Pesticide News Story: Ethylene Oxide Risk Management Decision Announced
For Release: April 16, 2008
EPA has completed its review of the pesticide uses of ethylene oxide (ETO) and determined that the benefits of continued use outweigh the associated occupational risks, provided that risk mitigation measures specified by the Agency are adopted and reflected on product labeling. ETO does not pose risks of concern to the general population or to the environment. In 2006, EPA concluded that, with implementation of risk mitigation measures, ETO does not present risks of concern through food-related pesticide uses. With additional risk mitigation measures required in the decision for non-food uses, all uses of ETO are eligible for reregistration. During reregistration, EPA has provided ample opportunity for pubic comment and stakeholder input through the full public participation process. Based on this reregistration eligibility decision, EPA plans to close out the ETO Special Review in the near future.
ETO is used primarily in hospitals and at contract facilities to sterilize medical and laboratory items and equipment. ETO treatment is also the principal method used to reduce bacterial levels in whole and ground spices and other herbs and seasonings. Other ETO uses, which account for less than one percent of the total annual usage, include sterilization of musical instruments, library and museum artifacts, and cosmetic ingredients. Under a Special Local Need (SLN) registration, ETO is also used for sterilization/fumigation of beekeeping equipment at a state-managed facility in North Carolina.
EPA has found potential human health cancer risks of concern for workers resulting from all uses of ETO. In addition, potential non-cancer health risks have been identified for workers who would not routinely wear respirators and are exposed to ambient ETO levels in parts of facilities other than the aeration/unloading rooms. Provided that the following risk mitigation measures are adopted, these risks are outweighed by the benefits expected from use of ETO.
- A single chamber process (i.e., sterilization and aeration occur in the same chamber) is required for ETO treatment in hospitals.
- Employee safety and awareness training is required for all employees (including office staff) in contract sterilization facilities.
- For the beekeeping use, respirators are required to be worn during chamber opening and unloading and tank change/maintenance activities.
Through these measures, EPA expects to reduce ambient ETO levels in hospitals, inform sterilization facility employees, reduce exposure to NC state beekeeping equipment fumigators, and reduce long-term non-cancer and potential cancer risks for hospital workers and NC beekeeping equipment fumigators.
The EPA Office of Research and Development (ORD) is currently analyzing ETO’s carcinogenicity based on human epidemiological data, and a cancer assessment is anticipated for publication in the ORD Integrated Risk Information System (IRIS) in September 2009. If necessary, based on this or other new information, EPA can revisit its current decision about the pesticide uses of ETO at any time.
EPA’s ETO Reregistration Eligibility Decision (RED) and related information are available in docket number EPA-HQ-OPP-2005-0203 at Regulations.gov, and on the Agency’s ETO reregistration Web page. The Federal Register notice announcing the availability of the ETO RED is available on the Agency's Web site.