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Pesticides: Topical & Chemical Fact Sheets |  |
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ParaformaldehydeThe 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.
A white, crystalline powder with the odor of formaldehyde, paraformaldehyde has been used as a fumigant for more than 30 years to decontaminate laboratory facilities and to disinfect sickrooms, clothing, linen, and sickroom utensils. When heated, paraformaldehyde releases formaldehyde gas, which may be used as a decontaminant. Paraformaldehyde is also used in dentistry and in the manufacture of synthetic resins and artificial ivory.
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 (i.e., sanitizers, disinfectants, sterilants) that 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 an unregistered use of a 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 multidisciplinary risk assessment of the requested use, relying largely on data that have already been 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 Paraformaldehyde
In 1964, paraformaldehyde was registered as a sanitizer and fungicide for use on barber and beauty shop equipment. Since then, paraformaldehyde has been registered and used as a disinfectant, sanitizer, fungicide, and microbicide. Sites on which this chemical is registered for use include household and domestic dwellings; ships and shipholds; bedding and clothing; and nonfood/nonfeed-transporting trucks.
Until recently, paraformaldehyde was registered and used to control microbial growth in laboratories and to decontaminate animal facilities. However all registrations for this use of paraformaldehyde were canceled due to nonpayment of fees by the manufacturer. Subsequently, paraformaldehyde has been allowed for quarantine use in a poultry health laboratory in Arkansas, a use which is effective through June 15, 2004 (quarantine exemptions are authorized for 3 years.) The same use pattern has also been authorized to the Department of Defense since 1993 and is effective until July 6, 2002 (three quarantine exemptions). Since 1992, USDA also had similar exemptions for the use of paraformaldehyde to decontaminate high-containment microbiological laboratories at Plum Island, NY, and Ames, IA (effective until June 15, 2001).
Determination of Safety and Efficacy for Registration EPA has reviewed data related to safety and effectiveness before allowing an emergency exemption for paraformaldehyde to be used specifically for anthrax decontamination. Based on a review of the data made available to the Agency to support the emergency exemption request, EPA has determined that paraformaldehyde could be effective for use in a decontamination program that includes pre-sampling, treatment, and post-treatment sampling.
To apply paraformaldehyde, the fine white powder must first be heated, releasing the formaldehyde gas that fumigates and decontaminates all surfaces in the enclosed space. Liquid disinfectants cannot reach every surface, including crevices, so a fumigant such as paraformaldehyde is used when all surfaces need to be decontaminated.
Emergency Use of Paraformaldehyde for Anthrax Decontamination During the course of October 2001, the U.S. Government identified several incidents of contamination of several government and commercial buildings with spores of Bacillus anthracis, commonly known as anthrax. Because these incidents have posed an immediate threat to public health, EPA has worked to immediately identify and employ agents that might be effective in the decontamination efforts. EPA has identified paraformaldehyde as potentially effective for use on the surfaces and crevices of electronic and mechanical equipment. In order to decontaminate and eliminate anthrax spores from a mail sorting and stamping device located at the Department of Justice mailroom in Landover, MD, EPA declared a crisis exemption for the limited sale, distribution, and use of unregistered paraformaldehyde, manufactured by Hoechst-Celanese, containing 95 percent paraformaldehyde (CAS#30525-89-4). EPA declared this crisis exemption on January 7, 2002, but application was delayed until February 12, 2002. All onsite work will be performed by experienced personnel who are certified to perform hazardous materials decontamination work. To ensure the safety of the applicators and those in the surrounding community, EPA has approved specific guidelines regarding air monitoring and application procedures. The site will be set-up so that contamination does not migrate to outside the work area as a result of work activities. Physical barriers and security controls will be established to ensure that only authorized personnel, with all necessary training and personal protective equipment, can access the site. After fumigation has been completed, authorized personnel will conduct environmental sampling to determine whether any viable anthrax spores remain. If viable organisms are found in specific locations, either fumigation treatment will be repeated or an alternative means of decontamination will be used.
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 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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