 This module covers the five log pathogen reduction standard and some of the currently available technologies that you may use to achieve the standard in your juice. From this discussion, you will learn what the standard is, why you need to use it, when and where you need to use it, and how to prove your process works to achieve it. In addition, methods to monitor and document your process will be covered. The five log pathogen reduction standard, often referred to only as the five log standard, isn't just some weird abstract number pulled out of a hat to confuse processors. This standard assures that the juice you produce is safe for everyone to drink regardless of the method you use to process it. The standard is based on the advice of a panel of recognized food safety experts, the National Advisory Committee on Microbiological Criteria for Foods, known as NACMCF. These experts based their advice on the best available scientific information. They first assumed a worst-case scenario for a food illness outbreak and added a 100-fold safety margin. The five log reduction is based on logarithmic numbers, hence five log. Each log represents a 10-fold difference. For example, one log is 10, two log is 100, three log is 1000, four log is 10,000, and five log is 100,000. Therefore, if you were going to reduce the number 100,000 by five log, you would need to go down to one. Alternatively, if you started from 100, you would need to go down to .001. Of course, the five log reduction standard doesn't refer to a hypothetical number. It refers to the population of the pertinent pathogen that may be in your juice. Obviously, you can't go from 100 organisms to less than one, but you can go from finding 100 organisms in one cup of juice to finding one organism in 100 cups of juice. This reduction is applied to the population of the most pertinent pathogen. Pathogenic microorganisms are everywhere in the world around us. What pathogens end up in juice depends on what the fruit or vegetable has been exposed to. Once contaminated, the risk of that pathogen remaining on the fruit and surviving in the juice will depend on the type of pathogen and how well it can survive in those conditions. The conditions a pathogen can survive include the characteristics of the fruit and how the fruit or juice from that fruit is treated. The most pertinent pathogen is the pathogen most likely to be present and survive in your juice and to survive any treatment you give to your juice. This pertinent pathogen may not be the same for all juice products or even all processes. To determine the pathogens most likely to present a hazard in any specific juice, it's required that you obtain the assistance of someone trained in the application of HACCP principles to juice processing. Training requirements are spelled out in CFR 120.13. Once you have determined the pertinent pathogen for your product, you must validate the process you use for the 5 log reduction. There are many factors that affect the survival of any microorganism in a juice product. Some factors likely to affect survival in any particular process include pH of the juice or pH of the treatment process, bricks, viscosity, total solids, the presence of particulate material, temperatures of treatment or treatments, and even color. Consequently, validation needs to be performed with clearly defined physical and chemical parameters. In addition, if you are using a pilot or model system or using whole citrus fruit or other juices that have been artificially inoculated or inoculated at higher than normal pathogen levels, you must run additional studies to ensure that your method mimics actual processing conditions. Because of the complexity of validation of 5 log reductions in any food, it's highly recommended that you use a process authority familiar with your method. A process authority should be someone with a thorough knowledge of the scientific literature on the processes used to control the appropriate pathogen. Such qualified experts may be identified through trade associations or through educational institutions. Some state agencies may also have such experts on their staffs. It's important to recognize that although some equipment vendors may retain such experts, the salesperson who wishes to sell you juice processing equipment is likely not an expert. Validation of your HACCP plan will need to be documented within 12 months of implementation and at least once annually. If at any time your process or product changes significantly from your original plan, your entire process may need to be revalidated. In addition, once your system is in place, you must maintain records to verify that you are following the procedure and monitoring as required by your HACCP plan. These procedures and monitoring requirements were identified and discussed earlier in this video. The juice HACCP regulation requires that the 5 log pathogen reduction treatment be applied directly to the juice and not the fruit or vegetable, with one exception for citrus products. For citrus products only, cumulative surface treatments may be used to achieve all or part of a 5 log reduction in the pertinent pathogen. In this case, the 5 log treatment may be applied to whole fruit. However, the standard is applied only after the fruit has been appropriately cold and cleaned. No dropped, damaged or ground harvested fruit may be used for this type of juice product. Furthermore, all such cumulative treatments for the 5 log reduction must occur in one facility prior to final consumer packaging. The 5 log pathogen reduction standard, whether it's applied as a single surface treatment or as cumulative surface treatments on citrus, must still be validated. Again, because validation in such a system is complex, it is highly recommended that you use a process authority. Many surface treatment processes to accomplish the 5 log standard involve a series of cleaning, brush washing and sanitizing steps. For each of the steps, verification will require that the concentration of the chemical used be monitored. If the chemical is chlorine based, it may also be critical to monitor the pH, as chlorine will be largely ineffective under alkaline conditions. In addition, the duration of exposure to the cleaner or chemical may be critical to the 5 log process. Consequently, you may also need to monitor the conveyor speed or contact time of the sanitizer. Some surface treatments use heat, either as a water bath or as a steam tunnel to achieve the 5 log reduction standard. For these systems, critical control points may include the temperature of treatment as well as the conveyor speed to assure a long enough treatment at the appropriate temperature. For some citrus products, the extraction method may also be part of the cumulative 5 log reduction. Extraction methods that may be included consist of a single pinpoint extraction method that is described in module 6. For this method, only a single puncture is made and care is taken that the peel of the fruit is not brought into contact with the extracted juice. Under federal regulation, use of service treatments on citrus for achieving the 5 log pathogen reduction standard requires that end product microbial testing be implemented as part of the verification process. End product testing for citrus juice is detailed in 21 CFR 120.25. Testing consists of examining a specific amount of juice for the presence of non-pathogenic E. coli. If, in a series of seven tests, two samples are found to be positive for E. coli, then the process to achieve the 5 log reduction standard will be assumed to be inadequate and corrective steps will need to be taken. Such corrective action steps are outlined in 21 CFR 120.25. Pasteurization is a commonly used heating method for the reduction of pathogens in many fluid products. Pasteurization will not kill all microorganisms present and will not provide a shelf-stable product. The purpose of pasteurization is to provide only enough heat to destroy pathogens present. Some processors will use a heat treatment that goes far beyond pasteurization that will result in a shelf-stable product. Such shelf-stable products are exempt from the 5 log standard control requirement provided they include a copy of their heat treatment process with their written hazard analysis. Pasteurization has historically been used for fluid milk and appropriate heating requirements for dairy products are well-established. Unfortunately, appropriate parameters for juice products are not as well-established. On the other hand, factors that will influence the efficacy of such a heat treatment are well-known and characterized. For example, a higher solids content in your product will require a more extensive heat treatment. Consequently, it's important that any pasteurization process be validated for each specific product. Again, the actual validation process with the numerous factors that can influence the outcome requires a high level of expertise in the field of food processing. Process authorities should be consulted for assistance with validation procedures. Basically, there are two types of thermal pasteurization methods used in juice processing. The first is a batch method. In a batch method, heat is applied to juice in one large lot or batch in a container. The temperature is brought up to the point where it will result in the death of the pathogenic organisms. The entire batch is then held long enough to ensure the pathogens are reduced in population by at least 5 log. Following the holding period, the juice is cooled. The second type of pasteurization method is a continuous method. In this type of method, juice is pumped at a specific rate from a storage vessel to heat exchanger plates and brought to the temperature required for pathogen destruction. From the heat exchanger, the juice continues through the plumbing referred to as the holding tubes. The holding tubes are generally insulated pipes that will maintain the temperature of the juice required for pathogen destruction. These holding tubes need to be designed long enough and large enough with proper slope to ensure the juice maintains the appropriate temperature long enough to achieve the 5 log standard. How long the juice remains in the holding tubes will be determined by the pump rate. Therefore, calibration and proper operation of the pump will be important to the success of such a process. In the holding period, the juice will once again pass through heat exchangers to bring the temperature back to what is required for filling and packaging. This may include both hot filling and or cold filling. Continuous systems have an advantage over batch systems in the speed at which they can heat and cool the product. Consequently, the amount of heat applied can be better controlled. Frequently, temperatures used are higher than in a batch system. This results in faster destruction of the pathogen and consequently a much shorter holding time is required. For this reason, such systems are called high temperature short time or HTSD pasteurization. Some processors will use very high temperatures in order to further reduce holding times to seconds instead of minutes. Such systems are referred to as flash pasteurization or ultra high temperature UHD systems. Only a process authority can determine what system may be best for you as well as establishing the parameters needed for your pasteurization system. In addition to heat exchangers and holding tubes, HTSD systems frequently contain flow diversion valves. The purpose of such valves is to redirect any juice that doesn't meet the minimum temperature requirement back to the storage tank for reprocessing. Such flow diversion valves are very important safety features of this type of equipment. If equipment you have does not have such a feature and your juice fails to meet your minimum temperature requirements, you will need to segregate that juice so that it may be reprocessed at a later time. For all such systems, you will be required to monitor temperatures throughout the processing and ensure that appropriate holding times for your process are maintained. Again, you should consult a process authority to determine how best to set up, maintain and document that your system is set up correctly and functioning properly. Although pasteurization is currently the most common and hence well studied process for achieving the five log standard, other methods do exist and are becoming more popular. One of these is the use of UV irradiation. UV irradiation was approved in 2000 for use on juices. Current requirements include the use of low pressure mercury lamps emitting 90% of the emission at a wavelength of 253.7 nanometers or 2,537 angstroms. In addition, any juice treated with UV irradiation must undergo turbulent flow through tubes with a minimum Reynolds number of 2,200. Again, if you are unfamiliar with such technology, a process authority can help you acquire appropriate equipment and assist in setting up the correct monitoring and documenting of the system. UV irradiation works primarily by breaking apart the DNA of organisms. The amount of such irradiation required to kill microorganisms can vary dramatically. UV irradiation is absorbed by many of the components in juice. Therefore, the energy may have very limited penetration. In general, the more colored a juice is and the more particles there are in a juice, the more difficult it will be to kill any microorganisms present. Consequently, each type of juice will likely require its own processing parameters. Because of issues with penetration, UV irradiation may not be applicable to all types of juices. Ozone was also approved for food use in June 2001. Ozone is a strong oxidizing agent that has historically been used to clean and disinfect water. Its mode of action is therefore similar to chlorine. Ozone is a highly unstable chemical and is also toxic to people in very low concentrations. Although it's approved for food use, care should be taken to prevent excessive exposure to workers. As with UV irradiation, parameters for usage are not well characterized and the use of a process authority is highly recommended. A number of other processes are used to a more limited extent. Most of these processes such as pulsed light, use of high hydrostatic pressure or the use of CO2 in combination with high pressure are still in developmental stages and may become more generally available in the future. However, as with ozone and UV irradiation, the use of any new technology will require proper validation and documentation of the five log reduction process. After validation, proper controls and records must be maintained to assure the process is properly implemented. For both validation and verification, it is best to consult with and seek the advice of a process authority. The five log pathogen reduction standard is based on accumulated scientific expertise and data available to date. Applying this standard to your processes will assure juice that is microbiologically safe for everyone. Determination of processing parameters to achieve the standard must take into account a variety of factors such as microbial growth and resistance, physical and chemical parameters of the juice or whole produce, and physical and chemical parameters of your process. Because of the complexity of some processing systems, use of a process authority is critical to the successful application of the five log reduction standard.