[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: 21CFR120.24]
[Page 273-274]
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
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 274]]
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.
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