A weeklong valve leak at a Becton Dickinson (NYSE:BDX) medtech sterilization plant in Covington, Ga., recently released 54 lbs. of ethylene oxide into the air, according to a City of Covington incident report.
The plant began experiencing intermittent elevated levels of EO indoors Sept. 15, but inspections and systems checks failed to locate the source, according to the report. The source was discovered Sept. 23 – a vacuum exhaust valve to a rooftop stack was not fully closed. The valve was subsequently closed and tested to verify complete closure, and the cumulative level of emissions was below BD’s reporting requirements, according to the report.
BD told Medical Design & Outsourcing that it voluntarily reported the leak to city officials and the Georgia Environmental Protection Division. The company’s 2018 permit would have allowed the plant to emit approximately 10,000 lbs. pounds of EO for the year, but BD reported only 656 lbs., noted BD spokesman Troy Kilpatrick.
“So while no one wants to have any type of unintended release, even the cumulative total of 54.5 added to our annual emissions doesn’t get us anywhere near our permit allowance,” Kirkpatrick told us via email. “We are still emitting less than 10% of our permit allowance. Also, we have only had one reportable release in Covington in the last 20 years. These instances are very infrequent.”
The leak occurred after workers at the plant re-routed all vacuum pump exhaust to an emissions-control device in order to simplify the system and eliminate a potential point of failure. EO levels in the 1-32 ppm range were discovered at various locations inside the building Sept. 15, and the report concludes that EO was emitted outdoors as well.
EO plants across the country sterilize millions of medical devices annually and have come under scrutiny at all levels of government. Sterigenics, which also operates an EO plant in Atlanta, permanently closed its EO plant in Willowbrook, Ill., this week, citing “inaccurate and unfounded claims regarding Sterigenics and the unpredictable legislative and regulatory landscape in Illinois.” The U.S. Environmental Protection Agency considers EO to be carcinogenic and is under court order to upgrade its emissions standard for the sterilant gas by March 2020.
Today, the company also announced that emissions abatement tests conducted by an outside firm Sept. 12-13 showed that the Covington plant’s equipment destroys the sterilant gas at an efficiency rate of more than 99.999%. Those results compare with the 99.97% EO destruction efficiency rate found during the last required stack test at the Covington plant in 2012, the company said.
The voluntary stack test was conducted by ECSI of San Clemente, Calif., under an EPD-accepted test protocol and with two EPD source monitoring workers on-site to observe the test. Based on these results, BD said it would have reported only 3.5 pounds of EO point-source emissions for the full year (0.15 oz. per day), which is 28 times lower than BD’s previously reported 100.7 pounds of EO point-source emissions from Covington in 2018.
EO emissions from medtech sterilization plants drew the spotlight after Illinois temporarily shut down a Sterigenics EO plant in February. Citing “inaccurate and unfounded claims regarding Sterigenics and the unpredictable legislative and regulatory landscape in Illinois,” Sterigenics announced on Monday that it would never reopen the plant in Willowbrook.
That closure, combined with state and local scrutiny of Sterigenics’ and BD’s EO plants in Georgia and a Viant plant in Michigan, have raised concerns of a “rolling effect” on EO plants across the country, according to AdvaMed. BD also operates an EO plant in Madison, Ga.
BD said the test results announced today are not from the Covington plant operating its emissions reduction equipment differently, but rather from the use of more-sensitive, higher-resolution testing equipment that can detect and measure EO levels at much lower concentrations than previous technology. BD said it still intends to install $8 million in emissions-control upgrades at both of its Georgia EO plants.
“The results of the latest stack test confirm that we operate our facility in a safe and responsible way, with newer, more sophisticated technology confirming that our stack emissions are extremely low,” environment, health & safety VP Ellen Kondracki said in a news release. “Given these new test results, it can be inferred that past emission reporting from BD (and previously C. R. Bard) overestimated the amount of [EO] released from our stacks, and historic reported emissions would have been significantly lower if prior stack testing had the ability to detect to today’s level of precision. With stack testing confirming emissions to be lower than expected, we have turned our focus to the previously announced $8 million investment for planned improvements to further reduce fugitive emissions from the facility, and we are on schedule to submit our permit application on or before the end of the month.”
Because emissions modeling by the EPA and the Georgia EPD are based on emissions reported using the EPA’s destruction or removal efficiency protocol from the previous stack test, the modeling results from the 2018 National Air Toxics Assessment and Georgia EPD’s modeling exercise from June 2019 would have shown significantly lower emissions in their models as well, BD concluded.
Using the updated 99.999% destruction efficiency, BD estimates 2019 emissions from the stack will be approximately 3 to 5 lbs. BD will report 2019 emissions through the EPA’s Toxic Release Inventory using the updated destruction rate by July 1, 2020, in accordance with EPA requirements. BD does not intend to restate reported emissions from 2018 or earlier based on the results of this stack test.