

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Page 14: Ethylene Oxide Monitoring Experience in Colorado

Sampling photo

examples

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Page 15: Ethylene Oxide Monitoring Experience in Colorado

Monitoring Results

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Page 16: Ethylene Oxide Monitoring Experience in Colorado

Cancer Risk

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Page 17: Ethylene Oxide Monitoring Experience in Colorado

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%

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Page 18: Ethylene Oxide Monitoring Experience in Colorado

Cancer rates in the community

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Page 19: Ethylene Oxide Monitoring Experience in Colorado

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

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Page 20: Ethylene Oxide Monitoring Experience in Colorado

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