For example, blue crab is pasteurized by placing containers of blue crab into a hot water bath tank for a minimum time and temperature, and then cooling them in ice water. 1.1 What Does the "Pertinent Microorganism" Mean? The product is held in the vat for the required time. The training must be at least equivalent to that received under the standardized curriculum described in section VI. Their preservation time is from several days to dozens of days in cold storage. This is illustrated in Column 3 of the HACCP plan examples in section VII. Alarm system with optical and acoustical signals for temperature and pressure differences. Length of the pasteurization cycle (speed of the belt for a continuous pasteurizer). Another example of pasteurized shellfish is oysters. FDA Comments/Recommendations: We believe that the process recommended in the NFPA study is adequate to ensure a 5-log reduction of the three stated vegetative bacterial pathogens, (E. coli O157:H7, Salmonella and Listeria monocytogenes) at juice pH values comparable to those in the study. Patulin is a mycotoxin that is produced by fungi commonly found on apples. Section 120.7 (c) lists specific types of hazards, e.g., natural toxins, microbial contaminants, undeclared allergenic ingredients, that at a minimum, we recommend be considered in your hazard analysis. 15 In practice, this processor should establish visual criteria for what constitutes a damaged apple that should be culled. The important thing to understand is that each log of kill is capable of causing a tenfold reduction in the number of organisms of the pathogen that the treatment is designed to kill, i.e., the "pertinent microorganism." Such a process delivers a degree of thermal inactivation of pathogens that is extraordinarily beyond the required 5-log reduction (see Reference #68 in the juice HACCP final rule). C for availability information). for volume of a liquid at a standard temperature, usually 20C. We also recommend that you consider the following questions in consultation with your process authority: High pressure processing, a technology in which pressure (in excess of 30,000 to 45,000 psig) is the principal anti-microbial agent, has been shown to be effective in reducing vegetative pathogens. Describe the pasteurization method for whole eggs. Both fruits are ready to juice about this time of year, so I was. However, because patulin levels in juice can be affected by many factors as noted previously, not all processors may be able to acquire data or other information to perform a comprehensive hazard analysis considering all of the factors noted in the previous section. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. 523-527, and Harp, James A., Fayer, Ronald, Pesch, Bruce A., and Jackson, George J., Effect of Pasteurization on Infectivity of Cryptosporidium parvum Oocysts in Water and Milk, Applied and Environmental Microbiology, Vol. For example, after January 22, 2003, very small businesses may still use label-warning statements for an additional year. Enjoy! For this example, surface treatment of the orange peel is performed to achieve the 5-log pathogen reduction. Continuous processes have been developed using this technology. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required. To pasteurize apple juice, you must heat the juice to a specific temperature for a particular time. Calibration of all monitoring, corrective action and verification instruments. Moreover, the survival of Lactobacillus plantarum after fermentation . Fallen fruit, apples that have been damaged, e.g., by insects or birds, or bruised, e.g., during handling, are more susceptible to the growth of patulin-producing molds. Needs thorough cleaning and sanitizing of large surface areas on heating partition. 12 The juice HACCP regulation requires control measures that will achieve a 5-log reduction in the "pertinent microorganism" for all juices except shelf stable juices, juice concentrates, and juices subject to the low acid canned foods or acidified foods regulations. Fill the saucepan with the juice. Proper agricultural control practices by the grower, e.g., insect control, anti-fungal applications when needed, can assist in minimizing mold growth and rot on apples. These are provided as examples for you to consider when you conduct your hazard analysis and write your HACCP plan. 2.0 Example Hazard Analysis for Pasteurized Refrigerated Apple Juice. Effective dates for the regulation are January 20, 2002, January 21, 2003, or January 22, 2004, depending upon the size of your business. The verification procedure could consist of periodic auditing of the supplier to ensure that the supplier is following the provisions of the guarantee, or testing the juice periodically to confirm that it does not contain high levels of patulin. Now boil for 15 minutes. Validated cleaning process parameters: e.g., values for pre-rinse time & temperature; alkali cleaner %, time, and temperature; and/or rinse time and temperature - whatever values for control measures that are critical for allergen control, Monitoring devices used to measure cleaning parameters, Every time the cleaning process is performed, Monitoring, corrective action and CCP verification records. Records pasteurization temperatures and times. Harmful pesticide residues in the juice are not likely because in U.S. produce, unapproved pesticide residues occur infrequently and the public health impact is typically not severe. Save my name, email, and website in this browser for the next time I comment. Were committed to providing the world with free how-to resources, and even $1 helps us in our mission. Of course, this is only a sterilization process in small-scale fruit juice production. Food and Drug Administration Pasteurization can simply occur by heating a juice at 750C and holding this temperature for 20 minutes. The training requirements are in 21 CFR 120.13. Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. However, as noted above, looking at test results over an extended time period may allow you to spot a trend towards loss of process control and take appropriate action before your system fails. These checks for core rot would constitute a third CCP. To counteract the effect, you should pasteurize any juice that is labelled as raw. Likewise, if you use UV radiation as your pathogen control measure, that UV treatment must be carried out to achieve consistently at least a 5-log reduction in the "pertinent microorganism. Reprocess, destroy, or divert (to non-food use) the affected product. What cleaning procedures should be carried out between runs to ensure that residues, e.g., particulates, do not accumulate in the equipment that would reduce the effectiveness of the treatment? Is the delivery of a minimum level of UV energy critical to the process? This results in uniform product and temperature throughout the vat. For beverages containing less than 100 percent juice, only the juice ingredient must be made applying HACCP principles. To carry out these tasks, your employees should familiarize themselves, as appropriate, with HACCP principles and acquire any necessary HACCP training. If you produce a juice that is subject to the requirements of 21 CFR Parts 113 or 114, i.e., the regulations for low acid canned foods and acidified foods, you do not have to include control measures in your HACCP plan for the potential hazards that are addressed through compliance with 21 CFR Parts 113 or 114, e.g., hazards associated with the formation of Clostridium botulinum toxin. and Listeria monocytogenes in fruit juices, NFPA calculated that this typical process used for shelf stable juices would achieve a 50,000 log reduction for these pathogens without taking into account the cumulative lethality during the cool down period. Although it is not common for levels of tin in canned juice to approach 200 ppm, if you pack juice in unlacquered metal cans, we recommend that you know what levels of tin are present in your juice after the longest anticipated storage time at the highest anticipated storage temperature for the juice. Although your process authority will likely be your source for information on the critical limits for your pathogen reduction process, you will have to know what those limits are, e.g., the time and temperature parameters for a pasteurization process, or the amount of UV energy to which the juice is exposed; these values serve as the critical limits in your HACCP plan. Not likely to occur due to SSOP for water quality. Patulin is a mycotoxin that can occur on rotten, moldy, bruised or damaged apples, and may occur at hazardous levels if such apples are used to make juice. As the death point of most bacteria is 68 and under 30 min, so this process can eliminate most bacteria. For pesticides, the hazard identification and evaluation exercise would be identical to the one shown for apple juice. We recommend that, as part of meeting the validation requirements of 21 CFR 120.11, you ensure that studies have been done to establish that contamination of juice by pathogens that may be present on the peel will not occur during the extraction operation. This increase in temperature is dependent on the composition of the food product, the initial temperature of the product/vessel, the pressure transmitting fluid for batch systems, and the time the product is held at the processing pressure. Generally, you will carry out your control measures at CCPs (which are specific points in the process for producing juice) identified in your HACCP plan. Any person who has a thorough understanding of the proper condition of the glass handling equipment and surrounding area may perform monitoring. The potential for high levels of patulin to occur depends on several factors. 3.0 Requirements for Certain Citrus Juices. To kill harmful bacteria in pasteurized juice, it must be heated to a high temperature in a short period of time. If you have opted to control a facility sanitation related hazard through your SSOPs, it is not necessary to classify it as reasonably likely to occur. The authors noted that a pH in the range of 3.6 to 4.0 has been reported as a non-significant variable in the heat resistance of E. coli O157:H7. List critical control points of a HTST system. Pasteurization technology is also applied in other fields, like seafood. Many different types of processes may be used to reduce the level of the organism of concern. 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. 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