EPA Considers New Requirements for Toxic Chemical Used in Medical Equipment Sanitization at Coventry Facility
November 2, 2021
COVENTRY, R.I. — Proposed Environmental Protection Agency (EPA) reporting requirements on a dangerous chemical used to sterilize medical equipment could throw a loop into the pandemic-weathered medical supply chain, and a local facility is on the list of those that could feel the effects.
Last month, the EPA alerted 31 facilities nationwide that they could face new reporting requirements next year related to the use of ethylene oxide — a carcinogenic chemical widely used to sterilize medical devices. The requirements, which were flagged by the Food and Drug Administration (FDA) in 2019 as a potential threat to sanitization procedures, could impact Boston Scientific Corporation’s Coventry facility.
“EPA believes this facility may meet TRI [Toxics Release Inventory] reporting thresholds for on-site activities involving ethylene oxide and ethylene glycol, and the public would benefit from increased information disclosure related to those releases,” according to an EPA letter sent to Boston Scientific on Oct. 1.
Boston Scientific was given 30 days to respond to the EPA request for comment before the reporting requirements are finalized. Boston Scientific supplied a response to EPA, but both parties declined to share the communication with ecoRI News. According to EPA public affairs specialist Emily Bender, relevant documents will be made public after deliberations are complete and if action is pursued.
Ethylene oxide is a flammable, colorless gas used to sterilize medical equipment and in the production of ethylene glycol — a clear, colorless liquid used in antifreeze and hydraulic brake fluids, which can cause severe health issues if ingested.
According to a 2016 EPA assessment, ethylene oxide is “carcinogenic to humans” if inhaled and was linked to an increased risk of lymphohematopoietic cancers and female breast cancer. Ethylene oxide was also found to be genotoxic and mutagenic, meaning it can interact with and alter cellular DNA.
“Because [ethylene oxide] is mutagenic … and children may be more susceptible to the harmful effects of mutagenic substances, the proximity of young children to a facility using ethylene oxide concerns EPA,” according to the Oct. 1 letter
A total of 71,144 people, including more than 3,500 children younger than the age of 5 — live within 5 miles of the Coventry facility, according to the EPA. Data from the National Center for Education Statistics show at least 16 schools are also located within a 5-mile radius of the Industrial Drive facility.
The Rhode Island Department of Environmental Management (DEM) Office of Air Resources permitted operations at Boston Scientific’s Coventry facility starting in 2010, after it was bought from the STERIS Corp. According to a permit issued in May, ethylene oxide emissions are reduced using two primary tray aerators, which process wastewater produced during the sterilization process. Process air is also routed through a wet acid scrubber, which removes gases and particulates and reduces smoke opacity, and a series of dry bed scrubbers, which reportedly reduce emissions by 99.9 percent.
DEM caps emissions from the facility at 67 pounds per day and 1,298 pounds annually, and facility usage of ethylene oxide must fall under 1,500 pounds daily, according to the permit.
Karen Slattery, deputy administrator of DEM’s Office of Air Resources, said the state agency requires Boston Scientific, and other ethylene oxide users, to “report information on processes and amount used so that an estimate of emissions can be made.”
If the EPA decides to act, Boston Scientific would be required to submit annual information related to ethylene oxide and ethylene glycol to the EPA’s Toxics Release Inventory. The TRI gathers data related to the release and waste management of 770 toxic chemicals.
The EPA has long flagged ethylene oxide and ethylene glycol — produced using ethylene oxide — as potentially hazardous chemicals, listing both on the TRI since 1987. According to Bender, the EPA is also reviewing the rules regarding ethylene oxide commercial sterilizers, which were established in 1994 and last updated in 2006.
Boston Scientific was obligated to report data on ethylene oxide and ethylene glycol until 2005. The requirements were since dropped, but if reinstated, reports would include information on the quantity of regular and accidental releases of ethylene oxide and ethylene glycol, and releases from “catastrophic or other one-time events.” Reports on the maximum amount of ethylene oxide and glycol stored on-site in a calendar year, as well as the amount contained in waste both on- and off-site, would also be required.
Boston Scientific spokesperson Kate Haranis said the company had “no concerns with the EPA’s letter regarding reporting requirements.” She said the facility would comply with all reporting requests from EPA, DEM, and other agencies.
“When ethylene oxide is used in our sterilization process, we regularly monitor exposure levels and comply with all legal and environmental regulations, including the parameters of our permit from the state of Rhode Island,” she said.
Haranis said no interruption to Boston Scientific operations is anticipated related to the pending reporting changes.
The medical industry has warned that the tightening of environmental regulations related to ethylene oxide could trigger a shortage of sanitized equipment available to medical facilities already stretched thin because of the coronavirus pandemic. Even before COVID, in 2019, officials at the FDA told MedTech Dive that a pause in facility operations could lead to shortages and medical logistical failures.
“We would be concerned if even one additional facility shut down,” Suzanne Schwartz, director of FDA’s Office of Strategic Partnerships and Technology Innovation, told MedTech Dive. “We will start to see spot shortages; there is no question about that. In terms of a more catastrophic national impact, with two facility shutdowns, it is almost a certainty.”
According to an article in Clinical Oncology News in May 2020, the offline status of several ethylene oxide facilities, with operations paused to enhance safety features and eliminate emissions, may have contributed to equipment shortages early in the pandemic. The EPA agreed to move some ethylene oxide facilities back online during the pandemic to meet demand.
Ethylene oxide is used to sterilize about 50 percent of all medical devices in the United States, according to the FDA, including gowns, wound dressings, syringes, surgical kits, catheters, and ventilators.
Alternative sterilization techniques do exist, including heat, radiation, and vaporized hydrogen peroxide, which has been used in facilities across the country to sterilize N95 masks for reuse during the pandemic. But for many medical devices, ethylene oxide is the only method that can effectively sterilize without risking damage to delicate features.