Technical Information

Regulation of Disinfectant and Sterilants

Federal laws and regulations govern the sale, distribution, and use of liquid chemical disinfectants and sterilants. In the United States liquid chemical germicides are regulated by the U.S. Environmental Protection Agency (EPA) and the U.S Food and Drug Administration (FDA). The EPA regulates disinfectant products used on environmental surfaces and the FDA regulates liquid chemical sterilants/high-level disinfectants used on critical and semicritical patient care devices. Disinfectants are also regulated in interstate commerce by the Antimicrobial Division of the EPA under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947, as amended in 1996. In addition, EPA registered disinfectant products must be registered with the individual states to be sold in commerce.