[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: 21CFR114.89]
[Page 258]
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.
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