Becton Dickinson (NYSE:BDX) failed to disclose to Georgia environmental officials a warehouse that it has leased since May to store medical devices sterilized with ethylene oxide (EtO), the company said on Friday.
BD notified the Georgia Environmental Protection Division (EPD) of its use of the 40,000-square-foot warehouse in Covington, Ga., on Friday after the agency cited the company for allegedly emitting excess ethylene oxide from a larger distribution center in the same city without an air quality permit. State officials calculated that the distribution center might emit 5,600 lb. of the carcinogenic gas per year. Any facility that may emit more than 4,000 lb. per year of EtO must apply for a state permit to do so.
BD signed a consent order with the EPD in October, agreeing to aerate EtO-sterilized devices for 24 hours after they leave sterilization chambers at its plants in Covington and Madison, Ga. State officials consider BD’s failure to disclose the second warehouse a violation of that consent order, according to a letter that state officials sent the company on Friday.
BD was to conduct air monitoring of the newly disclosed warehouse Friday and Saturday and report those results to the EPD within 24 hours, according to a letter the EPD sent to the company on Friday. The company has until 5 p.m. today to empty the smaller warehouse in Covington. Last week, the EPD ordered BD to:
- Stop storing EtO-sterilized medical devices at the Covington distribution center from Dec. 23 through Jan. 6, 2020.
- Submit a list of the amount of products currently at the warehouse that were sterilized at BD facilities in Covington and Madison, Ga., as well as products sterilized at non-BD facilities within and outside of Georgia.
- List other Georgia warehouses where EtO-sterilized devices are stored.
- Explain why the amount of fugitive EtO emissions from sterilized devices is higher than the company estimated in its air-quality permits for its Covington and Madison plants.
- Submit a plan to remove Foley catheter procedural trays from the Covington distribution center until the warehouse has an air-quality permit, and to stop storing additional Foley catheter trays there.
BD said it agreed to these terms. It also said it would conduct air monitoring at the nearest residential area and school as well as weekly indoor air monitoring and outdoor fence-line monitoring at the distribution center. BD said it is required to submit a permit application for the distribution center to the EPD by February 3, 2020.
BD also told state environmental officials that it has been conducting exposure monitoring at the distribution center for years, and that EtO levels were within federal and state regulatory limits.
“At this point, we know of no current U.S. Environmental Protection Agency (EPA) or industry standard for calculating fugitive emissions from a medical device distribution facility storing medical devices sterilized with EtO, and EPA is currently researching this very issue in the context of EtO,” the company said. “We are also not aware of any facility in the country like the (distribution center) that requires a permit for purely fugitive product emissions. We expect to work closely with EPD to develop a workable system at the (distribution center) for these challenging technical issues.”
Emissions of ethylene oxide from medical device sterilization plants — and now, warehouses, — has galvanized state and local officials and residents who live near EtO sterilization plants in Illinois, Georgia and Michigan. The medtech industry and the FDA continue to warn of possible device shortages as they search for other methods that would be as effective and efficient as EtO. Ethylene oxide sterilization works at low temperatures — between 90°F and 135°F — making it a viable option for devices made of multiple components and materials, including plastics, polymers, metals and glass, as well as coatings, bonds and packaging from damage. It can also penetrate different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously.