[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: 21CFR1.227]

[Page 18-19]
 
                        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 H_Registration of Food Facilities
 
Sec.  1.227  What definitions apply to this subpart?

    (a) The act means the Federal Food, Drug, and Cosmetic Act.
    (b) In addition, for the purposes of this subpart:
    (1) Calendar day means every day shown on the calendar.
    (2) Facility means any establishment, structure, or structures under 
one ownership at one general physical location, or, in the case of a 
mobile facility, traveling to multiple locations, that manufactures/
processes, packs, or holds food for consumption in the United States. 
Transport vehicles are not facilities if they hold food only in the 
usual course of business as carriers. A facility may consist of one or 
more contiguous structures, and a single building may house more than 
one distinct facility if the facilities are under separate ownership. 
The private residence of an individual is not a facility. Nonbottled 
water drinking water collection and distribution establishments and 
their structures are not facilities.
    (i) Domestic facility means any facility located in any State or 
Territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico that manufactures/processes, packs, or holds 
food for consumption in the United States.
    (ii) Foreign facility means a facility other than a domestic 
facility that manufactures/processes, packs, or holds food for 
consumption in the United States.
    (3) 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 of, and 
cooling produce are considered part of harvesting. The term ``farm'' 
includes:
    (i) 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
    (ii) 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.
    (4) Food has the meaning given in section 201(f) of the act (21 
U.S.C. 321(f)),
    (i) Except for purposes of this subpart, it does not include:
    (A) Food contact substances as defined in section 409(h)(6) of the 
act (21 U.S.C. 348(h)(6)), or
    (B) Pesticides as defined in 7 U.S.C. 136(u).
    (ii) 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.
    (5) Holding means storage of food. Holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, and 
liquid storage tanks.
    (6) 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.
    (7) 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)).
    (8) Packaging (when used as a verb) means placing food into a 
container that directly contacts the food and that the consumer 
receives.

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    (9) Packing means placing food into a container other than packaging 
the food.
    (10) 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.
    (i) 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
    (ii) Pet shelters, kennels, and veterinary facilities in which food 
is provided to animals are restaurants.
    (11) Retail food establishment means an establishment that sells 
food products directly to consumers as its primary function. A retail 
food establishment may 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 
grocery stores, convenience stores, and vending machine locations.
    (12) Trade name means the name or names under which the facility 
conducts business, or additional names by which the facility is known. A 
trade name is associated with a facility, and a brand name is associated 
with a product.
    (13) U.S. agent means a person (as defined in section 201(e) of the 
act (21 U.S.C. 321(e))) residing or maintaining a place of business in 
the United States whom a foreign facility designates as its agent for 
purposes of this subpart. A U.S. agent cannot be in the form of a 
mailbox, answering machine or service, or other place where an 
individual acting as the foreign facility's agent is not physically 
present.
    (i) The U.S. agent acts as a communications link between FDA and the 
foreign facility for both emergency and routine communications. The U.S. 
agent will be the person FDA contacts when an emergency occurs, unless 
the registration specifies under Sec.  1.233(e) another emergency 
contact.
    (ii) FDA will treat representations by the U.S. agent as those of 
the foreign facility, and will consider information or documents 
provided to the U.S. agent the equivalent of providing the information 
or documents to the foreign facility.
    (iii) Having a single U.S. agent for the purposes of this subpart 
does not preclude facilities from having multiple agents (such as 
foreign suppliers) for other business purposes. A firm's commercial 
business in the United States need not be conducted through the U.S. 
agent designated for purposes of this subpart.
    (14) You or registrant means the owner, operator, or agent in charge 
of a facility that manufactures/processes, packs, or holds food for 
consumption in the United States.

             Procedures for Registration of Food Facilities