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Pesticide News Story: Ethylene Oxide Risk Assessment Available for Comment
For Release: August 12, 2005
On August 3, 2005, EPA announced in the Federal Register the availability of the Agency's preliminary human health risk assessment and related documents for the fumigant/sterilant pesticide ethylene oxide (ETO). EPA is issuing these documents for public comment as part of the Agency's process to involve the public in developing pesticide reregistration and tolerance reassessment decisions. The Agency is interested in receiving comments and input to further refine its preliminary human health risk assessment for ETO. Comments must be received by October 3, 2005.
In its preliminary risk assessment, EPA is predicting exposures that pose cancer risks of concern for workers at the current regulatory levels established by the Occupational Safety and Health Administration (OSHA) and recommended by the National Institute of Occupational Safety and Health (NIOSH). Non-cancer worker risk is also estimated to be of concern at the OSHA levels, but not at the NIOSH recommended limit.
ETO alone does not pose food or drinking water risks of concern; however, EPA's preliminary assessment indicates that dietary exposure concerns may exist from ETO reaction products ethylene chlorohydrin and ethylene glycol due to persistent high levels of these compounds found after sterilization. Acute dietary exposure estimates for ethylene chlorohydrin are above the Agency's level of concern for all supported commodities.
ETO is a fumigant and sterilant used primarily to sterilize medical or laboratory equipment, pharmaceuticals, and aseptic packaging. ETO treatment is the principal method used to reduce bacterial levels in spices, herbs, and black walnuts. Less than 1% of all ETO applied is used to reduce microbial load in cosmetics, beekeeping equipment, artifacts, archival material, or library objects. Sterlization/fumigation with ETO must be performed in vacuum or gas tight chambers designed only for use with this pesticide. ETO is applied by commercial applicators only; there are no residential uses. Since ETO has no outdoor uses, exposure to wildlife and aquatic organisms is not expected.
The ETO preliminary human health risk assessment and supporting documents are available
in the Federal Docket Management System at www.regulations.gov; see Docket number
OPP-2005-0203. See also the Agency's ETO Web page at http://www.epa.gov/pesticides/reregistration/status.htm. For additional information on this and other pesticide issues, see EPA's Pesticide Program web site, http://www.epa.gov/pesticides.