The regulation does not preempt the existing requirements to follow the current Good Manufacturing Practice (CGMP) regulations for your juice processing operations. The second exception applies to the bulk transport and packaging of shelf-stable single strength juice that is transported in aseptic packaging. It is processed in plate heat exchangers and widely used for milk production. Process Authority means an expert in the processes for controlling pathogenic microorganisms in food, and as such, is qualified by training and experience to evaluate all of the aspects of your pathogen control measures, e.g., process time, temperature, type of equipment, etc., and determine that your control measures, if properly implemented, will control pathogens effectively. 3.0 Developed by HACCP-trained Employee or Consultant. The fruit must be tree-picked, cleaned, and culled prior to application of treatments to achieve the 5-log pathogen reduction (see 21 CFR 120.24(b)). The critical limit might be designated as "no broken or missing metal parts from equipment at the CCPs for metal inclusion." The log also will record all cleanings of the equipment, and will denote the cleaning procedure, e.g., pre-rinse, then caustic followed by rinse, and the time of the cleaning. Pasteurizing is a fairly simple process. It can achieve sterilization effects in short time and at low temperature, so as to protect the color, flavor, and taste of the food from high temperature destruction. Autoclave pasteurization is the industrial process of sterilizing apple juice in 248F (120C) steam with a varying 20 40 minutes time range. Juice concentrate means the aqueous liquid expressed or extracted from one or more fruits or vegetables and reduced in weight and volume through the removal of water from the juice. Unlike PHEs, THEs have no contact points in the product channel. In general, vat pasteurization equipment is constructed to prevent or reduce contamination. Although Listeria monocytogenes has not been linked specifically to an illness outbreak from juice, it is ubiquitous in nature. The table below lists some key areas to inspect and considerations for those areas. You may extract juice from the fruit in one location and ship the untreated juice to a second location for processing (i.e., to achieve the 5-log pathogen reduction requirement) and packaging. The product exits the cooling section and rises to an elevation of at least 12 inches above any raw product. In addition, moderate abuse could occur if consumers purchase a product on a warm day, place it in their car, and run errands before refrigerating the product. Doing so at home would require a piece of quite sophisticated equipment a juice pasteurizer. The use of contaminated produce to produce the juice, and the ability of some of these pathogens to survive in acidic foods like juices, along with use of inadequate controls for these pathogens during juice processing, are believed to be among the causative factors for these outbreaks. By establishing the three aforementioned controls, i.e., exclusion of fallen fruit, culling or trimming of rotten, moldy, bruised and damaged apples from production stream, and eliminating stored apples with high levels of core rot, it is likely that you will be able to adequately control patulin levels in your juice. Remove the fluff. The cookie is used to store the user consent for the cookies in the category "Analytics". Your control could provide that the equipment would not be used for juice until the prescribed cleaning procedure was carried out, and recorded in the log (See Example SSOP in section VII C). Before a pesticide may be sold in the United States, the Environmental Protection Agency (EPA) evaluates the pesticide and determines whether or not to grant a registration that permits its sale and use. If produce used to make your juice is to be purchased from a source, e.g., a country, a geographic region, or a local region, that is known or suspected to have lead contamination problems with produce, you should consider in your hazard analysis whether lead is a hazard that is reasonably likely to occur. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required. An example of pasteurized shellfish is crabmeat. Culling or trimming apples just prior to juice production to eliminate damaged, bruised, moldy, and rotting apples will reduce patulin levels in the juice. Ultra-high pressure (UHP) pasteurized: This juice has been put under such high pressure that it has been heated to reach a temperature above the boiling point of the product. This results in uniform product and temperature throughout the vat. Pasteurization is originally developed to solve the sour of wine. Thus, total quality and heat-sensitive valuable nutrients of fruit juices processed in extreme conditions are affected negatively. This means that you might have to leave the juice in the water for a more extended period of time to ensure that it is sufficiently heated. Expert Interview. Any processor making a product that could be labeled as 100 percent juice under 21 CFR 101.30, or a concentrate of that juice for subsequent beverage use must apply HACCP principles. Visual check of positive displacement pump setting, Continuous monitoring with visual check hourly, Segregate and hold affected product for evaluation, destroy, or divert to nonfood use. This will kill any bacteria that could spoil your juice. We recommend that such studies be included among the records you make available for official review under 21 CFR 120.12. This section lists definitions of several terms as they appear in FDA's juice HACCP regulation. Will the raw milk drain freely back from the raw side of the milk-to-milk regenerator when all flow-promoting devices are stopped? The recalled carrot juice was processed at the correct time and temperature in a vat pasteurizer, but after pasteurization, entire 55-gallon drums of hot carrot juice were placed in a refrigerator for an unknown cool-down time. Some of the illnesses associated with juices have been very severe (e.g., cases of long-term reactive arthritis and severe chronic illness). Patulin is not a concern for citrus juices. It also discusses control measures and CCPs you may wish to consider for your HACCP plan, should you determine that patulin is reasonably likely to occur in your juice. Who should perform the monitoring? Thus, the 5-log performance standard means that you must treat your juice using a process capable of reducing levels of the pertinent pathogen in the juice by at least 100,000-fold (10 X 10 X 10 X 10 X 10 = 100,000). This guidance entitled "Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices," is available on the website listed in section I. 2.0 Location of Juice Extraction, Processing, and Packaging. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition, https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/manual-compliance-policy-guides, Juice Guidance Documents & Regulatory Information, Product is shelf stable per attached process. Shelf stable productmeans a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth. The juice hazard analysis is a process of collecting and evaluating information on hazards associated with juice, to determine which hazards are reasonably likely to occur and, thus, pursuant to 21 CFR 120.8(a) must be addressed in a HACCP plan. Is the delivery of a minimum level of UV energy critical to the process? FDA Recommended Pasteurization Time/Temperatures. Length of the pasteurization cycle (speed of the belt for a continuous pasteurizer). However, as with any method of pasteurization, the vat method requires proper mixing and temperature monitoring. The water provides heat to the top pot, but it is gentler than a typical burner. Chilled pasteurized juice is screened and filled into cartons. This pasteurization process may put such products at risk for recontamination after pasteurization from defective containers or contaminated cooling water. Span not less than 25 F, and be graduated in 0.5 F divisions. Measure belt marking speed with stopwatch, 1. The product is held in the vat for the required time. After production If records review indicates that critical limits may not have been met, place the entire production of product on hold and assess for allergen hazard. Raised edges to prevent potential contaminant from flowing back into equipment, Overlapping drip deflectors on inserted implements. As the death point of most bacteria is 68 and under 30 min, so this process can eliminate most bacteria. These plates are pressed with surface patterns to create and increase turbulence in the product stream and enhance the heat transfer. Not likely to occur due to SSOP for water quality. For a small processor who harvests apples from his own orchard, we recommend, in lieu of a supplier guarantee, that the processor's apple pickers be instructed not to harvest fallen fruit and the processor confirm that the workers are adhering to the instructions. Juice should not be boiled. When conducting an inspection of a vat pasteurizer, it is essential to focus on these critical control points. If you use batch pasteurization equipment, we recommend that you continuously monitor both the time and temperature of the juice treatment as critical limits to ensure that your process is achieving the 5-log pathogen reduction. On the other hand, drinking fermented unpasteurized juices is likely to cause foodborne illnesses. 68 No. Use low heat and a thermometer to gauge temperature accurately. Un-pasteurized juice is also received in tankers. While the mixture is heating, give it frequent stirs. Processing steps other than those cited as critical control points are also important to ensuring a safe juice. In particular, you should be alert to new or emerging problems. You can eyeball it, but using a thermometer is the best method. C above. You should now be able to: The next lesson will discuss the pasteurization of juice. Examples of a CCP and an SSOP for cleaning operations are given in Section VII. FDA recommends that this guidance be used in conjunction with FDA's final regulation (21 CFR Part 120) that requires a processor of juice to evaluate its operations using Hazard Analysis Critical Control Point (HACCP) principles and, if necessary, to develop and implement HACCP systems (i.e., a system of preventive control measures based upon HACCP principles) for it's operations. This is the first edition of the Food and Drug Administration's (FDA) "Juice HACCP Hazards and Controls Guidance." HTST (high temperature short time) pasteurization is a flowing process. 3, 2001, pp. The vat method of juice pasteurization is often used by small juice operators. In the example, the process steps are simplified as compared with what may be performed in an actual process, but all critical process steps for this type of juice are included. These juicers are pasteurized at 80 95C to destroy any bacteria. Packaging materials are delivered in clean, well-maintained and covered vehicles. In the space between the walls, circulating water, steam, or heating coils of water and steam heat the product in the vat. Pasteurizing raw juice kills harmful bacteria so it can't make you sick. If there are significant changes in your process or in factors that may affect patulin levels, e.g., a change in the variety of apples you use to make juice, a change in your storage practices, a new supplier, or abnormal weather conditions, we also recommend that you re-validate your hazard analysis by testing juice made under the new conditions. As noted in the previous section, hazards that arise in juice processing from unsanitary food contact surfaces that can contaminate juice with residues of food allergens should be considered to be "reasonably likely to occur." 2.0 Control Measures for Allergens that Can Contaminate Juice from Improperly Cleaned Shared Processing Equipment. You establish a CCP at a culling step in the process at which any damaged fruit is removed prior to any pathogen reduction treatments on the fruit surface. This exemption applies to the following types of products: Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP system, when properly implemented, will control effectively the identified food hazards. Container size (e.g., can dimensions, pouch thickness). In a letter dated January 22, 2002 (and a January 25, 2002 letter of correction), FDA stated that it would consider the exercise of enforcement discretion with respect to the "single facility" requirement as applied to producers and users of high degree Brix concentrate(6) where the following three conditions are satisfied: (1) the producer and user establish appropriate prerequisite programs and SSOPs for the transport of high Brix juice concentrate; (2) the producer and user designate as a CCP in their respective HACCP plans the transport of high Brix concentrate from the production facility to a second facility for formulation and final packaging of concentrates; and (3) the producer and user establish control measures to prevent, reduce, or eliminate the risk of recontamination of the concentrate during transport (The January 22, 2002, letter and a correction to that letter dated January 25, 2002, are available at the website listed in section I. 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Haccp regulation areas to inspect and considerations for those areas word should in Agency documents! Recommended, but not required should be alert to new or emerging problems the category `` Analytics.... `` Analytics '' high temperature short time ) pasteurization is a flowing process and... Should not demonstrate any microbial growth the records you make available for official review 21!
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