At town halls in August, Georgia’s chief environmental regulator told anxious residents in Cobb and Newton counties that the fastest way to curb emissions from medical sterilizing plants was to seek “voluntary” improvements, rather than taking the companies to court.
The message was in keeping with the state’s longstanding business-friendly approach to environmental regulation.
But on Monday, the state made a dramatic about-face by seeking a court order to temporarily shut down sterilizing operations at the Becton Dickinson plant, one of Newton County's largest employers. Two weeks ago, the state broke precedent and said it will not issue a new permit to Sterigenics, near Smyrna, until it can prove its emissions will be as clean as the company claims.
Both companies have permits to legally emit the carcinogenic gas ethylene oxide from their facilities.
The moves have upended decades of past practices in which regulators attempted to coax companies into reform through negotiated consent orders and fines. The Georgia Environmental Protection Division hasn’t sought an injunction for a violation of state environmental law since 2007, a spokesman said.
The tougher approach has shocked both the regulated companies and critics who have long complained that EPD goes too soft on polluters.
“It’s environmental regulation at a level we’ve never seen, not for a long, long time,” said Neill Herring, who has been a lobbyist for the Sierra Club’s Georgia branch for decades. “This is definitely a new leaf, so far.”
Organized protests, letter-writing campaigns and other pressure from residents in politically important suburbs of metro Atlanta helped push the state to crack down on BD and Sterigenics, observers told The Atlanta Journal-Constitution.
Local governments in Covington and Cobb also played a role. Covington conducted seven days of independent air testing that, though not definitive, challenged the state's earlier findings that emissions from BD posed no serious threat. Cobb has squeezed Sterigenics over the validity of its building permits, forcing the company to halt operations.
Both efforts raised the stakes on Georgia officials to act.
Two months ago, Gov. Brian Kemp held closed-door meetings with executives from both companies in his office. Now he's squaring off with one of them in Newton County Superior Court.
On Monday, Kemp pilloried BD for “months of failed negotiations, empty promises, and misleading reports of ethylene oxide leaks.” The remarks came as the state sued to halt BD’s operations until the company proves it can work safely, accusing it of negligence and failing to act “expeditiously to accomplish reductions” in emissions.
Kurt Ebersbach, an attorney with the Southern Environmental Law Center, said he’s never seen the state seek a restraining order against a company in this way during his two decades of legal practice.
“I think it reflects the seriousness of the situation, and also that the two sides are clearly at an impasse,” Ebersbach said.
The state’s more aggressive posture also whipsawed BD, which sent a letter to Kemp Oct. 17 lamenting that “our partnership with EPD has gotten off track.” BD also accused state regulators and the media of contributing to overblown fears of ethylene oxide.
“We are profoundly disappointed by the escalating disruptive business environment in Georgia which is a result of decisions made by the EPD,” the company’s letter said. “The actions that EPD has taken … do not align with the expectations that you conveyed to all parties.”
Brian Robinson, a Republican political operative who formerly served as the spokesman for Gov. Nathan Deal, said Kemp didn’t initially “bash the industry” when concerns arose about ethylene oxide.
“He worked with them. He didn’t turn into a populist warrior overnight,” Robinson said. “He obviously feels the companies betrayed his good faith.”
Still, the state faces a high bar to convince a judge to suspend operations at BD.
Politically, Robinson said, “even if courts rule against the state, he’s in the right spot on this.”
“Standing up for Georgians against polluters is a political ad that writes itself,” Robinson said. “Maybe next time he’s got a rifle in his lap on TV he’ll be talking to a CEO. On the official leadership side, he’s laid down a marker that he won’t walk away from a fight.”
BD said in the letter to Kemp that the company “is in full compliance with all laws (and) operates well within regulatory limits.”
“We are confident in the safety of our plant, the skill and competence of our employees and the effectiveness of our processes,” BD said. “We also know that until science has a seat at the table, the hysteria over (ethylene oxide) will not be adequately addressed.”
In court filings Friday, BD said the state’s arguments fail to meet the standard necessary to close the plant, and there is “no evidence” ethylene oxide detected in the air originates from the plant or that the facility is a public health risk.
Until the state’s complaint the EPD had repeatedly said BD was in compliance with the law, according to the company’s court filing. BD said it has already implemented the fixes demanded by the state in its complaint.
The federal Food and Drug Administration, physician groups and a trade organization for the medical device industry have warned closing the Covington plant and curtailing use of ethylene oxide will hurt patients who need life-saving medical devices, BD said.
Kemp declined to comment on the specifics of the case.
“I took the oath to protect the public and that’s what we’re doing. I can’t really speak much more to that because we have a legal issue that we’re dealing with now,” Kemp told the AJC Wednesday. “Everybody will have their say in court.”
‘Environmental Permitting Division’
The sudden and muscular regulatory response has made for a jarring juxtaposition to how Georgia historically has treated industrial polluters — which has been mostly with compliance orders and “slap-on-the-wrist” fines that companies can treat as a cost of doing business, Ebersbach of the Southern Environmental Law Center said.
An AJC review of the EPD’s enforcement database, examining a five-year period ending in July, found that close to 90% of all penalties levied amounted to $5,000 or less.
Of about 3,300 enforcement actions in that period, only 10 resulted in six-figure settlements. The highest was a $378,000 fine on the city of Atlanta in 2016, for a litany of violations including spewing millions of gallons of sewage-tainted waste water into the Chattahoochee River and other creeks.
The highest air pollution penalty came earlier this year against International Paper Company — $143,000 for exceeding hydrogen chloride emissions limits at a mill in Rome.
“It begins with the permits themselves being lax, so you don’t have a lot of violations of the law because the permits are very easy to comply with,” Ebersbach said. “But the lack of significant penalties is the other side of that coin, which shows that the state wants to inflict some pain, but not enough that’s really going to matter in a larger sense.”
Herring, the Sierra Club lobbyist, said he calls the agency the “Environmental Permitting Division.”
“They have this whole language about people that have permits — those are ‘customers,’” Herring said. “And they brag about their customer service, and how fast they get permits out, and how fast they renew them. They think that their job is to promote economic development.”
Officials with the EPD declined to be interviewed for this story, citing ongoing litigation. But in a September interview, EPD Director Richard Dunn and others in the agency defended how they had handled the two sterilization plants up to that point.
Few questions on BD’s lower emissions
The agency's business-friendly philosophy seemed to be on full display in EPD's dealings with BD and Sterigenics in the months following the 2018 release of a U.S. Environmental Protection Agency's National Air Toxics Assessment (NATA), which flagged census tracts near the plants for potential elevated cancer risks. Both plants legally use ethylene oxide, also known as EtO, to sterilize medical devices, such as catheters and surgical kits.
The federal EPA reclassified ethylene oxide as a carcinogen in 2016 and increased its cancer risk factor by up to 60-fold.
The AJC reviewed thousands of emails and other state records and found that, before the public became aware of the threat, state officials treated the NATA report with skepticism, declining to test the air around the plants. Instead, EPD’s air protection branch maintained that mathematical modeling would be more scientifically valid, and staffers spent months waiting for the two companies to hand over emissions figures and building and smokestack dimensions.
In January, records show, EPD regulators asked few questions when the BD plant significantly reduced their estimated emissions — from thousands of pounds down to hundreds of pounds per year. The company said in a letter that third-party stack testing from 2012 showed emissions were much cleaner than what had previously been reported.
Jason McCarthy, who leads a Covington-area chapter of the group Stop EtO, said he never trusted the state’s air modeling because he didn’t trust BD’s self-reported figures.
The Covington air tests, which were completed Sept. 23 and showed the presence of ethylene oxide well above federal EPA guidelines for safe long-term exposure to the gas, were "the first real independent test," McCarthy said. "They flat failed. What they chose to tell us is different than what's actually happening. Shocker."
BD says new emissions tests conducted in September showed the company is even more efficient than its 2012 tests and its current emissions are a fraction of what Georgia EPD used for modeling earlier this year.
Praise turns to criticism
In July, when WebMD and Georgia Health News highlighted the NATA report, residents mobilized against the two companies. The next month, executives from Sterigenics and BD met with Kemp.
Both companies committed to millions of dollars in upgrades to emissions controls. Sterigenics had already entered into a legally binding agreement known as a consent order, but BD did not.
After the meeting, Kemp praised Sterigenics for signing the consent order and panned BD.
But Sterigenics quickly got sideways with Kemp by proceeding with its emissions upgrades without giving the state time to review its plans.
Cobb County officials stepped in and reclassified the facility from “storage” to “high hazard industrial” and imposed more stringent fire safety regulations. Until the county issues new construction permits, the facility is prohibited from construction or sterilization.
Sterigenics has threatened to respond with legal action, accusing the county of causing “irreparable harm.”
Even if Sterigenics does receive the necessary county approvals, the state has now said it will not issue a new operational permit until performance testing is completed on the new system to ensure it really is as efficient at capturing emissions as the company claims.
EPD director Richard Dunn said the company has not responded to written notification of the testing requirements.
“We thought it would just be good, given the precision that they are assuming in the permit application, that we actually test that,” Dunn said Tuesday.
A leak at BD
BD officials thought their August meeting with Kemp had gone well, and later acted with surprise when Kemp publicly criticized them.
Emails between BD and state officials since August, contained in BD’s court filings, show talks between the two sides were cordial, with BD officials providing frequent updates about upcoming emissions tests and plans to upgrade its facilities.
But relations seemed to change in September. BD revealed a leak of 54.5 pounds of ethylene oxide that occurred from Sept. 15-22, caused by a valve that wasn’t properly closed. Seven days of air testing by Covington, which overlapped several days with the leak, showed elevated levels of the gas and triggered alarm in the community.
The air test readings prompted Covington Mayor Ronnie Johnston and City Council members to call for the plant to suspend operations.
BD refused. The company said the leak is fixed and experts hired by the company said the release posed no danger to the community.
Johnston said when the results came in he “worked the phones,” to win support of state and local officials to demand BD suspend operations.
“I think the test results opened up people’s eyes,” he said. “I think the strong stance the city of Covington took, it put some people in a position of saying, ‘Uh oh, we need to do something.’”
Five days later, the state filed suit. The case goes before Newton County Judge Eugene Benton on Monday.
Credit: John Spink / John.Spink@ajc.com
Credit: Nathan Posner for the AJC