The Public Concern Over Ethylene Oxide, Explained
January 31, 2022
By: DAVID BERKOWITZ
As federal regulations for Ethylene Oxide (EtO) continue to form, some states are taking action before the United States Environmental Protection Agency (USEPA) does.
The Illinois EPA, for example, requires facilities to take actions to reduce EtO emissions in order to protect ambient air quality. Senate Bill 1852 requires sterilization facilities to capture 100% of all fugitive EtO emissions and reduce EtO emissions in the atmosphere from each exhaust point by at least 99.9% or to 0.2 parts per million. The bill also requires an initial emissions test within 180 days and annual tests after that. The results must be sent to the Illinois EPA. If the facility fails the test, they must:
- Immediately cease operations
- Notify the Illinois EPA within 24 hours
- Conduct a root cause analysis of the failed emission test within 60 days
- Take corresponding corrective actions and seek IEPA approval prior to restart of operations
These facilities must also conduct quarterly ambient air testing and obtain construction permits from the IEPA before making any modifications. After January 1, 2020, any new facility must be located at least 10 miles from schools or parks.
Issues in Willowbrook, Illinois
One company in Willowbrook, Illinois made the decision to shut down their facility after heavy public pressure.
In 2018, the EPA’s revised 2014 National Air Toxics Assessment (NATA) report showed an increase in cancer risks in the area surrounding this facility based on EtO emissions. The EPA then contacted the company about its emissions and the company voluntarily took steps to reduce them in 2018.
Because of this released report, however, the company faced over 700 lawsuits based on their EtO emissions. In 2019, the EPA installed monitoring equipment that showed elevated concentrations of EtO. The IEPA was forced to shut down the facility. That same year, Illinois passed the previously discussed legislation with stricter requirements for EtO emissions.
The next month, the company and the IEPA reached an agreement to resume operations. But because of what the company identified as an “unpredictable legislation and regulatory landscape” the company eventually left their Willowbrook operations.
Issues in Smyrna, Georgia
Another plant ran into similar trouble in Smyrna, Georgia.
When the EPA released their 2014 NATA report, it showed increased cancer risks in the Smyrna area. The community were outraged.
The facility shut down to implement voluntary measures to reduce emissions. While they were closed, they received a letter from the county telling them to remain shut down pending a review of fire and building codes. The company has been back and forth with the county ever since – and they face consistent backlash from the Smyrna community.
Issues in Covington, Georgia
One facility in Covington, Georgia raised public outrage in the community after a July 2019 WebMD and Georgia Health News report detailed the cancer risks associated with EtO.
The company signed a consent order with the state to estimate fugitive emissions of EtO at its warehouse. Air sample tests came back “higher than anticipated,” estimating the warehouse releases 2.8 tons of EtO into the air each year from EtO off-gassing of medical products.
In December of 2019, the Georgia EPD charged the company with a violation for operating its warehouse without an air quality permit. This notice of violation prevents the company from putting any supplies sterilized with EtO into the storage facility and requests that they monitor air at residential areas and schools near their distribution center. The state also requires the company to submit a permit application that includes the installation of air pollution control equipment to destroy no less than 99% of EtO emissions. State fines could be as high as $25,000.
Once their emission-limiting equipment was installed, they were able to resume operations in 2020.
Issues in Grand Rapids, Michigan
Other companies, like one in Grand Rapids, Michigan, have ceased all work with EtO. Again the 2014 EPA NATA report showed increased cancer risks in Grand Rapids near one facility.
Using agency modeling in 2018, the facility found issues with state ambient EtO standards. The Michigan EPA filed several enforcement actions against the company for permit violations.
Ambient monitoring was completed at the site, but detection levels were still above state health protective levels.
Eventually the company agreed to sign a consent order in November 2019 to stop using EtO in the sterilization of medical devices by December 2020.
If your organization is concerned about keeping up with EtO regulations, contact the experts at Montrose Environmental to walk through how we can help you.
Fenceline Monitoring Expert
David Berkowitz brings over 29 years of industry expertise to the Montrose team where he currently works as our Fenceline Monitoring Testing expert. Prior to joining Montrose, he worked for Enthalpy Analytical and Triangle Laboratories. David is a member of the Air and Waste Management Association, the American Fuel and Petrochemical Association, and the American Chemical Society. He holds a Bachelor’s degree from North Carolina State University.