A new EPA rule cutting exposure to cancer-causing ethylene oxide will require further emissions cuts from Colorado medical sterilizers like Lakewood-based Terumo BCT, according to state officials, who said Thursday they welcomed the federal action on the highly toxic substance.
Four facilities in Colorado, including Terumo’s large sterilizing operations, must meet the new rules requiring 90% cuts to emissions of ethylene oxide, or EtO, from previous regulations, according to the Colorado Department of Public Health and Environment. Lakewood neighbors of Terumo have questioned the plant’s operations since federal and state officials said in 2022 that EtO exposure levels might eventually lead to higher than expected numbers of cancer cases in the area.
Terumo has another layer of EtO-filtering systems underway, and state officials said Thursday the Air Pollution Control Division “will conduct air quality monitoring around both before and after the new equipment is in place and fully operational. The follow-up monitoring will likely start in fall 2024.”
The new rules will “require continuous emissions monitoring and quarterly reporting for most commercial sterilizers,” according to the EPA’s announcement Thursday.
Environmental advocates welcomed the EPA’s focus on the toxic gas, but wanted more.
“We’re excited EPA held its ground against intense industrial pressure to weaken the EtO rule for emissions levels,” said Ean Tafoya of Colorado GreenLatinos, who graduated from Lakewood High School near the Terumo plant. “Unfortunately, the rule came up short on ensuring fence-line and community monitoring of the impact from emissions from facilities and warehouses where sterilized goods are stored.”
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Earthjustice, a longtime advocate for tighter EtO regulation, also backed the EPA move. But they also sought more requirements for community air monitoring around sterilizing plants, and are still pushing the EPA to ban EtO use in food sterilization. The substance is used to prevent bacteria in spices and other dried foods.
Colorado supports the new EtO rules from EPA, the state said in a statement from division director Michael Ogletree. The EPA has been under pressure from national health advocates to tighten EtO regulation at the handful of facilities around the nation that handle large amounts of the sterilizing agent.
Terumo said Thursday that its current emissions controls capture and destroy more than 99% of EtO emissions, and that the company operates “well below our permissible limits.”
“We have invested in an additional system that will reduce emissions even further,” spokesperson Christine Romero said in a statement. Romero said the new EPA rules comprise more than 400 pages and that company analysts are still studying them before they can say whether even more control systems will be required.
The EPA heightened metro Denver concerns in 2022 when it released a map showing an outline of potentially higher cancer cases that might result from EtO emissions at Terumo. Terumo said at the time the increased dangers are theoretical and that unexpected cases have not appeared in actual epidemiological data from the area.
“State and federal regulators have identified no increased cancer rates in neighborhoods surrounding Terumo BCT’s Lakewood facility,” Terumo’s 2022 statement said.
That was confirmed by the state’s information page on its reviews of Terumo operations, where the health department said it did not find evidence of above-normal cancer cases in the area up through 2017 epidemiological data.
Terumo’s Lakewood plant makes blood drawing and infusion tubes and containers used in a number of medical settings, from blood banks to hospitals to apheresis centers. Before shipping, boxes of finished equipment are loaded into sterilization chambers.
An injection of ethylene oxide gas permeates the shipping boxes and packaging materials as the medical equipment sits on large pallets, Terumo has explained, in past media tours. EtO sterilizes the equipment over hours, and the boxes sit inside the sealed bays for hours longer while the gas dissipates.
A vacuum system sucks nearly all of the spent gas to an internal scrubbing system, Terumo said. The product boxes continue to emit leftover gases for some hours, and Terumo washes the bay with clean air that is also sent to scrubbers. When employees finally open the chambers to remove products for shipping, the vacuum pulls any remaining traces of air away from the open end and sends it through vents to filters. Terumo notes that EtO traces are so low at that point, the employees aren’t required by OSHA to wear ventilators or masks.
About half of medical devices that must be sterile are treated with EtO, the Food and Drug Administration says. The gas is one of the few methods that penetrates all packaging and will not damage delicate plastic or glass materials. The state’s ethylene oxide guide says short-term or acute effects from high exposure “include central nervous system depression, respiratory and eye irritation, and gastrointestinal effects. Long-term (chronic) exposure to ethylene oxide can cause respiratory and eye irritation, and damage to the nervous system.”
The guide says there is also some evidence of effects on reproduction, including miscarriages and decreased sperm count and increased risk of breast cancer.
A Colorado air toxin monitoring bill passed in 2022 gives state health officials new tools to assess the risks of specific chemicals, set limits in permits, and create six permanent monitoring stations chosen to assess the highest potential dangers in the state. Current state monitoring stations do not target acutely toxic chemicals, but rather measure an EPA-regulated set of combustion related, multiple-source air pollutants like ozone, nitrogen oxides, sulfur dioxide and particulate matter.
“We’re not ruling out Terumo as a possible site,” for one of the permanent monitors, Ogletree said last year. “It’s obviously on our radar.” When other community leaders suggested the state could put mobile monitoring equipment near Terumo, Ogletree said the state was considering that as well.
Ogletree said Thursday, “The division is committed to informing and engaging with community members on concerns about ethylene oxide. Our experts are actively working to further measure and reduce air toxics, more broadly across Colorado. This ongoing work includes implementing the state’s Public Protections from Toxic Air Contaminants Act.”
Community residents near Terumo and other national sterilization plants have sued the companies over past emissions, claiming EtO contributed to their serious health problems. Many of those lawsuits are still pending.
Terumo officials say the Lakewood plant has never emitted more than a fraction of the ethylene oxide waste that the EPA has previously allowed them under air permits.