On the heels of extensive study, public input, and peer review, the Texas Commission on Environmental Quality (TCEQ) on May 15 finalized its updated safe exposure level (ESL) for ethylene-oxide, a chemical used in sterilizing medical equipment.
The agency has established a long-term effects screening level of 2.4 parts per billion, which it determined to be the health-protective air concentration used in setting limits for proposed air permits in Texas. TCEQ’s previous ethylene oxide ESL, a preliminary standard, was 1 ppb.
TCEQ’s final ethylene oxide ESL comes during a unique period of strain on the nation’s medical industry. TCEQ’s ethylene oxide cancer dose-response assessment finds that this chemical, which is used to sterilize half of the approximately 40 billion medical devices used in the United States every year, poses less risk than previously thought.
Previous assessments of the chemical’s risk by other agencies forced the closure of some ethylene oxide sterilization facilities in other parts of the country, and threaten more closures. According to TCEQ, these closures have caused a shortage of pediatric tracheostomy (breathing) tubes, and the U.S. Food and Drug Administration has issued an alert on possible additional disruptions in the supply of sterile medical devices.