[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: 21CFR113.89]
[Page 254-255]
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. 113.89 Deviations in processing, venting, or control of critical
factors.
Whenever any process is less than the scheduled process or when
critical factors are out of control for any low-acid food or container
system as disclosed from records by processor check or otherwise, the
commerical processor of that low-acid food shall either fully reprocess
that portion of the production involved, keeping full records of the
reprocessing conditions or, alternatively, must set aside that portion
of the product involved for further evaluation as to any potential
public health significance. Such 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 this evaluation
demonstrates that the product had been given a thermal process that
rendered it free of microorganisms of potential public health
significance, the product set aside shall be either fully reprocessed to
render it commercially sterile or destroyed. A record shall be made of
the evaluation procedures used and the results. Either upon completion
of full reprocessing and the attainment of commerical sterility or after
the determination that no significant potential for public health hazard
exists, that portion of the product involved may be shipped in normal
distribution. Otherwise, the portion of the product involved shall be
destroyed. All process deviations involving a failure to satisfy the
minimum requirements of the
[[Page 255]]
scheduled process, including emergencies arising from a jam or breakdown
of a continuous agitating retort necessitating cooling the retort for
repairs, shall be recorded and made the subject of a separate file (or a
log identifying the appropriate data) detailing those deviations and the
actions taken.
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