EPA Plans Draft Risk Assessment of Ethylene Oxide

As the U.S. Environmental Protection Agency pursues its mission to protect human health and the environment, addressing ethylene oxide (EtO) continues to be a major priority, the agency said in a news release.

As part of a cross-agency effort, EPA took the next step in its review of the pesticide registration for EtO by releasing a draft risk assessment for public comment. Based on EPA’s review of the body of available information about EtO’s toxicity, the agency believes that additional steps are needed to mitigate the risks associated with the use of EtO. EtO is used to sterilize certain medical equipment and spices.

“EtO is used on half of all sterilized medical devices in the United States annually and, in some cases, it is the only sterilization method available,” EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn said in the news release. “We look forward to receiving the public’s input on our draft risk assessment so that we can strengthen safeguards for those who work in facilities that use EtO and those who live near facilities that use or manufacture EtO.”

EPA regulates EtO’s use as a sterilant, which is considered an antimicrobial pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act. Every 15 years, EPA evaluates a wide variety of potential human health and environmental effects associated with the use of a pesticide through the registration review process. As part of EtO’s registration review, the agency is continuing to assess potential human health risks that come from working in facilities that fumigate with EtO, living in communities near EtO facilities, and consuming spices treated with EtO.

The draft risk assessment for the registration review presents multiple analyses that capture a wide range of possible levels of EtO that could affect a person’s risk of getting cancer from long-term, chronic exposures to EtO, either in the workplace or through the outdoor air. Based on all available information about EtO’s toxicity, EPA found that inhaling EtO over many decades can cause cancer risks of concern. Therefore, additional mitigation measures are necessary to protect the health of workers and surrounding communities.

The next step in the FIFRA process would be to issue a proposed interim decision, which is used to outline the potential risk management options to address any potential risks of concern.

EPA also is working to reduce EtO emissions to the outdoor air by reviewing Clear Air Act rules for industries that emit EtO and by coordinating with state air agency partners to identify opportunities for early reductions. In addition, the agency is working to gather data on background EtO concentrations in the air through monitoring at existing air toxic monitoring sites. EPA is also evaluating new technologies and methods for measuring the chemical.

EtO is a pesticide used on 50 percent of all sterilized medical devices in the United States annually. It is also used on approximately 30 percent of spices in the United States.

The agency will take public comment on the draft risk assessment for 60 days following its publication in the Federal Register via www.regulations.gov. After considering public comments, EPA will finalize the draft risk assessment and turn to the next step in the FIFRA process, which is taking steps to address the risks identified in the draft risk assessment.

More information on EPA’s registration review of EtO, including this risk assessment’s methods and findings, is available on EPA’s website.