FDA is responsible for regulating the use of irradiation in the treatment of food and food packaging. This authority derives from the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) where Congress explicitly defined a source of radiation as a food additive (Section 201(s) of the FD&C Act). The 1958 Food Additives Amendment also provides that a food is adulterated (that is, it cannot be marketed legally) if it has been irradiated, unless the irradiation is carried out in conformity with a regulation prescribing safe conditions of use (Section 402(a)(7) of the FD&C Act). Thus, FDA regulates the lawful use of irradiation through the food additive petition process, the completion of which results in the promulgation of a regulation published in the Federal Register prescribing the approved use.
This website is intended to serve as a source of general as well as more specific regulatory and scientific information about the irradiation of food and packaging for consumers, representatives from industry, and other stakeholders.