CHAPTER 7: Scombrotoxin (Histamine) Formation 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. that the methods of control used to inhibit the bacteria that result in histamine formation will Scombrotoxin (histamine) formation as a result also inhibit the bacteria that produce other of time and temperature abuse of certain species biogenic amines. of fish can cause consumer illness. The illness Symptoms of scombrotoxin poisoning include is closely linked to the development of histamine tingling or burning in or around the mouth or in these fish. In most cases, histamine levels in throat; rash or hives on the upper body; drop in illness-causing fish have been above 200 ppm, blood pressure; headache; dizziness; itching of the often above 500 ppm. However, there is some skin; nausea; vomiting; diarrhea; asthmatic-like evidence that other chemicals (e.g., biogenic constriction of the air passage; heart palpitation; amines such as putrescine and cadaverine) may and respiratory distress. Symptoms usually also play a role in the illness. The possible role of occur within a few minutes to a few hours of these chemicals in consumer illness is the subject consumption and last from 12 hours to a few days. of Chapter 8. • Scombrotoxin (histamine) formation Seafood-related scombrotoxin poisoning is Certain bacteria produce the enzyme histidine primarily associated with the consumption of decarboxylase during growth. This enzyme reacts tuna, mahi-mahi, marlin, and bluefish. Table 3-2 with histidine, a naturally occurring amino acid (Chapter 3) identifies other species that are also that is present in larger quantities in some fish capable of developing elevated levels of histamine than in others. The result is the formation of when temperature abuse occurs. scombrotoxin (histamine). The illness caused by the consumption of fish Histamine-forming bacteria are capable of growing in which scombrotoxin has formed is most and producing histamine over a wide temperature appropriately referred to as “scombrotoxin range. Growth of histamine is more rapid, however, poisoning.” The illness has historically been at high-abuse temperatures (e.g., 70°F (21.1°C) known by other names. Originally, the illness or higher) than at moderate-abuse temperatures was termed “scombroid poisoning” because of its (e.g., 45°F (7.2°C)). Growth is particularly rapid association with fish in the families Scombridae at temperatures near 90°F (32.2°C). Histamine is and Scomberesocidae. However, other species more commonly the result of high temperature of fish are now known to cause the illness. The spoilage than of long-term, relatively low- terms “histamine poisoning” and “histamine fish temperature spoilage, which is commonly associated poisoning” have also been applied to the illness. with organoleptically detectable decomposition. However, because biogenic amines other than Nonetheless, there are a number of opportunities histamine have been associated with the illness, for histamine to form under more moderate-abuse these terms also present difficulties. Nonetheless, temperature conditions. this chapter refers to control measures to prevent the formation of histamine. It is expected

CHAPTER 7: Scombrotoxin (Histamine) Formation 113 Once the enzyme histidine decarboxylase is species that generate heat, resulting in internal present in the fish, it can continue to produce temperatures that may exceed environmental histamine in the fish even if the bacteria are not temperatures and increasing the likelihood active. The enzyme can be active at or near of conditions favorable to growth of enzyme- refrigeration temperatures. The enzyme remains forming bacteria. stable while in the frozen state and may be The potential for histamine formation is increased reactivated very rapidly after thawing. when the scombrotoxin-forming fish muscle is in Freezing may inactivate some of the enzyme- direct contact with the enzyme-forming bacteria. forming bacteria. Both the enzyme and This direct contact occurs when the fish are the bacteria can be inactivated by cooking. processed (e.g., butchering or filleting) and can However, once histamine is produced, it cannot be particularly problematic when the surface-to­ be eliminated by heat (including retorting) or volume ratio of the exposed fish muscle is large, freezing. After cooking, recontamination of such as minced tuna for salads. Even when such the fish with the enzyme-producing bacteria products are prepared from canned or pouch is necessary for additional histamine to form. retorted fish, recontamination can occur during For these reasons, histamine development is salad preparation, especially with the addition of more likely in raw, unfrozen fish but should raw ingredients. The mixing in of the bacteria not be discounted in other product forms of throughout the product and the high surface-to­ scombrotoxin-forming fish species. volume ratio can result in substantial histamine formation if time and temperature abuse occurs. The kinds of bacteria that are associated with histamine development are commonly present in At least some of the histamine-forming bacteria the saltwater environment. They naturally exist are halotolerant (salt tolerant) or halophilic (salt on the gills, on external surfaces, and in the gut loving). Some are more capable of producing of live, saltwater fish, with no harm to the fish. histamine at elevated acidity (low pH). As a Upon death, the defense mechanisms of the fish result, histamine formation is possible during no longer inhibit bacterial growth in the muscle processes such as brining, salting, smoking, tissue, and histamine-forming bacteria may start drying, fermenting, and pickling until the product to grow, resulting in the production of histamine. is fully shelf-stable. Refrigeration can be used Evisceration and removal of the gills may reduce, to inhibit histamine formation during these but not eliminate, the number of histamine- processes. forming bacteria. Packing of the visceral cavity A number of the histamine-forming bacteria are with ice may aid in chilling large fish in which facultative anaerobes that can grow in reduced internal muscle temperatures are not easily oxygen environments. As a result, reduced reduced. However, when done improperly, these oxygen packaging (e.g., vacuum packaging, steps may accelerate the process of histamine modified atmosphere packaging, and controlled development in the edible portions of the fish by atmosphere packaging) should not be viewed as spreading the bacteria from the visceral cavity to inhibitory to histamine formation. the flesh of the fish. Histamine is water soluble (dissolves in water) With some harvesting practices, such as and would not be expected in significant longlining and gillnetting, death may occur many quantity in products such as fish oil that do not hours before the fish is removed from the water. have a water component. However, histamine Under the worst conditions, histamine formation could be present in products such as fish protein can already be underway before the fish is concentrate that are prepared from the muscle or brought onboard the vessel. This condition aqueous (water-based) components of fish tissue. can be further aggravated with certain tuna

CHAPTER 7: Scombrotoxin (Histamine) Formation 114 • Controlling scombrotoxin (histamine) formation Rapid chilling of scombrotoxin-forming fish immediately after death is the most important element in any strategy for preventing the formation of scombrotoxin (histamine), especially for fish that are exposed to warm waters or air, and for tunas which generate heat in their tissues. Some recommendations follow: • Fish exposed to air or water temperatures above 83°F (28.3°C) should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than 6 hours from the time of death; or • Fish exposed to air and water temperatures of 83°F (28.3°C) or less should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than 9 hours from the time of death; or • Fish that are gilled and gutted before chilling should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than 12 hours from the time of death; or • Fish that are harvested under conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than the time limits listed above, with the time period starting when the fish leave the 65°F (18.3°C) or less environment.

Note: If the actual time of death is not known, an estimated time of the first fish death in the set may be used (e.g., the time the deployment of a longline begins).

CHAPTER 7: Scombrotoxin (Histamine) Formation 115 9 6 -­ -­ -­ -­ 12 ONBOARD LANDING IS… THE TIME OF… 6 6 9 -­ -­ -­ 12 1 TIME OF DEATH IS… TIME OF DEATH DEATH OF THE FISH OR EARLIEST ESTIMATED OF THE FISH OR EARLIEST ESTIMATED DEATH THEN, THE MAXIMUM TIME IN HOURS TO GET FISH INTO CHILLING MEDIUM (≤ 40°F) FROM TABLE 7-1 TABLE FOR UNEVISCERATED FISH: FOR UNEVISCERATED SCOMBROTOXIN FORMATION FOR FISH EVISCERATED ONBOARD BEFORE CHILLING: FOR FISH EVISCERATED Any Any Any ≤ 83 ≤ 83 > 83 > 83 AND THE AIR TEMPERATURE (°F) IS… AND THE AIR TEMPERATURE WHEN… 2 2 2 > 65 > 65 > 83 ≤ 65 ≤ 65 ≤ 65 THE WATER THE WATER > 65, but ≤ 83 > 65, TEMPERATURE (°F) IS… TEMPERATURE 1. This table is a summary of the preceding recommendations. For complete understanding recommendations, refer to text above. 2. Provided exposure of the fish in water at 65°F or less is ≤ 24 hours. RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST VESSELS TO PREVENT RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST

CHAPTER 7: Scombrotoxin (Histamine) Formation 116 The controls listed above for onboard chilling • The size of the fish; will prevent the rapid formation of the enzyme • The chilling method: histidine decarboxylase. Once this enzyme is Ice alone takes longer to chill fish formed, control of the hazard is unlikely. It is ˚ than does an ice slurry or recirculated important to recognize that the parameters listed refrigerated seawater or brine, a above are intended to control scombrotoxin consequence of reduced contact area formation; these criteria may not effectively control and heat transfer; the activity of other spoilage organisms, raising the possibility that fish may become adulterated ˚ The quantity of ice or ice slurry and because of decomposition (not a food safety the capacity of refrigerated seawater or hazard covered by the Procedures for the Safe and brine systems, as well as the physical Sanitary Processing and Importing of Fish and arrangement of the fish in the chilling Fishery Products regulation, 21 CFR 123, called media, should be suitable for the the Seafood Hazard Analysis Critical Control Point quantity of catch. (HACCP) Regulation in this guidance document) Once chilled, the scombrotoxin-forming fish before scombrotoxin (histamine) is formed. should be maintained as close as possible to the Further chilling toward the freezing point is also freezing point (or held frozen) until it is consumed. desirable to safeguard against the less common, Exposure to temperatures above 40°F (4.4°C) longer term, lower temperature development of should be minimized. The amount of post-harvest histamine. Additionally, the shelf life and quality time at elevated temperatures (after proper chilling of the fish are significantly compromised when onboard the harvest vessel) to which a fish can product temperature is not rapidly dropped to be exposed (e.g., during processing, storage, and near freezing. distribution) without adverse effects is dependent primarily upon whether the fish was previously Although it may be possible for a harvest vessel frozen (e.g., onboard the harvest vessel) or heat to completely avoid onboard chilling and still processed sufficiently to destroy scombrotoxin­ deliver fish to the processor within the time and forming bacteria. temperature limitations recommended above for chilling the fish, this practice is discouraged. Extended frozen storage (e.g., 24 weeks) or Failure to chill onboard may permit bacteria and cooking minimizes the risk of additional enzymes, including those that form scombrotoxin histamine development by inactivating the (histamine), to increase unnecessarily. enzyme-forming bacteria and, in the case of cooking, the enzyme itself. As previously The time required to lower the internal mentioned, recontamination with enzyme- temperature of fish after capture will be forming bacteria and significant temperature dependent upon a number of factors, including: abuse is necessary for histamine formation • The harvest method: following cooking. Such recontamination may ˚ Delays in removing fish from the water not be likely if the fish is processed under a after capture, such as those captured by conscientious sanitation program. However, a longline, may significantly limit the addition of raw ingredients, employee contact, amount of time left for chilling and may or poor sanitary conditions could reintroduce allow some fish to heat up; contamination. Further guidance is provided below: ˚ Large quantities of fish captured in a single fishing set, such as those captured • Scombrotoxin-forming fish that have not on a purse seiner, may exceed a vessel’s been previously frozen or heat processed ability to rapidly chill the product; sufficiently to destroy scombrotoxin­ forming bacteria should not be exposed to

CHAPTER 7: Scombrotoxin (Histamine) Formation 117 temperatures above 40°F (4.4°C) for: ˚ More than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C); or ˚ More than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C). • Scombrotoxin-forming fish that have been previously frozen, or heat processed sufficiently to destroy scombrotoxin-forming bacteria and are subsequently handled in a manner in which there is an opportunity for recontamination with scombrotoxin­ forming bacteria (e.g., contact with fresh fish, employees, or introduction of raw ingredients), should not be exposed to temperatures above 40°F (4.4°C) for: ˚ More than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C); or ˚ More than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C); • Scombrotoxin-forming fish that have been heat processed sufficiently to destroy scombrotoxin-forming bacteria and enzymes and are not subsequently handled in a manner in which there is an opportunity for recontamination with scombrotoxin-forming bacteria (e.g., no contact with fresh fish, employees, or raw ingredients) are at low risk for further scombrotoxin (histamine) development.

CHAPTER 7: Scombrotoxin (Histamine) Formation 118 TABLE 7-2

RECOMMENDED MAXIMUM HOURS OF EXPOSURE OF SCOMBROTOXIN-FORMING FISH TO AMBIENT TEMPERATURES GREATER THAN 40°F TO PREVENT SCOMBROTOXIN FORMATION AFTER PROPER ONBOARD HARVEST VESSEL CHILLING, FOR DIFFERING TEMPERATURE EXPOSURE AND PREVIOUS PROCESSING CONDITIONS1

WHEN THE AMBIENT TEMPERATURE (°F) OF EXPOSURE IS… THEN, THE MAXIMUM HOURS OF EXPOSURE TIME FOR… Fresh fish (not heat processed Previously frozen fish, or heat processed fish (that has been or previously frozen) is … exposed to possible recontamination), is…

> 70 AT ANY TIME ≤ 4 ≤ 12

≤ 70 DURING ENTIRE EXPOSURE ≤ 8 ≤ 24

1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above. CHAPTER 7: Scombrotoxin (Histamine) Formation CHAPTER 7:Scombrotoxin (Histamine)Formation 119 • Detection histamine testing is dependent upon the design Sensory evaluation of the sampling plan. The amount of sampling required to accommodate such variability of Sensory evaluation is generally used to screen distribution is necessarily quite large. The fish for indicators of spoilage that develop when method of collection of the fish sample is also the fish is exposed to time and temperature critical. In large scombrotoxin-forming fish, the abuse. Odor in particular is an effective means lower, anterior (forward) portion of the fish loin of detecting fish that have been subjected to a (not the belly flap) is likely to provide the best variety of abusive conditions. However, odors of information about the histamine content of the decomposition that are typical of relatively low fish. The number of samples (i.e., scombrotoxin­ temperature spoilage may not be present if the forming fish) necessary to make a judgment fish has undergone high temperature spoilage. about a lot depends on the anticipated variability, This condition makes sensory examination but should not be fewer than 18 samples per lot, alone an ineffective control for preventing unless the lot contains less than 18 fish, in which scombrotoxin (histamine) formation. case a sample should be collected from each fish. It is important to recognize that the Federal Where samples are composited to reduce the Food, Drug, and Cosmetic Act (the FFD&C Act) number of analyses needed on a lot, it should prohibits interstate commerce of adulterated be done in a manner that ensures meaningful foods (21 U.S.C. 331). Under the FFD&C results. No more than three samples should be Act, a food that is decomposed is considered composited, in order to minimize masking of adulterated (21 U.S.C 342). Accordingly, a fish problematic fish. Furthermore, the analytical or fishery product that is decomposed in whole method and instrument used should be capable or in part is prohibited from entering interstate of reliably detecting histamine at the lower levels commerce even if the type of decomposition that are necessary for composited samples (e.g., may not lead to scombrotoxin (histamine) 17 ppm histamine in a three-sample composite, formation. You should distinguish between rather than 50 ppm in an uncomposited sample ). recommendations in this chapter for sensory screening, as a component of a HACCP control Combining additional indicators of conditions strategy for scombrotoxin formation, and your that can lead to histamine formation, such as obligation to avoid otherwise violating the sensory examination and internal temperature FFD&C Act with regard to the distribution of measurement, with histamine testing can provide decomposed food. better assurance of product safety. Observation for the presence of honeycombing (voids in Chemical testing the fish flesh) in cooked tuna loins intended Chemical testing is an effective means of for canning is a valuable means of screening detecting the presence of histamine in fish flesh. for fish that have been exposed to the kinds of However, the variability in histamine levels temperature abuse that can lead to histamine between fish and within an individual fish can be development. Any scombrotoxin-forming fish large, even in fish from the same harvest vessel. that demonstrate the trait should be destroyed or For this reason, a guidance level has been set of diverted to a non-food use. 50 ppm histamine in the edible portion of fish. If 50 ppm is found in one section of a fish or lot, there is the possibility that other sections may exceed 500 ppm. Because histamine is generally not uniformly distributed in a fish or a lot, the validity of

CHAPTER 7: Scombrotoxin (Histamine) Formation 120 DETERMINE WHETHER THE POTENTIAL a refrigerated (not frozen) raw or cooked HAZARD IS SIGNIFICANT. product from another processor (see Chapter 12). The in-transit controls for secondary The following guidance will assist you in processors recommended in Chapter 12 are determining whether scombrotoxin (histamine) similar to those recommended in this chapter. formation is a significant hazard at a processing 2. Is it reasonably likely that unsafe levels of step: histamine will form at this processing step? 1. Is it reasonably likely that unsafe levels of To answer this question, you should consider histamine will be introduced at this processing step the potential for time and temperature abuse (do unsafe levels come in with the raw material)? in the absence of controls. You may already Table 3-2 (Chapter 3) lists those species of have controls in your process that minimize fish that are generally known to be capable the potential for time and temperature abuse of producing elevated levels of histamine if that could result in unsafe levels of histamine. temperature abused. Such species of fish This guidance will help you determine have this capability because they contain whether those or other controls should be naturally high levels of histidine. They also included in your HACCP plan. have this capability because they are marine Time and temperature abuse that occurs fish that are likely to harbor the kinds of at successive processing and storage steps bacteria that produce histidine decarboxylase. may be sufficient to result in unsafe levels It is, therefore, reasonable to assume that of histamine, even when abuse at one without proper onboard vessel controls, these step alone would not result in such levels. species of fish will contain unsafe levels of For this reason, you should consider the histamine upon receipt by the primary (first) cumulative effect of time and temperature processor. abuse during the entire process. Information However, if the worst case environmental is provided above to help you assess the conditions (i.e., air and water temperatures) significance of time and temperature abuse during the harvest season in a particular that may occur in your process. region would not permit the formation of 3. Can unsafe levels of histamine formation that are histamine during the time necessary to reasonably likely to occur be eliminated or reduced harvest and transport the fish to the primary to an acceptable level at this processing step? processor, onboard controls may not be necessary. For example, such conditions Scombrotoxin (histamine) formation should might exist if the fish are harvested when air also be considered a significant hazard at any and water temperatures do not exceed 40°F processing or storage step where a preventive (4.4°C), as evidenced by supporting data. measure is or can be used to eliminate the hazard if it is reasonably likely to occur. It is also reasonable to assume that without Preventive measures for scombrotoxin proper controls during refrigerated (not (histamine) formation can include: frozen) transportation between processors, scombrotoxin-forming species of fish will • Examining harvest vessel records contain unsafe levels of histamine upon to ensure that incoming fish were receipt by the secondary processor (including properly handled onboard the warehouses). In addition, you may need harvest vessel, including: to exercise control to prevent pathogen ° Rapidly chilling the fish immediately growth or toxin formation when receiving after death;

CHAPTER 7: Scombrotoxin (Histamine) Formation 121 ° Controlling onboard refrigeration IDENTIFY CRITICAL CONTROL POINTS. (other than frozen storage) temperatures; The following guidance will assist you in ° Performing proper onboard icing; determining whether a processing step is a • Testing incoming fish for critical control point (CCP) for scombrotoxin histamine levels; (histamine) formation: • Ensuring that incoming fish 1. If scombrotoxin (histamine) formation is a were handled properly during significant hazard at the receiving step, you refrigerated transportation from the should identify receiving as a CCP for this previous processor, including: hazard. Controlling refrigeration temperatures ° a. If you are the primary processor of the during transit; scombrotoxin-forming fish (i.e., if you ° Performing proper icing during receive the fish directly from the harvest transit; vessel) and have a relationship with the • Checking incoming fish to ensure operator of the harvest vessel(s) from that they are not at an elevated which you purchase fish that enables temperature at time of receipt; you to obtain documentation of onboard practices, you should identify the • Checking incoming fish to ensure following preventive measures for control that they are properly iced or of this hazard: refrigerated at time of receipt; • Examining harvest vessel records • Performing sensory examination on to ensure that incoming fish incoming fish to ensure that they do were properly handled onboard not show signs of decomposition; the harvest vessel, including: • Controlling refrigeration ˚ Rapidly chilling the fish temperatures in your plant; immediately after death; • Performing proper icing in your plant; ˚ Controlling onboard refrigeration (other than frozen storage) • Controlling the amount of time that the temperatures; product is exposed to temperatures that would permit histamine ˚ Performing proper onboard icing; formation during processing. • Checking incoming fish to ensure These preventive measures are ordinarily employed that they are not at an elevated at receiving, processing, and storage steps. temperature at time of receipt; and, • Performing sensory examination of • Intended use incoming fish to ensure that they do Because of the heat stable nature of histamine, not show signs of decomposition. the intended use of the product is not likely to affect the significance of this hazard. Example: A mahi-mahi processor that regularly purchases from the same harvest vessels should require harvest vessel records as a condition of purchase.

CHAPTER 7: Scombrotoxin (Histamine) Formation 122 The processor should also check you should identify the following the internal temperatures of preventive measures for control of this incoming fish and perform sensory hazard: examination of these fish. The • Ensuring that incoming fish were processor should then set a CCP for properly refrigerated during histamine formation at receiving. transportation from the previous This control approach is a control strategy processor, by controlling refrigeration referred to in this chapter as “Control temperatures during transit or, Strategy Example 1 - Harvest Vessel • Checking incoming fish to Control.” ensure that they are properly b. If you are the primary processor of the iced at time of receipt. scombrotoxin-forming fish (i.e., if you Example: receive the fish directly from the harvest A tuna processor that receives fish vessel) and do not have a relationship from another processor should require with the operator of the harvest vessel(s) evidence of temperature control that enables you to obtain documentation throughout transit as a condition of of onboard practices, you should identify receipt. The processor should then the following preventive measures for set a CCP for histamine formation at control of this hazard: receiving. • Testing incoming fish for This control approach is a control strategy histamine levels; referred to in this chapter as “Control • Checking incoming fish to ensure Strategy Example 3 - Transit Control.” that they are not at an elevated This control strategy, in addition to temperature at time of receipt and, “Control Strategy Example 1 - Harvest Vessel Control” or “Control Strategy • Performing sensory examination of Example 2 - Histamine Testing,” may incoming fish to ensure that they do also be applicable if you are a primary not show signs of decomposition. processor and transport the fish by truck Example: from your harvest vessel unloading site to A canned tuna processor that your processing facility. purchases from a variety of harvest vessels should subject incoming fish 2. If scombrotoxin (histamine) formation is a from each harvest vessel to histamine significant hazard at one or more processing testing, internal temperature checks, steps, you should identify the processing step(s) and sensory examination. The as a CCP for this hazard. processor should then set a CCP for a. The preventive measure for this type of histamine formation at receiving. control is: This control approach is a control strategy • Controlling the amount of time referred to in this chapter as “Control that the scombrotoxin-forming Strategy Example 2 - Histamine Testing.” product is exposed to temperatures c. If you are a secondary processor of the that would permit histamine scombrotoxin-forming fish (i.e., if you formation during processing. receive the fish from another processor),

CHAPTER 7: Scombrotoxin (Histamine) Formation 123 Example: • Receiving; A mahi-mahi processor should • Processing, such as: control histamine formation Thawing; by limiting exposure time and ° temperature of the product during ° Brining and salting; processing. The processor should ° Smoking; then set CCPs for histamine ° Heading and gutting; formation at the processing steps. ° Manual filleting and steaking; This control approach is a control strategy ° Fermenting; referred to in this chapter as “Control Pickling; Strategy Example 4 - Processing Control.” ° Drying; This control strategy is intended for ° processing at ambient and air-conditioned ° Stuffing; temperatures. “Control Strategy ° Mixing (e.g., salad preparation); Example 5 - Storage Control” may be ° Portioning; more appropriate for processing under • Packaging; refrigerated conditions. • Final chilling after processing 3. If scombrotoxin (histamine) formation is a and packaging; significant hazard at a storage step for raw material, in-process product, or finished product, • Storing raw material, in-process product, you should identify the storage step(s) as a CCP and finished product under refrigeration. for this hazard. Note: Rather than identify each processing step as an individual CCP when the controls are the same at those steps, it may be more a. The preventive measures for this type of convenient to combine into one CCP those processing steps that control are: together contribute to a cumulative time and temperature exposure.

• Controlling refrigeration • Unlikely CCPs temperatures in your plant or, Time and temperature controls will usually not be needed at processing steps that meet • Performing proper icing the following conditions: in your plant. • Continuous, mechanical processing Example: steps that are brief, such as: A mahi-mahi processor should control histamine formation by icing the ° Mechanical filleting; product during raw material, in-process • Processing steps that are brief and product, and finished product storage. unlikely to contribute significantly The processor should then set CCPs for to the cumulative time and histamine formation at the storage steps. temperature exposure, such as: This control approach is a control strategy ° Date code stamping; referred to in this chapter as “Control ° Case packing; Strategy Example 5 - Storage Control.” • Processing steps where the product • Likely CCPs is held in a frozen state, such as: Following is further guidance on processing ° Assembly of orders for distribution; steps that are likely to be identified as CCPs ° Frozen product storage; for this hazard:

CHAPTER 7: Scombrotoxin (Histamine) Formation 124 • Retorting and post-retorting steps (if the • Sensory examination; product is covered by the Thermally • Internal temperature measurements. Processed Low-Acid Foods Packaged in Hermetically Sealed Containers Harvest vessel records: regulation, 21 CFR 113 (called the • All scombrotoxin-forming fish lots received Low-Acid Canned Foods Regulation are accompanied by harvest vessel records in this guidance document)); that show: ˚ Fish exposed to air or water temperatures DEVELOP A CONTROL STRATEGY. above 83°F (28.3°C) were placed in ice, or in refrigerated seawater, ice slurry, or The following guidance provides examples of five brine of 40°F (4.4°C) or less, as soon control strategies for scombrotoxin (histamine) as possible after harvest, but not longer formation. It may be necessary to select more than 6 hours from the time of death; than one control strategy in order to fully control OR the hazard, depending upon the nature of your Fish exposed to air and water temperatures operation. You may select a control strategy ˚ of 83°F (28.3°C) or less were placed in that is different from those which are suggested, ice, or in refrigerated seawater, ice slurry, provided it complies with the requirements of the or brine of 40°F (4.4°C) or less, as soon as applicable food safety laws and regulations. possible after harvest, but not longer than 9 The following are examples of control strategies hours from the time of death; included in this chapter: OR ˚ Fish that were gilled and gutted before chilling were placed in ice, or MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY in refrigerated seawater, ice slurry, or PROCESSOR PROCESSOR brine of 40°F (4.4°C) or less, as soon Harvest vessel control  as possible after harvest, but not longer Histamine testing  than 12 hours from the time of death; Transit control   OR Processing control   ˚ Fish that were harvested under Storage Control   conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less were placed in ice, or in refrigerated seawater, ice slurry, or • CONTROL STRATEGY EXAMPLE 1 - HARVEST brine of 40°F (4.4°C) or less, as soon VESSEL CONTROL as possible after harvest, but not more It may be necessary to select more than one than the time limits listed above, with the control strategy in order to fully control the time period starting when the fish left the hazard, depending upon the nature of your 65°F (18.3°) or less environment; operation. OR Set Critical Limits. ˚ Other critical limits for onboard handling (e.g., maximum refrigerated brine or The critical limits for this control strategy should seawater temperature, maximum fish include three components: size, maximum fish to brine/seawater/ • Harvest vessel records; ice ratio, maximum initial temperature of

CHAPTER 7: Scombrotoxin (Histamine) Formation 125 the fish) necessary to achieve a cooling (10°C) or below; rate that will prevent development of OR an unsafe level of histamine in the specific species, as established through a • For fish held cedi or refrigerated (not frozen) scientific study. onboard the vessel from 12 to less than 15 hours after death: Note: If the actual time of death is not known, an estimated time of the first fish death in the set may be used (e.g., the time the ˚ The internal temperature should be 60°F deployment of a longline begins). Table 7-1 provides a summary of (15.6°C) or below; the preceding recommended critical limits. OR AND • For fish held cedi or refrigerated (not frozen) ˚ For fish held refrigerated (not frozen) onboard the vessel less than 12 hours after onboard the vessel: death: • The fish were stored at or below ˚ The internal temperature should 40°F (4.4°C) after cooling; be sufficiently below water and air OR temperatures to indicate that appropriate chilling methods were implemented • The fish were stored completely onboard the harvest vessel. Chilling and continuously surrounded of the fish should begin on the harvest by ice after cooling; vessel regardless of the time from death AND until off-loading from the vessel by the processor unless the environmental Sensory examination: conditions (e.g., air and water • Sensory examination of a representative temperatures) are below 40°F (4.4°C) sample of scombrotoxin-forming fish shows from the time of death until off-loading decomposition (persistent and readily from the vessel by the processor; perceptible) in less than 2.5% of the fish in OR the sample. For example, no more than 2 fish in a sample of 118 fish may show signs • For fish held iced or refrigerated (not frozen) of decomposition. Note that the FFD&C onboard the vessel: Act prohibits interstate commerce of any ˚ Elapsed time from death and internal decomposed fish whether or not the HACCP temperatures at the time of off-loading critical limit has been exceeded; from the vessel by the processor should be consistent with cooling curves that AND will prevent development of an unsafe Internal temperature measurements: level of histamine in the specific species, • For fish held iced or refrigerated (not frozen) as established through a scientific study. onboard the vessel 24 or more hours after death: Establish Monitoring Procedures. The internal temperature should be 40°F ˚ » What Will Be Monitored? (4.4°C) or below; Harvest vessel records containing the following OR information: • For fish held cedi or refrigerated (not frozen) • Method of capture*; onboard the vessel from 15 to less than 24 hours after death: AND ˚ The internal temperature should be 50°F • Where applicable to the critical limit, the

CHAPTER 7: Scombrotoxin (Histamine) Formation 126 date and time of landing the fish onboard • The presence of ice that completely the harvest vessel; and continuously surrounds the fish. AND (*These items may be documented by the primary (first) processor, on the receiving records, rather than by the harvest vessel operator, • Where applicable to the critical limit, the on the harvest vessel records, provided the primary processor has estimated earliest date and time of death for direct knowledge about those aspects of the harvesting practices and fish brought onboard in the fishing set (e.g., has made first-hand observations for each lot received. The vessel operator should document other onboard handling information. The trawl, gillnet, longline, or purse seine); primary processor should maintain all relevant information.) AND AND • Where applicable to the critical limit, the Sensory examination: air and water temperatures at the time of landing the fish onboard the harvest vessel*; • Amount of decomposition in the lot; AND AND • Where applicable to the critical limit, the Internal temperature measurement: water temperature at the depth where dead • For fish held iced or refrigerated (not frozen) fish may remain until harvest; onboard the vessel: AND ˚ The internal temperature of a • Where applicable to the critical limit, the representative number of the largest method of cooling* and temperature of the fish in the lot at the time of off-loading cooling medium; from the harvest vessel, concentrating on any fish that show signs of having been AND mishandled (e.g., inadequately iced); • Where applicable to the critical limit, the AND date and time cooling began and/or the date and time when the last fish in a fishing set ˚ Date and time of off-loading. (e.g., trawl, gillnet, longline, or purse seine) Example: was placed in the cooling medium; A primary processor receives AND bluefish from several day-boats that catch the fish when the air • Where applicable to the critical limit, those and water temperatures are below factors of the cooling process that have been 83°F (28.3°C). The day-boats take established through a scientific study as critical on ice at the processor’s facility to achieving the cooling rate critical limits (e.g., immediately before setting out for the refrigerated brine or seawater temperature, fish day and return within 9 hours to the size, fish to brine/seawater/ice ratio, maximum processor’s facility with the iced catch. initial temperature of the fish); The processor monitors and records AND the date and time of departure of • For fish held iced or refrigerated (not frozen) the vessels after they take on ice; the onboard the vessel: date and time of the return of the The storage temperature, as evidenced by: vessels; the ambient water and air ˚ temperatures of the fishing grounds; • The temperature of refrigerated and the adequacy of icing of the seawater or brine in which catch at the time of off-loading. The the fish are stored; processor also conducts sensory OR evaluations and checks the internal

CHAPTER 7: Scombrotoxin (Histamine) Formation 127 temperature of the catch upon arrival. of the fish. Randomly select fish from The harvest vessel operators perform throughout the lot. Lots that show a high no monitoring or record keeping. level of temperature variability or lots of very small fish may require a larger » How Will Monitoring Be Done? sample size; • For harvest vessel records: AND Review controls documented in the ˚ Visually determine the date and time of records; ˚ off-loading. AND » How Often Will Monitoring Be Done (Frequency)? • For sensory examination: • Every lot of scombrotoxin-forming fish Examine at least 118 fish, collected ˚ received. representatively throughout each lot (or the entire lot, for lots smaller than 118 fish). » Who Will Do the Monitoring? Additional fish should be xaminede if • For sensory examination: variability in fish-to-fish histamine content is expected to be high. Lots should ˚ Any person who is qualified by consist of only one species of fish; for experience or training to perform the vessels delivering multiple species, testing examination; should generally be done separately on AND each species. All fish within a lot should • For other checks: have a similar history of harvest. If the Any person who has an understanding of fish are received frozen, this monitoring ˚ the nature of the controls. procedure may be performed by a sensory examination on the warmed flesh produced by drilling the frozen fish (drill Establish Corrective Action Procedures. method). It may also be performed after Take the following corrective actions to a product thawing, rather than at receipt; involved in a critical limit deviation: AND • In the absence of harvest vessel records or when one of the harvester-related critical • For fish held iced or refrigerated (not frozen) limits has not been met, or when the internal onboard the vessel: temperature critical limit at receiving has not ˚ Use a temperature-indicating device been met: (e.g., a thermometer) to measure the Chill and hold the affected lot (i.e., internal temperature of a representative ˚ fish of common origin) until histamine number of the largest fish in each analysis is performed on a minimum lot, concentrating on any that show of 60 fish representatively collected signs of having been mishandled (e.g., from throughout the lot, including any inadequately iced). For example, fish measured to have temperatures when receiving 10 tons or more of fish, that exceeded the critical limit (or the measure a minimum of one fish per ton, entire lot for lots smaller than 60 fish). and when receiving less than 10 tons of Reject the lot if any fish are found with fish, measure a minimum of one fish per histamine greater than or equal to 50 1,000 pounds. Measure a minimum of ppm. The fish collected for analysis 12 fish, unless there are fewer than 12 may be composited for analysis if the fish in the lot, in which case measure all action point is reduced accordingly. For

CHAPTER 7: Scombrotoxin (Histamine) Formation 128 example, a sample of 60 fish may be Establish a Recordkeeping System. composited into 20 units of 3 fish each, • Harvest vessel records containing the provided the action point is reduced information described above; from 50 ppm to 17 ppm for each unit; AND OR • Receiving records showing the date and time ˚ Reject the lot; of off-loading; AND AND • When the sensory examination critical limit • Results of sensory examination; has not been met: AND ˚ Chill and hold the affected lot (i.e., fish of common origin) until histamine • For fish held iced or refrigerated (not frozen) analysis is performed on a minimum onboard the vessel: of 60 fish representatively collected ˚ Internal temperatures of the fish. from throughout the lot, including all fish in the lot that show evidence of Establish Verification Procedures. decomposition (persistent and readily • Collect a representative sample of the raw perceptible odors) (or the entire lot for material, in-process product, or finished lots smaller than 60 fish), and reject the product, and analyze it for histamine at least lot if any fish is found with histamine quarterly; greater than or equal to 50 ppm; AND AND • Ensure that new sensory examiners receive ˚ If any fish in the lot are to proceed training to calibrate their ability to identify into commerce for food use, perform decomposed fish and that all sensory a sensory examination of all fish in the examiners receive periodic refresher training; lot to ensure that no decomposed fish proceed; AND • Where histamine testing is part of a AND corrective action plan, periodically verify ˚ Any individual fish found to be the findings (e.g., by comparing results with decomposed (persistent and readily those obtained using an Association of perceptible) should be destroyed or Official Analytical Chemists (AOAC) method); diverted to a non-food use; AND OR • Before a temperature-indicating device (e.g., ˚ Reject the lot. a thermometer) is put into service, check AND the accuracy of the device to verify that the factory calibration has not been affected. Take the following corrective action to regain control This check can be accomplished by: over the operation after a critical limit deviation: Immersing the sensor in an ice slurry • Discontinue use of the supplier until ˚ (32°F (0°C)), if the device will be used at evidence is obtained that the identified or near refrigeration temperature; harvesting and onboard practices and controls have been improved. OR ˚ Comparing the temperature reading on the device with the reading on a

CHAPTER 7: Scombrotoxin (Histamine) Formation 129 known accurate reference device (e.g., • Review monitoring, corrective action, a thermometer traceable to the National and verification records within 1 week of Institute of Standards and Technology preparation to ensure they are complete and (NIST) standards) under conditions that any critical limit deviations that occurred are similar to how it will be used (e.g., were appropriately addressed. product internal temperature) within the temperature range at which it will be used; OR ˚ Following the manufacturer’s instructions; AND • Once in service, check the temperature- indicating 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 • Calibrate the temperature-indicating 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 show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND

CHAPTER 7: Scombrotoxin (Histamine) Formation 130 TABLE 7-3 CONTROL STRATEGY EXAMPLE 1 - HARVEST VESSEL CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Harvest Vessel Control.” This example illustrates how a fresh mahi-mahi processor that receives the fish on ice directly from harvest vessels that use a hook and line technique (fish brought onboard alive) can control scombrotoxin formation. 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.

Histamine formation 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., metal fragments).

Example Only See Text for Full Recommendations (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) CRITICAL MONITORING CRITICAL LIMITS SIGNIFICANT CORRECTIVE CONTROL FOR EACH RECORDS VERIFICATION HAZARD(S) ACTION(S) POINT PREVENTIVE WHAT HOW FREQUENCY WHO CHAPTER 7: Scombrotoxin (Histamine) Formation CHAPTER 7:Scombrotoxin (Histamine)Formation MEASURE Receiving Scombrotoxin All lots received are accompanied Harvest vessel Review of Every Receiving Reject Harvester Perform histamine analysis on fresh formation by harvest vessel records that show records controls lot supervisor the lot vessel 1 incoming lot every 3 months mahi­ documented received records (18 fish per sample) (1) placement of fish on ice mahi on in the records Discontinue within 9 hours of death if the ice from use of the Review monitoring, corrective maximum exposure temperature

131 harvest supplier action, and verification records does not exceed 83°F or within 6 vessels until within 1 week of preparation hours if the maximum exposure evidence temperature exceeds 83°F; is obtained (2) The fish were stored that completely and continuously harvesting surrounded by ice after capture and Less than 2.5% decomposition Amount Sensory Every Quality onboard Receiving Provide sensory training (persistent and readily perceptible) of examination lot control practices record for new fish examiners and in the incoming lot decomposition (118 fish per received staff and annual training for all fish in the incoming lot; or all fish controls examiners lot in the lot if have been less than 118 improved Review monitoring, corrective fish) action, and verification records within 1 week of preparation Internal temperatures of all fish Internal Digital Every Receiving Receiving Check the digital thermometer are to meet the following criteria temperature thermometer lot supervisor record for accuracy and damage and based on the time since the death of the fish at (1 fish/1,000 received to ensure that it is operational of the fish: time of pounds; before putting it into operation; >24 hours g ≤ 40° off-loading minimum of perform these same checks 15 to < 24 hours g ≤ 50° from vessel; 12 fish per daily, at the beginning of 12 to < 15 hoursg ≤ 60° lot) operations; and calibrate it once < 12 hours g below ambient Date and time per year air and water temperatures of off-loading commensurate with size of fish and Review monitoring, corrective time since death action, and verification records within 1 week of preparation • CONTROL STRATEGY EXAMPLE 2 - HISTAMINE ˚ The internal temperature should be 50°F TESTING (10°C) or below; It may be necessary to select more than one OR control strategy in order to fully control the • For fish held cedi or refrigerated (not frozen) hazard, depending upon the nature of your onboard the vessel from 12 to less than 15 operation. hours after death: Set Critical Limits. ˚ The internal temperature should be 60°F (15.6°C) or below; The critical limits for this control strategy should include three components: OR • Histamine testing; • For fish held cedi or refrigerated (not frozen) onboard the vessel less than 12 hours after • Sensory examination; death: • Internal temperature measurements. ˚ The internal temperature should Histamine testing: be sufficiently below water and air • Analysis of a representative sample of temperatures to indicate that appropriate scombrotoxin-forming fish shows less than chilling methods were implemented 50 ppm histamine in all fish in the sample; onboard the harvest vessel. Chilling of the fish should begin on the harvest AND vessel regardless of the time from death Sensory examination: until off-loading from the vessel by the • Sensory examination of a representative processor, unless the environmental sample of scombrotoxin-forming fish shows conditions (e.g. air and water decomposition (persistent and readily temperatures) are below 40°F (4.4°C) perceptible) in less than 2.5% of the fish in from the time of death until off-loading the sample. For example, no more than 2 from the vessel by the processor; fish in a sample of 118 fish may show signs OR of decomposition. Note that the FFD&C • For fish held iced or refrigerated (not frozen) Act prohibits interstate commerce of any onboard the vessel: decomposed fish whether or not the HACCP critical limit has been exceeded; ˚ Elapsed time from death and internal temperatures at the time of off-loading AND from the vessel by the processor should Internal temperature measurements: be consistent with cooling curves that will prevent development of an unsafe • For fish held iced or refrigerated (not frozen) level of histamine in the specific species, onboard the vessel 24 or more hours after as established through a scientific study. death: The internal temperature should be 40°F ˚ Establish Monitoring Procedures. (4.4°C) or below; OR » What Will Be Monitored? • For fish held cedi or refrigerated (not frozen) Histamine testing: onboard the vessel from 15 to less than 24 • Histamine content in the scombrotoxin­ hours after death: forming fish flesh; AND

CHAPTER 7: Scombrotoxin (Histamine) Formation 132 Sensory examination: • For sensory examination: • Amount of decomposition in the ˚ Examine at least 118 fish, collected scombrotoxin-forming fish lot; representatively throughout each lot (or the entire lot, for lots smaller than AND 118 fish). Additional fish should be Internal temperature measurement: examined if variability in fish-to-fish • For scombrotoxin-forming fish held iced or histamine content is expected to be high. refrigerated (not frozen) onboard the vessel: Lots should consist of only one species ˚ The internal temperature of a of fish; for vessels delivering multiple representative number of the largest species, testing should generally be fish in the lot at the time of off-loading done separately on each species. If the from the harvest vessel by the processor, fish are received frozen, this monitoring concentrating on any fish that show procedure may be performed by a signs of having been mishandled (e.g., sensory examination on the warmed inadequately iced); flesh produced by drilling the frozen fish (drill method). It may also be performed AND after thawing, rather than at receipt; Date and time of off-loading. ˚ AND » How Will Monitoring Be Done? • For fish held iced or refrigerated (not frozen) • For histamine analysis: onboard the vessel: ˚ Test a minimum of 18 fish, collected ˚ Use a temperature-indicating device representatively throughout each lot (or (e.g., a thermometer) to measure the the entire lot when there are fewer than internal temperature of a representative 18 fish in the lot). Additional fish should number of the largest fish in each be examined if variability in fish-to-fish lot, concentrating on any that show histamine content is expected to be high. signs of having been mishandled (e.g., Lots should consist of only one species inadequately iced). For example, of fish; for vessels delivering multiple when receiving 10 tons or more of fish, species, testing should generally be done measure a minimum of one fish per ton, separately on each species. Reject the and when receiving less than 10 tons of lot if any fish are found with histamine fish, measure a minimum of one fish per greater than or equal to 50 ppm. The 1,000 pounds. Measure a minimum of fish collected for analysis may be 12 fish, unless there are fewer than 12 composited if the critical limit is reduced fish in the lot, in which case measure all accordingly. For example, a sample of of the fish. Randomly select fish from 18 fish may be composited into 6 units throughout the lot. Lots that show a high of 3 fish each, provided the critical limit level of temperature variability or lots is reduced from 50 ppm to 17 ppm for of very small fish may require a larger each unit; sample size; AND AND ˚ Visually determine the date and time of off-loading.

CHAPTER 7: Scombrotoxin (Histamine) Formation 133 » How Often Will Monitoring Be Done (Frequency)? OR • Every lot of scombrotoxin-forming fish received. • Reject the lot; » Who Will Do the Monitoring? AND • For sensory examination and histamine • When the sensory examination critical limit testing: has not been met: ˚ Any person who is qualified by ˚ If histamine did not exceed 50 ppm in experience or training to perform the the initial testing: work; • Chill and hold the affected lot AND (i.e., fish of common origin) until • For other checks: histamine analysis is performed on a minimum of 60 fish representatively Any person who has an understanding of ˚ collected from throughout the lot, the nature of the controls. including all fish in the lot that show evidence of decomposition Establish Corrective Action Procedures. (persistent and readily perceptible Take the following corrective actions to a product odors) (or the entire lot for lots involved in a critical limit deviation: smaller than 60 fish). Reject the • When the histamine-level critical limit at the lot if any fish are found with receiving step has not been met, reject the lot; histamine greater than or equal to 50 ppm. The fish collected for AND analysis may be composited for • When the internal temperature critical limit analysis if the action point is reduced has not been met: accordingly. For example, a sample ˚ If histamine did not exceed 50 ppm in of 60 fish may be composited into the initial testing: 20 units of 3 fish each, provided the action point is reduced from • Chill and hold the affected lot 50 ppm to 17 ppm for each unit; (i.e., fish of common origin) until histamine analysis is performed on a AND minimum of 60 fish representatively ˚ If any fish in the lot are to proceed collected from throughout the lot, into commerce for food use, perform including any fish measured to a sensory examination of all fish in the have temperatures that exceeded lot to ensure that no decomposed fish the critical limit (or the entire lot proceed; for lots smaller than 60 fish). Reject AND the lot if any fish are found with histamine greater than or equal ˚ Any individual fish found to be to 50 ppm. The fish collected for decomposed (persistent and readily analysis may be composited for perceptible) should be destroyed or analysis if the action point is reduced diverted to a non-food use; accordingly. For example, a sample OR of 60 fish may be composited into Reject the lot. 20 units of 3 fish each, provided ˚ the action point is reduced from AND 50 ppm to 17 ppm for each unit;

CHAPTER 7: Scombrotoxin (Histamine) Formation 134 Take the following corrective action to regain control traceable thermometer) under conditions over the operation after a critical limit deviation: that are similar to how it will be used (e.g., • Discontinue use of the supplier until evidence product internal temperature) within the is obtained that the identified harvesting and temperature range at which it will be used; onboard practices have been improved. OR Following the manufacturer’s instructions; Establish a Recordkeeping System. ˚ AND • Receiving records showing: • Once in service, check the temperature- Date and time of off-loading; ˚ indicating device daily before the beginning AND of operations. Less frequent accuracy checks • Results of histamine analysis; may be appropriate if they are recommended by the instrument manufacturer and the history AND of use of the instrument in your facility has • Results of sensory examination; shown that the instrument consistently remains AND accurate for a longer period of time. In addition to checking that the device is accurate • For fish held iced or refrigerated (not frozen) onboard the vessel: by one of the methods described above, this process should include a visual examination of Internal temperatures of the fish. ˚ the sensor and any attached wires for damage or kinks. The device should be checked to Establish Verification Procedures. ensure that it is operational; • Periodically verify histamine findings (e.g., by AND comparing results with those obtained using an AOAC method or by analyzing proficiency • Calibrate the temperature-indicating device samples); against a known accurate reference device (e.g., a NIST-traceable thermometer) at AND least once a year or more frequently if • Ensure that new sensory examiners receive recommended by the device manufacturer. training to calibrate their ability to identify Optimal calibration frequency is dependent decomposed fish and that all sensory upon the type, condition, past performance, examiners receive periodic refresher training; and conditions of use of the device. AND Consistent temperature variations away from the actual value (drift) found during checks • Before a temperature-indicating device (e.g., and/or calibration may show a need for more a thermometer) is put into service, check frequent calibration or the need to replace the accuracy of the device to verify that the the device (perhaps with a more durable factory calibration has not been affected. device). Calibration should be performed at This check can be accomplished by: a minimum of two temperatures that bracket ˚ Immersing the sensor in an ice slurry the temperature range at which it is used; (32°F (0°C)), if the device will be used at or near refrigeration temperature; AND • Review monitoring, corrective action, OR and verification records within 1 week of ˚ Comparing the temperature reading on preparation to ensure they are complete and the device with the reading on a known any critical limit deviations that occurred accurate reference device (e.g., a NIST- were appropriately addressed.

CHAPTER 7: Scombrotoxin (Histamine) Formation 135 TABLE 7-4

CONTROL STRATEGY EXAMPLE 2 - HISTAMINE TESTING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Histamine Testing.” This example illustrates how a canned tuna processor that receives frozen tuna directly from the harvest vessel can control scombrotoxin formation. 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.

Histamine formation 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., Clostridium botulinum growth and toxin formation).

Example Only See Text for Full Recommendations

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

CRITICAL MONITORING CHAPTER 7: Scombrotoxin (Histamine) Formation CHAPTER 7:Scombrotoxin (Histamine)Formation CRITICAL LIMITS SIGNIFICANT CONTROL FOR EACH CORRECTIVE ACTION(S) RECORDS VERIFICATION HAZARD(S) POINT PREVENTIVE WHAT HOW FREQUENCY WHO MEASURE Receiving Scombrotoxin Less than Fish fl esh for Histamine testing Every lot Quality Reject the lot; Reports of Do a quarterly frozen formation 50 ppm histamine using the AOAC received assurance histamine comparison of histamine

136 tuna from histamine in content 977.13 method staff Discontinue use of the supplier analysis test results with AOAC harvest all fish in the on a minimum until evidence is obtained method vessels sample of 18 fish per that harvesting and onboard lot (36 fish from practices have been improved Review vessels with monitoring, high variability If the initial histamine sample corrective action, and of histamine was <50 ppm, perform verification records detected histamine analysis on a within 1 week of between fish min, of 60 fish, collected preparation or when 1 of representatively from the lot the first 18 fish and reject the lot if any fish exceeds 30 ppm contains ≥50 ppm histamine; histamine) and if all fish <50 ppm Less than 3 Amount of Sensory Every lot Quality Conduct sensory evaluation of Sensory Provide sensory training decomposed decomposition examination (118 received assurance all fish in the lot, removing and examination for new fish examiners fish in the fish per lot, or all staff destroying all decomposed fish record and annual training for (persistent incoming lot fish if lot is less all fish examiners and readily than 118 fish) Discontinue use of the supplier perceptible) until evidence is obtained Review monitoring, in a 118-fish that harvesting and onboard corrective action, and sample practices have been improved verification records within 1 week of preparation • CONTROL STRATEGY EXAMPLE 3 - TRANSIT a controlled temperature environment) of 4 CONTROL hours or less (optional control strategy): It may be necessary to select more than one ˚ Time of transit does not exceed 4 hours; control strategy in order to fully control the hazard, AND depending upon the nature of your operation. ˚ Internal temperature of the fish at the Set Critical Limits. time of delivery does not exceed 40°F (4.4°C). • For fish delivered refrigerated (not frozen): Note: Processors receiving fish with transit times of 4 hours or less may All lots received are accompanied by ˚ elect to use one of the controls described for longer transit times instead. transportation records that show that the fish were held at or below an ambient Establish Monitoring Procedures. or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance » What Will Be Monitored? for routine refrigeration defrost cycles may • For scombrotoxin-forming fish delivered be necessary; refrigerated (not frozen): OR ˚ The internal temperature of the fish • For fish delivered under ice: throughout transportation; ˚ Fish are completely surrounded by ice at OR the time of delivery; ˚ The ambient temperature within the truck OR or other carrier throughout transportation; • For fish delivered under ice on an open-bed OR truck: • For scombrotoxin-forming fish delivered under ˚ Fish are stored completely surrounded by ice: ice; ˚ The adequacy of ice surrounding the AND product at the time of delivery; ˚ The internal temperature of the fish at the OR time of delivery is 40°F (4.4°C) or below; • For scombrotoxin-forming fish delivered under OR ice on an open-bed truck: • For fish delivered under chemical cooling ˚ The adequacy of ice surrounding the media such as gel packs: product at the time of delivery; ˚ There is an adequate quantity of AND cooling media that remain frozen to ˚ The internal temperature of the fish at have maintained product at an internal time of delivery; temperature of 40°F (4.4°C) or below throughout transit; OR • For scombrotoxin-forming fish held under AND chemical cooling media such as gel packs: The internal temperature of the fish at the ˚ The quantity and frozen status of cooling time of delivery is 40°F (4.4°C) or below; ˚ media at the time of delivery; OR AND • For fish delivered refrigerated (not frozen) The internal temperature of the fish at the with a transit time (including all time outside ˚ time of delivery;

CHAPTER 7: Scombrotoxin (Histamine) Formation 137 OR ˚ Make visual observations of the • For scombrotoxin-forming fish delivered adequacy and frozen state of the cooling refrigerated (not frozen) with a transit time of media in a representative number of 4 hours or less: containers (e.g., cartons and totes) from throughout the shipment; ˚ The date and time fish were removed from a controlled temperature AND environment before shipment and the ˚ Use a temperature-indicating device (e.g., date and time delivered; a thermometer) to determine internal AND product temperatures in a representative number of fish from throughout the The internal temperature of a representative ˚ shipment, at delivery; number of fish at the time of delivery. OR » How Will Monitoring Be Done? • For fish delivered refrigerated (not frozen) • For fish delivered refrigerated (not frozen): with a transit time of 4 hours or less: ˚ Use a continuous temperature-recording ˚ Review carrier records to determine the device (e.g., a recording thermometer) date and time fish were removed from for internal product temperature or a controlled temperature environment ambient air temperature monitoring before shipment and the date and time during transit; delivered; OR AND • For fish delivered under ice: ˚ Use a temperature-indicating device (e.g., ˚ Make visual observations of the adequacy a thermometer) to determine internal of ice in a representative number of product temperatures in a representative containers (e.g., cartons and totes) from number of fish randomly selected from throughout the shipment, at delivery; throughout the shipment, at delivery. OR Measure a minimum of 12 fish, unless there are fewer than 12 fish in a lot, in • For fish delivered under ice on an open-bed which case measure all of the fish. Lots truck: that show a high level of temperature ˚ Make visual observations of the variability or lots of very small fish may adequacy of ice surrounding the product require a larger sample size. in a representative number of containers (e.g., cartons and totes) from throughout » How Often Will Monitoring Be Done (Frequency)? the shipment, at delivery; • Every scombrotoxin-forming fish lot received. AND » Who Will Do the Monitoring? Use a temperature-indicating device (e.g., ˚ • For continuous temperature-recording a thermometer) to determine internal devices: product temperatures in a representative Monitoring is performed by the device itself. number of fish from throughout the ˚ The visual check of the data generated shipment, at delivery; by the device, to ensure that the critical OR limits have consistently been met, may • For fish delivered under chemical cooling be performed by any person who has an media such as gel packs: understanding of the nature of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation 138 OR • The number of containers examined • For other checks: and the sufficiency of ice for each; ˚ Any person who has an understanding of AND the nature of the controls. • The number of containers in the lot; Establish Corrective Action Procedures. OR For chemical cooling media checks: Take the following corrective action to a product ˚ involved in a critical limit deviation: • The number of containers • Chill and hold the affected lot until histamine examined and the frozen status analysis is performed on a minimum of of the cooling media for each; 60 fish representatively collected from AND throughout the lot, including any with temperatures that exceeded a critical limit • The number of containers in the lot; and any fish observed to have been exposed AND to inadequate cooling media (or the entire lot ˚ Results of internal product temperature for lots smaller than 60 fish). Reject the lot if monitoring, where applicable, including: any fish is found with histamine greater than or equal to 50 ppm. • The number of containers examined and the internal The fish collected for analysis may be temperatures observed for each; composited if the action point is reduced accordingly. For example, a sample of 60 fish AND may be composited into 20 units of 3 fish • The number of containers in the lot; each, provided the action point is reduced AND from 50 ppm to 17 ppm for each unit; ˚ Date and time fish were initially OR removed from a controlled temperature • Reject the lot. environment and the date and time fish AND were delivered, when applicable.

Take the following corrective action to regain control Establish Verification Procedures. over the operation after a critical limit deviation: • Before a temperature-indicating device (e.g., • Discontinue use of the supplier or carrier a thermometer) is put into service, check until evidence is obtained that the identified the accuracy of the device to verify that the transportation-handling practices have been factory calibration has not been affected. improved. This check can be accomplished by: Immersing the sensor in an ice slurry Establish a Recordkeeping System. ˚ (32°F (0°C)), if the device will be used at • Receiving records showing: or near refrigeration temperature; For continuous temperature monitoring: ˚ OR • Printouts, charts, or readings from Comparing the temperature reading on temperature-recording devices (e.g., ˚ the device with the reading on a known temperature recorder); accurate reference device (e.g., a NIST- OR traceable thermometer) under conditions ˚ For ice checks: that are similar to how it will be used

CHAPTER 7: Scombrotoxin (Histamine) Formation 139 (e.g., product internal temperature) the device with the reading on a known within the temperature range at which it accurate reference device (e.g., a NIST- will be used; traceable thermometer) under conditions that are similar to how it will be used (e.g., air OR temperature) within the temperature range at ˚ Following the manufacturer’s instructions; which it will be used; AND AND • Once in service, check the temperature- • When visual checks of ice are used, indicating device daily before the beginning periodically measure internal temperatures of operations. Less frequent accuracy checks of fish to ensure that the ice are sufficient may be appropriate if they are recommended to maintain product temperatures at 40°F by the instrument manufacturer and the (4.4°C) or less; history of use of the instrument in your facility has shown that the instrument AND consistently remains accurate for a longer • Review monitoring, corrective action, period of time. In addition to checking that and verification records within 1 week the device is accurate by one of the methods of preparation are complete and any described above, this process should include critical limit deviations that occurred were a visual examination of the sensor and any appropriately addressed. attached wires for damage or kinks. The device should be checked to ensure that it is operational; AND • Calibrate the temperature-indicating 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 show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND • Check the accuracy of temperature-recording devices that are used for monitoring transit conditions upon receipt of each lot. The accuracy of the device can be checked by comparing the temperature reading on

CHAPTER 7: Scombrotoxin (Histamine) Formation 140 TABLE 7-5 CONTROL STRATEGY EXAMPLE 3 - TRANSIT CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Transit Control.” This example illustrates how a fresh mahi-mahi secondary processor that receives the product by air under chemical coolant (gel packs) can control scombrotoxin formation. 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.

Histamine formation 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., metal fragments).

Example Only See Text for Full Recommendations

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

MONITORING CRITICAL

CHAPTER 7: Scombrotoxin (Histamine) Formation CHAPTER 7:Scombrotoxin (Histamine)Formation CRITICAL LIMITS SIGNIFICANT CONTROL FOR EACH CORRECTIVE ACTION(S) RECORDS VERIFICATION HAZARD(S) POINT PREVENTIVE WHAT HOW FREQUENCY WHO MEASURE

Receiving Scombrotoxin Adequate Quantity Visual observation Every lot Receiving Reject the lot Receiving Check the formation quantity of and frozen of a minimum of received clerk record thermometer for 141 frozen gel condition of 25% of shipping Discontinue use of the accuracy and packs to gel packs containers in the supplier or carrier until damage, and to maintain the lot but not fewer evidence is obtained that ensure that it product at than 12 containers transportation-handling is operational 40°F or less (or all containers if practices have been before putting throughout lot has less than 12 improved into operation; transit; and containers) perform these same checks daily at the beginning of operations, and Internal Internal core Digital thermometer Every lot Receiving Reject the lot Receiving calibrate it once per temperatures temperature for internal received clerk record year of all fish at and a temperature of Discontinue use of the delivery are near-surface one fish in 25% of supplier or carrier until Review 40°F or below temperature shipping containers evidence is obtained that monitoring, of each fish but not fewer than transportation-handling corrective action, 12 containers (or practices have been and verification all containers if lot improved records within 1 has less than 12 week of preparation containers) • CONTROL STRATEGY EXAMPLE 4 - PROCESSING ˚ The fish are not exposed to ambient CONTROL temperatures above 40°F (4.4°C) for It may be necessary to select more than one more than 12 hours, cumulatively, if any control strategy in order to fully control the portion of that time is at temperatures hazard, depending upon the nature of your above 70°F (21.1°C); operation. OR Set Critical Limits. ˚ The fish are not exposed to ambient temperatures above 40°F (4.4°C) for • During processing (e.g., butchering, more than 24 hours, cumulatively, as cleaning, brining, salting, smoking, drying, long as no portion of that time is at fermenting, pickling, mixing, fermenting, temperatures above 70°F (21.1°C). stuffing, packing, labeling, and staging) of Note: Only one of the two limits above should be selected. They scombrotoxin-forming fish that have not should not be added for a total exposure of 36 hours. been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming Establish Monitoring Procedures. bacteria: What Will Be Monitored? ˚ The fish are not exposed to ambient » temperatures above 40°F (4.4°C) for • The length of time the scombrotoxin-forming more than 4 hours, cumulatively, if any fish are exposed to unrefrigerated conditions portion of that time is at temperatures (i.e., above 40°F (4.4°C)); above 70°F (21.1°C); AND OR • The ambient temperatures during the ˚ The fish are not exposed to ambient exposure periods. temperatures above 40°F (4.4°C) for Note: If the critical limit is based on an assumption that temperatures more than 8 hours, cumulatively, as may exceed 70°F (21.1°C), then only the length of exposure may long as no portion of that time is at need to be monitored. temperatures above 70°F (21.1°C). » How Will Monitoring Be Done? Note: Only one of the two limits above should be selected. They • Make visual observations of the length of should not be added for a total exposure of 12 hours. time of product exposure to unrefrigerated OR conditions (i.e., above 40°F (4.4°C)); • During processing (e.g., thawing, butchering, AND cleaning, brining, mixing, fermenting, • Measure ambient air temperature, using: stuffing, packing, labeling, and staging) of scombrotoxin-forming fish or fishery ˚ A continuous temperature-recording products that have been (1) previously device (e.g., a recording thermometer) frozen or (2) heat processed sufficiently to located in the processing area; destroy scombrotoxin-forming bacteria and OR are processed in a manner where there is ˚ A temperature-indicating device (e.g., a an opportunity for recontamination with thermometer) located in the processing scombrotoxin-forming bacteria (e.g., contact area. with fresh fish, employees, or introduction Note: Where multiple processing locations are combined in a of raw ingredients), such as in a tuna salad cumulative exposure control strategy, temperature monitoring may be made from canned tuna with added raw needed in each of the processing locations. ingredients:

CHAPTER 7: Scombrotoxin (Histamine) Formation 142 Example: » Who Will Do the Monitoring? A fresh tuna processor using raw • For a continuous temperature-recording device: material that was not previously Monitoring is performed by the device frozen has identified a series of ˚ itself. The visual check of the data processing steps (i.e., from raw generated by the device, to ensure that material cooler to finished product the critical limits have consistently been cooler) as CCPs for scombrotoxin met, may be performed by any person formation. The processor establishes who has an understanding of the nature a critical limit of no more than 4 of the controls; cumulative hours of exposure to unrefrigerated temperatures in OR excess of 40°F (4.4°C) during these • For other checks: processing steps. The processor uses ˚ Any person who has an understanding of a marked product to monitor the the nature of the controls. progress of the product through the processing steps. The time that the Establish Corrective Action Procedures. marked product is removed from refrigeration to the time the last of Take the following corrective action to a product the marked product is placed in the involved in a critical limit deviation: finished product cooler is monitored • Chill and hold the affected product until visually and recorded. It is not histamine analysis is performed on a necessary for the processor to measure minimum of 60 fish representatively collected temperature because the critical limit from throughout the affected lot. Destroy is based on an assumption that the the lot or divert it to a non-food use if any product temperature may exceed 70°F fish is found with histamine greater than (21.1°C). or equal to 50 ppm. The fish collected for analysis may be composited if the action » How Often Will Monitoring Be Done (Frequency)? plan is reduced accordingly. For example, • For exposure time: a sample of 60 fish may be composited into ˚ At least every 2 hours; 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 17 ppm for AND each unit; • For temperature measurements: OR ˚ For a continuous temperature-recording device: • Destroy the product; • Continuous monitoring during OR processing operations is • Divert the product to a non-food use. accomplished by the device itself, AND with a visual check of the device at least once per lot or batch, but Take the following corrective actions to regain control no less often than once per day; over the operation after a critical limit deviation: • Add ice to the product; OR ˚ For a temperature-indicating device: OR • Return the affected product to the cooler; • At least every 2 hours. AND

CHAPTER 7: Scombrotoxin (Histamine) Formation 143 • Modify the process as needed to reduce the by the instrument manufacturer and the time and temperature exposure. history of use of the instrument in your facility has shown that the instrument Establish a Recordkeeping System. consistently remains accurate for a longer • Processing records showing the results period of time. In addition to checking that of time and temperature exposure the device is accurate by one of the methods measurements. described above, this process should include a visual examination of the sensor and any Establish Verification Procedures. attached wires for damage or kinks. The device should be checked to ensure that it is • Before a temperature-indicating device (e.g., operational and has sufficient ink and paper, a thermometer) or a temperature-recording where applicable; device (e.g., a recording thermometer) is put into service, check the accuracy of the AND device to verify that the factory calibration • Calibrate the temperature-indicating device has not been affected. This check can be or temperature-recording device against a accomplished by: known accurate reference device (e.g., a ˚ Immersing the sensor in an ice slurry NIST-traceable thermometer) at least once a (32°F (0°C)), if the device will be used at year or more frequently if recommended by or near refrigeration temperature; the device manufacturer. Optimal calibration OR frequency is dependent upon the type, condition, past performance, and conditions Immersing the sensor in boiling water ˚ of use of the device. Consistent temperature (212°F (100°C)) if the device will be used variations away from the actual value (drift) at or near the boiling point. Note that found during checks and/or calibration may the temperature should be adjusted to show a need for more frequent calibration compensate for altitude, when necessary; or the need to replace the device (perhaps OR with a more durable device). Calibration ˚ Doing a combination of the above if should be performed at a minimum of two the device will be used at or near room temperatures that bracket the temperature temperature; range at which it is used; OR AND ˚ Comparing the temperature reading on • Review monitoring, corrective action, the device with the reading on a known and verification records within 1 week of accurate reference device (e.g., a NIST- preparation to ensure they are complete and traceable thermometer) under conditions any critical limit deviations that occurred that are similar to how it will be used (e.g., were appropriately addressed. air temperature) within the temperature range at which it will be used; AND • Once in service, check the temperature- indicating device or temperature-recording device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended

CHAPTER 7: Scombrotoxin (Histamine) Formation 144 TABLE 7-6

CONTROL STRATEGY EXAMPLE 4 - PROCESSING CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Processing Control.” This example illustrates how a fresh bluefish processor that butchers, cleans, packs, labels, and boxes the fish at ambient temperature can control scombrotoxin formation. 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.

Histamine formation 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., metal fragments).

Example Only See Text for Full Recommendations

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

MONITORING CHAPTER 7: Scombrotoxin (Histamine) Formation CHAPTER 7:Scombrotoxin (Histamine)Formation CRITICAL CRITICAL LIMITS SIGNIFICANT CORRECTIVE CONTROL FOR EACH RECORDS VERIFICATION HAZARD(S) ACTION(S) POINT PREVENTIVE WHAT HOW FREQUENCY WHO MEASURE

Processing Scombrotoxin The product Time of product Visual tracking Every batch of Quality control Ice and hold Processing Review (butchering, formation is not out of exposure to of time for a fish supervisor the record monitoring, 145 cleaning, refrigeration unrefrigerated marked batch removed from affected batch corrective packaging, for more conditions of product to raw material in raw material action, and labeling, and than 4 hours during move from raw cold storage for cooler verification boxing) cumulatively processing material cold processing records within operations storage to final Perform 1 week of product cold histamine preparation storage analysis on a minimum of 60 fish in the affected batch

Destroy the entire batch if any fish exceeds 50 ppm histamine

Modify the process, if necessary, to reduce delays • CONTROL STRATEGY EXAMPLE 5 - STORAGE Establish Monitoring Procedures. CONTROL » What Will Be Monitored? It may be necessary to select more than one control strategy in order to fully control the • For refrigerated storage of scombrotoxin­ hazard, depending upon the nature of your forming fish: operation. ˚ The temperature of the cooler; Set Critical Limits. OR • For storage under ice of scombrotoxin­ • For refrigerated (not frozen) storage or forming fish: processing of raw material, in-process product, or finished product: ˚ The adequacy of ice surrounding the product. ˚ The product is held at a cooler temperature of 40°F (4.4°C) or » How Will Monitoring Be Done? below. Note that allowance for • For refrigerated storage: routine refrigeration defrost cycles Measure cooler temperature using a may be necessary. On the other ˚ continuous temperature-recording device hand, minor variations in cooler (e.g., a recording thermometer); temperature measurements can be avoided by submerging the sensor OR for the temperature-recording device • For storage under ice: (e.g., temperature-recorder) in a liquid ˚ Make visual observations of the that mimics the characteristics of the adequacy of ice in a representative product. Also note that critical limits number of containers (e.g., cartons and during refrigerated storage that specify totes) from throughout the cooler. a cumulative time and temperature of exposure to temperatures above » How Often Will Monitoring Be Done (Frequency)? 40°F (4.4°C) are not ordinarily suitable • For continuous temperature-recording devices: because of the difficulty in tracking ˚ Continuous monitoring during storage is the specific products and the specific accomplished by the device itself, with a cumulative temperature exposures visual check of the recorded data at least that those products experience. The once per day; cumulative exposure for each product OR would then need to be determined prior to shipping. If you chose this approach, • For storage under ice: the critical limit for cumulative exposure ˚ Monitoring with sufficient frequency to to temperatures above 40°F (4.4°C) ensure control. should include time during transit, refrigerated storage, and refrigerated and » Who Will Do the Monitoring? unrefrigerated processing; • For continuous temperature-recording devices: Monitoring is performed by the device OR ˚ itself. The visual check of the data • For raw material, in-process product, or generated by the device, to ensure that finished product stored under ice: the critical limits have consistently been ˚ The product is completely and met, may be performed by any person continuously surrounded by ice who has an understanding of the nature throughout the storage time. of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation 146 OR OR • For other checks: ˚ Make adjustments to the ice application ˚ Any person who has an understanding of operations. the nature of the controls. Establish a Recordkeeping System. Establish Corrective Action Procedures. • For refrigerated storage: Take the following corrective action to a product ˚ Printouts, charts, or readings from involved in a critical limit deviation: continuous temperature-recording devices; • Chill and hold the product until it can be evaluated based on its total time and AND temperature exposure, including exposures ˚ Record of visual checks of recorded data; during prior processing operations. OR OR • For storage under ice: • Chill and hold the affected product until The number of containers examined and histamine analysis is performed on a ˚ the sufficiency of ice for each; minimum of 60 fish collected from throughout each affected lot. Destroy the lot or divert AND it to a non-food use if any fish is found ˚ The approximate number of containers with histamine greater than or equal to 50 in the cooler. ppm. The fish collected for analysis may be composited if the action point is reduced Establish Verification Procedures. accordingly. For example, a sample of 60 fish • Before a temperature-recording device (e.g., may be composited into 20 units of 3 fish a recording thermometer) is put into service, each, provided the action point is reduced check the accuracy of the device to verify that from 50 ppm to 17 ppm for each unit; the factory calibration has not been affected. OR This check can be accomplished by: • Destroy the product; ˚ Immersing the sensor in an ice slurry (32°F (0°C)), if the device will be used at OR or near refrigeration temperature; • Divert the product to a non-food use. OR AND ˚ Comparing the temperature reading on Take the following corrective actions to regain control the device with the reading on a known over the operation after a critical limit deviation: accurate reference device (e.g., a NIST- • Prevent further deviation: traceable thermometer) under conditions Add ice to the product; that are similar to how it will be used (e.g., ˚ air temperature) within the temperature OR range at which it will be used; Move some or all of the product in the ˚ AND malfunctioning cooler to another cooler; • Once in service, check the temperature- AND recording device daily before the beginning • Address the root cause: of operations. Less frequent accuracy checks ˚ Make repairs or adjustments to the may be appropriate if they are recommended malfunctioning cooler; by the instrument manufacturer and the

CHAPTER 7: Scombrotoxin (Histamine) Formation 147 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., 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 show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND • When visual checks of ice are used, periodically measure internal temperatures of fish to ensure that the ice is sufficient to maintain product temperatures at 40°F (4.4°C) or less; 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 7: Scombrotoxin (Histamine) Formation 148 TABLE 7-7

CONTROL STRATEGY EXAMPLE 5 - STORAGE CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - Storage Control.” This example illustrates how a fresh fish processor can control scombrotoxin formation. 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.

Histamine formation 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., metal fragments).

Example Only See Text for Full Recommendations

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

CRITICAL MONITORING CHAPTER 7: Scombrotoxin (Histamine) Formation CHAPTER 7:Scombrotoxin (Histamine)Formation CRITICAL LIMITS SIGNIFICANT CORRECTIVE CONTROL FOR EACH RECORDS VERIFICATION HAZARD(S) ACTION(S) POINT PREVENTIVE WHAT HOW FREQUENCY WHO MEASURE Raw material Scombrotoxin Maximum Cooler Time and Continuous, Production Ice and hold the Data Check the and finished formation cooler temperature temperature with a visual supervisor affected product logger data logger for

149 product cold temperature of data logger check of inside the cooler printout accuracy and storage (shared 40°F recorded data damage and to cooler) once per day Check ensure that it sufficiency of ice is operational on the product before putting two times per into operation; day until cooler perform these is functioning checks daily, at reliably the beginning of operations; Perform and calibrate it histamine analysis once per year on a minimum of 60 fish Review representative monitoring, of the affected corrective product action, and verification Destroy all records within affected 1 week of product if any fish preparation exceeds 50 ppm histamine

Adjust and repair cooler as needed BIBLIOGRAPHY. seafood science). Elsevier, New York, NY. • Fletcher, G. C., G. Summers, and P. W. C. We have placed the following references on van Veghel. 1998. Levels of histamine and display in the Division of Dockets Management, histamine-producing bacteria in smoked fish Food and Drug Administration, 5630 Fishers from New Zealand markets. J. Food Prot. Lane, rm. 1061, Rockville, MD 20852. You may 61(8):1064-1070. see them at that location between 9 a.m. and 4 • Frank, H. A., and D. H. Yoshinaga. 1984. p.m., Monday through Friday. As of March 29, Histamine formation in tuna, p. 443-451. In 2011, FDA had verified the Web site address for E. Ragelis (ed.), Seafood toxins. American the references it makes available as hyperlinks Chemical Society, Washington, DC. from the Internet copy of this guidance, but FDA • Frank, H. A., D. H. Yoshinaga, and W. is not responsible for any subsequent changes Nip. 1981. Histamine formation and to Non-FDA Web site references after March 29, honeycombing during decomposition of 2011. skipjack tuna. Katsuwonus pelamis, at • Arnold, S., and D. Brown. 1978. Histamine elevated temperatures. Mar. Fisheries Rev. toxicity from fish products. Adv. Food Res. 43(10):9-14. 24:113-154. • Hernández-Herrero, M. M., A. X. Roig-Sagués, • Baranowski, J. D., H. A. Frank, P. A. Brust, J. J. Rodríguez-Jerez, and M. T. Mora-Ventura. M. Chongsiriwatana, and R. J. Premaratne. 1999. Halotolerant and halophilic histamine- 1990. Decomposition and histamine content forming bacteria isolated during the ripening in mahimahi (Coryphaena hippurus). J. Food of salted anchovies (Engraulis encrasicholus). Prot. 53(3):217−222. J. Food Prot. 62(5):509-514. • Behling, A. R., and S. L. Taylor. 1982. • Inestia, C. 1973. Significance and detection Bacterial histamine production as a function of histamine in food, p. 327-347. In of temperature and time of incubation. J. Microbiological safety of food. Academic Food Sci. 47:1311-1317. Press, New York, NY. • Bjeldanes, L. F., D. E. Schultz, and M. M. • Lehane, L., and J. Olley. 2000. Review: Morris. 1978. On the aetiology of scombroid histamine fish poisoning revisited. Int. J. poisoning: cadaverine potentiation of Food Microbiol. 58:1-37. histamine toxicity in the guinea pig. Food • Predy, G., L. Honish, W. Hohn, and S. Jones. Cosmet. Toxicol. 16:157-159. 2003. Was it something she ate? Case report • Brillantes, S., S. Paknol, and A. Totakien. and discussion of scombroid poisoning. Can. 2002. Histamine formation in fish sauce Med. Assoc. J. 168(5):587-588. production. J. Food Sci. 67:2090-2094. • Silva, C. C. G., J. B. Da Ponte, and M. L. N. • Concon, J. (ed.), 1988. Food toxicology, p. Enes Dapkevicius. 1998. Storage temperature 511-605. Marcel Dekker, Inc., New York, NY. effect on histamine formation in big eye tuna • Eitenmiller, R., and S. DeSouza. 1984. and skipjack. J. Food Sci. 63(4):644-647. Enzymatic mechanisms for amine formation • Staruszkiewicz, W. F. April 2007. Report in fish, p. 431-442. In E. Ragelis (ed.), on the 2005 Hawaii Bigeye Tuna Research Seafood toxins. American Chemical Society, Project. Effects of onboard fish handling on Washington, DC. the formation of histamine. • Farn, G., and C. Sims. 1987. Chemical indices • Staruszkiewicz, W. F., J. D. Barnett, P. L. of decomposition in tuna, p. 175-184. In D. Rogers, R. A. Benner, Jr., L. L. Wong, and Kramer and J. Liston (ed.), Seafood quality J. Cook. 2004. Effects of on-board and determination (Book 15 of Developments in

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