Establishments such as those identified in the question are exempt from the food facility
registration requirements if they are “nonprofit food establishments” (21 CFR 1.226(e)).
“Nonprofit food establishment” is defined in 21 CFR 1.227 as “a charitable entity that prepares or
serves food directly to the consumer or otherwise provides food or meals for consumption by
humans or animals in the United States. The term includes central food banks, soup kitchens, and
nonprofit food delivery services. To be considered a nonprofit food establishment, the
establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26
U.S.C. 501(c)(3)).”
To qualify under 26 U.S.C. 501(c)(3), an entity (such as a corporation, community chest, fund, or
foundation) must satisfy the following four criteria: (1) it must be organized and operated
exclusively for religious, charitable, or educational purposes (among others); (2) no part of the
net earnings of the entity may inure to the benefit of any private individual; (3) no substantial
part of the entity’s activities may be for the purpose of influencing legislation; and (4) the entity
cannot participate in any political campaign of any candidate for public office (26 U.S.C.
501(c)(3)). The requirement in the definition of “nonprofit food establishment” in 21 CFR
1.226(e) to “meet the terms of section 501(c)(3)” means that the institution or organization that
runs a food service program under which the establishment operates must satisfy the criteria of 26
U.S.C. 501(c)(3). However, the public institution or organization need not be formally
designated as a 26 U.S.C. 501(c)(3) institution or organization.
FDA is aware that certain lunch and food service programs are sponsored by private nonprofit
institutions or organizations that have been granted tax-exempt status under 26 U.S.C. 501(c)(3)
of the Internal Revenue Code. An establishment operating under a food service program that is
conducted by such an institution or organization is exempt from registration under 21 CFR
1.226(e) if, in addition to the institution or organization having 26 U.S.C. 501(c)(3) status, the
establishment satisfies the remaining elements of the “nonprofit food establishment” definition in
21 CFR 1.227.
FDA is also aware that many food service programs are conducted by public institutions or
organizations, such as public school systems, that do not have formal 26 U.S.C. 501(c)(3) status.
If a public institution or other organization that runs a food service program satisfies the four 26
U.S.C. 501(c)(3) criteria listed in a previous paragraph in this answer, an establishment operating
under a food service program of such an institution or organization is exempt from registration
under 21 CFR 1.226(e) if, in addition to the institution or organization satisfying the 26 U.S.C.
501(c)(3) criteria, the establishment satisfies the remaining elements of the “nonprofit food
establishment” definition in 21 CFR 1.227.
In addition, a “restaurant” (21 CFR 1.227) that is part of a school lunch or other food service
program is exempt from registration, regardless of whether it is a “nonprofit food establishment”.
Also, a “retail food establishment” (21 CFR 1.227) that is part of a school lunch or other food
service program is exempt from registration, regardless of whether it is a “nonprofit food
establishment”.
