Healthcare facilities include nursing homes, diagnostic and major surgery facilities, doctors offices, clinics, and other outpatient facilities. Other ethylene oxide derivatives are used in household cleaners and … For hospital and healthcare facility workers who are involved with the ETO sterilization process (e.g., loading/unloading ETO chambers, changing/maintaining ETO tanks), both long-term non-cancer and cancer risks are of concern. Instead, they may elect to have employees wear respirators. These emissions standards control ETO emissions to the outdoor environment, whereas the single chamber requirement seeks to reduce occupational exposures to hospital and healthcare facility workers that work indoors. Name of Pesticide Product: Ethylene Oxide Name and Address of Registrant (include ZIP Code) Sterigenics U.S., LLC 2015 Spring Road Oak Brook, IL 60523 Note Changes in labeling differing in substance from that acceptejj in connection with this registration must be submitted to and Ethylene oxide is a colorless and flammable gas with a faintly sweet odor. Further, other hospital and healthcare facility workers who are not involved with the ETO sterilization process may also be at risk from long-term ethylene oxide exposure. This measure is expected to lower ambient levels of ETO in hospitals and healthcare facilities, reducing potential long-term non-cancer and cancer risks for hospital and healthcare facility workers. It is the only sterilization method available for many medical devices and approximately 50 percent of all sterile medical devices in the United States are treated with EtO annually. During EPAs periodic review of ethylene oxide, EPA found that ETO has the potential to cause adverse health effects to hospital workers from long-term (greater than 6 months) inhalation exposure. Conventional Pesticide - Chemical Review Manager: Joy Schnackenbeck (schnackenbeck.joy@epa.gov), 703-308-8072, Antimicrobial Pesticide - Chemical Review Manager: Eliza Blair (blair.eliza@epa.gov), 703-308-7279, Publications | Glossary | A-Z For more information regarding EPAs National Emissions Standards for Ethylene oxide, please visit EPAs website at https://www.epa.gov/ttn/atw/eo/eopg.html. Most ethylene oxide is used as an intermediate in the production of other chemicals used to manufacture products, such as fabrics for clothes, upholstery, carpet and pillows. Ethylene oxide exposure has also been linked to reproductive damage. Note: This fact sheet is NOT related to EPAs National Emission Standards for Hazardous Air Pollutants (NESHAP), which regulate air emissions from hospitals that are area sources of ETO. Under this rule, hospitals that are area sources for ETO are required to, inter alia, institute management practices and collect records to reduce ETO emissions. It is a cyclic ether and the simplest epoxide: a three-membered ring consisting of one oxygen atom and two carbon atoms. Conventional Pesticide - Chemical Review Manager: Joy Schnackenbeck (schnackenbeck.joy@epa.gov), 703-308-8072 Antimicrobial Pesticide - Chemical Review Manager: Eliza Blair (blair.eliza@epa.gov), 703-308-7279 Docket Information. Publications | Glossary | A-Z Ethylene oxide is industrially produce… For further assistance, please contact Dennis Edwards (edwards.dennis@epa.gov) at 703-308-8078. 72 Fed. Documents related to EPA's review of this pesticide can be found in the following dockets: Current as of March 2010. For further assistance on this matter, please contact Hillary Ward (ward.hillary@epa.gov) at 919-541-3154. 73611 (December 28, 2007). Given the high health benefits of ETO use and the lack of any feasible replacements for ETO use in sterilizing certain medical equipment/devices, EPA has determined that ETO use on medical equipment in hospitals may continue. Ethylene Oxide (EtO) is an EPA-registered antimicrobial pesticide used to sterilize medical equipment and spices. Ethylene oxide, called oxirane by IUPAC, is an organic compound with the formula C 2H 4O. Ethylene Oxide (ETO): Hospitals and Healthcare Facilities Must Use a Single Chamber when Sterilizing Medical Equipment with ETO. Index | Jobs, Reregistration Eligibility Decision for Ethylene Oxide (PDF), Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment and Risk Management Decision (TRED) for Ethylene Oxide (PDF), Azinphos-methyl, Disulfoton, Esfenvalerate, Ethylene oxide, Fenvalerate, et al. Manufacturers of ETO have updated their product labels to state: Hospitals and healthcare facilities should check their current stock of ETO canisters to see if the labels bear this statement. ; Proposed Tolerance Actions, Ethylene Oxide; Preliminary Determination to Terminate Special Review, Ethylene Oxide; Reregistration Eligibility Decision, Ethylene Oxide; Revised Risk Assessments, Notice of Availability and Solicitation of Risk Reductions, Ethylene Oxide; Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability, Ethylene Oxide Risk Assessment; Notice of Availability, Ethylene Oxide (ETO) Revised Risk Assessments; Notice of Availability, and Solicitation of Risk Reduction Options (Phase 5 of 6-Phase Process), Ethylene Oxide Risk Assessment; Notice of Availability; Reopening of Comment Period, Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend to Terminate Certain Uses. For more information regarding EPAs single chamber requirement for ETO sterilization and EPAs human health risk assessment, please see the 2008 Ethylene Oxide Reregistration Eligibility Decision. In 2007, EPA issued new requirements for hospitals that are area sources within the meaning of the Clean Air Act. However, to mitigate potential non-cancer and cancer risk concerns for workers exposed to ETO as a result of medical use, a single chamber treatment process must be adopted. It is used to produce ethylene glycols for engine antifreeze that keeps our automobiles performing. Ethylene Oxide . After February 28, 2010, a single chamber process (that is, sterilization and aeration occur in the same chamber) is required for ethylene oxide (ETO) treatment of medical equipment and devices in hospitals and healthcare facilities. Ethylene oxide constitutes 11 percent of the mixture and may be discharged from the container without the risk of fire or explosion. This single chamber requirement is independent of EPAs National Emissions Standards for new and existing hospital sterilizers that emit ETO. Hospitals may choose to send some of their medical equipment to contract facilities for sterilization to ease their transition to a single chamber sterilization process. Ethylene oxide is isomeric with acetaldehyde and with vinyl alcohol. In France, the amount of ethylene oxide permitted in food is 0.05mg per kilogram. Ethylene oxide is a pesticide known to have cancer-causing effects, and can cause irritation of the eyes, skin, nose, throat, and lungs, and damage to the brain and nervous system. ; Tolerance Actions, Amendments to Terminate Certain Pesticide Uses, Azinphos-methyl, Disulfoton, Esfenvalerate, Ethylene oxide, Fenvalerate, et al. Because it is a strained ring, ethylene oxide easily participates in a number of addition reactions that result in ring-opening. If the label DOES NOT bear this language, then hospitals may deplete their current stock of ETO containers and may continue to sterilize medical equipment according to current label instructions until the product bearing the old label language is depleted. Documents related to EPA's review of this pesticide can be found in the following dockets. Meanwhile, the public health benefits associated with the use of ETO to sterilize medical equipment are extremely high. If the label bears this language, then hospitals should begin using a single chamber for ETO sterilization immediately. Reg. Contract sterilization facilities are not required to adopt the single chamber process. Implementation of New Label Restrictions to Protect Hospital and Healthcare Facility Employees from ETO Exposure EPA announced the February 28, 2010 deadline in its 2008 ETO Reregistration Eligibility Decision to give hospitals and medical facilities time to come into compliance.
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