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e-CFR data is current as of July 1, 2020

Title 21Chapter ISubchapter BPart 120 → Subpart B


Title 21: Food and Drugs
PART 120—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS


Subpart B—Pathogen Reduction


Contents
§120.20   General.
§120.24   Process controls.
§120.25   Process verification for certain processors.

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§120.20   General.

This subpart augments subpart A of this part by setting forth specific requirements for process controls.

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§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., 105) 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 §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 §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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§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 °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 °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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