The Environmental Protection Agency has announced new proposed standards to reduce exposure to ethylene oxide (EtO). The colorless gas is used to produce other chemicals and products like antifreeze or plastic bottles. It is also used to sterilize medical equipment, and it has been linked to an increased risk of cancer, especially for those who work with the substance or live near facilities that do. A new analysis from the EPA estimates an additional cancer risk between 1 in 36 and 1 in 10 for those who apply the chemical in sterilization facilities. The risk is between 1 in 25 and 1 in 12 for workers who use EtO in healthcare settings.
The announcement on April 11 came four months after nonprofit environmental law group Earthjustice filed a lawsuit against the EPA for failing to update its EtO emissions rules on schedule. While the federal Clean Air Act requires the agency to update its rules on sterilizers every eight years, the last time the EPA reviewed these rules was in 2006.
Sheila Serna is the climate science and policy director at the Rio Grande International Study Center (RGISC), one of the groups involved in the Earthjustice lawsuit. The lawsuit is still in progress, but Serna told Prism she believes the pressure has helped push the EPA to act.
“I think that it’s a result of the activism from RGISC and [on] the other plaintiffs’ part that has pushed the needle and moved this proposed rule to be released,” she said. “I do think that we’ve played a really big part.”
RGISC is located in Laredo, Texas, which is 95% Latinx. An estimated 22% of the population lives in poverty, almost double the national average. Laredo is also one of 23 cities where the EPA found an elevated risk of EtO exposure and cancer. A Midwest Sterilization plant was identified as a major source of these emissions in Laredo, though the plant has implemented some mitigation strategies since the analysis.
More than 700 miles away in St. James Parish, Louisiana, Sharon Lavigne serves as the founder of RISE St. James. Lavigne founded the organization to advocate against a proposed Formosa Plastics expansion in the area after discovering that the plant, located two miles from her home, would emit EtO to the surrounding neighborhood.
St. James Parish’s fourth and fifth districts, which are 53% and 86% Black, respectively, were recategorized from residential to residential/industrial in 2014.
Lavigne said the new rules from the EPA give her hope. When asked if she believed the moves on EtO were driven by public pressure, Lavigne said she thought it had more to do with what the EPA saw when agents visited the parish.
“The good thing is, they came down to see about us. They cared enough to come down to Cancer Alley, to St. John the Baptist Parish, to St. James Parish, to see how we’re living,” Lavigne said. “And when they saw all these industries right next to people’s homes, it was devastating.”
The EPA’s proposed rule requires all 86 commercial sterilizers nationwide to comply with stricter pollution controls. These include reducing the amount of EtO used where possible, installing engineering controls, and conducting real-time monitoring of the substance. If implemented, the EPA said these new efforts could reduce EtO emissions by 80% per year.
According to the announcement, new technology is able to accurately detect EtO in facilities down to 10 parts per billion. If levels exceed that threshold, workers would be required to wear personal protective equipment.
Serna, who previously worked as an inspector for the Texas Commission on Environmental Quality, said this requirement is sorely needed, because she saw many workers without face shields while inspecting Midwest Sterilization.
“Especially the forklift drivers who would go into the chambers after the sterilization process was completed—they did not have any full-face or half-face respirators,” Serna said. “There’s no way all the ethylene oxide was removed from those chambers before they were opened.”
Five days before the EPA released these proposed standards, the agency issued a separate proposal requiring certain plants that produce air toxics like EtO to conduct fenceline monitoring, which is done around the perimeter of a facility. Serna said this kind of measure would make sure pollution control equipment inside the facilities, meant to capture fugitive emissions, is functioning correctly. She said fenceline monitoring should be required at all plants using EtO to protect nearby residents.
When it comes to broader EtO use, the agency has opted to rely on total enclosure systems within the facilities, citing their effectiveness at detecting EtO levels.
According to the EPA, communities near the plants covered by the April 6 proposal have a higher-than-average percentage of Black, low-income, and Latinx residents. The agency said it expects the new standard to reduce the disproportionate harm these groups face due to pollution.
The standards covered in last week’s proposal would work on an expedited timeline, requiring facilities to comply within 18 months of implementation. Violators could face civil or criminal enforcement action. Serna told Prism that 18 months is still too long to wait, especially when it is unclear when the standards will be finalized.
Lavigne agreed.
“People are dying this year, dying today,” she said. “People are getting sick today. So that means that we have to wait a whole ‘nother year?”
Representatives from the EPA said mitigation measures could be implemented quicker than the regulatory process requires with cooperation from states and individual facilities.
“For example, in Georgia, the state worked with two commercial sterilizers in the Atlanta area, which have installed equipment to significantly reduce EtO emissions,” said Shayla R. Powell with the EPA Office of Public Affairs in an email to Prism.
In the meantime, the agency aims to find alternatives to EtO by learning from initiatives like the Food and Drug Administration’s sterilization master file pilot programs.
The EPA has encouraged the stakeholders from communities, industry, and public health to participate in its public comment process.
The new rule has already drawn pushback from medtech companies. Lobbying group AdvaMed released a statement from president and CEO Scott Whitaker, who downplayed the risks of working with EtO.
“The EPA’s characterization of employee risk appears to overstate the risk and disregard the strong employee protections already in practice,” Whitaker’s statement reads.
While the EPA acknowledged many facilities are already implementing some of the measures it calls for in the proposal, the new rule would require them nationwide.
Both Lavigne and Serna expected the industry to resist the changes.
“I think our challenges are mainly [the] industry’s constant push of misinformation and discrediting EPA’s science and EtO risk assessment,” Serna said. “So we’ve had to mobilize and advocate for ourselves, which is why we formed the Clean Air Loredo Coalition.”
Lavigne added, “I know the industry is going to be against the EPA. I understand that. But if EPA follows the laws and does what it’s supposed to do, don’t worry about how the industry feels. You’re supposed to be protecting the people, not the industry.”
Agency representatives directed those who are concerned about their EtO risk to keep up with routine health screenings and utilize resources like the clinician brief on ethylene oxide and the Pediatric Environmental Health Specialty Unit locator.
The EPA will host a public webinar on Monday, May 1 at 8 p.m. EST to discuss its proposed actions on EtO exposure. The public comment period will be open for 60 days after the docket’s publication in the federal registrar.
