V. 1.2; 12/19/2017 Copyright © 2016-2020, Iowa State University of Science and Technology. All Rights
Reserved.
Food Safety Checklist for Human Food 55
(A) All food used in such activities is consumed on that farm or another farm under the same management; or
(B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same
management consists only of:
(1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating
grapes to produce raisins), and packaging and labeling such commodities, without additional
manufacturing/processing (an example of additional manufacturing/processing is slicing);
(2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene
gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing;
and
(3) Packaging and labeling raw agricultural commodities, when these activities do not involve additional
manufacturing/processing (an example of additional manufacturing/processing is irradiation); or
(2) Secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm,
devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided th
at the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities
harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the
secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary
production farm as described in paragraphs (1)(ii) and (iii) of this definition.
Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act:
(1) Except for purposes of this subpart, it does not include:
(i) Food contact substances as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act; or
(ii) Pesticides as defined in 7 U.S.C. 136(u).
(2) Examples of food include: Fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as
food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives,
dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water),
live food animals, bakery goods, snack foods, candy, and canned foods.
Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating,
modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities
include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural
commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing,
packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening,
trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding.
Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the
consumer receives.
Packing means placing food into a container other than packaging the food and also includes re-packing and activities
performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or
repacking of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)),
but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg) of the Federal Food, Drug, and
Cosmetic Act.
Restaurant means a facility that prepares and sells food directly to consumers for immediate consumption. “Restaurant”
does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do
not prepare and serve food directly to consumers.
(1) Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food
establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and
nursing home kitchens are restaurants; and
(2) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.
Retail food establishment means an establishment that sells food products directly to consumers as its primary function.
The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's
primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds,
directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual
monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food
products to all other buyers. The term “consumers” does not include businesses. A “retail food establishment” includes