Ethylene Oxide: Texas Commission on Environmental Quality Revises Safe Exposure Level

The Texas Commission on Environmental Quality (“TCEQ”) issued a May 15th news release stating it finalized an updated “safe exposure level for ethylene oxide.”

TCEQ is setting a long-term effects screening level of 2.4 parts per billion.

Ethylene oxide is a flammable, colorless gas. Two key uses include:

• Sterilization of devices that cannot be sterilized using steam (i.e., medical and dental equipment)
• Production of other chemicals that are used to create everyday products (i.e., antifreeze, plastics, detergents, etc.)

The previous safe exposure limit set by TCEQ is stated to be one part per billion.

The safe exposure level is the air concentration used by TCEQ to determine limits for proposed air permits in Texas.

TCEQ’s efforts regarding ethylene oxide are characterized as occurring:

. . . during a unique period of strain on the nation’s medical industry.

TCEQ notes in part:

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. These closures have already caused a shortage of pediatric tracheostomy (breathing) tubes, and the U.S. Food and Drug Administration has issued an alert about possible additional disruptions in the supply of sterile medical devices.

While the agency’s assessment is a purely scientific exercise and does not consider the implications for the supply of sutures, surgical kits, and other medical devices, TCEQ’s final ESL for ethylene oxide may help mitigate these supply chain risks. Using the most current science, the new limit remains protective for people living near facilities that emit ethylene oxide while providing flexibility for the medical sterilization industry to continue its own critical role in patient care in the state of Texas.

A copy of the news release can be downloaded here.