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SOUTHEAST TEXAS RECORD

Tuesday, April 23, 2024

TCEQ says new ethylene oxide exposure level is based on latest data, scientifically sound

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AUSTIN – “Everything gives us cancer nowadays” is a common phrase. And while the assertion might ring true for some trial lawyers, a chemical that has been cast as the culprit in many toxic torts may actually be safer than previously thought.

Following years of extensive study, on May 15 the Texas Commission on Environmental Quality finalized its updated safe exposure level for ethylene oxide – a critical chemical used for sterilizing medical equipment.

Derived in 2003, TCEQ’s previous ethylene oxide effect screening level was 1 parts per billion (ppb). The new effect screening level has ben set at 2.4 ppb, which is now the health-protective air concentration used to determine limits for proposed air permits in Texas.

In addition to being emitted from industrial plants and medical sterilizing facilities, ethylene oxide also occurs naturally in ambient air.

And although the chemical was not routinely monitored for in ambient air in the past, the Environmental Protection Agency recently began to monitor for it around a number of facilities across the country.

The EPA found background concentrations of ethylene oxide to be around 0.2 ppb and concentrations around facilities that use ethylene oxide to be around 2 ppb.

So now that the new effect screening level is 2.4 ppb what does that exactly mean for Texas’ industrial sector?

Facilities in Texas should meet TCEQ’s health-protective levels if they follow their permit requirements, says Andrew Keese, a media relations specialist for the TCEQ. 

“The result of TCEQ’s years long process to review the safe exposure limit of ethylene oxide revealed that the chemical was safer than previously thought,” says Keese. “TCEQ started its new assessment in 2017 after the EPA finalized its value. After finding out new information was available, TCEQ wanted to thoroughly assess the scientific data itself.

“TCEQ’s new exposure level is based on the latest available data and is scientifically sound.”

Keese says TCEQ’s standard for changing any safe exposure limit “is high.”

“Any change to an effect screening level requires rigorous scientific inquiry and public comment,” Keese said. “Changes to controversial chemicals like ethylene oxide further undergo peer review by outside scientists.”

Toxic torts alleging harm over ethylene oxide exposure have been on the rise the past couple of years, with numerous lawsuits already filed in courthouses near Chicago.

Fears over the chemical have even caused plant shutdowns.

In December, the TCEQ hinted that a new exposure limit might be on the horizon, as it argued concerns that ethylene oxide exposure may cause cancer were ill founded at a medical device sterilization conference.

Texas’ Jefferson County, which is highly industrialized, has more ethylene oxide emissions on a square mile basis than any other county in Texas, with over 300 times more than the U.S. at large, according to the TCEQ.

“The incidents of leukemia, non-Hodgkin’s lymphoma, and breast cancer are lower in Jefferson County than in the general U.S. population,” states TCEQ’s conference notes.

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 demonstrates that the chemical, which is used to sterilize half of the approximately 40 billion medical devices used in the U.S. every year, poses less risk than was 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.

“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,” a TCEQ press release states.

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.

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