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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2019]
[CITE: 21CFR120.25]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 120 -- HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

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 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 120.10.

(e) If two samples in a series of seven tests are positive for E. coli, the control 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 120.10. Corrective actions shall include ensuring no product enters commerce that is injurious to health as set forth in 120.10(a)(1).

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