Fish and Fishery Products Hazards and Controls Guidance

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying

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. expected conditions of storage and distribution. Additionally, finished product package closures Pathogenic bacteria growth and toxin formation should be free of gross defects that could expose in the finished product as a result of inadequate the product to moisture during storage and drying of fishery products can cause consumer distribution. Chapter 18 provides guidance on illness. The primary pathogens of concern are control of container closures. Staphylococcus aureus (S. aureus) and Clostridium Some dried products that are reduced oxygen botulinum (C. botulinum). See Appendix 7 for a packaged (e.g., vacuum packaged, modified description of the public health impacts of atmosphere packaged) are dried only enough these pathogens. to control growth and toxin formation by C. botulinum type E and non-proteolytic types B • Control by Drying and F (i.e., types that will not form toxin with Dried products are usually considered shelf stable a water activity of below 0.97). These dried and are, therefore, often stored and distributed products are then refrigerated to control growth unrefrigerated. Examples of shelf-stable dried and toxin formation by C. botulinum type A and fish products are salmon jerky, octopus chips, proteolytic types B and F and by other pathogenic dried shrimp, stock fish, and shark cartilage. The bacteria that may be present in the product, characteristic of dried foods that makes them including S. aureus. The products might have the shelf stable is their low water activity (A ). Water w appearance of a fully dried product. Therefore, activity is the measure of the amount of water their packaging should include “keep refrigerated” in a food that is available for the growth of labeling to ensure that temperature controls are microorganisms, including pathogenic bacteria. A applied throughout distribution. water activity of 0.85 or below will prevent the growth and toxin production of all pathogenic Distributing partially dried, reduced oxygen bacteria, including S. aureus and C. botulinum, packaged products frozen also could be used and is critical for the safety of a shelf-stable dried to control these pathogens. However, labeling product. S. aureus grows at a lower water activity with “keep frozen” instructions would then be than other pathogenic bacteria, and should, important to ensure food safety. More information therefore, be considered the target pathogen for on C. botulinum and reduced oxygen packaging is drying for shelf-stable products. contained in Chapter 13. You should select a packaging material that will This chapter does not cover the growth of prevent rehydration of the product under the pathogenic bacteria, including S. aureus, which may occur as a result of time and temperature

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 293 abuse during processing, including before or of the viscera or its contents is left behind, the during the drying process. That hazard is risk of toxin formation by C. botulinum remains. covered in Chapter 12. It also does not cover the Small fish, less than 5 inches in length, that are control of C. botulinum type A and proteolytic processed in a manner that eliminates preformed types B and F and that of other pathogenic toxin and prevents toxin formation and that bacteria that may be present, including S. aureus, reach (1) a water phase salt content of 10%, a during refrigerated storage of reduced oxygen value based on the control of C. botulinum type packaged, partially dried products. That hazard A and proteolytic types B and F, in refrigerated is covered in Chapters 12 and 13, respectively. products; or (2) a water activity of 0.85 or below (note that this is a value based on the minimum Controlling pathogenic bacteria growth and toxin water activity for toxin production by S. aureus, formation by drying is best accomplished by: in shelf-stable products); or (3) a pH (acidity) • Scientifically establishing a drying process level of 4.6 or less in shelf-stable products are not that reduces the water activity to 0.85 or subject to the evisceration recommendation. below if the product will be stored and distributed unrefrigerated (shelf stable). Note • Strategies for controlling pathogenic that a heat treatment, addition of chemical bacteria growth additives, further drying, or other treatment Pathogens can enter the process on raw materials. may be necessary to inhibit or eliminate They can also be introduced into foods during spoilage organisms, for example, mold; processing, from the air, unclean hands, insanitary • Scientifically establishing a drying process utensils and equipment, contaminated water, and that reduces the water activity to below 0.97 sewage. There are a number of strategies for the if the product will be stored refrigerated (not control of pathogenic bacteria in fish and fishery frozen) in reduced oxygen packaging; products. They include: • Designing and operating the drying • Controlling the amount of moisture that is equipment so that every unit of a product available for pathogenic bacteria growth receives at least the established minimum (water activity) in the product by drying process; (covered in this chapter); • Packaging the finished product in a container • Controlling the amount of moisture that is that will prevent rehydration. available for pathogenic bacteria growth (water activity) in the product by formulation The drying operation used in the production of (covered in Chapter 13); smoked or smoke-flavored fish is not designed to result in a finished product water activity of 0.85 • Controlling the amount of salt or or below. The controls for these products are preservatives, such as sodium nitrite, in the described in Chapter 13. product (covered in Chapter 13); • Controlling the pH in the product (covered Because spores of C. botulinum are known to be by the Acidified Foods regulation, 21 CFR present in the viscera of fish, any product that 114, for shelf-stable acidified products, and will be preserved by salting, drying, pickling, by Chapter 13 for refrigerated acidified or fermentation should be eviscerated prior to products); processing (see the “Compliance Policy Guide,” Sec. 540.650). Without evisceration, toxin • Controlling the source of molluscan shellfish formation is possible during the process even and the time from exposure to air (e.g., by with strict control of temperature. Evisceration harvest or receding tide) to refrigeration to should be thorough and performed to minimize control pathogens from the harvest area contamination of the fish flesh. If even a portion (covered in Chapter 12);

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 294 • Controlling the introduction of pathogenic if drying is not properly performed. Note bacteria after the pasteurization process that drying to control toxin formation by S. (covered in Chapter 18); aureus will also control toxin formation by C. • Managing the amount of time that food is botulinum in these products. exposed to temperatures that are favorable 2. For shelf-stable, dried products, can S. aureus for pathogenic bacteria growth and toxin toxin formation that is reasonably likely to occur production (covered generally in Chapter 12; be eliminated or reduced to an acceptable level for C. botulinum, in Chapter 13; and for S. at this processing step? aureus in hydrated batter mixes, in Chapter 15); Pathogenic bacteria growth and toxin • Killing pathogenic bacteria by cooking formation as a result of inadequate drying or pasteurization (covered in Chapter 16) should also be considered a significant or by retorting (covered by the Thermally hazard at any processing step where a Processed Low-Acid Foods Packaged in preventive measure is, or can be, used to Hermetically Sealed Containers regulation, 21 eliminate the hazard of S. aureus toxin CFR 113 (called the Low-Acid Canned Foods formation (or reduce the likelihood of its Regulation in this guidance document)); occurrence to an acceptable level) if it is reasonably likely to occur. The preventive • Killing pathogenic bacteria by processes that measure that can be applied for pathogenic retain raw product characteristics (covered in bacteria growth and toxin formation as a Chapter 17). result of inadequate drying are: DETERMINE WHETHER THE POTENTIAL • Proper design and control of the drying HAZARD IS SIGNIFICANT. process (covered in this chapter); 3. For refrigerated or frozen, partially dried (i.e., The following guidance will assist you in not shelf stable) products, is it reasonably likely determining whether pathogenic bacteria growth that C. botulinum type E and nonproteolytic types and toxin formation as a result of inadequate B and F will grow and form toxin in the finished drying is a significant hazard at a processing step: product if the product is inadequately dried? 1. For shelf-stable, dried products, is it reasonably Table A-1 (Appendix 4) provides information likely that S. aureus will grow and form toxin in on the conditions under which C. botulinum the finished product if the product is inadequately type E and non-proteolytic types B and F dried? will grow. Because of the need to prevent Table A-1 (Appendix 4) provides information rehydration of dried products, these products on the conditions under which S. aureus will generally will be contained in a reduced grow. If your food that is not distributed oxygen package. If your refrigerated (not refrigerated or frozen and meets these frozen), reduced oxygen packaged food meets conditions (i.e., in Table A-1) before drying, these conditions (i.e., Table A-1) before drying, then drying will usually be important to the then drying will usually be important to the safety of the product, because it provides safety of the product, because it provides the barrier to S. aureus growth and toxin the barrier to growth and toxin formation formation. Under ordinary circumstances, it by C. botulinum type E and non-proteolytic would be reasonably likely that S. aureus will types B and F. Note that refrigeration will grow and form toxin in such products during control toxin formation by S. aureus and C. finished product storage and distribution botulinum type A and non-proteolytic types B and F in these products. Under ordinary

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 295 circumstances, it would be reasonably likely • Proper design and control of the drying that C. botulinum type E and non-proteolytic process (covered in this chapter); types B and F will grow and form toxin • Refrigeration (covered in Chapter in such products during finished product 12) and labeling to ensure that the storage and distribution if drying is not product is held refrigerated throughout properly performed. In addition, controlling distribution (covered in this chapter); labeling (e.g., “keep refrigerated” labeling) to ensure that the product is held refrigerated • Freezing (Chapter 13 provides guidance throughout distribution may be important to on labeling controls to ensure that a the safety of the product, because the product frozen product that otherwise supports may appear to retailers, consumers, and end the growth of non-proteolytic C. users to be shelf stable. botulinum is distributed frozen).

However, if your dried, reduced oxygen • Intended use packaged product is distributed frozen, then Because of the highly stable nature of S. aureus freezing may provide the barrier to growth toxin and the extremely toxic nature of C. and toxin formation by C. botulinum type botulinum toxin, it is unlikely that the intended E and non-proteolytic types B and F, rather use will affect the significance of the hazard. than drying. In this case, labeling to ensure that the product is distributed frozen may IDENTIFY CRITICAL CONTROL POINTS. be important to the safety of the product. Chapter 13 provides guidance on labeling The following guidance will assist you in controls to ensure that frozen product that determining whether a processing step is a critical supports the growth of non-proteolytic C. control point (CCP) for pathogenic bacteria growth botulinum is distributed frozen. and toxin formation as a result of inadequate drying: 4. For refrigerated or frozen, partially dried, reduced 1. If you identified the hazard of pathogenic oxygen packaged dried products, can growth bacteria growth and toxin formation as a result of and toxin formation by C. botulinum type E and inadequate drying as significant because drying non-proteolytic types B and F that are reasonably (rather than, or in addition to, refrigeration) is likely to occur be eliminated or reduced to an important to the safety of the product, you should acceptable level at this processing step? identify the drying step as a CCP for this hazard. Pathogenic bacteria growth and toxin Example: formation as a result of inadequate drying A salmon jerky processor that distributes should be considered a significant hazard the product unrefrigerated should set at any processing step where a preventive the CCP for controlling the hazard of measure is, or can be, used to eliminate pathogenic bacteria growth and toxin the hazard (or reduce the likelihood of its formation as a result of inadequate drying occurrence to an acceptable level) if it is at the drying step. The processor would reasonably likely to occur. The preventive not need to identify the processing steps measures that can be applied for pathogenic prior to drying as CCPs for that hazard. bacteria growth and toxin formation as a However, these steps may be CCPs for result of inadequate drying for refrigerated the control of other hazards, such as the or frozen, partially dried, reduced oxygen growth of pathogenic bacteria as a result packaged products are: of time and temperature abuse during processing, covered by Chapter 12.

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 296 This control approach is a control strategy DEVELOP A CONTROL STRATEGY. referred to in this chapter as “Control Strategy Example 1 - Control by Drying.” The following guidance provides examples of 2. If you identified the hazard of pathogenic two control strategies for pathogenic bacteria bacteria growth and toxin formation as a result growth and toxin formation that occurs as a of inadequate drying as significant because result of inadequate drying. It may be necessary refrigeration (in addition to drying) is important to select more than one control strategy in order to the safety of the product, you should identify to fully control the hazard, depending upon the finished product storage step and the the nature of your operation. It is important labeling step, where you will ensure that the to note that you may select a control strategy “keep refrigerated” labeling is included on every that is different from those that are suggested, package, as a CCP, for this hazard. provided it complies with the requirements of the applicable food safety laws and regulations. Example: The following are examples of control strategies A partially dried catfish processor that included in this chapter: distributes the product refrigerated and reduced oxygen packaged should set MAY APPLY TO MAY APPLY TO the CCPs for controlling the hazard of CONTROL STRATEGY PRIMARY SECONDARY pathogenic bacteria growth and toxin PROCESSOR PROCESSOR formation as a result of inadequate Control by drying   drying at the drying step, finished Control by refrigeration   product labeling step, and finished with labeling product storage step. The processor would not need to identify the processing steps • CONTROL STRATEGY EXAMPLE 1 - CONTROL BY prior to drying as CCPs for that hazard. DRYING However, these steps may be CCPs for It may be necessary to select more than one the control of other hazards, such as the control strategy in order to fully control the growth of pathogenic bacteria as a result hazard, depending upon the nature of your of time and temperature abuse during operation. processing, covered by Chapter 12. The control by drying is covered in “Control Set Critical Limits. Strategy Example 1 - Control by Drying.” • The minimum or maximum values for the Control of labeling is referred to in this critical factors established by a scientific chapter as “Control Strategy Example 2 study (i.e., for shelf-stable products, those Control by Refrigeration With Labeling.” It which must be met in order to ensure that should be used along with “Control Strategy the finished product has a water activity of Example 1 - Control by Drying.” Note that 0.85 or below; for refrigerated (not frozen), control of refrigerated finished product storage reduced oxygen packaged products, those is covered in Chapter 12. Note also that which must be met in order to ensure that Chapter 13 provides guidance on labeling the finished product has a water activity of controls to ensure that a frozen product less than 0.97). These will likely include that otherwise supports the growth of non drying time, input/output air temperature, proteolytic C. botulinum is distributed frozen. humidity, and velocity, as well as flesh thickness. Other critical factors that affect the rate of drying of the product may also be established by the study;

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 297 OR ° Use a continuous temperature-recording • The minimum percent weight loss device (e.g., a recording thermometer); established by a scientific study (i.e., for AND shelf-stable products, that which must be met • For all other critical factors specified by the in order to ensure that the finished product study: has a water activity of 0.85 or below; for refrigerated (not frozen), reduced oxygen ° Use equipment appropriate for the packaged products, that which must be met measurement; in order to ensure that the finished product OR has a water activity of less than 0.97); • For percent weight loss: OR ° Weigh all, or a portion, of the batch • For shelf-stable products: before and after drying; ° Maximum finished product water activity OR of 0.85 or above; • For water activity analysis: OR ° Collect a representative sample of the • For refrigerated (not frozen), reduced oxygen finished product and conduct water packaged products: activity analysis. ° Maximum finished product water activity For continuous drying equipment: of less than 0.97. • For input/output air temperature: Note: A heat treatment, addition of chemical additives, further Use a continuous temperature-recording drying, or other treatment may be necessary to inhibit or eliminate ° spoilage organisms (e.g., mold) in shelf-stable products. device (e.g., a recording thermometer); AND Establish Monitoring Procedures. • For drying time: » What Will Be Monitored? ° Measure: • Critical factors of the established drying process • The revolutions per minute (RPM) that affect the ability of the process to ensure of the belt drive wheel, using the desired finished product water activity (i.e., a stopwatch or tachometer; 0.85 or below for shelf-stable products, less OR than 0.97 for refrigerated (not frozen), reduced oxygen packaged products). These may • The time necessary for a test unit include drying time, air temperature, humidity, or belt marking to pass through the and velocity, as well as flesh thickness; equipment, using a stopwatch; OR AND • Percent weight loss; • For all other critical factors specified by the study: OR Use equipment appropriate for the • Water activity of the finished product. ° measurement; » How Will Monitoring Be Done? OR For batch drying equipment: • For percent weight loss: • For drying time and input/output air ° Weigh all, or a portion, of the batch temperature: before and after drying;

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 298 OR • For water activity: • For water activity: ° Each lot of finished product. Collect a representative sample of the ° » Who Will Do the Monitoring? finished product and conduct water activity analysis. • For continuous temperature-recording devices: » How Often Will Monitoring Be Done (Frequency)? ° Monitoring is performed by the For batch drying equipment: equipment itself. The visual check of the data generated by this equipment, • For time and temperature: to ensure that the critical limits have ° Continuous monitoring, with a visual consistently been met, may be performed check of the recorded data at least once by any person who has an understanding during each batch; of the nature of the controls; AND AND • For all other critical factors specified by the • For all other critical factors specified by the study: study: ° As often as necessary to maintain control; ° Any person who has an understanding of OR the nature of the controls; • For percent weight loss: OR ° Each batch; • For percent weight loss: OR ° Any person who has an understanding of • For water activity: the nature of the controls; ° Each batch. OR For continuous drying equipment: • For water activity: • For temperature: ° Any person with sufficient training to perform the analysis. ° Continuous monitoring, with a visual check of the recorded data at least once per day; Establish Corrective Action Procedures. Take the following corrective action to a product AND involved in a critical limit deviation: • For time: • Redry the product (provided that redrying ° At least once per day, and whenever any does not present an unacceptable changes in belt speed are made; opportunity for pathogenic bacteria growth); AND OR • For all other critical factors specified by the • Chill and hold the product for an evaluation study: of the adequacy of the drying process. ° As often as necessary to maintain control; The evaluation may involve water activity OR determination on a representative sample of the finished product. If the evaluation • For percent weight loss: shows that the product has not received an ° Each lot of finished product; adequate drying process, the product should OR be destroyed, diverted to a use in which

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 299 pathogenic bacteria growth in the finished critical factors (e.g., a drying log that indicates product will be controlled by means other input/output air humidity and/or velocity); than drying, diverted to a non-food use, or OR redried; • Record of weight before and after drying; OR OR • Divert the product to a use in which the critical limit is not applicable because • Record of water activity analysis. pathogenic bacteria growth in the finished For continuous drying equipment: product will be controlled by means other • Record of continuous temperature than drying (e.g., divert inadequately dried monitoring; fish to a frozen fish operation); AND OR • Record of visual checks of recorded data; • Divert the product to a non-food use; AND OR • Drying log that indicates the RPM of the belt • Destroy the product. drive wheel or the time necessary for a test unit or belt marking to pass through the drier; AND AND Take the following corrective action to regain control • Records that are appropriate for the other over the operation after a critical limit deviation: critical factors (e.g., a drying log that indicates • Adjust the air temperature or velocity; input/output air humidity and/or velocity); OR OR • Adjust the length of the drying cycle to • Record of weight before and after drying; compensate for a temperature or velocity drop, humidity increase, or inadequate OR percent weight loss; • Record of water activity analysis. OR Establish Verification Procedures. • Adjust the belt speed to increase the length • Process validation study (except where a of the drying cycle. water activity analysis of the finished product is the monitoring procedure): Establish a Recordkeeping System. ° The adequacy of the drying process For batch drying equipment: should be established by a scientific • Record of continuous temperature study. For shelf-stable products, the monitoring; drying process should be designed to AND ensure the production of a shelf-stable product with a water activity of 0.85. • Record of visual checks of recorded data; For refrigerated (not frozen), reduced AND oxygen packaged products, it should be • Record of notation of the start time and end designed to ensure a finished product time of the drying periods; water activity of less than 0.97. Expert knowledge of drying process calculations AND and the dynamics of mass transfer in • Records that are appropriate for the other processing equipment may be required

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 300 to establish such a drying process. Such ° Doing a combination of the above if knowledge can be obtained by education the device will be used at or near room or experience or both. Establishment of temperature; drying processes may require access to OR adequate facilities and the application of recognized methods. The drying ° Comparing the temperature reading equipment should be designed, operated, on the device with the reading on a and maintained to deliver the established known accurate reference device (e.g., drying process to every unit of a product. a thermometer traceable to National In some instances, drying studies may Institute of Standards and Technology be required to establish the minimum (NIST) standards) under conditions that process. In other instances, existing are similar to how it will be used (e.g., literature that establishes minimum air temperature) within the temperature processes or adequacy of equipment is range at which it will be used; available. Characteristics of the process, AND product, and/or equipment that affect • Once in service, check the temperature- the ability to achive the established recording device daily before the beginning minimum drying process should be of operations. Less frequent accuracy checks taken into consideration in the process may be appropriate if they are recommended establishment. A record of the process by the instrument manufacturer and the establishment should be maintained; history of use of the instrument in your AND facility has shown that the instrument • Finished product sampling and analysis to consistently remains accurate for a longer determine water activity at least once every period of time. In addition to checking that 3 months (except where such testing is the device is accurate by one of the methods performed as part of monitoring); described above, this process should include a visual examination of the sensor and any AND attached wires for damage or kinks. The • Before a temperature-recording device (e.g., device should be checked to ensure that it a recording thermometer) is put into service, is operational and, where applicable, has check the accuracy of the device to verify sufficient ink and paper; that the factory calibration has not been AND affected. This check can be accomplished by: • Calibrate the temperature-recording device against a known accurate reference device Immersing the sensor in an ice slurry ° (e.g., a NIST-traceable thermometer) at (32°F (0°C)) if the device will be used at least once a year or more frequently if or near refrigeration temperature; recommended by the device manufacturer. OR Optimal calibration frequency is dependent ° Immersing the sensor in boiling water upon the type, condition, past performance, (212°F (100°C)) if the device will be used and conditions of use of the device. at or near the boiling point. Note that Consistent temperature variations away from the temperature should be adjusted to the actual value (drift) found during checks compensate for altitude, when necessary; and/or calibration may show a need for more frequent calibration or the need to replace OR the device (perhaps with a more durable

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 301 device). For example, 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 • Calibrate other instruments as necessary to ensure their accuracy; AND • Review monitoring, corrective action, and verification records within 1 week of preparation to ensure they are complete and any critical limit deviations that occurred were appropriately addressed.

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 302 TABLE 14-1

CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying Drying Inadequate of aResult as Toxin and Formation Growth 14: Bacteria CHAPTER Pathogenic only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.

Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, 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 CORRECTIVE CONTROL RECORDS VERIFICATION HAZARD(S) PREVENTIVE ACTION(S) POINT WHAT HOW FREQUENCY WHO MEASURE Drying Pathogenic Maximum Product Preset slicer to Once per Slicer Re-adjust Processing log Documentation (forced bacteria growth product thickness just less than ¼ day before operator slicer of drying process convection and toxin thickness: ¼ inch operations establishment 303 oven) formation inch Check the data logger for accuracy and damage and to ensure that it is operational before putting into operation; check it daily, at the beginning of operations; and calibrate it once per year

Analyze the finished product sample once every 3 months for water activity

Review of monitoring, corrective action and verification, records within 1 week of preparation TABLE 14-1

CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - Control by Drying.” This example illustrates how a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation. CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying Drying Inadequate of aResult as Toxin and Formation Growth 14: Bacteria CHAPTER Pathogenic

Example Only See Text for Full Recommendations

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

CRITICAL LIMITS MONITORING CRITICAL SIGNIFICANT FOR EACH CORRECTIVE CONTROL RECORDS VERIFICATION HAZARD(S) PREVENTIVE ACTION(S) POINT WHAT HOW FREQUENCY WHO MEASURE Drying Pathogenic Minimum Drying time Digital time and Continuous, Oven Continue Data logger Documentation (forced bacteria growth drying time: 5 temperature with visual operator drying printout of drying process convection and toxin hours data logger check of establishment

304 oven) formation recorded data each batch Check the data logger for accuracy and damage and to ensure that it is operational before putting into operation; check it daily, at the beginning of operations; and calibrate it once per year

Analyze the finished product sample once every 3 months for water activity

Review of monitoring, corrective action and verification, records within 1 week of preparation TABLE 14-1

CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

Example Only See Text for Full Recommendations

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

CRITICAL LIMITS MONITORING CRITICAL SIGNIFICANT FOR EACH CORRECTIVE CONTROL RECORDS VERIFICATION HAZARD(S) PREVENTIVE ACTION(S) POINT WHAT HOW FREQUENCY WHO MEASURE Drying Pathogenic Minimum oven Oven air input Digital time and Continuous, Oven Extend Data logger Documentation (forced bacteria growth temperature: temperature temperature with visual operator drying printout of drying process convection and toxin 140°F data logger check of process establishment

305 oven) formation recorded data To achieve each batch Segregate the Check the data a final water product and logger for accuracy activity of 0.85 hold under and damage and or less refrigeration to ensure that for it is operational evaluation before putting into operation; Evaluate by check it daily, at performing the beginning of water operations; and activity calibrate it once analysis on per year finished product Analyze the finished product Redry if less sample once every than 0.85 3 months for water activity

Review of monitoring, corrective action and verification, records within 1 week of preparation • CONTROL STRATEGY EXAMPLE 2 - CONTROL BY AND REFRIGERATION WITH LABELING • Determine and correct the cause of improper It may be necessary to select more than one labels. control strategy in order to fully control the hazard, depending upon the nature of your Establish a Recordkeeping System. operation. • Record of labeling checks. Set Critical Limits. Establish Verification Procedures. • All finished product labels must contain • Review monitoring and corrective action a “keep refrigerated” statement (e.g., records within 1 week of preparation “Important, keep refrigerated until used”). to ensure they are complete and any critical limit deviations that occurred were Establish Monitoring Procedures. appropriately addressed. » What Will Be Monitored? • Finished product labels for presence of “keep refrigerated” statement.

» How Will Monitoring Be Done? • Visual examination.

» How Often Will Monitoring Be Done (Frequency)? • Representative number of packages from each lot of a finished product.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Segregate and relabel any improperly labeled product. AND Take the following corrective actions to regain control over the operation after a critical limit deviation: • Segregate and return or destroy any label stock or pre-labeled packaging stock that does not contain the proper statement;

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 306 TABLE 14-2

CONTROL STRATEGY EXAMPLE 2 - CONTROL BY REFRIGERATION WITH LABELING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Control by Refrigeration With Labeling.” This example illustrates how a processor of

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying Drying Inadequate of aResult as Toxin and Formation Growth 14: Bacteria CHAPTER Pathogenic refrigerated, partially dried catfish can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.

Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides 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

307 Receipt of C. botulinum All finished Finished Visual One label from Receiving Segregate and Label receiving Review labeling toxin product labels product examination each case of employee re-label any record monitoring and formation must contain a labels for the labels at improperly correction during “keep presence of receipt labeled product action records finished refrigerated” the “keep within 1 week product statement refrigerated” Segregate of preparation storage statement and return or destroy any label stock that does not contain the proper statement

Determine and correct the cause of improper labels

*Note: Chapter 12 covers control of pathogenic bacteria growth at the CCP of finished product storage. 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.

• Hilderbrand, K. S. 1992. Fish smoking procedures for forced convection smokehouses, Special report 887. Oregon State University, Extension Service, Corvallis, OR. • Hilderbrand, K. S., Jr. 1996. Personal communication. Oregon State University, Extension Service, Corvallis, Oregon. • McClure, P. J., M. B. Cole, and J. P. P. M. Smelt. 1994. Effects of water activity and pH on growth of Clostridium botulinum. J. Appl. Bact. Symp. Suppl. 76:105S-114S. • Tatini, S. R. 1973. Influence of food environments on growth of Staphylococcus aureus and production of various enterotoxins. J. Milk Food Technol. 36:559-563.

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