EPA informs public about risks of ethylene oxide (EtO) emissions from medical sterilization facilities

Posted by Brianna Crandall — September 16, 2022 — In August, the U.S. Environmental Protection Agency (EPA) announced its plans to engage and inform communities, states, Tribes, EPA logo 2022Territories, and stakeholders about up-to-date information on the risks posed by air emissions of ethylene oxide (EtO) from commercial medical sterilizers, as well as EPA’s efforts to address these risks.

EPA is releasing new information on specific sterilization facilities where lifetime risk levels are the highest to people who live nearby and is encouraging impacted communities to participate in a series of public engagements to learn more. Later this year, EPA expects to propose an air pollution regulation to protect public health by addressing EtO emissions at commercial sterilizers.

EPA analysis indicates that the air near sterilization facilities does not exceed short-term health benchmarks. 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.

EPA Administrator Michael S. Regan stated:

Today, EPA is taking action to ensure communities are informed and engaged in our efforts to address ethylene oxide, a potent air toxic posing serious health risks with long-term exposure. 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.

EPA is taking a phased outreach approach to engage the American public on this issue. This includes detailed web material with risk information for high-risk communities and a national public webinar (PDF presentation available on-demand) as well as upcoming community meetings. EPA will be following this national level outreach with community-specific engagements starting with communities where the risk is the highest.

EPA is continuing to gain access to more information about EtO, and to refine its scientific understanding of the risks it poses. Later in 2022, EPA will release additional, national-level information about the risks that ethylene oxide creates to those who work in EtO facilities, as well as those who spend time near them.

Medical sterilization is a critical function that ensures a safe supply of medical devices for patients and hospitals. 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.

Since 2018, EPA has been working with federal partners, communities, states, Tribes, and stakeholders to reduce the risks posed by EtO exposure. Recently, EPA collected information in support of a Clean Air Act regulation to control EtO from commercial sterilizers. EPA used updated EtO emissions information from commercial sterilizers to estimate the increased risk of cancer related to the EtO emitted from almost 100 commercial sterilizers.  The agency found elevated risks at or above 100 in a million in residential areas at 23 of those sterilizers. Long-term exposure to high concentrations of EtO can increase the lifetime risk of getting cancer.

The agency is sharing this risk information so that communities located near the highest-risk commercial sterilizers, and members of the public concerned about EtO exposure, have up-to-date information about emissions and health risks from EtO and can make informed decisions. EPA expects to propose an air pollution regulation later this year to protect public health by addressing EtO emissions at commercial sterilizers. This regulation will rely on the best available science and proven air pollution controls.

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.

To view the list of sterilization facilities with elevated risk, click here.

In addition to the community outreach announced in August, EPA says it continues to take significant action to address EtO and advance critical EtO research. These actions include:

  • Reviewing Clean Air Act regulations for industries that emit EtO into the air, particularly rules to control air toxic emissions from commercial sterilizers and facilities that manufacture chemicals;
  • Working with state, Territory, local and Tribal environmental agencies to reduce EtO emissions;
  • Expanding environmental reporting requirements for sterilization facilities;
  • Using enforcement options as appropriate;
  • Reevaluating how EtO is used within sterilization facilities with the goal of reducing risks to workers who handle EtO and those who are exposed in other ways; and
  • Conducting research to better understand and measure EtO.

About Ethylene oxide

Ethylene oxide, a colorless gas, is used to sterilize devices that cannot be sterilized using steam or radiation, such as some medical and dental equipment. According to the Food and Drug Administration (FDA), EtO is currently used to treat approximately 50% of sterile medical devices, about 20 billion medical devices annually. EtO is the only safe and effective sterilization method currently available for some devices. However, EPA is working to reduce EtO emissions and FDA is looking to identify alternatives to EtO.

Ethylene oxide is also produced in large volumes at some chemical manufacturing facilities. In the U.S., it is primarily used to make other chemicals that are used to make a range of products, including antifreeze, textiles, plastics, detergents and adhesives. EtO is also used to sterilize some food products and spices.

To stay up to date on the latest activities and actions related to EtO, visit EPA’s Ethylene Oxide Risk from Commercial Sterilizers website.

EPA expands TRI reporting requirements

In December EPA expanded the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide (EtO) releases. Under the Emergency Planning and Community Right-to-Know Act (EPCRA), the EPA Administrator has the discretionary authority to extend TRI 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 releases of the chemical at the facility, or other factors the Administrator deems appropriate.

According to EPA, exposure to EtO can cause cancer in humans and damage DNA. Other effects of EtO exposure include eye, skin, nose, throat, and lung irritation as well as harm to the brain and nervous system (causing effects such as headaches, memory loss, numbness). Workers in facilities that use EtO and people in communities—including historically underserved communities — located adjacent to these facilities have the highest chance of being exposed to EtO. Additionally, because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by EtO.

EtO and ethylene glycol have been on the TRI toxic chemical list since its inception in 1987, but not all facilities that use these chemicals have been subject to TRI reporting requirements.  After providing notice in October 2021, EPA decided to extend TRI reporting requirements to 29 of the 31 facilities for EtO and to 16 of the 31 facilities for ethylene glycol. Ethylene glycol is produced using ethylene oxide; thus, these chemicals may co-occur at facilities.

To learn more about the TRI reporting requirements determination, or to view a list of commercial sterilization facilities by state, visit the EPA website.