EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end

Regulatory NewsRegulatory News | 03 August 2022 |  By 

EPA Administrator Michael Regan (Source: EPA)

The US Environmental Protection Agency (EPA) has published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. The agency also plans to publish a long-awaited rule later this year that could have serious consequences for medical device manufacturers as half of all US devices are sterilized with the gas. 


On 3 August, the EPA announced it will finally publish a rule that stakeholders have been waiting on for years regarding EtO air pollution. Advocacy groups have long complained that communities near EtO plants have increased incidence of certain cancers due to exposure to the sterilization agent. The medtech industry, on the other hand, argues the levels of EtO near such plants are comparable to what’s found naturally and there’s no evidence to prove they are responsible for increasing cases of cancer. 


While the US Food and Drug Administration (FDA) has been working to reduce reliance on EtO over the past few years, all eyes have been on the EPA to research the risk EtO potentially poses to communities and publish a rule on how much gas may be allowed into the atmosphere. 


“EPA analysis indicates that the air near facilities does not exceed short-term health benchmarks,” the agency’s statement said. “However, the concern is that a lifetime of exposure to EtO emissions could lead to long-term health impacts if some of these facilities continue to emit at the current levels. EPA is working with these facilities to take appropriate steps to reduce emissions.” 


The EPA notes that it has collected data through the Clean Air Act and used that data from about 100 commercial sterilizers to assess the potential of increased cancer risk. 


“The agency found elevated risks at or above 100 in a million in residential areas at 23 of those sterilizers,” according to the statement. “Long-term exposure to high concentrations of EtO can increase the lifetime risk of getting cancer.” 

Specifically, EPA analysis indicate that exposure to EtO for 24 hours a day for 70 years at levels often found near commercial sterilizers can increase a person’s risk for cancer. The agency named 23 facilities that it is concerned with releasing excess amounts of EtO into the atmosphere on its website. On top of the list are facilities in Puerto Rico, Maryland, Tennessee, Texas and New Jersey.  


EPA Administrator Michael Regan said the agency wants to make sure nearby communities are kept informed about its findings and efforts and characterized EtO as a “potent air toxin” that poses serious health risks from long-term exposure, which is much stronger language than has been used by the agency in the past few years. 


“Under my watch, EPA will do everything we can to share critical information on exposure risk to the people who need and deserve this information, and to take action to protect communities from pollution,” he added. 


As part of the agency’s efforts to inform communities, the EPA is holding a public webinar on 10 August and will reach out to specific high-risk communities to get their feedback. 


The EPA says it is still analyzing data as it receives them and is refining its scientific understanding of the risk potential. With that in mind, the agency plans to release additional data later in the year on the risk of EtO not just to nearby communities but also to those who work at EtO facilities and a rule on how much EtO can be released into the atmosphere by sterilizers. 


“EPA expects to propose an air pollution regulation later this year to protect public health by addressing EtO emissions at commercial sterilizers,” the agency announced. “At the same time, EPA will release proposed limits on how EtO can be used within sterilization facilities with the goal of reducing risks to workers who handle EtO and those who are exposed in other ways like working or attending school near a facility. The agency is working with state and local governments, territories, tribes, facilities, and other partners to identify and implement near-term steps to reduce this pollution as soon as possible.” 


The environmental regulator however also notes that EtO sterilization is critical to ensuring medical devices are safe to use and there aren’t disruptions in the device supply chain. 


“EPA is committed to addressing the pollution concerns associated with EtO in a comprehensive way that ensures facilities can operate safely in communities while also providing sterilized medical supplies,” according to the statement. 


While steam, heat and radiation also are used to sterilize medical devices, EtO is often the preferred choice because it can permeate into and through small spaces such the pores of cardboard boxes that medical devices are often packaged in. EtO is effective in breaking down genetic materials to eradicate bacteria, viruses and other microbes that may be present on medical devices but that’s also why it has the potential to cause cancer in high enough doses. 


Several states have taken action to restrict the use of EtO in recent years. For instance, Illinois law requires ethylene oxide facilities to recapture all the gas they have emitted, leading some sterilizers to leave the state. Massachusetts and Georgia also have sought to further restrict the use of the gas. Facilities in Georgia and Michigan have closed either temporarily or permanently over concerns they have leaked dangerous levels of EtO into the environment. 


Scott Whitaker, CEO of AdvaMed, said it’s critical that the EPA is clear about the science and actual risk posed by EtO sterilization. He praised the agency for being forthright about what it does and does not know about the potential risks and for acknowledging that more research needs to be done.  


“It is critical that the EPA get this right. Too much is at stake,” said Whitaker. “The shutdown of medical device sterilization facilities due to misinformed political pressure, as well as the uncertainty regarding which regulations the facilities must adhere to, given the absence of an updated federal rule and the resulting patchwork of state and local regulation, would be disastrous to public health under the best of circumstances; it could be catastrophic, in light of the fragile global supply chain, which hospitals are already strained to address.” 


The FDA also is looking into EtO usage. The agency held a public workshop and requested stakeholder feedback to discuss reducing reliance on the gas to sterilize medical devices. It notes EtO is the most widely used medical device sterilization method in the US accounting for approximately half of all medical device sterilization. About 20 billion devices annually are sterilized via EtO, including wound dressings, routine hospital kits and more. 


“The FDA shares concerns about the release of [EtO] at unsafe levels into the environment,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health. “We have been proactively working with medical device sterilizers to reduce the amount of EtO they use while still effectively sterilizing products to help ensure they meet the EPA's standards for ethylene oxide emission levels. In addition, we have been working with companies on the development of novel sterilization methods to replace the use of ethylene oxide.” 


In June, the FDA said it was considering a pilot program to allow lower radiation levels for sterilization for premarket approved (PMA) products, though it would not apply to 510(k) devices. The pilot would include gamma radiation sterilization and possibly allow some products to be sterilized with radiation instead of EtO. (RELATED: FDA considers pilot for lower radiation levels for device sterilization, Regulatory Focus 8 June 2022)


In 2019, the agency also launched the EtO Sterilization Master File Pilot Program for PMA holders of high-risk devices, allowing certain changes between sterilization processes and facilities to reduce the use of EtO without compromising safety and effectiveness. To date, the agency says 11 sites and 28 class III devices are included in the pilot. Regulators say several organizations have also expressed interest in its recently announced 510(k) master file pilot program, which exponentially expands the number of medical devices that are eligible for pilot participation. (RELATED: CDRH Unveils Pilot Project for Sterilization Changes, Regulatory Focus 25 November 2019)


The FDA launched an Innovation Challenge the same year to encourage new strategies to reduce EtO emissions. Participating facilities were able to cut EtO emissions between 20%-35% while participating manufacturers were able to target an EtO cycle concentration up to two-thirds lower than is typical. Program participants also are exploring other sterilization methods such as vaporized hydrogen peroxide, supercritical carbon dioxide and nitrogen dioxide for certain types of medical devices.  


“Collectively, these programs encourage new ways to sterilize medical devices that reduce the potential impact of [EtO] on the environment and public health, and we are committed to continuing to prioritize these efforts,” said CDRH Director Jeff Shuren. “While signs of innovation are promising, other methods of sterilization cannot currently replace the use of EtO for many devices. To that end, we are equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”  


“Our supply chain program is ready to work with industry to help prevent and mitigate potential shortages due to reduced supply of certain ethylene oxide sterilized medical devices,” he added. 


EPA statement 


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