[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: 21CFR113.81]
[Page 252-253]
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
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 253]]
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.
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