[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR114.89]

[Page 253]
 
                        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. 114.89  Deviations from scheduled processes.

    Whenever any process operation deviates from the scheduled process 
for any acidified food and/or the equilibrium pH of the finished product 
is higher than 4.6, the commercial processor of the acidified food shall 
either: (a) Fully reprocess that portion of the food by a process 
established by a competent processing authority as adequate to ensure a 
safe product; (b) thermally process it as a low-acid food under part 113 
of this chapter; or (c) set aside that portion of the food involved for 
further evaluation as to any potential public health significance. The 
evaluation shall be made by a competent processing authority and shall 
be in accordance with procedures recognized by competent processing 
authorities as being adequate to detect any potential hazard to public 
health. Unless the evaluation demonstrates that the food has undergone a 
process that has rendered it safe, the food set aside shall either be 
fully reprocessed to render it safe, or be destroyed. A record shall be 
made of the procedures used in the evaluation and the results. Either 
upon completion of full reprocessing and the attainment of a safe food, 
or after the determination that no significant potential for public 
health hazard exists, that portion of the food involved may be shipped 
in normal distribution. Otherwise, the portion of the food involved 
shall be destroyed.