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Fish and Fishery Products Hazards CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. UNDERSTAND THE POTENTIAL HAZARD. competition. Rapid growth of pathogenic bacteria that may be introduced after pasteurization is, The introduction of pathogenic bacteria after therefore, a concern. This chapter covers control pasteurization and certain specialized cooking of recontamination after pasteurization. processes can cause consumer illness. The For some products that are marketed refrigerated, primary pathogens of concern are Clostridium cooking is performed immediately before reduced botulinum (C. botulinum), Listeria monocytogenes, oxygen packaging (e.g., vacuum packaging, Campylobacter jejuni, pathogenic strains of modified atmosphere packaging). For these Escherichia coli, Salmonella spp., Shigella spp., products, the cooking process is targeted to Yersinia enterocolitica, Staphylococcus aureus (S. eliminate the spores of C. botulinum type E aureus), Vibrio cholerae, Vibrio vulnificus, and and non-proteolytic types B and F, particularly Vibrio parahaemolyticus. See Appendix 7 for a when the product does not contain other description of the public health impacts of barriers that are sufficient to prevent growth and these pathogens. toxin formation by this pathogen (e.g., many refrigerated, vacuum packaged hot-filled soups, • Goal of pasteurization and specialized chowders, and sauces). cooking processes Pasteurization is a heat treatment applied to These specialized cooking processes, which are eliminate the most resistant pathogenic bacteria discussed in Chapter 16, have much in common of public health concern that is reasonably likely with pasteurization processes, which are also to be present in the food. With fishery products, discussed in Chapter 16. For example, control pasteurization is usually performed after the product of recontamination after the product is placed in is placed in the hermetically sealed finished product the finished product container is critical to the container. It is applied to fishery products that are safety of these products. Additionally, because distributed either refrigerated or frozen. Examples these products are cooked before they are of pasteurized fishery products follow: pasteurized packaged, they are at risk for recontamination crabmeat, pasteurized surimi-based analog products, between cooking and packaging. The risk of this and pasteurized lobster meat. recontamination may be minimized by filling directly from the cook kettle using a sanitary, In addition to eliminating pathogenic bacteria, automated, continuous-filling system (designed to the pasteurization process also greatly reduces minimize the risk of recontamination) while the the number of spoilage bacteria present in the product is still hot (i.e., hot filling). This control fishery product. Spoilage bacteria normally strategy may not be suitable for products such as restrict the growth of pathogenic bacteria through crabmeat, lobster meat, or crayfish meat that are CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 345 handled between cooking and filling. Hot filling provide limited lethality for any non-proteolytic is covered in this chapter. C. botulinum spores present on the packaging material. • Control of pathogenic bacteria introduction after pasteurization and after specialized It may also be prudent to use packaging that has cooking processes been manufactured or treated to inactivate spores of C. botulinum type E and non-proteolytic There are three primary causes of types B and F (e.g., gamma irradiation and hot recontamination after pasteurization and after extrusion). FDA is also interested in comment on cooking that is performed immediately before the utility of such measures. reduced oxygen packaging: • Defective container closures; • Strategies for controlling pathogenic • Contaminated container cooling water; bacteria growth • Recontamination between cooking and There are a number of strategies for the control reduced oxygen packaging. of pathogenic bacteria in fish and fishery products. They include: Poorly formed or defective container closures • Controlling the introduction of pathogenic can increase the risk of pathogens entering the bacteria after the pasteurization process container through container handling that occurs and after the cooking process performed after pasteurization or after the cooked product is immediately before reduced oxygen filled into the reduced oxygen package. This risk packaging (covered in this chapter); is a particular concern during container cooling performed in a water bath. Contaminated • Controlling the amount of moisture that is cooling water can enter through the container available for pathogenic bacteria growth closure, especially when the closure is defective. (water activity) in the product by drying Container closure can be controlled by adherence (covered in Chapter 14); to seal guidelines that are provided by the • Controlling the amount of moisture that is container or sealing machine manufacturer. available for pathogenic bacteria growth Control is accomplished through periodic seal (water activity) in the product by formulation inspection. (covered in Chapter 13); Contamination of cooling water can be controlled • Controlling the amount of salt or either by ensuring that a measurable residual preservatives, such as sodium nitrite, in the of chlorine, or other approved water treatment product (covered in Chapter 13); chemical, is present in the cooling water or by • Controlling the level of acidity (pH) in the ensuring that ultraviolet (UV) treatment systems product (covered by the Acidified Foods for the cooling water are operating properly, regulation, 21 CFR 114, for shelf-stable particularly for systems in which the water is acidified products, and by Chapter 13 for reused or recirculated. refrigerated acidified products); Recontamination between cooking and reduced • Controlling the source of molluscan shellfish oxygen packaging in continuous filling systems, and the time from exposure to air (e.g., by where the product is packaged directly from harvest or receding tide) to refrigeration the kettle, can be controlled by hot filling at to control pathogens from the harvest area temperatures at or above 185°F (85°C). FDA (covered in Chapter 4); is interested in information on the value of • Killing pathogenic bacteria by cooking adding a time component (e.g., 3 minutes) to or pasteurization (covered in Chapter 16) this hot filling temperature recommendation to or by retorting (covered by the Thermally CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 346 Processed Low-Acid Foods Packaged in pathogenic bacteria after pasteurization can Hermetically Sealed Containers regulation, 21 include: CFR 113, called the Low Acid Canned Foods • Controlling container sealing; regulation in this guidance document); • Controlling the residual of chlorine, • Killing pathogens by processes that retain the raw product characteristics (covered in or other approved water treatment Chapter 17); chemical, in container cooling water; • Managing the amount of time that food is • Controlling UV light intensity of bulbs exposed to temperatures that are favorable used for treating container cooling water for pathogenic bacteria growth and toxin and the flow rate of the cooling water production (covered generally in Chapter 12; moving through the UV treatment system; for C. botulinum, in Chapter 13; and for S. • Hot filling the product into the final aureus in hydrated batter mixes, in Chapter 15). container in a continuous filling system. DETERMINE WHETHER THE POTENTIAL • Intended use HAZARD IS SIGNIFICANT. It is unlikely that the intended use will affect the significance of this hazard. The following guidance will assist you in determining whether introduction of pathogenic IDENTIFY CRITICAL CONTROL POINTS. bacteria after pasteurization is a significant hazard at a processing step: The following guidance will assist you in determining whether a processing step is a 1. Is it reasonably likely that pathogenic bacteria critical control point (CCP) for introduction of will be introduced at this processing step pathogenic bacteria after pasteurization. (consider post-pasteurization and post-cooking processing steps only)? If you identified the hazard as significant, you should identify the container sealing step, the It is reasonable to assume that in the absence water bath container cooling step, and the hot of controls, pathogens of various types may filling step (where applicable) as the CCPs for this enter the finished product container after hazard. pasteurization or after filling the cooked product into the reduced oxygen package. Example: This is a particular concern for products that A crabmeat processor that pasteurizes the are cooled in a water bath. finished product cans after filling and cools them
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