Birth Defects and Ethylene Oxide Sterilization

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Dangers posed by use of ethylene oxide at medical device sterilization facilities

Ethylene oxide (EtO) is a gas widely used in the sterilization of medical devices. It is also a highly toxic carcinogen and mutagen, exposure to which has been shown to lead to cancer, DNA mutations, and adverse birth outcomes. California’s Proposition 65 lists EtO as developmentally toxic, reproductively toxic (male and female), and as causing cancer. As more research has been done on EtO, we have realized how dangerous it really is. Most recently, in 2016, the U.S. Environmental Protection Agency (EPA) reclassified EtO as a Level 1 carcinogen, saying it was 30 times worse than previously thought [1].

Cancers associated with chronic exposure to EtO include but are not limited to leukemias, myelomas, lymphomas, breast cancer, stomach cancer, brain cancer, lung cancer, glioblastoma, and pancreatic cancer. As the same mutagenic processes which cause cancer also can result in birth defects in an unborn child, EtO is also considered a reproductive and developmental toxin.  Scientific and medical evidence shows that chronic exposure to EtO during pregnancy can lead to miscarriages, spontaneous abortion, and other adverse birth outcomes [2].

In 1991 NIOSH conducted an industry cohort study of 18,235 men and women exposed to EtO from 14 sterilizer plants around the country. This study evaluated mortality rates of exposed employees given the elevated risk for blood cancers in men and breast cancers in women exposed to ETO. NIOSH estimated that 270,000 people were exposed to ETO in the US in the 1980s, 21,000 through commercial sterilization [3].

 

Dangerous EtO exposure levels across the country

The EPA found “EtO emissions from sterilization facilities to be among the most hazardous air pollutants posing the greatest health risks in the largest number of urban areas” [4].

In June 2019 the EPA shut down the Illinois manufacturing plant of Sterigenics, a leading industrial sterilization company for medical device, pharma, commercial and food industries due to elevated levels of EtO found both inside and outside of the facility. Another Chicago facility, Medline Industries, also had to shut down to comply with EtO emission standards [5]. See below for a list of U.S. counties with the highest rates of EtO emissions [4]:

U.S. Counties with High EtO Cancer Risk

(>1:10,000 people, Source: EPA NATA)

County State Facility Total EtO Emissions (Tons/Year)
St. Charles Louisiana Union Carbide 15.03
Jefferson Texas Port Neches Plant 10.77
Webb Texas Midwest Sterilization Corp 7.86
Harrison Texas Texas Operations 7.4
Cape Girardeau Missouri Midwest Sterilization Corp 3.49
Lehigh Pennsylvania B Braun 3.3
Newton Georgia C R Bard 3.02
Kanawha West Virginia Union Carbide 2.9
Doña Ana New Mexico Sterigenics 2.88
DuPage Illinois Sterigenics 2.78
Iberville Louisiana BCP Ingredients 2.5
St. John the Baptist Louisiana Air Products Performance Manufacturing 1.61
Lake Illinois Medline Industries 1.53
New Castle Delaware CRODA Inc. 1.35
Jefferson Colorado TERUMO 1.11
Harris Texas Channelview Plant 0.95
Anasco Puerto Rico Edwards Lifesciences Corp 0.69
Warren New Jersey BASF 0.5

Trust our birth defect attorneys to help

The Thornton Law Firm has investigated cases in Missouri and Georgia on behalf of workers whose children suffered birth defects and persons with cancer from exposure to EtO.

Contact the Boston law firm of Thornton Law Firm online or at 844-999-6942 for a free consultation with a recognized leader in toxic tort and birth defect litigation. Toxic chemicals at your workplace may have caused your child’s birth defect. We offer a fair and accurate assessment of your case. You have nothing to risk.

Sources:

[1] EPA IRIS Executive Summary. “Ethylene oxide.” Retrieved October 19, 2020 from https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?&substance_nmbr=1025.

[2] Rowland, A. “Ethylene oxide exposure may increase the risk of spontaneous abortion, preterm birth, and postterm birth.Epidemiology. 1996. Retrieved October 20, 2020 from https://pubmed.ncbi.nlm.nih.gov/8793361/.

[3] Steenland, K. “Mortality among workers exposed to ethylene oxide.” New England Journal of Medicine. 1991 May; 324(20):1402-1407. Retrieved October 21, 2020 from https://www.cdc.gov/niosh/nioshtic-2/00200974.html.

[4] West, D. “Action Needed to Protect Americans from Toxic EtO Pollution.” Natural Resources Defense Council. February 14, 2019. Retrieved October 19, 2020 from https://www.nrdc.org/experts/dan-west/action-needed-protect-americans-toxic-eto-pollution.

[4] Hawthorne, M. “Sterigenics is leaving Willowbrook, eliminating key source of cancer-causing ethylene oxide in Chicago’s western suburbs.” The Chicago Tribune. September 30, 2019. Retrieved October 19, 2020 from https://www.chicagotribune.com/news/environment/ct-sterigenics-ends-ethylene-oxide-operation-willowbrook-20190930-nkelcjshkbawdhxx2snjk3oaxe-story.html.

[5] Crotti, N. “Medline Industries temporarily halts EtO sterilization at Illinois plant.” Medical Design & Outsourcing. January 21, 2020. Retrieved October 20, 2020 from https://www.medicaldesignandoutsourcing.com/medline-industries-temporarily-halts-eto-sterilization-at-illinois-plant/.

 

 

 

 

 

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