Actions to Protect Communities and Workers from Ethylene Oxide (EtO) Risk
Ethylene Oxide (EtO) is a colorless gas. It is typically odorless at levels found in air outside of facilities or in communities. EtO is a chemical that is used for two main purposes:
- Make other chemicals and products like antifreeze and plastic bottles.
- Sterilize items that can’t be sterilized by other methods, such as some types of medical equipment.
According to the Food and Drug Administration, EtO is currently used to treat approximately 50 percent of sterile medical devices, about 20 billion medical devices annually. For some devices, EtO is the only safe and effective sterilization method currently available.
Although important for sterilization, EtO is also known to cause cancer among people who are regularly exposed to EtO over long periods of time. When people breathe in EtO over the course of years it can increase their risk of cancers of the blood and, in women, breast cancer. EPA scientists have found no indication of short-term or acute health risks associated with EtO exposure in community or facility settings. EPA is working to reduce the long-term risks that might occur over the course of a lifetime or a career, in close coordination with other expert federal agencies including FDA, OSHA, and CDC. In addition, FDA is working to identify safe alternatives to EtO for sterilizing medical supplies.
Reducing EtO Emissions from Commercial Sterilizers: On March 14, 2024, EPA issued final amendments to air toxics standards for EtO Commercial Sterilizers. This action strengthens emission standards for nearly 90 commercial sterilizers that are currently operating across the country as well as for new sterilizers. These requirements will significantly reduce the amount of EtO that comes out of commercial sterilizers by 90 percent and will reduce risk in nearby communities to levels below the Clean Air Act benchmark for elevated risk.
In April 2023, EPA also issued a proposal that will further reduce risk in communities and for workers:
Reducing Risk to Workers in the Sterilization Industry: On April 11, 2023, EPA proposed a broad set of new protections under the Federal Insecticide, Fungicide, and Rodenticide Act that will reduce risk for all workers who use EtO to sterilize things and for others who work, live, or go to school near sterilization facilities.
EPA is committed to addressing EtO risk using the best science and every regulatory tool available under the law. As a part of this work, EPA completed a new draft risk assessment to understand how people are impacted when EtO is used to sterilize things. This analysis showed elevated risks for workers who spend an entire 35-year career in the sterilization setting and has informed EPA’s proposal of a comprehensive set of new protective measures to reduce risk.
Together this final action and proposal provide a path for EtO facilities to operate more safely while continuing to fill the national need for sterilized medical supplies and other products made using EtO.
Reducing EtO Emissions from Chemical Plants: On April 9, 2024, EPA announced a set of final rules that will significantly reduce emissions of toxic air pollution from chemical plants, including EtO and chloroprene. The reductions will dramatically reduce the number of people with elevated air toxics-related cancer risks in communities surrounding the plants that use those two chemicals, especially communities historically overburdened by air toxics pollution.
Reducing EtO Emissions from Commercial Sterilizers
Under the Clean Air Act, EPA finalized new requirements for nearly 90 commercial sterilizers across the country. These requirements will reduce EtO coming out of these facilities by 90 percent. This will reduce EtO-related risk levels in all communities near commercial sterilizers down to or below the Clean Air Act benchmark for lifetime cancer risk. The final rule requires facilities to install new pollution controls, which have already proven to be effective and achievable based on the experience of some facilities in the industry. Facilities will be given reasonable time to install new technologies to ensure they can come into compliance while minimizing any potential impacts to the supply chain. The rule will also require nearly every facility to use continuous emissions monitoring (CEMs) to demonstrate compliance, with the exception of smaller facilities that use less than 0.05 tons of EtO per year.
The Clean Air Act standards EPA is finalizing will reduce lifetime cancer risks associated with EtO emissions from commercial sterilizers down to or below the benchmark of 100 cancer cases per million people exposed under the Clean Air Act. And the number of people with a potential risk of greater than or equal to one in one million will be reduced by approximately 92 percent.
EPA conducted extensive outreach leading up to this final action, including public hearings, community meetings and webinars. More than 100 people provided oral testimony and the Agency received more than 46,000 comments to the rulemaking docket. The feedback and input generated by this outreach informed and strengthened this final rule.
Read more about the final rule for commercial sterilizers.
Reducing EtO Emissions from Chemical Plants
On April 9, 2024, EPA announced a set of final rules that will significantly reduce emissions of toxic air pollution from chemical plants, including EtO and chloroprene. The reductions will provide critical health protections hundreds of thousands of people living near chemical plants that make synthetic organic chemicals and plants that make polymers and resins. It would do this by reducing emissions of hazardous air pollutants (also called “air toxics”) including the potent air toxics EtO and chloroprene. The proposal would dramatically reduce air toxics-related cancer risks for people who live near approximately 200 plants across the country that make synthetic organic chemicals. Most of the facilities covered by the proposal are owned by large conglomerates.
The biggest risk reductions from chemical plants would come from cutting EtO emissions from eight plants that currently pose the highest risk to surrounding communities in Texas and Louisiana.
Reducing Risk to Workers in the Sterilization Industry
In addition to new emissions standards, EPA is proposing a comprehensive set of new mitigation measures that will decrease risk for workers who use EtO to sterilize products and equipment and for others who live, work, or go to school or daycare near sterilization facilities.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA’s proposed interim decision includes new protective requirements including:
- Prohibiting certain uses of EtO where alternatives exist including use in museums, archival settings, beekeeping, some cosmetics, and musical instruments;
- Reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance;
- Requiring engineering controls, such as automation or emissions capture technology; and
- Requiring Personal Protective Equipment (PPE) to be used in sterilization facilities when tasks are performed that may result in EtO exposure.
Some commercial sterilization facilities have already successfully implemented some of these measures, including reducing the amount of EtO used for sterilization and installing engineering controls that reduce worker and community exposures. EPA’s proposal would now require these measures nationwide to further protect workers at EtO commercial sterilization facilities and healthcare facilities and people in communities near these facilities.
EPA is proposing that workers in sterilization facilities wear PPE during certain tasks of the sterilization process when EtO exposures could be higher, and unprecedented real-time monitoring of EtO using technology that can accurately measure EtO within sterilization facilities down to 10 parts per billion (ppb). If levels surpass 10 ppb, workers would be required to wear PPE. EPA is also instructing industry to develop technologies and methods to quantify lower concentrations of EtO, below 10 ppb), inside contract sterilization facilities.
EPA’s proposal also includes new data collection and reporting requirements that would help identify and improve protective monitoring technologies and assess the effectiveness of the proposed mitigation measures. Based on this data, EPA intends to initiate the next round of registration review for EtO earlier than the mandated timeframe, including assessing these measures and incorporating additional protections based on advances in technology that occur.
Learn more about these risk reduction measures.
New Risk Assessment: Workers and Others Who Work, Live, or Go to School Near Commercial Sterilization Facilities May Face High Risk
EPA is moving urgently to advance these new protections based on the agency’s latest assessment of lifetime risks from EtO in occupational settings, which are more significant than previously understood. Of note, EPA has not found that exposure to EtO causes short-term or acute health risks.
EPA’s new analysis, released in April 2023, estimates the additional life-time cancer risk associated with continuous workplace exposure to EtO for 8 hours a day, for 240 days per year, over a period of 35 years in an occupational setting. This risk estimate is between 1 in 36 and 1 in 10 for workers who apply EtO in sterilization facilities, and between 1 in 25 and 1 in 12 for workers who apply EtO in healthcare facilities.
In commercial sterilization facilities, EPA also found that workers who do not directly handle EtO, but who work in other areas of these same facilities, and people who work, live, or go to school very near to these facilities may also be at increased risk. EPA expects risks to be much lower to those near hospital sterilization settings than those near commercial sterilization facilities. The amount of EtO applied in healthcare facilities is significantly less than the amount of EtO applied in commercial sterilizing facilities.
These estimates are based on current understanding of facility operations and do not reflect the mitigation measures that are being proposed. These measures are expected to reduce risk.