[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
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
[[Page 39]]
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.
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