[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR114.80]

[Page 251-252]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 114--ACIDIFIED FOODS--Table of Contents
 
               Subpart E--Production and Process Controls
 
Sec. 114.80  Processes and controls.


    (a) Processing operations. The manufacturer shall employ appropriate 
quality control procedures to ensure that finished foods do not present 
a health hazard.
    (1) Acidified foods shall be so manufactured, processed, and 
packaged that a finished equilibrium pH value of 4.6 or lower is 
achieved within the time designated in the scheduled process and 
maintained in all finished foods. Manufacturing shall be in accordance 
with the scheduled process. Acidified foods shall be thermally processed 
to an extent that is sufficient to destroy the vegetative cells of 
microorganisms of public health significance and those of nonhealth 
significance capable of reproducing in the food under the conditions in 
which the food is stored, distributed, retailed and held by the user. 
Permitted preservatives may be used to inhibit reproduction of 
microorganisms of nonhealth significance (in lieu of thermal 
processing).
    (2) Sufficient control, including frequent testing and recording of 
results, shall be exercised so that the finished equilibrium pH values 
for acidified foods are not higher than 4.6. Measurement of acidity of 
foods in-process may be made by potentiometric methods, titratable 
acidity, or colorimetric methods. If the finished equilibrium pH of the 
food is above 4.0, the measurement of the finished equilibrium pH shall 
be by a potentiometric method, and the in-process measurements by 
titration or colorimetry shall be related to the finished equilibrium 
pH. If the finished equilibrium pH is 4.0 or below, then the measurement 
of acidity of the final product may be made by any suitable method. 
Special care should be taken when food ingredients have been subjected 
to lye, lime, or similar high pH materials.
    (3) Procedures for acidification to attain acceptable equilibrium pH 
levels in the final food include, but are not limited to, the following:
    (i) Blanching of the food ingredients in acidified aqueous 
solutions.
    (ii) Immersion of the blanched food in acid solutions. Although 
immersion of food in an acid solution is a satisfactory method for 
acidification, care must be taken to ensure that the acid concentration 
is properly maintained.
    (iii) Direct batch acidification, which can be achieved by adding a 
known

[[Page 252]]

amount of an acid solution to a specified amount of food during 
acidification.
    (iv) Direct addition of a predetermined amount of acid to individual 
containers during production. Liquid acids are generally more effective 
than solid or pelleted acids. Care must be taken to ensure that the 
proper amount of acid is added to each container.
    (v) Addition of acid foods to low-acid foods in controlled 
proportions to conform to specific formulations.
    (4) Testing and examinations of containers shall occur often enough 
to ensure that the container suitably protects the food from leakage or 
contamination.
    (b) Coding. Each container or product shall be marked with an 
identifying code permanently visible to the naked eye. If the container 
does not permit the code to be embossed or inked, the label may be 
legibly perforated or otherwise marked, as long as the label is securely 
affixed to the product container. The required identification shall 
specify in code the establishment where the product was packed, the 
product contained therein, and the year, day, and period during which it 
was packed. The packing period code shall be changed often enough to 
enable ready identification of lots during their sale and distribution. 
Codes may be changed periodically on one of the following bases: 
intervals of 4 to 5 hours; personnel shift changes; or batches, as long 
as the containers constituting the batch do not represent those 
processed during more than one personnel shift.