Even as federal agencies push for sterilization plants to reopen and boost production to bolster supplies of medical products needed to fight COVID-19, a squabble has broken out among federal environmental regulators, in part, over continued demands for federal officials to engage with activists seeking to shut down sterilization plants.
On March 31, U.S. Environmental Protection Agency Administrator Andrew Wheeler demanded the agency’s inspector general rescind and redo a report, which chided the EPA for allegedly not offering enough opportunities for those living around 16 facilities, including sterilization plants, that use a chemical known as ethylene oxide, to sound off on the continued operations of the those facilities.
“The tone and substance of this report indicates a disconnect in the U.S. EPA IG’s office,” Wheeler said in a statement responding to the report.
U.S. EPA Administrator Andrew Wheeler
That report also had been issued on March 31 by the EPA Inspector General’s office.
In the report, the EPA IG called on the EPA to conduct a series of public forums “for the interactive exchange of information” over alleged risks to public health from the use of ethylene oxide (EtO).
EtO is used by chemical manufacturers as a building block compound to make a host of different essential consumer products. The chemical is also used by companies to sterilize medical devices for distribution to hospitals and other health care settings.
The devices sterilized include personal protective equipment (PPE), including masks and gowns, as well as IV tubes, catheters, respirators, syringes, and other medical equipment used by doctors and nurses in operating rooms and to treat patients infected by the novel coronavirus that causes COVID-19.
The EPA has hosted or engaged in public forums over the use of EtO at sterilization plants since 2018. Those began in the Chicago suburb of Willowbrook, after the release of a report from the federal Agency for Toxic Substances and Disease Registry used EPA EtO emissions data and modeling to assert a heightened cancer risk faced by those who lived near a now-shuttered sterilization plant operated by commercial sterilizer Sterigenics in Willowbrook.
Sterigenics has consistently disputed the findings in that ATSDR report.
In 2018, it was reported ATSDR regional director Mark Johnson told those attending a town hall a week after the report was released, he “did not anticipate the report would be released.” That followed a reported conference call, which included EPA representatives, in which Johnson reportedly told local government officials that the report had not been intended for public release, was for “internal use only” and was based on “worst case scenarios.”
However, the report has been seized upon by activists and trial lawyers to sustain their efforts to drive sterilization plants, including the Willowbrook plant, out of business.
In the months that have followed, those anti-EtO efforts have resulted in the closure of four sterilization plants, including two each in Illinois and Georgia.
Those closures produced alarms from the U.S. Food and Drug Administration and the medical device industry that the closures were straining the availability of medical devices, even in normal environments. However, as the COVID-19 outbreak has slammed hospitals across the country, federal officials have urged state officials to allow sterilization plants to reopen to produce badly needed PPE and other sterilized supplies for hospitals responding to COVID-19.
The Willowbrook Sterigenics plant remains closed.
But a sterilization plant operated by medical device maker Medline in Waukegan was finally cleared to reopen last week, after Medline voluntarily ceased operations at the plant in December to install and test a new $10 million emissions control system mandated by the state of Illinois to comply with the state’s strict new EtO emissions rules.
In Georgia, the FDA wrote to Gov. Brian Kemp, asking the state and officials in Cobb County to allow the Sterigenics plant there to reopen.
Cobb County, however, only partially relented, allowing Sterigenics to sterilize only PPE.
The company sued, however, claiming the county was acting to satisfy anti-EtO activists and had concocted illegal reasons to keep them under operational restrictions.
A federal judge has issued a temporary restraining order to allow the company to resume full operations.
Even as the federal government pushes for more production of sterilized medical equipment amid a pandemic that has shut the nation down, the EPA inspector general said the EPA still should move ahead with forums that have been dominated by anti-EtO activists, particularly in the Chicago area and in Georgia.
The report indicated the EPA had conducted forums in communities near nine of 25 identified “high-priority sites.” However, the inspector general recommended the EPA still meet with residents near 16 of the sites, which include chemical manufacturing plants and sterilization facilities.
In the report, the inspector general’s office noted they could identify no law or rule requiring the EPA to conduct public forums in those communities. Instead, the report pointed only to the EPA’s mission statement to justify its recommendation the EPA not “delay providing forums for interactive outreach with residents in these communities.”
The report triggered a quick response from EPA Administrator Wheeler.
He said the report caught EPA leadership by surprise, as he said the agency was not aware of any “unresolved issues” between the EPA and its IG’s office.
Wheeler noted the EPA is already in the process of crafting new rules on EtO emissions, and has held public hearings and collected public comments for months. He said the EPA expects to release proposed rulemaking regarding EtO use by commercial sterilizers this summer.
“… We are formally requesting the EPA IG rescind the report so it can be appropriately updated,” Wheeler said in the statement.