[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.24]

[Page 267-268]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 120_HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
--Table of Contents
 
                      Subpart B_Pathogen Reduction
 
Sec.  120.24  Process controls.

    (a) In order to meet the requirements of subpart A of this part, 
processors of juice products shall include in their Hazard Analysis and 
Critical Control Point (HACCP) plans control measures that will 
consistently produce, at a minimum, a 5 log (i.e., 10\5\) reduction, for 
a period at least as long as the shelf life of the product when stored 
under normal and moderate abuse conditions, in the pertinent 
microorganism. For the purposes of this regulation, the ``pertinent 
microorganism'' is the most resistant microorganism of public health 
significance that is likely to occur in the juice. The following juice 
processors are exempt from this paragraph:
    (1) A juice processor that is subject to the requirements of part 
113 or part 114 of this chapter; and
    (2) A juice processor using a single thermal processing step 
sufficient to achieve shelf-stability of the juice or a thermal 
concentration process that includes thermal treatment of all 
ingredients, provided that the processor includes a copy of the thermal 
process used to achieve shelf-stability or concentration in its written 
hazard analysis required by Sec.  120.7.
    (b) All juice processors shall meet the requirements of paragraph 
(a) of this section through treatments that are applied directly to the 
juice, except that citrus juice processors may use treatments to fruit 
surfaces, provided that the 5-log reduction process begins after culling 
and cleaning as defined in

[[Page 268]]

Sec.  120.3(a) and (f) and the reduction is accomplished within a single 
production facility.
    (c) All juice processors shall meet the requirements of paragraphs 
(a) and (b) of this section and perform final product packaging within a 
single production facility operating under current good manufacturing 
practices. Processors claiming an exemption under paragraph (a)(1) or 
(a)(2) of this section shall also process and perform final product 
packaging of all juice subject to the claimed exemption within a single 
production facility operating under current good manufacturing 
practices.