Updated: Mar 21, 2019
Sterigenics recently released a paid advertisement in the Chicago Tribune assuring residents of their safety, however, we still have concerns. In their advertisement, Sterigenics used EO to abbreviate ethylene oxide, which is also abbreviated EtO.
1. They never dispute the health hazards from ethylene oxide exposure:
Research has repeatedly shown breathing in ethylene oxide may cause cancer (13, 3). Sterigenics makes no comment regarding the scientifically proven links to ethylene oxide exposure and miscarriage, genetic mutation, chromosomal changes, respiratory disease, & organ damage (3, 8, 9, 16).
2. They claim we should feel safe because their emissions are lower than OSHA standards:
The 34 year-old OSHA standard does not apply to the general public (12). It was set for adult workers exposed for approximately 8.5 hrs/day, 5 days/week, 250 days/year for 25 years while wearing protective equipment and safety monitors. Residents will have up to 24 hrs/day, 7 days/week of exposure for a lifetime without such protection. Children exposed to carcinogens from birth to 2 years have a 10-fold increased risk for cancer. With exposure from 2-16 years, there is 3-fold increased cancer risk (17).
3. They claim we should feel safe because, “Less than 0.1% of ethylene oxide used is released into the air:”
Sterigenics uses so much ethylene oxide that even reducing their emissions to 0.1% still may not eliminate our risk. Sterigenics self-reported annual emissions of near 5,000 lbs in recent years. Ethylene oxide is long-lived in the atmosphere (11, 14). If Sterigenics reduced the emissions in July by 90%, we can expect current ambient air levels to remain 1,000 times higher than the “safe” value given in the ATSDR report (8).
4. They claim, “EO is produced by the human body” as an indicator it is safe:
The trace amounts of ethylene oxide that exist in the human body seem to be very dependent of various disease or stress conditions. The biological presence of this substance is not an indicator of human health (2, 6).
5. They claim plants emit ethylene oxide:
Arsenic is found in nature, that doesn’t make it safe. According to the World Health Organization, “Quantitative estimates of production from these natural sources are not available, but emissions are expected to be negligible (9)."
6. They claim there are “no alternatives:”
Patient complications have been documented as a result of trace amounts ethylene oxide remaining on medical devices following the ethylene oxide sterilization process (1, 4). This is one reason why many FDA approved ethylene oxide alternatives for sterilization have been developed. FDA approved medical sterilization methods include: Hydrogen Peroxide Gas Plasma, Nitrogen Dioxide, Peracetic Acid, and Steam (10, 7).
7. They state they are in full compliance with regulations:
The Clean Air Act requires standards for hazardous air pollutants like ethylene oxide to be updated every 8 years. It has been 12 years since emission standards for ethylene oxide have been updated (15). Current federal and state regulations do not reflect the categorization of ethylene oxide as a class 1 carcinogen (13).
8. They claim the risk evaluation is irrational:
In 2016, The EPA supported their reasoning for the risk evaluation, stating “the unit risk estimate is based on human data from a large, high-quality epidemiology study with individual worker exposure estimates.” They elaborated, “Confidence in the unit risk estimate is particularly high for the breast cancer component, which is based on over 200 incident cases (13)."
In summation, the ethylene oxide already emitted by Sterigenics has impacted and will continue to impact our community for years. The negative health impacts of human exposure to a known carcinogenic such as ethylene oxide have been scientifically established. We will only feel safe when ethylene oxide is no longer emitted in our community.
1. Bommer, J., Ritz, E. (1987). Ethylene oxide (ETO) as a major cause of anaphylactoid reactions in dialysis (a review). Artif Ogans, 2, 111-7. Retreived from: https://www.ncbi.nlm.nih.gov/pubmed/2954522?fbclid=IwAR15C-hV4M4vbY9mc4S7rMwWbOrhjAFZfmC8q3n8poes_sgd2VOzsD75JoI
2. Cristescu, S.M., Kiss, R., te Lintel Hekkert, S., Dal by,M., Harren, F.J.M., Risby, T.H., and Marczin, N. (2014). “Real-time monitoring of endogenous lipid peroxidation by exhaled ethylene in patients undergoing cardiac surgery” Am J Physiol Lung Mol Physiol, 307, L509-515.
3. International Agency for Research on Cancer. (2008). Ethylene Oxide, IARC Monographs, 97. Retrieved from: https://monographs.iarc.fr/wp-content/uploads/2018/06/mono97-7.pdf
4. Jackson, Gary, Windler, & Simon. (1990). Intraarticular reaction associated with the use of freeze-dried, ethylene oxide-sterilized bone-patella tendon-bone allografts in the reconstruction of the anterior cruciate ligament. The American Journal of Sports Medicine. Retrieved from: http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.1008.9740&rep=rep1&type=pdf&fbclid=IwAR0qSucW3BPVFJO6t0zpDWekb_XWxUgtQoPxd6ElQ6R751Af6w9zBnK1s1c
5. Kirman, C.R., Hays, S.M. (2017). Derivation of endogenous equivalent values to support risk assessment and risk management decisions for an endogenous carcinogen:Ethylene oxide, Regulatory Toxicology and Pharmacology, 91, 165-172.
6. Solka, Bruce. Oct. 22, 2018. Thoughts on significance of internally produced ethylene and ethylene oxide in humans. Retrieved from: https://www.stopsterigenics.com/blog/thoughts-on-significance-of-internally-produced-ethylene- and-ethylene-oxide-in-humans
7. Shahbandar, Lena. November 11, 2018. Alternatives to Ethylene Oxide. Retrieved from: https://www.stopsterigenics.com/blog/alternatives-to-ethylene-oxide
8. U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry. (2018, August 21). Evaluation of Potential Health Impacts from Ethylene Oxide Emissions, Sterigenics International, INC. Willowbrook, Illinois. Retrieved from: https://www.atsdr.cdc.gov/HAC/pha/sterigenic/Sterigenics_International_Inc-508.pdf
9. World Health Organization. (2003). Ethylene Oxide. Retrieved from: http://www.who.int/ipcs/publications/cicad/en/cicad54.pdf
10. Centers for Disease and Prevention. (2016, September). Guideline for Disinfection and Sterilization in Healthcare Facilities. Table 6. Summary of advantages and disadvantages of commonly used sterilization technologies. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/tables/table6.html
11. U.S. Environmental Protection Agency. (1987). Atmospheric Persistence of Eight Air Toxins. Retrieved from: https://nepis.epa.gov/Exe/ZyPDF.cgi/9100B6EK.PDF?Dockey=9100B6EK.PDF
12. Occupational Safety and Health Administration. 1984. Federal Register. Rules and Regulations. Retrieved from: https://www.osha.gov/sites/default/files/laws-regs/federalregister/1984-06-22.pdf
13. U.S. Environmental Protection Agency. (2016). Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide Executive Summary. Retrieved from: https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/1025_summary.pdf
14. Holmes, John R. (1993). Ethylene Oxide In The Atmosphere. California Environmental Protection Agency Air Resources Board. Retrieved from: https://www.arb.ca.gov/research/resnotes/notes/93-6.htm
15. Environmental Protection Agency. Clean Air Act. Retrieved from: https://www.epa.gov/laws-regulations/summary-clean-air-act
16. Jinot J, Fritz JM, Vulimiri SV, Keshava N. (2017). Carcinogenicity of Ethylene Oxide: Key Findings and Scientific Issues. Toxicol Mech Methods. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/29210319
17. U.S. Environmental Protection Agency. (2005, March). Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. Retrieved from: https://www3.epa.gov/airtoxics/childrens_supplement_final.pdf