Ethylene Oxide Risk from Commercial Sterilizers
Ethylene Oxide (EtO) is a colorless and flammable 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 steam, such as some types of medical equipment.
According to the Food and Drug Administration, EtO is currently used to treat approximately 50% of sterile medical devices, about 20 billion medical devices annually. For some devices, EtO is the only safe and effective sterilization method currently available. However, EPA is working to reduce EtO emissions and FDA is looking to identify alternatives to EtO.
Although important for sterilizing things, EtO is also known to cause cancer. When people breathe in EtO over the course of many years it can increase their risk of cancers of the blood and, in women, breast cancer.
EPA has recently completed an analysis that shows that EtO emissions from some commercial sterilizers in the U.S. contribute to elevated cancer risk for people living in nearby communities. Specifically, exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cancer.
Clean Air Act Regulation for Air Toxics
Commercial sterilizers that use EtO must follow the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act. EPA is in the process of updating this regulation to reflect our new understanding of risk from EtO and technologies available to reduce this risk.
We anticipate that a proposed rule will be available for public comment later this year.
As a part of the process to develop the revised regulation, EPA scientists and analysts recently completed a risk assessment for communities near the approximately 100 commercial sterilizers currently operating in the United States. This assessment will inform the Agency’s upcoming regulation and is helping us to better understand where risk is and how to reduce it.
In the coming weeks, EPA plans to engage with communities facing the highest risk to hear about their concerns and answer their questions as we share details about this risk assessment, community risk, and efforts to reduce this risk. For more information about the specific dates, please visit the relevant community pages at the links below.
Updated Risk Assessment for EtO New Commercial Sterilizers
EPA scientists and analysts recently completed a risk assessment for communities near the approximately 100 commercial sterilizers currently operating in the United States. This assessment will inform the Agency’s proposed rulemaking process and is helping us to better understand where risk is and how to reduce it. This assessment is based on the most up-to-date information available from commercial sterilizers.
This risk information is current as of July 27, 2022. If EPA receives new data, we will update this information. The risk information is based on EPA’s latest modeling of EtO emissions from these facilities. We are continuing to collect and verify information about these facilities and its emissions. If there are updates to EtO emissions or the systems in place at these facilities, there may be resulting updates to the risk information.
EPA’s risk assessment for commercial sterilizers focused on the extra cancer risk that would occur if a person breathed air containing EtO at the level expected in a residential community near each sterilizer for an entire lifetime (24 hours a day for 70 years). This is in addition to cancer risk from other causes.
Because of the results of this risk assessment, EPA is initiating efforts to engage the communities where risk is highest. EtO emissions from the facilities listed below are contributing to elevated cancer risk at or above 100 additional cancer cases per million people exposed (or 1 additional cancer case per 10,000 people exposed. Details about these facilities and maps are available at the links below.
As of summer 2022, EPA is beginning a process to share information about this important issue with impacted communities. We will be scheduling community meetings in the coming weeks in the communities with risk at or above a cancer risk level of 100 additional cancer cases per 1 million people. For more information about when these meetings are occurring and how to attend, please see the individual community pages below.
Expanding Reporting Requirements for Sterilization Facilities
EPA is committing to broadening Toxics Release Inventory (TRI) reporting on EtO to include certain contract sterilization facilities that use EtO that are not currently required to report this information to EPA. Under the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313(b)(2), the EPA Administrator has the discretionary authority to extend reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of chemical releases at the facility, or other factors the Administrator deems appropriate.
In December 2021, EPA issued a decision extending TRI reporting requirements for EtO to 29 facilities. Some of the facilities must also report for ethylene glycol. Read the Federal Register notice announcing this decision. These facilities were required to start tracking their chemical activities and releases and other waste management quantities in January 2022 and, if appropriate, submit TRI data beginning in 2023.
TRI is a resource for learning about annual chemical releases, waste management, and pollution prevention activities reported by nearly 21,000 industrial and federal facilities.
Workers in contract sterilization facilities that use EtO and communities – including historically underserved communities – living near these facilities are potentially at the highest risks of being exposed to EtO. Making more information available will inform the communities that live near these facilities and will assist the agency in identifying and responding to any human health and environmental threats such releases may cause. Having to report releases to TRI makes companies more aware of their use and emission of pollutants and can lead companies to find ways to reduce those emissions.
Locations and names of sterilizers where there are elevated risks at or above 100/million to nearby communities
A national public webinar was held on August 10, 2022.
A recording of the webinar and presentation materials (in English) are posted below. A compliant version of this webinar recording will be published here once available. The webinar recording in Spanish and Simplified Chinese will be provided when available.
If you wish to receive information about upcoming EtO-related actions and activities, please complete the form below. We will not share your information with any third party.
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