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Pesticides: Topical & Chemical Fact Sheets |  |
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Ethylene OxideThe following fact sheet is part of a series relating to chemicals that may be used in Federal Anthrax decontamination efforts. EPA has approved these pesticides against anthrax only for use by authorized personnel according to the specific requirements of the applicable crisis exemption and approved decontamination plans. These chemicals are not intended for use by the general public.
Ethylene Oxide (also known as EO, EtO, ETO, anprolene, dihydrooxirene, 1,2-epoxyethane, oxacyclopropane, oxane, oxidoethane, oxirane, and others) is an industrial chemical used in sterilizing medical items, fumigating spices, and manufacturing other chemicals. Pure ethylene oxide is a colorless gas at room temperature and a mobile, colorless liquid below 54 degrees Fahrenheit. Sold as a mixture with either carbon dioxide or fluorocarbon 12, ethylene oxide has been registered (licensed) by EPA for use as an antimicrobial pesticide since the 1940s. Ethylene oxide kills microorganisms by denaturing their proteins and subsequently modifying their molecular structure. This activity allows ethylene oxide to be effective as a sterilant.
Antimicrobial pesticides are substances used to control harmful microorganisms including bacteria, viruses or fungi on inanimate objects and surfaces. Types of antimicrobial products have traditionally included sanitizers, disinfectants, and sterilants.
EPA's Registration of Pesticides Before a pesticide can be marketed and used in the United States, EPA must evaluate the pesticide to ensure that it meets Federal safety standards for human health and the environment. Such evaluation is particularly important for antimicrobial pesticides (disinfectants, sterilants, and sporicides) which are used to reduce or eliminate microbial contamination. Once EPA determines that a pesticide meets federal safety standards, the Agency grants a license or "registration" permitting its distribution, sale, and use according to approved label instructions. In certain emergency situations, EPA may issue a crisis or emergency exemption allowing for the sale, distribution, and use of an unregistered pesticide product for a limited period of time. In order for the Agency to consider a pesticide for use in an emergency situation, a State or Federal agency must first request the crisis exemption, allowing EPA to review the safety and effectiveness of the proposed new use. Prior to issuing the exemption, EPA performs a multi-disciplinary risk assessment of the requested use, relying largely on data that have been already supplied for the pesticide. If, during this review, EPA notes any adverse human health or environmental concerns, EPA may deny the exemption request.
Currently Registered Uses for Ethylene Oxide EPA regulates ethylene oxide under the Clean Air Act; Comprehensive Environmental Response, Compensation, and Liability Act; Federal Insecticide, Fungicide, and Rodenticide Act; Resource Conservation and Recovery Act; Superfund Amendments and Reauthorization Act; and the Toxic Substances Control Act.
EPA first registered ethylene oxide as an antimicrobial pesticide in 1948. Ethylene oxide is used to sterilize hospital items; to treat processed spices and seasonings; and to treat commercial food processing, handling, and storage facilities. When used directly in the gaseous form or in nonexplosive gaseous mixtures with nitrogen or carbon dioxide, ethylene oxide can act as a disinfectant, fumigant, sterilizing agent, and insecticide.
Ethylene oxide is also used as an ingredient or as an intermediate in the production of several other chemicals including ethylene glycol and polyester. Ethylene glycol is used primarily in automotive antifreeze and polyester is used in fibers, film, and bottles. Ethylene oxide is also used to produce nonionic surfactants in household and industrial detergents. A surfactant is a chemical that reduces the surface tension of water.
Emergency Use of Ethylene Oxide in Anthrax Decontamination During October 2001, the U.S. Government identified incidents of contamination of several government and commercial buildings throughout the United States with spores of Bacillus anthrasis, commonly known as anthrax. Along with many other federal, state, and local agencies, EPA has responsibility ensuring effective cleanup of these contaminated sites. Because ethylene oxide is effective in killing spore-forming bacteria, EPA has identified this registered pesticide as a potential decontamination agent. Although ethylene oxide is not currently registered for use specifically against anthrax spores, EPA has determined that emergency conditions exist which necessitate its limited sale, use, and distribution for this purpose. This exemption was granted after considering available data and includes requirements which ensure protection of health and the environment. Therefore, based upon sampling results and a review of cleanup options, EPA has issued two crisis exemptions:
Ethylene oxide may only be used according to the specific guidelines and procedures of the approved "Capitol Buildings Incident Retrieved Offsite Decontamination Plan"and the "U.S. Department of Justice Mail Sterilization Test, Ethylene Oxide Method."
Determination of Safety and Efficacy All registered ethylene oxide products making sterilization claims have passed efficacy tests for their registered uses. EPA reviews efficacy and safety data to ensure that when used according to the strict guidelines of the label, the product will be effective and not pose any unreasonable adverse effect on human health or the environment. Before allowing an emergency exemption for ethylene oxide to be used specifically for anthrax decontamination, EPA reviewed data related to its efficacy and safety. The Agency has evaluated the efficacy of ethylene oxide as a sporicide using the AOAC Sporicidal Activity Test as the standard. More information regarding the AOAC analytical methods are available on the Web at: http://www.epa.gov/oppad001/dis_tss_docs/dis-09.htm. Based on a review of this data, EPA has determined that ethylene oxide would be effective for use in a decontamination program that includes pre-sampling, treatment, and post-treatment sampling. With strict adherence to the label's application instructions and applicable worker monitoring and safety requirements, the Agency believes that, no unreasonable adverse health effects will occur from use of this chemical. However, the treatment might affect certain products sent by mail. Products which may be adversely affected by ethylene oxide gas include biological samples, diagnostic kits, film, drugs and medicines, eyeglasses and contact lenses, and some garments. Ethylene oxide is applied as a gas and should leave no residues of concern after application.
More Information on Antimicrobial Pesticides You can find more information on ethylene oxide on EPA's Web site including: If you have general questions about the federal pesticide program browse the Web site, or contact EPA's pesticides office:
Tel: 703-305-5017 Fax: 703-305-5558 E-mail: opp-web-comments@epa.gov Other federal agencies with information on antimicrobial pesticides include:
ATSDR Information Center Tel: 1-888-42-ATSDR or 1-888-422-8737 Fax: 404-498-0057 E-mail: ATSDRIC@cdc.gov
Tel: 1-800-321-OSHA (6742) On-line E-mail: www.osha-slc.gov/html/Feed_Back.html
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