This story is in collaboration with Atlanta News First.
Thousands of warehouse workers across the US are likely regularly exposed to the cancer-linked chemical ethylene oxide. More than half of the country’s medical equipment is sterilized with the compound, which the EPA considered a carcinogen. Ethylene oxide evaporates from the surface of these medical products after they are sterilized, creating potentially dangerous concentrations of air pollutants in the buildings where they are stored.
Generally, the EPA not regulate these buildings — in fact, regulators don’t even know where most of them are. The Office of Safety and Health Administration, the federal agency in charge of worker protection known by its acronym, OSHA, has also done relatively little to evaluate worker exposure in these warehouses. But last week, OSHA opened a new investigation into a Georgia warehouse that stores medical devices sterilized with ethylene oxide, raising questions about whether the federal government is starting to act more quickly on these risks.
On March 13, the US Marshals Service and the Douglas County Sheriff office assisted OSHA in executing a search warrant at a warehouse leased by medical device company ConMed in Lithia Springs, 17 miles west of Atlanta. The surprising inspection is almost two weeks after a start Grist and Atlanta News First investigation revealed that workers employed by ConMed were unknowingly exposed to the chemical. Ambulances were frequently called to the facility as workers convulsed from seizures, lost consciousness and struggled to breathe.
The workers sued the company in 2020, but the lawsuit was ultimately dropped earlier this year after a judge dismissed some of their claims, citing state labor laws. (Under Georgia law, once employees seek workers’ compensation from the state, they are barred from suing employers separately.) ConMed denies the lawsuit’s allegations that it knowingly exposed workers to ethylene oxide and maintains that no individual medical emergency can be linked to exposure to the chemical. A company representative told Grist that it is “committed to being in full compliance” with all applicable regulations and conducts monthly ethylene oxide testing for its employees to review.
“Given our longstanding full cooperation with OSHA, as well as the fact that OSHA has inspected our Lithia Springs facility five times since 2019, ConMed was surprised by the manner in which OSHA decided to inspect the facility on March 13,” a company representative told Grist in an email.
Ethylene oxide is a powerful fumigant, but it poses significant health risks and has been linked to lung and breast cancer as well as diseases of the nervous system. Once medical devices are treated with ethylene oxide, the chemical continues to evaporate from the surface of the product as it moves through the supply chain. As the devices are transported to warehouses, stored and then shipped to hospitals, the products continue to quietly release ethylene oxide, endangering workers who come into contact with them.
In a new rule it published last weekthe EPA has said that it will starting with the regulation of toxic emissions from warehouses located on the same site as the sterilizer plants that actually apply the chemical. However, the agency argued that limitations stemming from the regulatory definition of the sterilization industry meant that off-site warehouses would be excluded from oversight. Even if the agency could clear that bureaucratic hurdle, it does not have “sufficient information to understand where these warehouses are located, who owns them, how they are operated, or what level of emissions potential they may have,” in the agency’s words.
What little the EPA knows about the threat from off-site warehouses is gleaned from a study conducted by state regulators in Georgia. That effort initially identified seven off-site warehouses and found that at least one of the state’s warehouses emits more ethylene oxide than the sterilization plant that first treats the medical products before sending them out for storage. Federal officials will begin collecting data on warehouses, according to the new EPA rule, and use it to determine whether to develop an entirely new regulation governing storage facilities. Such a process could take years, according to experts who spoke to Grist. All the while, warehouse workers across the country will continue to breathe ethylene oxide, in many cases without their knowledge.
“Until eight years ago, a lot of people had no idea that the sterilizer facility, which looks like your average office park facility, was poisoning them,” said Marvin Brown, an attorney at the environmental nonprofit Earthjustice. “Now we have this additional issue of these warehouses that are still poisoning people, and most people have no idea that they live next to one or work at one.”
Brown and other experts Grist spoke with said the agency could take one of two approaches to regulating warehouses. It could expand the definition of regulated facilities under the sterilizer rule it finalized earlier this month, or it could create a new category of facilities covering warehouses and develop a separate rule. Both come with challenges.
Reopening a new rule that has already been finalized is difficult, according to Scott Throwe, a former EPA enforcement officer who worked on a number of rules the EPA enacted in the decade after amendments to the Clean Air Act was accepted in 1990. It’s a huge can of worms,” he said. “Once you open a rule, you have to fix it and you have to fix it. It snowballs.”
Alternatively, the EPA could draft a new rule entirely, he added, but the agency is unlikely to do that either, because of the sheer amount of effort such a process would require. Throwe said the EPA’s decision not to include offsite warehouse regulations in its new rule means the agency doesn’t have the time, the resources or the will to tackle the emissions at this point.
“They’re going to declare victory on this one and move on,” he said. “They’re not reopening that rule unless someone sues them.”
An EPA spokesman said the agency has an “incomplete list” of warehouses and has not conducted any risk assessments of them. As a next step, the agency expects to follow up with sterilization companies that did not provide detailed information about the location of their warehouses in response to a 2021 request. Once those responses are received, the agency plans to conduct emissions tests at some of the warehouses. If the agency decides to pursue a separate rule for warehouses, that process could take four to five years, the spokeswoman said.
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The rule governing medical sterilization facilities was one of the first industry-specific air quality regulations the EPA ever drafted. In its amendments to the Clean Air Act in 1990, Congress published a list of 189 toxic air pollutants and asked the agency to develop regulations for every industry that emits at least one of them. Officials published the first standards for medical sterilizers in 1994 with little fanfare, according to Throwe. At the time, regulators and toxicologists were unaware of the true risks of ethylene oxide, which was used to fumigate a range of materials, from books to spices to cosmetics. With the new law giving the agency just a decade to draft dozens of new regulations, officials rushed the process and sacrificed the effectiveness of some standards.
“It was like drinking from a fire hose,” Throwe said. “Unrealistic statutory deadlines have become court-ordered deadlines.”
Drafting new regulations for a polluting industry, regulators quickly learned, was a lot of work. In addition to collecting and analyzing large amounts of data about a specific type of plant’s emissions and configuration, officials had to consult engineering experts to understand what kind of technology they might ask companies to use to control their emissions. Decades later, the process for revising these regulations to better protect exposed communities is no different. It took the EPA nearly a decade to publish its new sterilizer regulations, and it did so under a court-ordered deadline after missing a previous deadline to update the rule. If the agency were to issue a new rule for warehouses, the time and resource commitment would be steep, Throwe said.
While the EPA is not responsible for worker safety, it has found a workaround to increase protection for those who come into close contact with ethylene oxide. Since ethylene oxide is a fumigant, the agency is also pursuing separate oversight under a federal pesticide law. The Federal Insecticide, Fungicide and Rodenticide Act requires the agency to evaluate pesticides every 15 years and determine where, how and how much of a given pesticide may be used. In April the EPA proposed a new set of requirements including reducing the amount of ethylene oxide used for sterilization and mandating that workers wear protective equipment while engaged in tasks where there is a high risk of exposure to the chemical. Since the law applies to all facilities where ethylene oxide is used – not just sterilization plants – warehouse workers can benefit from the requirements once they are finalized.
Some state and local agencies proactively regulate warehouses themselves. After the Georgia Environmental Protection Division found that one warehouse was estimated to emit about nine times as much ethylene oxide as the facility that sterilized it, the agency set out to find similarly dangerous warehouses. After scouring the Internet and reaching out to companies, the agency identified four warehouses that were emitting more ethylene oxide than allowed under state law. The agency is now in the process of issuing permits and requiring controls for those facilities.
In Southern California, which has a large concentration of sterilization facilities, the local air quality regulator has included requirements for off-site warehouses in a rule which is mainly aimed at sterilization plants. The rule categorizes warehouses into two tiers — those with an indoor space of 250,000 square feet or more and those with between 100,000 and 250,000 square feet. Depending on the size of the facility, the warehouses are subject to different reporting and monitoring requirements. In the course of developing the rule, the agency identified 28 warehouses that fall into one of these two tiers. The agency finalized the rule in December, and larger warehouses will be studied for a year to determine if they emit significant amounts of ethylene oxide.
Editor’s note: Earthjustice is an advertiser with Grist. Advertisers play no role in Grist’s editorial decisions.
