What is Ethylene Oxide?
Ethylene oxide (also abbreviated as EO and EtO) is a versatile compound used in the production of other chemicals for a variety of industrial applications and everyday consumer products, including household cleaners, personal care items and fabrics textiles.
What is Ethylene Oxide used for?
Ethylene oxide is most commonly used in the production of other chemicals including the production of solvents, antifreeze, detergents, adhesives, polyurethane foam and pharmaceuticals. A small but important use of ethylene oxide is the sterilization of surgical and medical equipment, including the sterilization of personal protective equipment. It is estimated that ethylene oxide sterilizes 20 billion medical devices each year, helping to prevent disease and infection. Read about more ethylene oxide uses.
How is ethylene oxide used in sterilization?
Ethylene oxide sterilization processes can sanitize medical and pharmaceutical products that cannot support conventional, high-temperature steam sterilization procedures. A low-temperature sterilizer, ethylene oxide gas will not damage these types of medical devices. Approximately 50 percent of medical supplies are sterilized with ethylene oxide, making it critical to the U.S. healthcare industry. Read more about ethylene oxide sterilization uses.
Is the general population exposed to ethylene oxide?
Ethylene oxide is present in the environment and is created by various sources, including plants and the heating of cooking oils. The human body also converts ethylene to ethylene oxide. Exposure to ethylene oxide varies across urban, suburban and rural environments.
Ethylene oxide emissions from industrial manufacturing and other applications are strictly regulated under federal and in some cases state and local laws.
How is ethylene oxide regulated for worker safety?
OSHA has set exposure limits for employees working in facilities where ethylene oxide gas is present. In addition, employers must provide appropriate protective clothing and equipment to employees who may be exposed to ethylene oxide. The National Institute of Occupational Safety and Health6 and the American Conference of Governmental Industrial Hygienists7 also provide guidance for industrial exposure to ethylene oxide.
Is ethylene oxide a carcinogen that can cause cancer?
Any potential association between ethylene oxide and cancer is linked only to chronic exposure. There is minimal cancer risk for the general population because most people are not exposed to significant quantities of ethylene oxide.
In fact, one comprehensive lifetime exposure study of workers in ethylene oxide production facilities found no statistically significant excess cancer risk due to ethylene oxide exposure.9 A similar result was found in Michigan when the state analyzed the population near a facility that used ethylene oxide in Grand Rapids.10
Has EPA warned of an elevated risk of cancer due to ethylene oxide exposure levels?
In 2016, the EPA Integrated Risk Information System (IRIS) program released an updated cancer value based on modeling. Several independent reviews have raised substantive concerns about EPA’s IRIS program generally and its findings with respect to ethylene oxide specifically.
For instance, the Texas Commission on Environmental Quality (TCEQ) has said that EPA’s IRIS value for ethylene oxide is “without sound scientific basis.” 10
The ethylene oxide assessment also includes errors in modeling historical exposures to ethylene oxide. These errors combined result in a value that is based on selective science and results in an overly conservative cancer value. In fact, the ethylene oxide cancer value derived from EPA’s modeling is 19,000 times lower than the normal, naturally-created levels of ethylene oxide in the human body.
After independent, peer reviewed analysis of the IRIS value by TCEQ, EPA is currently reconsidering the use of the IRIS value in their rulemaking governing emissions from EO facilities producing EO.
2FDA – https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices
3CDC – Disinfection and Sterilization: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html
4FDA – https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures
5OSHA – Occupational Safety and Health Administration’s (OSHA) ethylene oxide standard
6NIOSH – https://www.cdc.gov/niosh/npg/npgd0275.html
7American Conference of Governmental Industrial Hygienist – https://www.acgih.org/
8EPA – EPA’s National Emission Standards for Hazardous Air Pollutants (NESHAP)
9Research Gate – https://www.researchgate.net/publication/24415937_Mortality_Study_Update_of_Ethylene_Oxide_Workers_in_Chemical_Manufacturing_A_15_Year_Update
10Fox News West Michigan – https://www.fox17online.com/2019/07/24/state-no-unusual-cancer-stats-near-grand-rapids-medical-manufacturer/