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EPA Regulation of Disinfectants and Sanitizers

EPA registers and regulates antimicrobial pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). To obtain registration, manufacturers of disinfectants or sanitizers must meet the basic standards, the foremost being: 1) that the product will not cause unreasonable adverse effects to human health or the environment, and 2) that product labeling and composition comply with the requirements of FIFRA. Moreover, manufacturers are required to submit to EPA detailed and specific information concerning the chemical composition of their product; effectiveness data to document their claims against specific microorganisms and to support the directions for use provided in labeling; labeling that reflects the required elements for safe and effective use; and toxicology data to document any hazards associated with use of the product.

Recently, some concern has emerged regarding whether public health products used to kill microorganisms pathogenic to man on inanimate surfaces and objects in hospitals, schools, restaurants, and homes work as claimed on the label. The private and public sector communities, including competitor registrants, have made the Agency aware of disinfectants which may be ineffective. EPA has responded to this situation by developing a comprehensive strategy to improve the regulation of antimicrobial pesticides. EPA is attempting to improve communications with the public, all levels of government, academia, user communities, industry, health professionals, trade organizations and independent testing groups. Also, EPA has committed funds to ensure that the tests used to demonstrate the efficacy of antimicrobial products are reliable and reproducible; is in the process of developing a complaint system to handle concerns regarding ineffective products; amplified internal controls to ensure the integrity of data submitted by registrants; and is currently publishing a quarterly newsletter designed to educate the general public about the status and direction of the regulation of disinfectants and sanitizers.