[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.3]

[Page 220-221]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 110_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
 
                      Subpart A_General Provisions
 
Sec.  110.3  Definitions.


    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) are applicable to such 
terms when used in this part. The following definitions shall also 
apply:
    (a) Acid foods or acidified foods means foods that have an 
equilibrium pH of 4.6 or below.
    (b) Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    (c) Batter means a semifluid substance, usually composed of flour 
and other ingredients, into which principal components of food are 
dipped or with which they are coated, or which may be used directly to 
form bakery foods.
    (d) Blanching, except for tree nuts and peanuts, means a 
prepackaging heat treatment of foodstuffs for a sufficient time and at a 
sufficient temperature to partially or completely inactivate the 
naturally occurring enzymes and to effect other physical or biochemical 
changes in the food.
    (e) Critical control point means a point in a food process where 
there is a high probability that improper control may cause, allow, or 
contribute to a hazard or to filth in the final food or decomposition of 
the final food.
    (f) Food means food as defined in section 201(f) of the act and 
includes raw materials and ingredients.
    (g) Food-contact surfaces are those surfaces that contact human food 
and those surfaces from which drainage onto the food or onto surfaces 
that contact the food ordinarily occurs during the normal course of 
operations. ``Food-contact surfaces'' includes utensils and food-contact 
surfaces of equipment.
    (h) Lot means the food produced during a period of time indicated by 
a specific code.
    (i) Microorganisms means yeasts, molds, bacteria, and viruses and 
includes, but is not limited to, species having public health 
significance. The term ``undesirable microorganisms'' includes those 
microorganisms that are of public health significance, that subject food 
to decomposition, that indicate that food is contaminated with filth, or 
that otherwise may cause food to be adulterated within the meaning of 
the act. Occasionally in these regulations, FDA used the adjective 
``microbial'' instead of using an adjectival

[[Page 221]]

phrase containing the word microorganism.
    (j) Pest refers to any objectionable animals or insects including, 
but not limited to, birds, rodents, flies, and larvae.
    (k) Plant means the building or facility or parts thereof, used for 
or in connection with the manufacturing, packaging, labeling, or holding 
of human food.
    (l) Quality control operation means a planned and systematic 
procedure for taking all actions necessary to prevent food from being 
adulterated within the meaning of the act.
    (m) Rework means clean, unadulterated food that has been removed 
from processing for reasons other than insanitary conditions or that has 
been successfully reconditioned by reprocessing and that is suitable for 
use as food.
    (n) Safe-moisture level is a level of moisture low enough to prevent 
the growth of undesirable microorganisms in the finished product under 
the intended conditions of manufacturing, storage, and distribution. The 
maximum safe moisture level for a food is based on its water activity 
(aw). An aw will be considered safe for a food if 
adequate data are available that demonstrate that the food at or below 
the given aw will not support the growth of undesirable 
microorganisms.
    (o) Sanitize means to adequately treat food-contact surfaces by a 
process that is effective in destroying vegetative cells of 
microorganisms of public health significance, and in substantially 
reducing numbers of other undesirable microorganisms, but without 
adversely affecting the product or its safety for the consumer.
    (p) Shall is used to state mandatory requirements.
    (q) Should is used to state recommended or advisory procedures or 
identify recommended equipment.
    (r) Water activity (aw) is a measure of the free moisture 
in a food and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.