[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.328]

[Page 38-40]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
    Subpart J_Establishment, Maintenance, and Availability of Records
 
Sec.  1.328  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 321) apply

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to such terms when used in this subpart. In addition, for the purposes 
of this subpart:
    Act means the Federal Food, Drug, and Cosmetic Act.
    Farm means a facility in one general physical location devoted to 
the growing and harvesting of crops, the raising of animals (including 
seafood), or both. Washing, trimming of outer leaves, and cooling 
produce are considered part of harvesting. The term ``farm'' includes:
    (1) Facilities that pack or hold food, provided that all food used 
in such activities is grown, raised, or consumed on that farm or another 
farm under the same ownership; and
    (2) Facilities that manufacture/process food, provided that all food 
used in such activities is consumed on that farm or another farm under 
the same ownership.
    Food has the meaning given in section 201(f) of the act. Examples of 
food include, but are not limited to 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 and additives, including substances that migrate into food 
from the finished container and other articles that contact food; 
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.
    Full-time equivalent employee means all individuals employed by the 
person claiming the exemption. The number of full-time equivalent 
employees is determined by dividing the total number of hours of salary 
or wages paid directly to employees of the person and of all of its 
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e., 
40 hours x 52 weeks).
    Holding means storage of food. Holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, and 
liquid storage tanks.
    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 are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or packaging.
    Nonprofit food establishment means 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)).
    Nontransporter means a person who owns food or who holds, 
manufactures, processes, packs, imports, receives, or distributes food 
for purposes other than transportation.
    Nontransporter immediate previous source means a person that last 
had food before transferring it to another nontransporter.
    Nontransporter immediate subsequent recipient means a nontransporter 
that acquires food from another nontransporter.
    Packaging means the outer packaging of food that bears the label and 
does not contact the food. Packaging does not include food contact 
substances as they are defined in section 409(h)(6) of the act (21 
U.S.C. 348(h)(6)).
    Person includes individual, partnership, corporation, and 
association.
    Recipe means the formula, including ingredients, quantities, and 
instructions, necessary to manufacture a food product. Because a recipe 
must have all three elements, a list of the ingredients used to 
manufacture a product without quantity information and manufacturing 
instructions is not a recipe.
    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) Facilities in which food is directly provided to humans, such as 
cafeterias,

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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.
    (2) Pet shelters, kennels, and veterinary facilities in which food 
is directly provided to animals are restaurants.
    Transporter means a person who has possession, custody, or control 
of an article of food in the United States for the sole purpose of 
transporting the food, whether by road, rail, water, or air. Transporter 
also includes a foreign person that transports food in the United 
States, regardless of whether that foreign person has possession, 
custody, or control of that food for the sole purpose of transporting 
that food.
    Transporter's immediate previous source means a person from whom a 
transporter received food. This source can be either another transporter 
or a nontransporter.
    Transporter's immediate subsequent recipient means a person to whom 
a transporter delivered food. This recipient can be either another 
transporter or a nontransporter.
    You means a person subject to this subpart under Sec.  1.326.