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Fish and Fishery Products Hazards

Fish and Fishery Products Hazards

CHAPTER 16: Pathogenic Survival Through or

This guidance represents the 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. Pasteurization is a treatment (usually, but not always, the application of heat) applied to The survival of through eliminate the most resistant pathogenic bacteria cooking or pasteurization can cause consumer of public health concern that is reasonably likely illness. The primary of concern are to be present in the food for as long as the shelf- botulinum (C. botulinum), life of the product, when stored under normal monocytogenes (L. monocytogenes), and moderate abuse conditions. With fishery jejuni (C. jejuni), pathogenic strains of products, pasteurization is usually performed after coli (E. coli), spp., spp., the product is placed in the hermetically sealed enterocolitica (Y. enterocolitica), finished product container. It is applied to fishery aureus (S. aureus), (V. cholera), products that are distributed either refrigerated or ( V. vulnificus), and Vibrio frozen. Examples of pasteurized fishery products parahaemolyticus (V. parahaemolyticus). See are pasteurized crabmeat, pasteurized surimi-based Appendix 7 for a description of the public health analog products, and pasteurized lobster . impacts of these pathogens. In addition to eliminating bacterial pathogens, It is not practical to target viral pathogens in cooking and pasteurization also greatly reduce cooking or pasteurization processes because of the number of spoilage bacteria present in the their extreme heat resistance. Viral pathogens fishery product. These bacteria normally restrict should be controlled through a rigorous the growth of pathogens through competition. regime as part of a prerequisite program or as Elimination of spoilage bacteria allows rapid part of Hazard Analysis Critical Control Point growth of newly introduced pathogenic bacteria. (HACCP) itself. The Procedures for the Safe and Sanitary Processing and Importing of Fish and Pathogenic bacteria that may be introduced after Fishery Products regulation, 21 CFR 123 (called cooking or pasteurization are, therefore, a concern. the Seafood HACCP Regulation in this guidance This is especially true for pasteurization, because document) requires such a regime. that process can significantly extend the shelf-life of the fishery product, providing more time for • Types of heat processing pathogenic bacteria growth and toxin formation. Cooking is a heat treatment, usually performed Retorting is a heat treatment that eliminates all before the product is placed in the finished product food-borne pathogens and produces a product container. It is applied to fishery products that are that is shelf stable. Mandatory controls for retorting distributed either refrigerated or frozen. Generally, are provided in the Thermally Processed Low-Acid after cooking, fishery products are referred to as Packaged in Hermetically Sealed Containers cooked, ready to eat. Examples of cooked, ready- to-eat fishery products are crabmeat, lobster meat, regulation, 21 CFR 113 (hereinafter, the Low Acid crayfish meat, cooked shrimp, surimi-based analog Canned Foods (LACF) Regulation), but are not products, seafood salads, seafood and covered in this chapter. , and hot-smoked fish.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 315 • Goal of pasteurization (38°F (3.3°C)) are not uncommon. Therefore, Selection of the target is critical to alone cannot be relied upon for the effectiveness of pasteurization. You should control of the C. botulinum hazard. When consider the potential that C. botulinum type freezing is relied upon to control the growth of E or non-proteolytic types B and F will survive C. botulinum type E and non-proteolytic types B the pasteurization process and grow under and F, controls should be in place to ensure that normal storage conditions or moderate abuse the product is labeled with instructions that it be conditions. This is of particular concern if the kept frozen throughout distribution. product is reduced oxygen packaged (e.g., For pasteurization processes that target C. vacuum packaged or modified atmosphere botulinum type E and non-proteolytic types B and packaged), does not contain a barrier that is F, generally a of six orders of magnitude sufficient to prevent growth and toxin formation (six logarithms, e.g., from 103 to 10 -3) in the level by this pathogen, is not equipped with a time of contamination is suitable. This is called a 6D and integrator, and is stored or process. However, lower degrees of destruction distributed refrigerated (not frozen). In such may be acceptable if supported by a scientific products, you should ordinarily select C. study of the normal levels in the food before botulinum type E and non-proteolytic types pasteurization. It is also possible that higher levels B and F as the target pathogen. For example, of destruction may be necessary in some foods, if vacuum-packaged lobster meat that is pasteurized especially high initial levels of the target pathogen to kill L. monocytogenes, but not C. botulinum are anticipated. Table A-4 (Appendix 4) provides type E or non-proteolytic types B and F, and 6D process times for a range of pasteurization is not equipped with a Time-Temperature , with C. botulinum type B (the Indicator should be frozen to prevent growth most heat resistant form of non-proteolytic C. and toxin formation by C. botulinum type E botulinum) as the target pathogen. The lethal rates and non-proteolytic types B and F, and should and process times provided in the table may not be labeled to be held frozen and to be thawed be sufficient for the destruction of C. botulinum under refrigeration immediately before use (e.g., type E and non-proteolytic types B and F in “Important, keep frozen until used, thaw under dungeness crabmeat, because of the potential that refrigeration immediately before use”). naturally occurring substances, such as lysozyme, If the product is not reduced oxygen packaged, may enable the pathogen to more easily recover or contains a barrier that is sufficient to prevent after heat damage. the growth and toxin formation by C. botulinum Examples of properly pasteurized products are type E or non-proteolytic types B and F, or fish and fishery products generally (e.g., surimi­ is equipped with a time and temperature based products, soups, or sauces) pasteurized integrator, or is distributed frozen, then selection to a minimum cumulative total lethality of F194°F of another target pathogen may be appropriate. (F90°C) = 10 minutes, where z = 12.6°F (7°C) for L. monocytogenes may be selected as the target temperatures less than 194°F (90°C) and z = 18°F pathogen for pasteurization of this type of (10°C) for temperatures above 194°F (90°C); blue product because it is the most resistant bacterial crabmeat pasteurized to a minimum cumulative pathogen of public health concern that is total lethality of F185°F (F85°C) = 31 minutes, where z reasonably likely to be present. = 16°F (9°C); and dungeness crabmeat pasteurized

Surveys of retail display cases and home to a minimum cumulative total lethality of F194°F refrigerators indicate that temperatures above the (F90°C) = 57 minutes, where z = 15.5°F (8.6°C). minimum growth temperature of C. botulinum Equivalent processes at different temperatures can type E and non-proteolytic types B and F be calculated using the z values provided.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 316 forming unit (CFU)/g and that approximately 91% EXAMPLES OF PROPERLY are contaminated at less than 1 CFU/g. Less than PASTEURIZED PRODUCTS 1% of raw seafood are contaminated at levels MINIMUM CUMULATIVE 3 PRODUCT Z VALUE greater than 10 CFU/g and none at levels greater TOTAL LETHALITY than 106 CFU/g. FDA’s limit for L. monocytogenes Fish and F194°F (F90°C) = 10 minutes 12.6°F (7°C), for fishery temperatures in ready-to-eat products, nondetectable, products less than 194°F corresponds to a level of less than 1 CFU/25g. generally (90°C) (e.g., surimi­ Table A-3 (Appendix 4) provides 6D process based 18°F (10°C) for products, temperatures times for a range of pasteurization temperatures, soups, or above 194°F (90°C) with L. monocytogenes as the target pathogen. sauces) Lower degrees of destruction may be acceptable Blue F (F ) = 31 minutes 16°F (9°C) 185°F 85°C if supported by a scientific study of the normal crabmeat levels in the food before pasteurization. It is also Dungeness F194°F (F90°C) = 57 minutes 15.5°F (8.6°C) crabmeat possible that higher degrees of destruction may be necessary in some foods if especially high In some pasteurized surimi-based products, salt, initial levels are anticipated. in combination with a milder heat pasteurization Products that are pasteurized in the finished process in the finished product container, works product container are at risk for recontamination to prevent growth and toxin formation by C. after pasteurization. Controls, such as container botulinum type E and non-proteolytic types B seal integrity and protection from contaminated and F. An example of a properly pasteurized cooling , are critical to the safety of these surimi-based product in which 2.4% water products and are covered in Chapter 18. salt is present is one that has been pasteurized at an internal temperature of 185°F (85°C) for • Goal of cooking for most products at least 15 minutes. This process may not be One reason for cooking products that will not suitable for other types of products because of be reduced oxygen packaged is to eliminate the unique formulation and processing involved vegetative cells of pathogenic bacteria (or reduce in the manufacture of surimi-based products. them to an acceptable level) that may have been Reduced oxygen-packaged foods that are introduced to the process by raw materials or pasteurized to control C. botulinum type E by processing that occurs before the cooking and non-proteolytic types B and F, but not C. step. Selection of the target pathogen is critical botulinum type A and proteolytic types B and to the effectiveness of cooking. Generally, L. F, and that do not contain barriers to its growth monocytogenes is selected as the target pathogen should be refrigerated or frozen to control C. because it is regarded as the most heat-tolerant, botulinum type A and proteolytic types B and foodborne bacterial pathogen that does not form F. Control of refrigeration is critical to the safety spores. Cooking processes are not usually designed of these products. Further information on C. to eliminate spores of bacterial pathogens. botulinum and reduced oxygen packaging is Determining the degree of destruction of the target contained in Chapter 13. pathogen is also critical. Generally, a reduction of six orders of magnitude (six logarithms, e.g., from In cases where L. monocytogenes is selected 103 to 10-3) in the level of contamination is suitable. as the target pathogen, a 6D process is also This is called a 6D process. generally suitable. FDA and U.S. Department of Agriculture’s L. monocytogenes risk assessment Table A-3 provides 6D process times for a range of indicates that approximately 8% of raw seafood cooking temperatures, with L. monocytogenes as are contaminated with from 1 to 103 colony the target pathogen. Lower degrees of destruction

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 317 may be acceptable if supported by a scientific properly cooked to eliminate C. botulinum type study of the normal levels in the food before E and non-proteolytic types B and F is a or pasteurization. It is also possible that higher that is cooked to a minimum cumulative degrees of destruction may be necessary in some total lethality of F194°F (F90°C) = 10 minutes, where foods if especially high initial levels are anticipated. z = 12.6°F (7°C) for temperatures less than 194°F (90°C) and z = 18°F (10°C) for temperatures • Goal of cooking refrigerated, reduced above 194°F (90°C). oxygen-packaged products Reduced oxygen-packaged soups or sauces that Cooking is sometimes performed on products are cooked immediately before packaging to immediately before placement in reduced oxygen control C. botulinum type E and non-proteolytic packaging (e.g., vacuum packaging or modified types B and F, but not C. botulinum type A and atmosphere packaging). These products include proteolytic types B and F, and that do not contain cooked, hot-filled soups, chowders, or sauces barriers to its growth should be refrigerated that are filled directly from the cook kettle using or frozen to control C. botulinum type A and sanitary, automated, continuous filling systems proteolytic types B and F. Control of refrigeration designed to minimize risk of recontamination. is critical to the safety of these products. Further They are often marketed under refrigeration, information on C. botulinum and reduced oxygen which is important for the control of C. packaging is contained in Chapter 13. botulinum type A and proteolytic types B and F. Cooking processes that target C. botulinum The cooking process for these products should type E and non-proteolytic types B and F have be sufficient to eliminate the spores of C. much in common with pasteurization processes. botulinum type E and non-proteolytic types B Like products that are pasteurized in the final and F. This is the case when the product does container, products that are cooked and then not contain other barriers that are sufficient placed in the final container also are at risk to prevent growth and toxin formation by for recontamination after they are placed in this pathogen. Generally, a 6D process (six the finished product container. Controls, such logarithms, e.g., from 103 to 10 -3) is suitable. as container seal integrity and protection from However, lower degrees of destruction may contaminated cooling water, are critical to the be acceptable if supported by a scientific safety of these products and are covered in study of the normal levels in the food before Chapter 18. pasteurization. It is also possible that higher degrees of destruction may be necessary in Additionally, because these products are cooked some foods if especially high initial levels are before they are packaged, they are at risk of anticipated. recontamination between cooking and packaging. The risk of recontamination may be minimized Table A-4 provides 6D process times for a range by filling the container in a sanitary, automated, of cooking temperatures, with C. botulinum type continuous filling system while the product is B (the most heat-resistant form of non-proteolytic still hot (i.e., hot filling). This is another critical C. botulinum) as the target pathogen. The lethal step for the safety of these products. This control rates and process times provided in the table strategy is suitable for products that are filled may not be sufficient for the destruction of C. directly from the cooking kettle, where the risk of botulinum type E and non-proteolytic types B recontamination is minimized. It is not ordinarily and F in soups or sauces containing dungeness suitable for products such as crabmeat, lobster crabmeat because of the potential that naturally meat, or crayfish meat that are handled between occurring substances, such as lysozyme, may cooking and filling. Hot filling is also covered in enable the pathogen to more easily recover Chapter 18. after damage. An example of a product that is

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 318 • Control by cooking or pasteurization cells of L. monocytogenes and destroying them Controlling pathogenic bacteria survival through requires an EPIPT that could be achieved only cooking or pasteurization is accomplished by: in a pressurized environment, making measurement impractical. Additional guidance • Scientifically establishing a cooking or pasteurization process that will eliminate on EPIPT monitoring can be found in Food pathogenic bacteria of public health concern Processors Association guidance document “FPA or reduce their numbers to acceptable levels; Guidance Document: Establishing or Verifying a Heat Process for Cooked, Ready-to-Eat • Designing and operating the cooking or Seafood Products, and Heat Process Monitoring pasteurization equipment so that every unit Considerations under HACCP,” 2nd Edition, of product receives at least the established February 2005 and purchased at the Grocery minimum process; Manufacturers Association, Washington DC 20005. • Continuously monitoring the critical process parameters to verify achievement of a • Strategies for controlling pathogenic scientifically established process (e.g., time bacteria growth and temperature). There are a number of strategies for the control You may monitor End-Point Internal Product of pathogenic bacteria in fish and fishery Temperature (EPIPT), a measurement of the products. They include: temperature of the product as it exits the heat • Killing pathogenic bacteria by cooking or process, instead of performing continuous time pasteurizing (covered in this chapter) or and temperature monitoring. This approach is retorting (covered by the LACF Regulation, 21 suitable if you have conducted a scientific study CFR 113); to validate that the EPIPT that you have selected • Killing pathogenic bacteria by processes that will provide an appropriate reduction in the retain the raw characteristics of the products numbers of the target pathogen (e.g., 6D) in the (covered in Chapter 17); slowest heating unit or portion of product under • Managing the amount of time that food is the worst set of heating conditions covered by exposed to temperatures that are favorable the scientific study. You should (1) conduct a for pathogenic bacteria growth and toxin temperature distribution study within the heating production (covered generally in Chapter system to identify any cold spots; (2) conduct 12; for C. botulinum, in Chapter 13; and a heat penetration study that accounts for the for S. aureus in hydrated batter mixes, in slowest heating product under the worst case Chapter 15); heating conditions covered by the scientific study; • Controlling the amount of moisture that is and identify other critical factors of processing available for pathogenic bacteria growth and/or packaging that affect the rate of product (water activity) in the product by drying heating when scientifically establishing a cooking (covered in Chapter 14); or pasteurization process (i.e., process validation). The EPIPT should be used as a monitoring • Controlling the amount of moisture that is technique only under those conditions that available for pathogenic bacteria growth were evaluated by the scientific study. Those (water activity) in the product by formulation conditions may need to be identified as critical (covered in Chapter 13); limits and monitored as part of the HACCP plan. • Controlling the amount of salt or preservatives, such as sodium nitrite, in the EPIPT monitoring may not be an option when product (covered in Chapter 13); the objective is control of C. botulinum type E and non-proteolytic types B and F spores. These • Controlling the level of acidity (pH) in the spores are far more heat resistant than vegetative product (covered by the Acidified Foods

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 319 regulation, 21 CFR 114, for shelf-stable of bacterial pathogens. For this reason, you acidified products, and by Chapter 13 for should consider it reasonably likely that refrigerated acidified products); low numbers of pathogenic bacteria will be • Controlling the source of molluscan shellfish present in the product. and the time from exposure to air (e.g., by 2. Can unsafe levels of pathogenic bacteria that harvest or receding tide) to refrigeration to were introduced at an earlier processing step be control pathogens from the harvest area eliminated or reduced to an acceptable level at (covered in Chapter 4); this processing step? • Controlling the introduction of pathogenic bacteria after the pasteurization process Pathogenic bacteria survival through cooking (covered in Chapter 18). or pasteurization should also be considered a significant hazard at any processing step DETERMINE WHETHER THE POTENTIAL where a preventive measure is, or can be, HAZARD IS SIGNIFICANT. used to eliminate the hazard (or reduce the likelihood of its occurrence to an acceptable level) if it is reasonably likely to occur. The The following guidance will assist you in preventive measure that can be applied determining whether pathogenic bacteria for pathogenic bacteria survival through survival through cooking and pasteurization is a cooking and pasteurization is proper design significant hazard at a processing step. and control of the cooking or pasteurization 1. Is it reasonably likely that unsafe levels of process. pathogenic bacteria will be introduced at this • Intended use processing step (do unsafe levels of pathogenic bacteria come in with the raw material, or will Because cooked or pasteurized products are the process introduce unsafe levels of pathogenic ready to eat, it is unlikely that the intended use bacteria)? will affect the significance of the hazard.

It is reasonable to assume that pathogens of IDENTIFY CRITICAL CONTROL POINTS. various types, including those listed in Table A-1 (Appendix 4), will be present on raw fish The following guidance will assist you in and fishery products. They may be present determining whether a processing step is a only at low levels or only occasionally, but critical control point (CCP) for the survival even such occurrences warrant consideration of pathogenic bacteria through cooking or because of the potential for growth and toxin pasteurization: production. Will the finished product be pasteurized in the final Pathogenic bacteria may also be introduced container? during processing, from the air, unclean hands, insanitary utensils and equipment, 1. If the finished product will be pasteurized in unsafe water, and sewage. Well-designed the final container, you should identify the sanitation programs will minimize the pasteurization step as the CCP. In this case, you introduction of pathogens. Such sanitation would not need to identify the cooking step as controls need not be part of your HACCP a CCP for the hazard of pathogenic bacteria plan if they are monitored under your survival through cooking. sanitation program (prerequisite program). Example: In most cases, it is not reasonable to assume A crabmeat processor cooks, picks, that they will fully prevent the introduction packs, and pasteurizes the crabmeat.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 320 The processor sets the CCP for pathogenic cook or pasteurization cycle (speed of the bacteria survival through cooking and belt for a continuous cooker or pasteurizer), pasteurization at the pasteurization step temperature of the steam or water used and does not identify the cooking step as for cooking or pasteurization (or visual a CCP for this hazard. observation of minutes at a for cooking), initial temperature of the product, container This control approach is a control strategy size (e.g., can dimensions, pouch thickness), referred to in this chapter as “Control Strategy and product formulation. Other critical Example - Cooking and Pasteurization.” factors that affect the rate of heating of the 2. If the product will not be pasteurized, you should product may also be established by the identify the cooking step as the CCP. study; This control approach is the same as the OR one above and is a control strategy also • The EPIPT, established by a scientific referred to in this chapter as “Control Strategy study. Other critical factors that affect the Example - Cooking and Pasteurization.” For rate of heating of the product may also be products in reduced oxygen packaging for established by the study.

which the cooking process does not target Note: EPIPT monitoring may not be an option when the objective C. botulinum type E and non-proteolytic is control of C. botulinum type E and non-proteolytic types B and F types B and F, see Chapter 13 for additional spores. guidance. Establish Monitoring Procedures. DEVELOP A CONTROL STRATEGY. » What Will Be Monitored? The following guidance provides a control • The critical factors established by a scientific strategy for survival of pathogenic bacteria study. These may include length of the cook through cooking or pasteurization. You may or pasteurization cycle (speed of the belt select a control strategy that is different from that for a continuous cooker or pasteurizer) and which is suggested, provided it complies with the temperature of the steam or water used requirements of the applicable laws for cooking or pasteurization (or visual and regulations. observation of minutes at a boil for cooking), initial temperature of the product, container The following is an example of the control size (e.g., can dimensions, pouch thickness), strategy included in this chapter: and product formulation; OR MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY • The EPIPT. PROCESSOR PROCESSOR Cooking and pasteurization   » How Will Monitoring Be Done? For batch cooking or pasteurization equipment: • CONTROL STRATEGY EXAMPLE - COOKING AND • For cooking or pasteurization temperature: PASTEURIZATION ° Use a continuous temperature-recording Set Critical Limits. device (e.g., a recording ). The device should be installed where • The minimum or maximum values for the it measures the coldest temperature of critical factors established by a scientific the cooking equipment (cold spot to be study. These may include length of the determined by a study). Where cooking

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 321 is performed at the point, visual ° Use equipment appropriate to the critical observation of minutes at a boil may be factor (e.g., initial temperature with a an acceptable alternative; temperature-indicating device, (e.g., a thermometer); AND • For the start and end of each cooking or OR pasteurization cycle: • For the EPIPT: ° Visual observation; ° Use a temperature-indicating device (e.g., a thermometer). AND • For other critical factors: » How Often Will Monitoring Be Done (Frequency)? ° Use equipment appropriate to the critical For batch cooking or pasteurization equipment: factor (e.g., initial temperature with a • For cooking or pasteurization temperature: temperature-indicating device, (e.g., a thermometer); ° Continuous monitoring, with a visual check of the recorded data at least once OR per batch; • For the EPIPT: AND Use a temperature-indicating device (e.g., ° • For the start and end of each cooking or a thermometer). pasteurization cycle: For continuous cooking or pasteurization ° Each batch; equipment: AND • For cooking or pasteurization temperature: • For other critical factors: ° Use a continuous temperature-recording device (e.g., a recording thermometer). ° With sufficient frequency to achieve The device should be installed where control; it measures the coldest temperature of OR the cooking equipment (cold spot to • For the EPIPT: be determined by a study). Because Each batch. of the extended time of operation of ° such equipment, it is unlikely that For continuous cooking or pasteurization visual observation of boiling will be an equipment: acceptable alternative, even if cooking is • For cooking or pasteurization temperature: performed at the ; ° Continuous monitoring, with a visual AND check of the recorded data at least once • For cooking or pasteurization time, use: per day; ° A stopwatch or tachometer to monitor AND the speed of the belt drive wheel; • For cooking or pasteurization time: OR ° At least once per day, and whenever any ° A stopwatch to monitor the time changes in belt speed are made; necessary for a test unit or belt marking AND to pass through the equipment; • For other critical factors: AND ° With sufficient frequency to achieve • For other critical factors: control;

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 322 OR AND • For the EPIPT: Take the following corrective action to regain control ° At least every 30 minutes, and whenever over the operation after a critical limit deviation: any changes in product-heating critical • Adjust the steam supply to increase the factors occur. processing temperature; » Who Will Perform the Monitoring? OR • For continuous temperature-recording • Extend the length of the cooking or devices: pasteurization cycle to compensate for a ° Monitoring is performed by the device temperature drop, using a process developed itself. The visual check of the data by a process authority; generated by the device, to ensure that OR the critical limits have consistently been • Process at a higher temperature to met, may be performed by any person compensate for a low initial temperature, who has an understanding of the nature using a process developed by a process of the controls; authority; AND OR • For other monitoring: • Adjust the belt speed. ° Any person who has an understanding of the nature of the controls. Establish a Recordkeeping System.

Establish Corrective Action Procedures. For batch cooking or pasteurization equipment: • For temperature monitoring: Take the following corrective action to a product Record of continuous temperature involved in a critical limit deviation: ° monitoring; • Recook or repasteurize the product; AND OR Record of visual checks of recorded data; • Chill and hold the product for an evaluation ° of the adequacy of the cooking or OR pasteurization process. If the product has • Cooking log that indicates visual observation not received an adequate process, it should of boiling, where cooking is performed at be destroyed, diverted to a non-food use, or the boiling point; recooked or repasteurized; AND OR • Record of notation of the start time and end • Divert the product to a use in which the time of the cooking or pasteurization periods; critical limit is not applicable (e.g., divert AND improperly cooked or pasteurized shrimp to a shrimp operation); • Records that are appropriate for the other critical factors (e.g., a cooking or OR pasteurization log that indicates the initial • Destroy the product; temperature); OR OR • Divert the product to a non-food use. • Record of EPIPT results.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 323 For continuous cooking or pasteurization the spores of C. botulinum type E and non­ equipment: proteolytic types B and F. This is the case • Record of continuous temperature monitoring; when the product does not contain other barriers that are sufficient to prevent growth AND and toxin formation by this pathogen (e.g., • Record of visual checks of devices; refrigerated, vacuum packaged hot-filled AND soups and sauces). Generally, a 6D process is suitable, regardless of the target bacterial • Cooking or pasteurization log that indicates pathogen. However, lower degrees of the RPM of the belt drive wheel or the time destruction may be acceptable if supported necessary for a test unit or belt marking to by a scientific study of the normal levels in pass through the tank; the food. Tables A-3 and A-4 provide 6D AND process times for a range of internal product • Records that are appropriate for the other temperatures, with L. monocytogenes and C. critical factors (e.g., a cooking or pasteurization botulinum type B (the most heat-resistant log that indicates the initial temperature); form of non-proteolytic C. botulinum) as the target pathogens. The values provided OR in Table A-4 may not be sufficient for the • Record of EPIPT results. destruction of C. botulinum type E and non-proteolytic types B and F in products Establish Verification Procedures. containing dungeness crabmeat because of For cooking, process validation study (process the potential protective effect of naturally establishment): occurring substances, such as lysozyme. • The adequacy of the cooking process Expert knowledge of thermal process should be established by a scientific study. It calculations and the dynamics of should be designed to ensure an appropriate in processing equipment may be required reduction in the number of pathogenic to establish such a cooking process. Such bacteria of public health concern. Selecting knowledge can be obtained by education or the target organism is critical. In most cases, experience, or both. Conducting a validation it will be a relatively heat-tolerant vegetative study for cooking processes may require pathogen, such as L. monocytogenes. access to suitable facilities and the application However, in some cases where outgrowth of recognized methods. The cooking of spore-forming pathogens, such as equipment should be designed, operated, and cereus, and maintained to deliver the established during the post-cook cooling step must be process to every unit of the product. In some prevented by eliminating these pathogens cases, thermal death time, heat penetration, during the cook step (e.g., because cooling temperature distribution, and inoculated after cooking is not controlled (see pack studies may be necessary to validate Chapter 12)), then they will be the target the minimum process. In many cases, organisms. Additionally, when cooking is establishing the minimum process may be performed immediately before reduced simplified by repetitively determining the oxygen packaging (e.g., vacuum packaging process needed to reach an internal product or modified atmosphere packaging), for temperature that will ensure the inactivation a product that will be marketed under of all vegetative bacterial pathogens of public refrigeration, it may be necessary for the health concern under the most difficult cooking process to be sufficient to eliminate heating conditions likely to be encountered

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 324 during processing. In other instances, in processing equipment may be required to existing literature or federal, state, or local determine the target bacterial pathogen and regulations that establish minimum processes to establish a pasteurization process. Such or adequacy of equipment are available. knowledge can be obtained by education Characteristics of the process, product, and/ or experience, or both. Conducting a or equipment that affect the ability of the validation study for pasteurization processes established minimum cooking process should may require access to suitable facilities and be taken into consideration in the validation the application of recognized methods. of the process. A record of the process The pasteurization equipment should be validation study should be maintained; designed, operated, and maintained to deliver the established process to every OR unit of the product. In some cases, thermal For pasteurization, process validation study death time, heat penetration, temperature (process establishment): distribution, and inoculated pack studies • The adequacy of the pasteurization process may be necessary to validate the minimum should be established by a scientific study. It process. In other instances, existing literature should be designed to ensure an appropriate or federal, state, or local regulations that reduction in the number of target bacterial establish minimum processes or adequacy pathogens. Selecting the target organism of equipment are available. Characteristics is critical. In most cases, it will be the of the process, product, and/or equipment spores of C. botulinum type E and non­ that affect the adequacy of the established proteolytic types B and F. In some cases minimum pasteurization process should be (e.g., products that are distributed frozen taken into consideration in the validation of or contain other barriers to prevent growth the process. A record of the validation study and toxin formation by C. botulinum type should be maintained; E and non-proteolytic types B and F), the AND process will target another pathogen, such • Before a temperature-indicating device (e.g., as L. monocytogenes. Generally, a 6D process a thermometer) or temperature-recording is suitable, regardless of the target pathogen. device (e.g., a recording thermometer) is However, lower degrees of destruction may put into service, check the accuracy of the be acceptable if supported by a scientific device to verify that the factory calibration study of the normal levels in the food. Tables has not been affected. This check can be A-3 and A-4 provide 6D process times for accomplished by: a range of internal product temperatures, with L. monocytogenes and C. botulinum ° Immersing the sensor in an ice slurry type B (the most heat-resistant form of (32°F (0°C)) if the device will be used at non-proteolytic C. botulinum) as the target or near refrigeration temperature; pathogens. The values provided in Table A-4 OR may not be sufficient for the destruction of C. Immersing the sensor in boiling water botulinum type E and non-proteolytic types ° (212°F (100°C)) if the device will be used B and F in products containing dungeness at or near the boiling point (note that crabmeat because of the potential protective the temperature should be adjusted to effect of naturally occurring substances, such compensate for altitude, when necessary); as lysozyme. OR Expert knowledge of thermal process calculations and the dynamics of heat transfer ° A combination of the above if the

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 325 device will be used at or near room show a need for more frequent calibration or temperature; the need to replace the device (perhaps with a more durable device). Devices subjected to OR high temperatures for extended periods of ° Comparing the temperature reading time may require more frequent calibration. on the device with the reading on a Calibration should be performed at a known accurate reference device (e.g., minimum of two temperatures that bracket a thermometer traceable to National the temperature range at which it is used; Institute of Standards and Technology (NIST) standards) under conditions that AND are similar to how it will be used (e.g., • Calibrate other instruments as necessary to steam temperature, water temperature, ensure their accuracy; product internal temperature) within the AND temperature range at which it will be used; • Review monitoring, corrective action, and verification records within 1 week of AND preparation to ensure they are complete and • Once in service, check the temperature- any critical limit deviations that occurred indicating device or temperature-recording were appropriately addressed. device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended by the instrument manufacturer and the history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational and, where applicable, has sufficient ink and paper; AND • Calibrate the temperature-indicating device or temperature-recording device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 326 TABLE 16-1

CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION (COOKING MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example - Cooking and Pasteurization (Cooking Model).” This example illustrates how a processor of wild-caught cooked shrimp can control cooking using a continuous steam cooker. It is provided for illustrative purposes only.

Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, food and color CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization Pasteurization or Cooking Through Survival 16:CHAPTER Bacteria Pathogenic additives, and metal fragments).

Example Only See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

MONITORING CRITICAL LIMITS CRITICAL SIGNIFICANT FOR EACH CORRECTIVE CONTROL RECORDS VERIFICATION HAZARD(S) PREVENTIVE ACTION(S) POINT WHAT HOW FREQUENCY WHO MEASURE*

327 Cooking Pathogenic Minimum Length of the Belt speed Once per day Cooker Extend process Cooking Scientific study establishing bacteria cook time: 2.5 cook cycle measurement and after any operator or elevate record the thermal process survival minutes with stopwatch adjustment temperature (process to compensate validation) for deviation from critical Check the Minimum cook Temperature Digital time and Continuous, Cooker limit, based Data logger data logger for temperature: of steam in temperature with visual operator on alternate printout accuracy and 210°F the cooker data logger check of processes damage and to ensure that Note: To recorded data provided by it is operational achieve a 6D once per day the process before putting reduction of L. authority into operation; check it monocytogenes daily, at the beginning of Chill and hold operations; and calibrate it for evaluation once per year

Calibrate the scale monthly Maximum Shrimp size Scale Hourly and Grader operator Grading shrimp size: 40 after every record Review count/pound raw material monitoring, lot change corrective action and or grader verification, records within adjustment 1 week of preparation

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. TABLE 16-2

CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION (PASTEURIZATION MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example - Cooking and Pasteurization (Pasteurization Model).” This example illustrates how a processor of pasteurized, refrigerated blue crabmeat can control pasteurization. It is provided for illustrative purposes only.

Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization Pasteurization or Cooking Through Survival 16:CHAPTER Bacteria Pathogenic other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, recontamination after pasteurization, and metal fragments).

Example Only See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

MONITORING CRITICAL LIMITS CRITICAL SIGNIFICANT FOR EACH CORRECTIVE CONTROL RECORDS VERIFICATION HAZARD(S) PREVENTIVE ACTION(S) POINT WHAT HOW FREQUENCY WHO MEASURE*

328 Batch Pathogenic Minimum Initial Dial Coldest Pasteurizer Extend the Pasteurization Process pasteurization bacteria initial temperature thermometer can entering operator process or log establishment survival product each batch elevate the temperature: temperature Check the 37°F to compensate temperature- for recording device and Minimum Time up to Temperature- Each batch Pasteurizer deviation Pasteurization dial thermometer for length of 189°F and recording operator from the log accuracy and damage pasteurization time cycle device critical and to ensure that they cycle: ends limit are operational before 120 minutes putting into operation; Segregate check it daily, at the and hold for beginning of operations; evaluation and calibrate it once per year

Review Minimum Temperature Temperature- Continuously, Recorder Recorder monitoring, water bath of water bath recording with visual thermometer, thermometer verification, and temperature: device check at end with visual chart corrective action records 189°F of batch check by within 1 week of pasteurizer preparation operator

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. BIBLIOGRAPHY. • National Advisory Committee on Microbiological Criteria for Foods. 1990. We have placed the following references on Recommendations of the National Advisory display in the Division of Dockets Management, Committee on Microbiological Criteria for Food and Drug Administration, 5630 Fishers Lane, Foods for Cooked Ready-to-Eat Shrimp and rm. 1061, Rockville, MD 20852. You may see Cooked Ready-to-Eat Crabmeat. Executive them at that location between 9 a.m. and 4 p.m., Secretariat, Food Safety and Inspection Monday through Friday. As of March 29, 2011, Service, U.S. Department of Agriculture, FDA had verified the Web site address for the Washington, DC. references it makes available as hyperlinks from • National Advisory Committee on the Internet copy of this guidance, but FDA is not Microbiological Criteria for Foods. 1990. responsible for any subsequent changes to Non- Recommendations of the National Advisory FDA Web site references after March 29, 2011. Committee on Microbiological Criteria for Foods for Refrigerated Foods Containing • Cockey, R. R., and M. C. Tatro. 1974. Survival Cooked, Uncured Meat or Poultry Products studies with spores of that are Packaged for Extended Refrigerated type E in pasteurized meat of the blue crab Shelf Life and that are Ready-to-Eat or Callinectes sapidus. Appl. Microbiol. 27:629-633. Prepared with Little or No Additional Heat • European Chilled Food Federation. 1997. Treatment. Executive Secretariat, Food Safety Guidelines for good hygienic practice in the and Inspection Service, U.S. Department of manufacture of chilled foods. Agriculture, Washington, DC. • Frazier, J. 2005. Establishing or verifying a • National Advisory Committee on heat process for cooked, ready-to-eat seafood Microbiological Criteria for Foods. 1991. products, and heat process monitoring : recommendations considerations under HACCP. 2nd ed. of the National Advisory Committee on Grocery Manufacturers Association (Food Microbiological Criteria for Foods for Products Association), Washington, DC. Refrigerated Foods. Intl. J. Food Microbiol. • Hilderbrand, K. S., Jr. 1996. Personal 14:185-246. communication. Oregon State University, • Peterson, M. E., G. A. Pelroy, F. T. Poysky, R. Extension Service, Corvallis, OR. N. Paranjpye, R. M. Dong, G. M. Pigott, and M. • Lum, K. C. 1996. Personal communication. W. Eklund. 1997. Heat-pasteurization process National Food Processors Association, for inactivation of nonproteolytic types of Seattle, WA. Clostridium botulinum in picked dungeness • Lynt, R. K., D. A. Kautter, and H. M. crabmeat. J. Food Prot. 60:928-934. Solomon. 1982. Differences and similarities • Peterson, M. E., R. N. Paranjpye, F. T. among proteolytic and nonproteolytic strains Poysky, G. A. Pelroy, and M. W. Eklund. of Clostridium botulinum types A, B, E and 2002. Control of nonproteolytic Clostridium F: a review. J. Food Prot. 45:466-474. botulinum types B and E in crab analogs • Lynt, R. K., H. M. Solomon, T. Lilly, and by combinations of heat pasteurization and D. A. Kautter. 1977. Thermal death time of water phase salt. J. Food Prot. 65:130-139. Clostridium botulinum type E in meat of the • Rippen, T., C. Hackney, G. Flick, G. Knobl, blue crab. J. Food Sci. 42:1022-1025. and D. Ward. 1993. Seafood pasteurization • Mackey, B. M., and N. Bratchell. 1989. The and minimal processing manual. Virginia heat resistance of Listeria monocytogenes: a Cooperative Extension Publication 600­ review. Lett. Appl. Microbiol. 9:89-94. 0061. Virginia Sea Grant Publication VSG

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 329 93-09. Virginia Seafood Research and Extension Center Publication VPI-SG-93-01. Blacksburg, VA. • U.S. Food and Drug Administration and U.S. Department of Agriculture. 2003. Quantitative assessment of the relative risk to public health from foodborne Listeria monocytogenes among selected categories of ready-to-eat foods. http://www.fda. gov/Food/ScienceResearch/ResearchAreas/ RiskAssessmentSafetyAssessment/ucm183966. htm. • U.S. Food and Drug Administration. Thermally processed low-acid foods packaged in hermetically sealed containers. In Code of Federal Regulations, 21 CFR 113. U.S. Government Printing Office, Washington, DC.

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