[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.25]

[Page 274-275]
 
                        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.  120.25  Process verification for certain processors.

    Each juice processor that relies on treatments that do not come into 
direct contact with all parts of the juice to achieve the requirements 
of Sec.  120.24 shall analyze the finished product for biotype I 
Escherichia coli as follows:
    (a) One 20 milliliter (mL) sample (consisting of two 10 mL 
subsamples) for each 1,000 gallons of juice produced shall be sampled 
each production day. If less than 1,000 gallons of juice is produced per 
day, the sample must be taken for each 1,000 gallons produced but not 
less than once every 5 working days that the facility is producing that 
juice. Each subsample shall be taken by randomly selecting a package of 
juice ready for distribution to consumers.
    (b) If the facility is producing more than one type of juice covered 
by this section, processors shall take subsamples according to paragraph 
(a) of this section for each of the covered juice products produced.
    (c) Processors shall analyze each subsample for the presence of E. 
coli by the method entitled ``Analysis for Escherichia coli in Citrus 
Juices--Modification of AOAC Official Method 992.30'' or another method 
that is at least equivalent to this method in terms of accuracy, 
precision, and sensitivity in detecting E. coli. This method is designed 
to detect the presence or absence of E. coli in a 20 mL sample of juice 
(consisting of two 10 mL subsamples). The method is as follows:
    (1) Sample size. Total-20 mL of juice; perform analysis using two 10 
mL aliquots.
    (2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC 
Broth (various manufacturers).
    (3) Method. ColiComplete (AOAC Official Method 992.30--modified).
    (4) Procedure. Perform the following procedure two times:
    (i) Aseptically inoculate 10 mL of juice into 90 mL of Universal 
Preenrichment Broth (Difco) and incubate at 35 [deg]C for 18 to 24 
hours.
    (ii) Next day, transfer 1 mL of preenriched sample into 10 mL of EC 
Broth, without durham gas vials. After inoculation, aseptically add a 
ColiComplete SSD disc into each tube.
    (iii) Incubate at 44.5 [deg]C for 18 to 24 hours.
    (iv) Examine the tubes under longwave ultra violet light (366 nm). 
Fluorescent tubes indicate presence of E. coli.
    (v) MUG positive and negative controls should be used as reference 
in interpreting fluorescence reactions. Use an E. coli for positive 
control and 2 negative controls--a MUG negative strain and an 
uninoculated tube media.
    (d) If either 10 mL subsample is positive for E. coli, the 20 mL 
sample is recorded as positive and the processor shall:
    (1) Review monitoring records for the control measures to attain the 
5-log reduction standard and correct those conditions and practices that 
are not met. In addition, the processor may choose to test the sample 
for the presence of pathogens of concern.
    (2) If the review of monitoring records or the additional testing 
indicates that the 5-log reduction standard was not achieved (e.g., a 
sample is found to be positive for the presence of a pathogen or a 
deviation in the process or its delivery is identified), the processor 
shall take corrective action as set forth in Sec.  120.10.
    (e) If two samples in a series of seven tests are positive for E. 
coli, the control

[[Page 275]]

measures to attain the 5-log reduction standard shall be deemed to be 
inadequate and the processor shall immediately:
    (1) Until corrective actions are completed, use an alternative 
process or processes that achieve the 5-log reduction after the juice 
has been expressed;
    (2) Perform a review of the monitoring records for control measures 
to attain the 5-log reduction standard. The review shall be sufficiently 
extensive to determine that there are no trends towards loss of control;
    (i) If the conditions and practices are not being met, correct those 
that do not conform to the HACCP plan; or
    (ii) If the conditions and practices are being met, the processor 
shall validate the HACCP plan in relation to the 5-log reduction 
standard; and
    (3) Take corrective action as set forth in Sec.  120.10. Corrective 
actions shall include ensuring no product enters commerce that is 
injurious to health as set forth in Sec.  120.10(a)(1).