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The Environmental Protection Agency is raising concerns over Ethylene Oxide emission from Becton, Dickinson and Company’s Columbus plant.

Becton Dickinson Pharmaceutical Systems, 920 E. 19th St., commonly referred to as BD East, is a producer of syringes that pharmaceutical companies use to deliver prefilled drugs and vaccines for patients and is a plastic molding facility that produces components for medical devices. Columbus’ other BD facility, known as BD West, produces needles, saline flush syringes and other similar products.

The BD East plant uses ethylene oxide (EtO) to sterilize medical equipment and materials. 

According to the EPA, EtO is a colorless and flammable gas often used to sterilize items that cannot be sterilized by steam. The Food and Drug Administration states that EtO is used to treat roughly 50% of sterile medical devices, which equals to about 20 billion medical devices annually.

For some devices, EtO is the only safe and effective sterilization method. A page on BD's website about EtO states that EtO is the only method of sterilization for its sensitive medical devices.

The EPA says that while EtO may be important for sterilizing items, it's known to potentially cause cancer.

“When people breathe in EtO over the course of many years it can increase their risk of cancers of the blood and, in women, breast cancer,” according a page on EPA’s website.

“EPA has recently completed an analysis that shows that EtO emissions from some commercial sterilizers in the U.S. contribute to elevated cancer risk for people living in nearby communities. Specifically, exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cancer.”

The EPA published a list of locations and names of sterilizers where there are “elevated risks at or above 100/million to nearby communities.” Columbus’ BD-East plant is listed, with the other closest facilities being LEMCO Ardmore in Ardmore, Oklahoma, and Midwest Sterilization Corporation in Jackson, Missouri.

EPA scientists and analysts completed a risk assessment to understand the impact of EtO emissions from the BD plant, which identified an “elevated cancer risk in the Columbus community.” The risk information is current as of July 27, 2022.

The assessment was completed using information about how much EtO BD emits into the air and the estimated cancer risks were modeled to people living nearby. EPA noted this is in addition to the risk of developing cancer from other causes, and it’s a worst-case scenario that assumes a person stays in the highest risk area 24 hours a day continuously for 70 years.

Information provided by BD states for every 100 pounds of EtO used, the Clean Air Act would allow 1 pound of emissions from the control equipment but, for the same amount of EtO used, BD’s technology reduces stack emissions to less than an ounce.

BD also stated that its programs and procedures are in compliance with regulations from multiple agencies, including EPA, OSHA, Nebraska DEE and FDA.

Although not required by the EPA or the Nebraska Department of Environment and Energy, BD says it is investing $18 million in the East plant to expand and install “a state-of-the-art capture and treatment system for residual EtO emissions in Columbus, which will be operational by the end of next year.”

BD officials also noted that the EPA’s risk assessment is more stringent than what the agency has used in the past.

“The amount of EtO that U.S. EPA used as its screening value for the new risk assessments is 10 to 20 times lower than what is found in ambient air measurements in areas across the country where there is no industrial source of EtO,” a Friday email from BD states. “While EPA is stating that some areas immediately adjacent to the Columbus facility show emissions that are currently above its new risk threshold, those levels are still less than half of what is found in ambient air across the country. And again, after the new controls are installed by the end of next year, emissions will be well below the US EPA’s revised and more stringent risk threshold.”

EPA’s website says the agency will hold a meeting in August or September in Columbus to share information about the public health risk posed by EtO emissions.

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