Lake County Gazette

The safe exposure level for ethylene oxide (EtO) is much higher than previously thought, according to a report from the Texas Commission on Environmental Quality.

That is good news for facilities that use EtO to sanitize medical equipment, including the Medline Industries’ sterilization plant in Waukegan, Ill.

The Waukegan plant underwent a $10 million emissions capture upgrade and, after being closed for more than three months, resumed production on March 27.

Ethylene oxide is used to sterilize 20 million pieces of medical equipment annually. Some facilities, including Medline’s in Waukegan, have recently closed, either temporarily or permanently, due to emissions concerns.

The basis for that fear has been lessened, first by a U.S. Environmental Protection Agency report stating that EtO exists on a common basis across the country and the air outside of facilities, like the one in Waukegan, have no more of the chemical than other areas, and less than many.

Now, the TCEQ’s May 15 report, based on extensive study, public input and peer review, indicates the safe level of EtO is higher than previously thought.

Texas Commission on Environmental Quality Media Relations Work Lead Brian McGovern said the agency has established a long-term effects screening level of 2.4 parts per billion, which is the health-protective air concentration used to determine limits for proposed air permits in Texas.

The previous figure was 1.1 parts per billion.

“TCEQ’s assessment uses new data and analyses that became available after EPA’s 2016 assessment was published,” McGovern told Lake County Gazette. “TCEQ’s new assessment uses the latest available scientific data, went through an extensive public comment period, went through an external independent scientific peer review, and represents the highest-quality science available.

“As mentioned in the news release, the agency has established a long-term effects screening level of 2.4 parts per billion, which is the health-protective air concentration used to determine limits for proposed air permits in Texas,” he said.

The report says this new cancer dose-response assessment demonstrates that the chemical poses less risk than was previously thought. That means is facilities that use it to sanitize 20 million pieces of medical equipment annually — half the amount used in the United States — will have less pressure to remain open.

In addition to the Waukegan plant, EtO operations in Illinois and Georgia have been under close scrutiny in the last year over emissions concerns.

The Becton Dickinson and Company (BD) Facility in Covington, Ga. closed briefly for an inspection but has otherwise remained in production.

Sterigenics Facility in Willowbrook, Ill. closed in February. It opened in 1984.

Sterigenics Facility in Atlanta was temporarily closed in August but reopened on April 1.

In late 2019, the U.S. Food and Drug Administration said it was concerned about a potential shortage in methods to sterilize medical equipment.

“The FDA will continue in our steadfast commitment to develop solutions to avoid potential device shortages and encourage new, innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health,” the federal agency reported on its website.

It commented on the issue earlier this year as well, saying it was “closely monitoring the supply chain effects of closures and potential closures of certain facilities that use ethylene oxide to sterilize medical devices prior to their use.”

The report from the Texas agency may help reduce that worry.

“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,” the TCEQ release states. “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.”

The report was written as a “purely scientific exercise,” but it may have a practical use as well. Research began in 2017 and a draft report was released in 2019 to seek input and public comment.

Th draft received a “rigorous final assessment” by experts in the field in 2020. The Texas agency has compiled much of the data and made it publicly available.

“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,” the report states.

It also should be welcome news for EtO facilities across the country.