Guidance for Industry: The Juice HACCP Regulation - Questions and Answers
Contains Nonbinding Recommendations
September 4, 2003
See additional Questions & Answers on the Juice HACCP Regulation (August 31, 2001)
Comments and suggestions regarding this document may be submitted at any time. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2003D-0348.
For questions regarding this document, contact Amy Green at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 301-436-2025 (Updated phone: 240-402-1642), (Fax) 301-436-2651, or e-mail email@example.com.
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Food and Drug Administration
Center for Food Safety and Applied Nutrition
Guidance for Industry(1)
The Juice HACCP Regulation
Questions & Answers
A. Applicability | B. Implementation Dates
C. Sanitation Standard Operating Procedures (SSOPs)
D. Hazard Analysis | E. HACCP Plan | F. Validation
G. Verification | H. Records | I. Training | J. Imported Juice
K. The 5-Log Reduction Performance Standard
On January 19, 2001, the FDA published a final rule in the Federal Register that requires processors of juice to develop and implement Hazard Analysis and Critical Control Point (HACCP) systems for their processing operations (66 FR 6138). To help the industry understand key aspects of the juice HACCP regulation, the FDA has published several guidance documents that included information on important aspects of the juice HACCP regulation such as effective dates, use of the label warning statement, and training. On August 31, 2001, the FDA published "The Juice HACCP Regulation Questions and Answers," a document that addressed important aspects of the regulation in a simple question and answer format. As a follow-up to that first set of questions and answers, this document contains a second set of questions and answers designed to further clarify the juice HACCP regulation and to address frequently asked questions.
Additional information on juice HACCP is available at www.cfsan.fda.gov under "Program Areas" and "HACCP." The information available at this website includes the juice HACCP regulation, the August 31, 2001, publication, "The Juice HACCP Regulation Questions and Answers," and additional guidance FDA has issued related to the juice HACCP regulation.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. QUESTIONS & ANSWERS
1. Is fruit nectar covered by the regulation?
The term "nectar" is generally accepted as the common or usual name in the U.S. and in international trade for a diluted juice beverage that contains fruit juice or puree, water, and may contain sweeteners. Therefore, to the extent that nectar is a beverage containing juice, it is not subject to part 120. However, the juice or puree ingredient in that nectar is subject to the regulation (§120.1(a)).
2. Is coconut milk and/or water covered by the regulation?
Yes. Coconut is considered to be a fruit and any liquid extracted from coconut (i.e., water or milk from the meat) is considered a juice and is therefore subject to the regulation (see 58 FR 2892 at 2910; January 6, 1993, and 63 FR 20450 at 20451; April 24, 1998).
3. Is juice used in alcoholic beverages (e.g., wines, alcoholic cider) covered under the regulation?
It depends. The regulation applies to any unfermented juice that is added to an alcoholic beverage (e.g., wine or cider) as an ingredient to adjust flavor or sweetness and retains and expresses its organoleptic (e.g., color, taste) and nutritional characteristics in the finished beverage (§120.1(a)). The regulation does not apply to juice used solely as a starting material for a fermented alcoholic product that is fermented such that the organoleptic and nutritional characteristics associated with the juice are modified to the extent that the original juice becomes an alcoholic beverage and is no longer recognizable as juice at the time processing is complete (comment #5, 58 FR 2897 at 2899; §101.3(k)).
B. Implementation Dates
4. If one juice processor makes a concentrate before the applicable effective date and stores it for a period of time, and a second juice processor processes the concentrate into juice after the applicable effective date, which processor is required to comply with the regulation?
The second juice processor must comply with the regulation (§120.1(a)).
C. Sanitation Standard Operating Procedures (SSOPs)
5. Are office toilets included in the mandatory SSOP for maintenance of such facilities?
It depends. If office toilet facilities are accessible to processing personnel, or if processing area toilet facilities are accessible to office personnel, the processor must make the determination as to how to control potential hazards that may be introduced through such use of facilities. This may involve including both office toilet facilities and processing area toilet facilities in the SSOP procedures (§120.6(a)(4)).
D. Hazard Analysis
6. Should a processor incorporate the receipt of raw ingredients into a juice HACCP plan?
If a processor decides that raw ingredient receipt is a Critical Control Point (CCP), then the firm must establish in its HACCP plan critical limits, corrective actions (optional), monitoring procedures, record keeping procedures, and verification activities related to the CCP (§120.8(b)).
7. How extensive does the hazard analysis have to be?
The type of product, the process, and the number and nature of potential hazards and hazards that are reasonably likely to occur will determine the extent of a hazard analysis. All hazards that are reasonably likely to occur must be identified in the course of the hazard analysis, whether those hazards are introduced within or outside the processing environment including hazards that can occur before, during, or after harvest (§120.8).
8. Where can I find more information on conducting a hazard analysis?
For more information on conducting a hazard analysis, see the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) publication, "Hazard Analysis and Critical Control Point Principles and Applications Guidelines," Journal of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998), the Juice Alliance's "Juice HACCP Training Curriculum," and FDA's Juice HACCP Hazards and Controls Guide.
9. Does the industry have to have original scientific reports (papers) available to substantiate its hazard analysis decisions?
There is no requirement that the processor keep the original scientific reports on hand. However, processors may want to keep on hand information that is not readily accessible both for their own use and to aid inspectors.
10. Can similar products such as pulp free orange juice and orange juice with extra pulp share the same hazard analysis and HACCP plan?
Yes. Similar products may share the same hazard analysis and HACCP plan when the food hazards, CCPs, critical limits, control measures, recordkeeping, etc. are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and followed in practice (§120.8(a)(2)).
In the example given, the presence of pulp may affect a critical limit such as the heating time needed to inactivate pathogenic microorganisms during pasteurization, and, if these critical limits differ, the HACCP plan would need to list both critical limits and identify which critical limit applies to which product, one for the orange juice with extra pulp and one for the orange juice without pulp.
It is the responsibility of each processor to look at their own products and processes to determine whether the similarities and differences warrant a separate hazard analysis and HACCP plan or whether the products and processes can share all or parts of the same analysis and plan.
E. HACCP Plan
11. How should added ingredients in a product considered to be 100 percent juice according to the "Percent Juice Labeling" regulation (21 CFR 101.30) be taken into account in the product's HACCP plan?
Added ingredients (e.g., 100 % orange juice with added calcium) are considered "juice," as defined in §120.1(a), and subject to the regulation. In conducting a hazard analysis for the juice, processors should include an evaluation of the added ingredients (§120.7(d)). If the processor determines that hazards are reasonably likely to occur due to those ingredients, controls for such hazards must be included in the product's HACCP plan (§120.7(e)). For example, if ingredients such as soy protein or preservatives (e.g., sulfites that can cause allergic or food intolerance reactions in sensitive individuals), or other ingredients that have the potential to cause severe allergic or food intolerance reactions in sensitive individuals are added, controls to ensure that the presence of such ingredients are declared on the label should be part of the HACCP plan.
12. How many critical control points (CCPs) should there be in a HACCP plan?
A HACCP plan need only have as many CCPs as the processor deems necessary to control the hazards that are reasonably likely to occur as identified in the hazard analysis for that product.
13. Can a firm use its existing juice HACCP plan and still comply with the regulation?
Yes. There is no requirement that juice processors develop new juice HACCP plans. If existing procedures in a firm's HACCP plan comply with the requirements in part 120, the processor may continue to use that HACCP plan.
14. Where can I find an example of a good juice HACCP plan?
Examples of juice HACCP plans that processors may modify for their product to address specific hazards in their processing facility can be found in the FDA's "Juice HACCP Hazards and Controls Guide".
15. How often should a juice manufacturer validate their HACCP plan(s)?
Each HACCP plan must be validated at least once within 12 months after implementation and no less than every 12 months thereafter (§120.11(b)). Validation of the HACCP plan also will be necessary when any changes have occurred in the process that might affect the hazard analysis or alter the HACCP plan in any way (§120.11(b)).
16. Will FDA be recommending or certifying laboratories for processing and end product testing of juice beverages in order to verify the reliability of the testing data?
No. Processors are responsible for choosing laboratories that are able to perform appropriate and accurate tests to ensure that their product meets all requirements and is safe for human consumption.
17. Will Clean-In-Place (CIP) recording charts be required for juice beverage fillers in order to provide records and verify cleaning under the mandatory equipment cleaning SSOP?
No. CIP recording charts are not required. The processor is only required to maintain records that, at a minimum, document the monitoring and corrective actions prescribed by §120.6(b) and meet recordkeeping requirements of §120.12.
18. When does a juice processor have to start keeping HACCP records?
A processor should start keeping HACCP records once the HACCP system has been accepted and implemented by the firm.
19. Are we able to scan records and store them electronically?
Yes, the maintenance of computer records, in accordance with 21 CFR part 11, is acceptable, provided the records also comply with record requirements of the regulation, are readily accessible, and are signed to signify that the records have been accepted by the firm (§120.12).
20. Does the regulation require that records be used exclusively for juice (e.g., juice pasteurization charts) or can they be combined with records for other products?
No. There is no requirement that processors have exclusive juice records as long as all records required by §120.12 are clearly marked and available.
21. Since processors of shelf-stable and thermally concentrated juice are already controlling a majority of their hazards, are they required to have as much HACCP training as other juice processors?
All processors subject to the regulation must comply with the training requirements of the regulation, regardless of what type of product they process (§120.13).
J. Imported Juice
22. Are foreign processors subject to the regulation?
Yes. Both domestic and foreign juice processors that ship juice products to the U.S. are subject to the regulation (§120.1(a)).
23. Do the same effective dates for domestic processors apply to foreign processors and importers?
Yes. The effective dates for large, small, and very small processors apply to both domestic and foreign processors and importers (§120.1(b)).
24. Must an importer ensure that the juice ingredient in a beverage has been processed in accordance with part 120?
No. The HACCP import requirements found in §120.14(d) apply only to importers of juice. Importers of beverages that contain juice (e.g., dilute juice beverages) are not covered by the regulation.
25. Will FDA conduct on-site inspections of foreign juice processors?
Yes. FDA does conduct some inspections of foreign firms, including juice firms.
26. Does an importer have to keep records for shipments of juice being imported into the United States?
Yes. The importer must have the necessary records for each shipment of juice to ensure that the juice was processed in accordance with the regulation (§120.14(c)).
27. What documentation is an importer required to have if imported juice or juice concentrate was prepared by a foreign firm prior to the applicable effective date (i.e. prepared under CGMPs but not under HACCP) then offered for import into the U.S. after the applicable effective date?
The importer should provide documentation sufficient to show that the juice was produced before the effective date of the regulation for that juice processor (§120.14(a)(2)(ii)). Documentation might include, but is not limited to, a letter from the processor that shows that the juice was produced before the effective date. For example, if juice or juice concentrate was prepared by a very small foreign firm prior to January 20, 2004, and then offered for import into the U.S. after January 20, 2004, the importer of that product should show that the juice or concentrate was produced before January 20, 2004.
28. If paperwork from an importer indicates that a particular lot of juice concentrate has a deviation and corrective action, can that concentrate be co-mingled with domestic concentrate for use in a pasteurized juice?
Yes. The concentrate can be co-mingled provided that corrective action was taken using an appropriate corrective action plan or by following the procedures listed in §120.10(b). A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that "no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation" and "the cause of the deviation is corrected" (§120.10(a)).
K. The 5-Log Reduction Performance Standard
29. Are imported juice concentrates exempt from the 5-log pathogen reduction standard?
Imported juice concentrates are exempt from the 5-log performance standard if thermal concentration and final product packaging occur in a single facility (§120.24(a)(2) and (c)). The thermal process used to achieve concentration must be included in the firm's hazard analysis (§120.24(a)(2)).
30. If a dairy processor purchases a juice concentrate from a juice manufacturer, then proceeds to put it into a beverage (e.g., 50% juice), does the concentrate need a 5-log treatment prior to being mixed with the other beverage ingredients?
No. If a dairy processor is not making juice as defined in §120.1(a), that product is not subject to the provisions in part 120. Therefore, a 5-log treatment is not required for the beverage made from that concentrate nor is an additional 5-log treatment required for that juice concentrate (i.e., the juice ingredient). However, the juice ingredient must have been produced under a HACCP system (§120.1(a)).
31. Do milk pasteurization times and temperatures provide sufficient heat treatment to meet the 5-log pathogen reduction requirement for juice covered under the regulation?
It depends. Pasteurization times and temperatures to achieve a 5-log reduction will vary depending on the type of product, the process, target microorganism, pH of the product, etc. In most cases, milk pasteurization treatment conditions of 161 degrees F for 15 seconds, will effectively achieve a 5-log pathogen reduction for juice; however, the processor must show that he or she has validated that the HACCP plan (including the processing conditions) is adequate to control food safety hazards that are reasonably likely to occur in that product (§ 120.11(b)).
32. I am a dairy processor who purchases juice concentrate from a concentrator and reconstitutes it to a single strength juice prior to packaging. Is a 5-log reduction at the concentrator's facility sufficient to address the 5-log performance standard?
No. Because you are making juice as defined in §120.1(a), you must treat the juice to achieve a 5-log reduction prior to final packaging as outlined under §120.24(c). The 5-log exemption for concentrates only applies when the product is processed and packaged at a single facility.
33. If I purchase a fruit puree that has been treated to achieve a 5-log reduction and blend it with juice that I have manufactured and treated to achieve a 5-log reduction, does the resulting blend need to be treated again to achieve a 5-log reduction?
Yes. Section 120.24(c) requires that the blended juice, including the puree, must receive a 5-log treatment at the final packaging facility.
34. What processing treatment and temperature is required for a juice to be considered shelf-stable?
Section 120.3(n) defines a shelf-stable product as a product that is hermetically sealed and, when stored at room temperature, does not demonstrate any microbial growth. The regulation does not provide for specific processing parameters for attaining shelf-stability.
(1)This guidance has been prepared by the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.
See additional Questions & Answers on the Juice HACCP Regulation (August 31, 2001).