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A community's continuous battle against ethylene oxide
Covington calls for BD to temporarily cease operations, BD responds; GA EPD opens investigation
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COVINGTON, Ga. - The City of Covington officials received the preliminary air testing results this week from Montrose Air Quality Services, the company contracted by the city to test the air quality in the city and surrounding areas.

After reviewing the results, which showed high levels of ethylene oxide in the area, the city called for Becton Dickinson, or BD, to temporarily cease operations at the Covington facility until additional safeguards are put in place.

PDF: Montrose Covington Air Test Results

PDF: 10-16-19 Letter to BD

PDF: 10-16-19 ETO Results

"Montrose tested the air over a seven day period for the presence of Ethylene Oxide, a chemical used by the BD facility for the sterilization of medical equipment," according to the city's Oct. 16 news release. "Ethylene Oxide is a known carcinogen. Montrose’s results indicated particularly high levels of the chemical in the Covington Mill and Settler’s Grove neighborhoods."

Mayor Ronnie Johnston expressed his appreciation for BD's presence in the community; however, he felt there was no choice but to ask the facility to temporarily cease operations until additional safeguards are put in place and the efficiency of those safeguards are verified.

“This is not a decision we took lightly, but when the safety of thousands of residents and BD employees is at risk, the only prudent action is to temporarily cease operations until we can be assured the safety of our community isn’t compromised," he said.

Montrose conducted tests in 11 different locations from Sept. 17 to Sept. 23, according to the news release. 

The locations included: the BD sterilization facility, in close proximity to the Covington Square, the Covington Mill and Settler’s Grove neighborhoods, south Covington and the Covington Airport. 

"To establish baseline readings in the area beyond Covington, testing also was undertaken at the Mount Pleasant area near Highway 11 in eastern Newton County, in rural southeastern Newton County, at a location in Conyers and a Georgia EPD facility in south DeKalb County," the news release stated.

'A fundamental misunderstanding'

A letter from the city was sent to BD officials requesting for the temporary cease, and BD responded to the letter, claiming there was "a fundamental misunderstanding on how to interpret air monitoring results."

PDF: BD letter to Mayor Ronnie Johnston

BD replied to Johnston in a lengthy letter highlighting the reasons why Montrose's sample was limited and unable to correctly assess the amount of EtO in the area.

"BD and our third-party toxicology experts believe the residents of Covington need to understand the views of multiple scientists who have spent their careers performing long-term risk assessments on human health," the letter stated.

BD claimed the sample tested by Montrose are "very limited" and only "snapshots in time."

"No one result can be taken as representative of long-term exposures, nor can short-term sampling provide enough data to determine lifetime risks," the letter stated.

Also, the company stated all measurements should be considered, not just the highest value since values fluctuate up and down.

"Long- term health risk generally depends on consistent long-term exposure," the letter stated.

BD used the geometric mean of the city's measurements, which showed the locations where testing had been completed. 

The company claimed the measurements "are below levels proposed by the Texas Commission on Environmental Quality for public safety."

"For workplaces, measurements are well below the OSHA permissible exposure levels (1 part per million over 8 hours or 1,800 μg/m3)," the letter stated. "TCEQ’s levels for community exposure limits took into account background EtO from other sources, including the human body."

The letter continued, "There is no question from toxicology experts who understand how to interpret these data that BD is operating our facility safely and there are no risks to short- or long-term health of our employees or the community."

BD concluded the letter by informing the city that facility operations will continue as normal as "there are absolutely no short- or long-term risks that would necessitate any reduction in operations at the site."

'Independent testing is so critical'

Shortly after the exchanged letters between BD and the City of Covington, Congressman Hank Johnson, who represents parts of Covington and western Newton County, released a statement regarding Montrose's air quality results.

“The preliminary air testing results from Montrose Air Quality Services show why independent testing is so critical in providing oversight for public health and safety,” he said. “This is a good first step, but I would like to see BD Bard make the necessary safety upgrades and the Centers for Disease Control & Prevention do an ambient air quality study as part of a public health assessment.”

BD and the City of Covington letters were sent to Georgia Gov. Brian Kemp.

'We are surprised and deeply concerned'

Following the Montrose results, the Georgia Environmental Protection Division released a statement regarding the EtO leak at the BD facility in Covington from Sept. 17 through Sept. 22.

PDF: BD response to Georgia EPD statement

In an incident report filed Sept. 23, BD self-reported an EtO release of 7 pounds over an eight-day period. 

BD was not required to report this leakage to anyone as the leakage remained below the reportable quantity of 10 pounds over a 24-hour period, according to BD Communication and Marketing Executive Troy Kirkpatrick.

The EtO released over the 7-day period was roughly 54.5 pounds, according to the Georgia EPD statement.

"Inexplicably, the facility failed to properly notify the Georgia Environmental Protection Division," the statement stated.

The Georgia EPD expressed uncertainty over the impact of the facility's EtO leak may of had on the city's air testing results, even though BD formerly reported their results - which showed low levels of EtO - were completed at the same time as the city's to "provide duplicate samples for comparison purposes," the Oct. 16 BD press release stated.

"We are surprised and deeply concerned by Georgia Environmental Protection Division’s new position that BD did not properly disclose the unintended release of ethylene oxide," BD expressed in an Oct. 17 statement. "That is simply not accurate and misleading based on our prior communications with EPD and other stakeholders."

In the statement, BD claimed the facility provided "a voluntary verbal report to Georgia EPD" on Sept. 25; a similar verbal update was provided to the City of Covington on Sept. 26. A formal, written report to EPD, the city and Gov. Brian Kemp was issued on Sept. 27.

"The unintended release of ethylene oxide at BD’s Covington facility was below the reportable threshold of 10 pounds per 24-hour period," the statement stated. "However, BD voluntarily and properly disclosed the unintended release as soon as we had confirmed the amount and cause."

BD provided a timeline of events in the statement, even going as far as sharing screenshots of emails between the facility and the Georgia EPD:

November/December 2018

EPD contacted BD to have a meeting (late Nov.). BD hosted at our facility in Covington (so as to provide a tour) on Dec. 4. EPD discussed redoing modeling for emissions from the facility. 

BD agreed to any data requests the EPD may have. In the days following the meeting, EPD provided BD with a data request for air modeling purposes.

Jan. 2, 2019

BD provided facility information to EPD via letter. BD and EPD agree that BD will perform additional analysis on product for fugitive emissions information.

June 19, 2019

BD received a call from EPD to review results of modeling. EPD delivered results of modeling memo. BD asked if there are any actions to take. 

EPD stated no actions requested, and that we should wait to see what Federal EPA does with revised NESHAP rule.

Sept. 25, 2019 

BD contacted EPD to voluntarily report unintended EtO release due to valve issue. Notified EPD of all details known to date (issue identified and determined under-reporting limit; working to determine accurate amounts using engineering information). 

EPD provided follow-up calls one hour later letting BD know that EDP passed the information along to another unit who would document the report on EPD’s end. Site should expect to hear from that person at EPD.

Sept. 25, 2019

EPD reached out to BD to have a call with the site team regarding the release. Call included a summary of the release. EPD asked that BD send an e-mail with summary of the incident by end of the week. BD agreed. 

EPD asked about GC levels and quantification of release amount. BD explained due to dynamics of situation and conditions that correlation of GC readings and release would not give valid results. 

The call concluded with EPD expressing appreciation for our time and response and would likely be back in touch once the incident report was received. 

Sept. 30, 2019 

EPD emailed BD about placing EPD sampling canisters on property. They spoke by phone on Oct. 1 and set-up time for Oct. 2 where EPD visits the site about canister placement.

Oct. 1, 2019

BD had regular update call with EPD. Asked about any questions from the incident report on the valve. EPD said it’s with EPD unit who was appreciative of the level of detail in the report. 

EPD staff on the phone had not heard of any questions from EPD unit. BD subsequently forwarded incident reports to EDP staff on the phone via email, as they had stated they had not seen the actual report. 

Oct. 15, 2019 

BD received a call from EPD. EPD was in the process of closing the release report and had question about how BD calculated the numbers in the table BD sent them. 

Explained to EPD how we calculated and EPD seemed satisfied. EPD said they should close the report that day. 

BD asked if we needed to do anything further. EPD responded that there should be no further required from us.

Oct. 16, 2019

BD called EPD to inform that BD is releasing its air monitoring results (duplicates from city sampling). BD subsequently forwarded statement to EPD via email. 

The second email to EPD shortly after to provide a link to the AdvaMed Montrose Report on emission levels of common sources of EtO.

Oct. 16, 2019

BD received a call from EPD regarding the release report. EPD had received a question from a reporter and was preparing a response. 

EPD asked if the nitrogen wash phase was typically routed through the vacuum exhaust valve to the roof. BD stated the vacuum exhaust valve would be closed for all post exposure phases, including nitrogen wash and vacuum pump exhaust is directed to the RTO.

BD concluded the statement with how important sterilizing medical equipment was in Georgia.

"What has not received enough attention is the millions of patients that rely on BD devices that are sterilized in Georgia," the company said. "We would not trade employee or community safety for patient safety but knowing that the science has revealed the safety of our operations, we must advocate for the patients around the world who use the more than 250 million devices each year that are sterilized by BD in Georgia."

Creating public hysteria with no basis in science does not serve the public interest and is putting millions of patients at risk worldwide."