[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.81]

[Page 278-279]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 113_THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS--Table of Contents
 
                Subpart E_Production and Process Controls
 
Sec.  113.81  Product preparation.


    (a) Before using raw materials and ingredients susceptible to 
microbiological contamination, the processor shall ensure that those 
materials and ingredients are suitable for use in processing low-acid 
food. Compliance with this requirement may be accomplished by receiving 
the raw materials and ingredients under a supplier's guarantee that they 
are suitable for use, by examining them for their microbiological 
condition, or by other acceptable means.
    (b) Blanching by heat, when required in the preparation of food for 
canning, should be effected by heating the food to the required 
temperature, holding it at this temperature for the required

[[Page 279]]

time, and then either rapidly cooling the food or passing it to 
subsequent processing without delay. Thermophilic growth and 
contamination in blanchers should be minimized by the use of adequate 
operating temperatures and by cleaning. If the blanched food product is 
washed before filling, potable water should be used.
    (c) The filling of containers, either mechanically or by hand, shall 
be controlled so as to ensure that the filling requirements specified in 
the scheduled process are met.
    (d) The exhausting of containers for the removal of air shall be 
controlled so as to meet the conditions for which the process was 
designed. Compliance with the requirement may be accomplished by heat 
exhausting, mechanical exhausting, hot brining, or steam injection.
    (e) When the maintenance of pH (above 4.6) of a normally low-acid 
food is a basis for a scheduled process, there shall be careful 
supervision to ensure that the equilibrium pH of the finished product 
meets that of the scheduled process. The methodology described in Sec.  
114.90 of this chapter should be used.
    (f) When the scheduled process sets forth critical factors to 
prevent the growth of microorganisms not destroyed by the thermal 
process, the factors shall be carefully controlled to ensure that the 
limits established in the scheduled process are not exceeded. When 
normally low-acid foods require sufficient solute to permit safe 
processing at low temperatures, such as in boiling water, there shall be 
careful supervision to ensure that the equilibrium water activity 
(aw) of the finished product meets that of the scheduled 
process. The scheduled thermal processes for foods having an 
aw greater than 0.85 and less than the aw that 
would allow the growth of spores of microorganisms of public health 
significance shall be sufficient to render the food free of 
microorganisms capable of reproducing in the food under normal 
nonrefrigerated conditions of storage and distribution.