[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: 21CFR113.89]

[Page 249-250]
 
                        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 CONTAINERS--Table of Contents
 
               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 250]]

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.