Regulation of Disinfectants

Regulation of Disinfectants

Chemical disinfectants in the United States are registered and regulated by the U.S. Environmental Protection Agency (EPA) under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (40 CFR Parts 150-189). Under FIFRA, chemical disinfectants are considered “antimicrobial pesticides” or “substances or mixtures of substances intended to destroy or suppress the growth of harmful microbiological organisms, and pesticides that protect inanimate objects and surfaces from organisms such as bacteria, viruses, or fungi.”

Prior to product registration and marketing, manufacturers are required to submit product chemistry, efficacy, and toxicity data, along with proposed labeling, for EPA’s review. FIFRA requires that any pesticide be registered or exempted before it may be sold or distributed in the United States. All EPA-registered pesticides must have an EPA registration number.

FIFRA further requires that all label use directions and safety precautions must be followed. The use of a registered disinfectant in a manner inconsistent with its labeling may not only result in an ineffective application, but it may be a “misuse” of the product subject to potential enforcement action. Thus, a chemical disinfectant should be selected not only on the basis of its desirable characteristics, but also on whether it is registered or exempted under FIFRA and whether it can be used in accordance with its label safety precautions and use directions for its intended use(s). Individual States also have regulations that may be stricter than Federal regulations.

The product label for any EPA-registered disinfectant may be retrieved by entering the registration number in the EPA’s Pesticide Product Label System (PPLS) Search engine at https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1.

Emergency Exemptions

In some situations, a particular pathogen may not be listed on the product label of an EPA-registered disinfectant. In these cases, Section 18 of FIFRA authorizes EPA to grant exemptions to Federal agencies or States to use unregistered pesticides for a limited time, if EPA determines that emergency conditions exist. If granted, such exemptions would allow the use of non-registered pesticides or the “off-label” uses of a registered pesticide for a specified time period. Use is only allowed for designated personnel and as described in the exemption.

A full explanation of FIFRA Section 18 exemption process can be found at https://www.epa.gov/pesticide-registration/pesticide-emergency-exemptions.

Federal regulations regarding emergency exemptions (40 CFR Part 166) are described at https://www.gpo.gov/fdsys/pkg/CFR-2004-title40-vol22/pdf/CFR-2004-title40-vol22-part166.pdf.


Additional Resources:

Information about the antimicrobial pesticide registration process, data requirements, labeling requirements and other issues pertaining to chemical disinfectants can be found on EPA’s web site at: https://www.epa.gov/pesticide-registration/antimicrobial-pesticide-registration.

EPA has developed a Label Review Manual that includes detailed information on content and format of labels and labeling. The manual can be found at https://www.epa.gov/pesticide-registration/label-review-manual.

An extensive list of potential EPA-approved pesticides for use against selected foreign animal disease agents in farm settings can be found at: https://www.aphis.usda.gov/animal_health/emergency_management/downloads/fad_epa_disinfectants.pdf.

Disinfectants recently approved for Section 18 exemption for use in the event of high consequence animal diseases can be found at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/emergency-management/ct_disinfectants.

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