CHAPTER 18: Introduction of Pathogenic Bacteria After and Specialized Processes

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. 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 , 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 , • 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 . 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 ; 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 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 the kettle, can be controlled by hot filling at to control pathogens from the harvest area 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 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 in a water bath should set the CCPs for 2. Can the introduction of pathogenic bacteria after introduction of pathogenic bacteria after pasteurization be eliminated or reduced to an pasteurization at the can seaming and water acceptable level here? bath can cooling steps. Introduction of pathogenic bacteria after This control approach is a control strategy pasteurization should also be considered referred to in this chapter as “Control Strategy a significant hazard at any processing step Example - Control of Recontamination.” where a preventive measure is, or can be, used to eliminate the hazard (or reduce the likelihood of its occurrence to an acceptable level) if it is reasonably likely to occur. Preventive measures for introduction of

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 347 DEVELOP A CONTROL STRATEGY. For container cooling: • For chemical treatment: The following guidance provides a strategy to ° Residual chlorine, or other approved control the introduction of pathogenic bacteria water treatment chemical, in the cooling into the product after pasteurization. You may water; select a control strategy that is different from that OR which is suggested, provided it complies with the requirements of the applicable laws • For UV treatment: and regulations. ° Intensity of UV light; The following is an example of a control strategy AND included in this chapter: ° Cooling water flow rate. For hot filling: MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY • Product temperature as the product enters PROCESSOR PROCESSOR the final container. Control of recontamination   » How Will Monitoring Be Done? • CONTROL STRATEGY EXAMPLE - CONTROL OF For container sealing: RECONTAMINATION Visual examination of containers (non­ Set Critical Limits. destructive): • Recommendations for visual examinations For container sealing: that ensure a reliable hermetic seal should • Container or sealing machine manufacturer’s be obtained from the container or sealing seal guidelines. machine manufacturer. They should include: For container cooling: ° For double-seamed metal and plastic • Measurable residual of chlorine, or other cans: approved water treatment chemical, at the • The external features of the double discharge point of the container cooling seam should be examined for tank; gross closure defects, including: OR cutovers, seam sharpness, false • Equipment manufacturer’s UV light intensity seams, deadheading, droop, damage and flow rate guidelines. to the countersink wall indicating a broken chuck, cable cuts, and For hot filling: product overlapping the flange. • Product temperature of 185°F (85°C) or In addition, visual examination higher as the product enters the final should include examination of container. the entire container for product leakage or other obvious defects; Establish Monitoring Procedures. OR » What Will Be Monitored? ° For pouches: For container sealing: • Visual examination should be • Container integrity. sufficient to detect gross closure defects, including: cuts, fractures,

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 348 non-bonding, malformation, testing (tensile strength), residual puncture, abrasion, blister, testing, electroconductivity contaminated seal, delamination, seal testing, and dye testing; creep, wrinkle, flex cracks, crushed OR package, or other obvious defects; ° For glass containers: OR • The examination should include cold For glass containers: ° water vacuum testing. Additional • Visual examination should be examinations may include: for sufficient to detect gross closure lug-type caps, security values (lug­ and glass defects, including: cap tension) and for lug-type, twist tilt, cocked cap, crushed lug, caps, pull-up (lug position). stripped cap, cut through, and For container cooling: chipped and cracked glass finish; • For chemical treatment: AND ° Measure residual of chlorine, or other Detailed examination of containers (destructive): approved water treatment chemical, • Recommendations for seal evaluation at the discharge point of the container measurements that ensure a reliable hermetic cooling tank; seal should be obtained from the container OR or sealing machine manufacturer. They • For UV treatment: should include: Use a UV light meter; ° For double-seamed metal and plastic ° cans: AND Use a flow rate meter. • The examination should include a ° teardown examination of the can. For hot filling: If the micrometer method is used, • Use a continuous temperature-measuring three measurements, approximately instrument (e.g., a recorder ). 120° apart around the double seam, should be made. Measurements » How Often Will Monitoring Be Done (Frequency)? should include: cover hook, For container sealing: body hook, width, tightness, and thickness. If the optical method Visual examination of containers: (seamscope or projector) is used, • At least one container from each sealing cuts should be made at at least two head at least every 30 minutes of sealing different locations, excluding the machine operation. At a minimum, visual side seam juncture. Measurements examinations should include those made should include body hook, at the beginning of the production day, overlap, tightness, and thickness; and immediately after a jam in the sealing machine, or after machine adjustment, repair, OR or prolonged shutdown; ° For pouches: AND • The examination should include burst, vacuum or testing. It may also include: drop testing, peel

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 349 Detailed examination of containers: Establish Corrective Action Procedures. • At least one container from each sealing Take the following corrective action to a product head at least every 4 hours of sealing involved in a critical limit deviation: machine operation. At a minimum, visual examinations should include those made For container sealing: at the beginning of the production day, • Repack and recook or repasteurize the and immediately after a jam in the sealing affected product; machine, or after machine adjustment, repair, OR or prolonged shutdown. • Segregate and hold the product to evaluate For container cooling: the seriousness of the defects, which may • For chemical treatment: include, but is not limited to, 100% visual ° At least once every 4 hours of use; inspection of all affected containers to remove the defective containers. Any OR containers that are found to be unsafe should • For UV treatment: be destroyed, diverted to a non-food use, or ° At least daily. repacked and recooked; For hot filling: OR • Continuous monitoring, with a visual check • Divert the product to a use in which the of the instrument at least once per batch of critical limit is not applicable (e.g., divert to a cooked product. canning operation);

» Who Will Do the Monitoring? OR • Destroy the product; For container sealing: • Monitoring may be performed by any person OR who is trained and qualified to conduct • Divert the product to a non-food use. container examinations. For hot filling: For container cooling: • Recook the product; • Monitoring may be performed by any person OR who has an understanding of the nature of • Segregate and hold the product for a safety the controls. evaluation. If the product is found to be For hot filling: unsafe, it should be destroyed, diverted to a • For continuous temperature-measuring non-food use, or recooked; instruments: OR Monitoring is performed by the ° • Divert the product to a use in which the equipment itself. The visual check of critical limit is not applicable (e.g., divert to a the data generated by the equipment, canning operation); to ensure that the critical limits have consistently been met, may be performed OR by any person who has an understanding • Destroy the product; of the nature of the controls. OR • Divert the product to a non-food use. AND

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 350 Take one or more of the following corrective actions to For hot filling: regain control over the operation after a critical limit • Record of continuous temperature deviation: monitoring; For container sealing: AND • Identify and correct the source of the defect. • Record of visual checks of recorded data. For container cooling: • If no measurable residual chlorine, or other Establish Verification Procedures. approved water treatment chemical, is For container sealing: detected, add chlorine or adjust the chlorine- • Obtain container seal guidelines from metering system and recheck for chlorine container or sealing machine manufacturer; residual; AND OR • Review monitoring and corrective action • If UV intensity is inadequate, replace or records within 1 week of preparation clean the bulbs or shields; to ensure they are complete and any OR critical limit deviations that occurred were appropriately addressed. • If flow exceeds the critical limit, adjust or replace the pump. For container cooling: For hot filling: • Obtain UV light intensity and flow rate guidelines from the UV light manufacturer; • Adjust the cooking equipment to increase the processing temperature; AND OR • Review monitoring and corrective action records within 1 week of preparation • Adjust the post-cook process to minimize to ensure they are complete and any time delays. critical limit deviations that occurred were appropriately addressed. Establish a Recordkeeping System. For hot filling: For container sealing: • Before a temperature-recording device (e.g., • Record of visual examination of containers; a recording thermometer) is put into service, AND check the accuracy of the device to verify that • Record of detailed examination of containers. the factory calibration has not been affected. This check can be accomplished by: For container cooling: ° Immersing the sensor in boiling water • For chemical treatment: (212°F (100°C)) if the device will be used ° Record of residual chlorine, or other at or near the (note that approved water treatment chemical; the temperature should be adjusted to compensate for altitude, when necessary); OR OR • For UV treatment: Comparing the temperature reading Record of UV intensity testing; ° ° on the device with the reading on a AND known accurate reference device (e.g., ° Record of flow rate testing. a thermometer traceable to National

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 351 Institute of Standards and Technology • Review monitoring, corrective action, (NIST) standards) under conditions that and verification records within 1 week of are similar to how it will be used (e.g., preparation to ensure they are complete and product internal temperature) within the any critical limit deviations that occurred temperature range at which it will be were appropriately addressed. used; AND • Once in service, check the temperature- recording 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-recording device against a known accurate reference device (e.g., 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 show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Devices subjected to high temperatures for extended periods of time may require more frequent calibration. Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 352 TABLE 18-1

CONTROL STRATEGY EXAMPLE - CONTROL OF RECONTAMINATION

This table is an example of a portion of a Hazard Analysis Critical Control Point plan using “Control Strategy Example - Control of Recontamination.” This example illustrates CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes Processes Cooking Specialized and Pasteurization After Bacteria 18: Pathogenic of CHAPTER Introduction how a processor of pasteurized blue crabmeat, packed in steel cans, can control introduction of pathogenic bacteria after pasteurization. It is provided for illustrative purposes only.

Pathogenic bacteria recontamination after 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, pathogenic bacteria survival through cooking and pasteurization, and metal fragments).

Example Only See Text for Full Recommendations

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

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

Container Pathogenic No visible cutovers, seam Container Visual seam One can per Seamer Identify and correct Visual seam Obtain

353 sealing bacteria sharpness, false seams, integrity examination seaming head operator the source of the examination can seam introduction deadheading, droop, every 30 defect record guidelines damage to the countersink minutes; at startup; from the can wall indicating a broken and after jams, Evaluate the manufacturer chuck, cable cuts, product adjustments, seriousness of the overlapping the flange, repairs, and defect, and hold for Review product leakage, or other prolonged further evaluation if monitoring obvious defects shutdowns necessary and corrective action records within 1 week Cover hook: .070 inch Container Double seam One can per Seamer Identify and correct Double of preparation minimum; integrity teardown seaming head operator the source of the seam body hook: .072-.088 inch; examination, every 4 hours; at defect teardown using a startup; and record width: .125 inch maximum; micrometer at after jams, Evaluate the thickness .052-.058 inch; 3 points on adjustments, seriousness of the tightness 80% the seam, 120° repairs, and defect, and apart prolonged hold for further shutdowns evaluation if necessary Water Pathogenic Measurable Residual Rapid test Every batch Pasteurizer Add chlorine and Residual bath bacteria residual chlorine chlorine operator recheck for residual chlorine container introduction in water record cooling bath

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

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of March 29, 2011, FDA had verified the Web site address for the references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to Non- FDA Web site references after March 29, 2011. • Gavin, A., and L. M. Weddig (ed.). 1995. Canned foods – principles of thermal process control, acidification, and container closure evaluation. National Food Processors Institute, Washington, DC.

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 354