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Pesticides: Topical & Chemical Fact Sheets |  |
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Vaporized Hydrogen PeroxideThe 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 for use against anthrax only 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.
What is Vaporized Hydrogen Peroxide (HVP)? Hydrogen peroxide in liquid form is an oxidizing agent used in industry for pulp, textile, and environmental applications. Industrial grade uses require concentrated solutions of 30% or greater. Dilute forms of hydrogen peroxide are common household products used as cleansers for cuts and scrapes, and are available in 3% to 10% solutions. Vaporized hydrogen peroxide (VHP), a low temperature sterilant, is created by a machine - a "generator"- and is often used as an antimicrobial pesticide (described below) for decontaminating sealed enclosures such as scientific workstations, isolators, passthrough rooms, medical and diagnostic devices, and for other biological safety applications.
Antimicrobial pesticides are substances used to control harmful microorganisms including bacteria, viruses or fungi on inanimate objects and surfaces primarily in indoor environments. Types of antimicrobial products have traditionally included sanitizers, disinfectants, and sterilants. A "sanitizer" is a substance that significantly reduces the bacterial population in the inanimate environment, but does not destroy or eliminate all bacteria or other microorganisms. A "disinfectant" is a substance that destroys or eliminates a specific species of infectious or other public health microorganism, but not necessarily bacterial spores, in the inanimate environment. A "sterilant" is a substance that destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses.
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. EPA grants a registration (or a license) for a public health pesticide product only after the Agency has reviewed efficacy and safety data to ensure that, when used according to the specific instructions on the label, the product is effective and does not cause any unreasonable adverse effects on human health or the environment. Such evaluation is particularly important for antimicrobial pesticides (sanitizers, disinfectants, and sterilants) which are used to reduce or eliminate microbial contamination. The pesticide label provides specific safety precautions and use directions for handling or using the product. EPA has concluded that vaporized hydrogen peroxide products registered to date have met federal standards for environmental and human health safety.
Uses for Vaporized Hydrogen Peroxide Vaporized hydrogen peroxide is an antimicrobial pesticide registered by EPA to kill bacterial spores on environmental surfaces in an enclosed area. It is used in commercial, institutional and industrial settings to decontaminate or sterilize sealed enclosures such as isolators, workstations, and passthrough rooms.
FIFRA Section 18 Emergency Exemption Under Section 18 of FIFRA, the EPA "may exempt any Federal or State agency from any provision of this Act if the Administrator determines that emergency conditions exist which require such exemption." Normally, a federal or state agency would submit an application for a FIFRA exemption to EPA for review and approval. If the EPA approves the request, it would issue either a specific or a public health exemption, as appropriate. However, if the emergency is of such urgency that a federal or state agency does not have enough time to submit an application for exemption and wait for EPA's approval, then the federal or state agency may issue a crisis exemption, which is effective for 15 days. In order for the crisis exemption to be extended beyond 15 days, the federal or state agency must submit an application for exemption to EPA. To handle all anthrax contamination cases as quickly as possible, the Agency has decided to issue all crisis exemptions itself. To obtain a crisis exemption from EPA for the unregistered use of a pesticide against anthrax, a State or Federal agency must submit a written request describing the antimicrobial product(s) to be used; how, when and where they will be used; the data demonstrating efficacy of the product for the intended purpose; and how human health and safety will be protected. Before issuing the exemption, EPA will perform a multi-disciplinary risk assessment of the requested use, relying on data supplied for the pesticide. If, during this review, EPA notes any adverse human health or environmental concerns, EPA may deny the exemption request. If, however, EPA believes that the proposed use of an antimicrobial product will be effective and will protect human health and the environment, EPA will issue a crisis exemption. Moreover, if EPA determines that use of the product is needed beyond the 15-day use period, EPA will complete an application for a public health exemption on behalf of the requesting entity, which allows the crisis exemption to continue in effect until it is either withdrawn or EPA issues a public health exemption.
Determination of Safety and Efficacy for Crisis Exemption for Vaporized Hydrogen Peroxide EPA has reviewed data related to safety and effectiveness before allowing an emergency exemption for vaporized hydrogen peroxide to be used specifically for anthrax decontamination. Available data using the AOAC Sporicidal Activity Test suggest that vaporized hydrogen peroxide will significantly reduce bacterial spore populations under specific conditions that include pre-cleaning, concentration, and contact time. Based on this review, EPA recently issued a crisis exemption for the limited sale, distribution, and use of registered VHP for use against anthrax spores. EPA has determined that the public health threat posed by the anthrax incidents constitutes a public health emergency of such immediacy that normal processing and review of a conventional public health exemption under FIFRA is neither prudent nor practical. Under this crisis exemption, Vaprox™ Hydrogen Peroxide Sterilant (EPA Registration Number 58779-4) may be used by the General Services Administration and its contractors for anthrax decontamination at Building 410, which is located in the Anacostia Naval Yard, Washington, D.C.
Use of Vaporized Hydrogen Peroxide in Anthrax Decontamination Under the Crisis Exemption Applications of the pesticide products under the crisis exemption will be limited to employees or contractors of the General Services Administration for use in anthrax decontamination at Building 410. Use of this product pursuant to this crisis exemption shall be limited to operations conducted under the supervision of the U.S. General Services Administration (GSA) and by its contractors. The procedures in GSA's "Work Plan for Environmental Cleanup at GSA Building 410, Anacostia Naval Yard, Washington, D.C.," dated June 17, 2002, shall be followed.
More Information on Antimicrobial Pesticides 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
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