chapter 13: clostridium botulinum toxin formation...

Chapter 13: Clostridium botulinum Toxin Formation (A Biological Hazard)

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Hazard Analysis Worksheet

STEP #10: UNDERSTAND THE POTENTIALHAZARD.

Clostridium botulinum toxin formation can result inconsumer illness and death. This chapter covers thepotential for C. botulinum growth and toxin forma-tion as a result of time/temperature abuse duringprocessing, storage and distribution. The growth ofother pathogens and the formation of other toxins asa result of time/temperature abuse during processingare covered in Chapters 7 (histamine formation),12 (pathogen growth during processing other thanC. botulinum), and 15 (Staphylococcus aureus toxinformation in hydrated batter mixes). Additionally,the prevention of C. botulinum toxin formationduring storage and distribution of the finishedproduct by drying is covered in Chapter 14. Theprevention of C. botulinum toxin formation duringstorage and distribution of the finished product byspecialized cooking and hot filling procedures iscovered in Chapter 16. The prevention of C. botuli-num toxin development during storage and distribu-tion of the finished product by pasteurization in thefinished product container is covered in Chapter 17.

When C. botulinum grows it can produce a potenttoxin, which can cause death by preventing breath-ing. It is one of the most poisonous naturally occur-ring substances known. The toxin can be destroyedby heat (e.g. boiling for 10 minutes), but processorscannot rely on this as a means of control.

There are two major groups of C. botulinum, theproteolytic group (i.e. those that break down pro-teins) and the nonproteolytic group (i.e. those that donot break down proteins). The proteolytic groupincludes C. botulinum type A and some of types Band F. The nonproteolytic group includes C. botuli-num type E and some of types B and F.

The vegetative cells of all types are easily killed byheat. C. botulinum is able to produce spores. In thisstate the pathogen is very resistant to heat. Thespores of the proteolytic group are much moreresistant to heat than are those of the nonproteolyticgroup. Table A-4 (Appendix 4) provides guidanceabout the conditions under which the spores of themost heat resistant form of nonproteolytic C. botuli-num, type B, are killed. However, there are someindications that substances that may be naturallypresent in some products, such as lysozyme, mayenable nonproteolytic C. botulinum to more easilyrecover after heat damage, resulting in the need for aconsiderably more aggressive process to ensuredestruction.

Temperature abuse occurs when product is exposedto temperatures favorable for C. botulinum growthfor sufficient time to result in toxin formation. Table#A-1 (Appendix 4) provides guidance about theconditions under which C. botulinum and otherpathogens are able to grow.

Packaging conditions that reduce the amount ofoxygen present in the package (e.g. vacuum packag-ing) extend the shelf life of product by inhibiting thegrowth of aerobic spoilage bacteria. The safetyconcern with these products is the increased potentialfor the formation of C. botulinum toxin beforespoilage makes the product unacceptable to consumers.

C. botulinum forms toxin more rapidly at highertemperatures than at lower temperatures. Theminimum temperature for growth and toxin forma-tion by C. botulinum type E and nonproteolytic typesB and F is 38˚F (3.3˚C). For type A and proteolytictypes B and F, the minimum temperature for growthis 50˚F (10˚C). As the shelf life of refrigerated foodsis increased, more time is available for C. botulinumgrowth and toxin formation. As storage temperaturesincrease, the time required for toxin formation issignificantly shortened. Processors should expectthat at some point during storage, distribution,

Chapter 13: C. botulinum167

display or consumer handling of refrigerated foods,proper refrigeration temperatures will not be main-tained (especially for the nonproteolytic group).Surveys of retail display cases indicate that tempera-tures of 45-50˚F (7-10˚C) are not uncommon.Surveys of home refrigerators indicate that tempera-tures can exceed 50˚F (10˚C).

In reduced oxygen packaged products in which thespores of nonproteolytic C. botulinum are inhibitedor destroyed (e.g., smoked fish, pasteurizedcrabmeat, pasteurized surimi), normal refrigerationtemperatures of 40˚F (4.4˚C) are appropriatebecause they will limit the growth of proteolyticC. botulinum and other pathogens that may bepresent. Even in products where nonproteolyticC. botulinum is the target organism for the pasteur-ization process and vegetative pathogens, such asListeria monocytogenes, are not likely to be present(e.g. pasteurized crabmeat, pasteurized surimi), astorage temperature of 40˚F (4.4˚C) is still appropri-ate because of the potential survival through thepasteurization process and recovery of spores ofnonproteolytic C. botulinum aided by naturallyoccurring substances, such as lysozyme. In this caserefrigeration serves as a prudent second barrier.

In reduced oxygen packaged products in whichrefrigeration is the sole barrier to outgrowth ofnonproteolytic C. botulinum and the spores have notbeen destroyed (e.g. vacuum packaged raw fish,unpasteurized crayfish meat), the temperature mustbe maintained at 38˚F (3.3˚C) or below from packingto consumption. Ordinarily processors can ensurethat temperatures are maintained at or below 38˚F(3.3˚C) while the product is in their control. How-ever, current distribution channels do not ensure themaintenance of these temperatures after the productleaves their control. The use of time temperatureintegrators on each consumer package may be anappropriate means of enabling temperature controlthroughout distribution. Alternatively, products ofthis type may be safely marketed frozen, withappropriate labeling. For some products, control ofC. botulinum can be achieved by breaking thevacuum seal before the product leaves the processor’scontrol.

• Sources of C. botulinum

C. botulinum can enter the process on raw materials.The spores of C. botulinum are very common innature. They have been found in the gills and visceraof fin fish, crabs, and shellfish. C. botulinum type Eis the most common form found in fresh water andmarine environments. Types A and B are generallyfound on land, but may also be occasionally found inwater. It should be assumed that C. botulinum willbe present in any raw fishery product, particularly inthe viscera.

• Reduced oxygen packaging

There are a number of conditions that can result inthe creation of a reduced oxygen packaging environ-ment. They include:

• Vacuum packaging or modified or controlledatmosphere packaging. These packaging methodsdirectly reduce the amount of oxygen in the package;

• Packaging in hermetically sealed containers (e.g.double seamed cans, glass jars with sealed lids, heatsealed plastic containers), or packing in deep contain-ers from which the air is expressed (e.g. caviar inlarge containers), or packing in oil. These and similarprocessing/packaging techniques prevent the entry ofoxygen into the container. Any oxygen present at thetime of packaging may be rapidly depleted by theactivity of spoilage bacteria, resulting in the forma-tion of a reduced oxygen environment.

Packaging that provides an oxygen transmission rateof 10,000 cc/m2/24hrs (e.g. 1.5 mil polyethylene) canbe regarded as an oxygen-permeable packagingmaterial for fishery products. This can be comparedto an oxygen-impermeable package which mighthave an oxygen transmission rate as low as or lowerthan 100 cc/m2/24hr (e.g. 2 mil polyester). Anoxygen permeable package should provide sufficientexchange of oxygen to allow aerobic spoilageorganisms to grow and spoil the product before toxinis produced under moderate abuse temperatures.However, use of an oxygen permeable package willnot compensate for the restriction to oxygen ex-change created by practices such as packing in oil orin deep containers from which the air is expressed.


• Control of C. botulinum in the finished product

There are a number of strategies to preventC. botulinum toxin formation during storage anddistribution of finished fishery products. Theyinclude:

For products that do not require refrigeration(i.e. shelf-stable products):

• Heating the finished product in its final containersufficiently by retorting to destroy the spores ofC. botulinum types A,B,E, and F (e.g. canned fish)(covered by the low acid canned foods regulations,21 CFR 113). Note: these controls are not required tobe included in your HACCP plan;

• Controlling the level of acidity (pH) in the finishedproduct sufficient to prevent the growth of C. botuli-num types A,B,E, and F (4.6 or below) (e.g. shelf-stable acidified products) (covered by the acidifiedfoods regulations, 21 CFR 114). Note: these controlsare not required to be included in your HACCP plan;

• Controlling the amount of moisture that is availablein the product (water activity) sufficient to prevent thegrowth of C. botulinum types A,B,E, and F and otherpathogens that may be present in the product (i.e.0.85 or below) (e.g. shelf-stable dried products)(covered by Chapter 14);

• Controlling the amount of salt in the productsufficient to prevent the growth of C. botulinum typesA, B, E, and F and other pathogens that may bepresent in the product (i.e. 20% salt or more)(e.g.shelf-stable salted products)(covered in this chapter).

For products that require refrigeration:

• Heating the finished product in its final containersufficiently by pasteurization to destroy the spores ofC. botulinum type E and nonproteolytic types B and F(covered in Chapter 17); and then controlling thegrowth of the surviving C. botulinum type A andproteolytic types B and F in the finished product withrefrigerated storage (e.g. pasteurized crabmeat, somepasteurized surimi-based products) (covered in thischapter and Chapter 12);

• Heating the product sufficiently to destroy thespores of C. botulinum type E and nonproteolytictypes B and F (covered in Chapter 16); and thenminimizing the risk of recontamination by hot fillingthe product into the final container in a continuousfilling system (covered in Chapter 18); and thencontrolling the growth of the surviving C. botulinumtype A and proteolytic types B and F and otherpathogens that may be present in the finished productwith refrigerated storage (covered in this chapter andChapter 12);

• Controlling the amount of moisture that is availablein the product (water activity) sufficient to inhibit thegrowth of C. botulinum type E and nonproteolytictypes B and F by drying (covered in Chapter 14); andthen controlling the growth ofC. botulinum type A, and proteolytic types B and F,and other pathogens that may be present in thefinished product through refrigerated storage (cov-ered in this chapter and Chapter 12);

• Controlling the level of acidity (pH), salt, moisture(water activity), or some combination of thesebarriers, in the finished product sufficiently toprevent the growth of C. botulinum type E andnonproteolytic types B and F by formulation (i.e. pH5 or below; salt 5% or more; or water activity below0.97) (covered in this chapter); and then controllingthe growth of C. botulinum type A and proteolytictypes B and F and other pathogens that may bepresent in the finished product with refrigeratedstorage (e.g. refrigerated acidified [“pickled”]products) (covered in this chapter and Chapter 12);

• Controlling the amount of salt and preservatives,such as sodium nitrite, in the finished product, incombination with other barriers, such as smoke, heatdamage and competitive bacteria, sufficient toprevent the growth of C. botulinum type E andnonproteolytic types B and F (covered in this chap-ter); and then controlling the growth of C. botulinumtype A and proteolytic types B and F and otherpathogens that may be present in the finished productwith refrigerated storage (e.g. salted, smoked, orsmoke-flavored fish) (covered in this chapter andChapter 12);

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• Controlling the amount of salt in the finishedproduct, in combination with heat damage frompasteurization in the finished product container,sufficient to prevent the growth of C. botulinum typeE and nonproteolytic types B and F (covered in thischapter); and then controlling the growth of C.botulinum type A and proteolytic types B and F andother pathogens that may be present in the finishedproduct with refrigerated storage (e.g. some pasteur-ized surimi-based products) (covered in this chapterand Chapter 12);

• Control of C. botulinum during processing andstorage

There are a number of strategies to preventC. botulinum toxin formation during the processingand storage of fishery products. They include:

• Managing the amount of time that food is exposedto temperatures that are favorable for C. botulinumgrowth and toxin formation during finished productstorage (covered in this chapter).

Note: The guidance in this chapter emphasizespreventive measures for the control of C. botulinumin products that are contained in reduced oxygenpackaging. As was previously described, this isbecause such an environment extends the shelf life ofthe product in a way that favors C. botulinum growthand toxin formation over aerobic spoilage. It is alsopossible for C. botulinum to grow and produce toxinin unpackaged or aerobically packaged product. Thisis because of the development within the product ofmicroenvironments that support its growth. How-ever, toxin formation under these circumstancesrequires the type of severe temperature abuse that isnot reasonably likely to occur in most food process-ing environments. Nonetheless, the Good Manufac-turing Practice Regulations, 21 CFR 110, requirerefrigeration of foods that support the growth ofpathogenic microorganisms. In addition Chapter 12provides recommendations for storage controls forpathogens other than C. botulinum.

• Evisceration of fish before processing. Becausespores are known to be present in the viscera of fish,any product that will be preserved by salting, drying,pickling, or fermentation must be eviscerated prior toprocessing (see Compliance Policy Guide sec.540.650). Without evisceration, toxin formation ispossible during the process even with strict control oftemperature. Evisceration must be thorough andperformed to minimize contamination of the fishflesh. If even a portion of the viscera or its contents isleft behind, the risk of toxin formation by C. botuli-num remains. Small fish, less than 5 inches in length(e.g. anchovies and herring sprats), that are processedin a manner that prevents toxin formation, and thatreach a water phase salt content of 10 percent inrefrigerated products, or a water activity of below0.85 (Note: this value is based on the minimum wateractivity for growth of S. aureus) or a pH of 4.6 or less,in shelf-stable products are exempt from the eviscera-tion requirement.

Examples of C. botulinum Controlin Specific Products:

• Control in refrigerated, reduced oxygen packagedsmoked and smoke-flavored fish

Achieving the proper concentration of salt and nitritein the flesh of refrigerated, reduced oxygen packagedsmoked and smoke-flavored fish is necessary toprevent the formation of toxin by C. botulinum type Eand nonproteolytic types B and F during storage anddistribution. Salt works along with smoke and anynitrites that are added to prevent growth and toxinformation by C. botulinum type E and nonproteolytictypes B and F (Note: nitrites may only be used insalmon, sable, shad, chubs, and tuna - FDA Compli-ance Policy Guide sections 540.500 and 540.200).

In hot-smoked products, heat damage to the spores ofC. botulinum type E and nonproteolytic types B and Falso helps prevent toxin formation. In these products,control of the heating process is critical to the safetyof the finished product. It is important to note,however, that this same heating process also reducesthe numbers of naturally occurring spoilage organ-isms. The spoilage organisms would otherwise havecompeted with, and inhibited the growth of,C. botulinum.


• Control in refrigerated, reduced oxygen packaged,pasteurized fishery products

Refrigerated, reduced oxygen packaged, pasteurizedproducts fall into two categories: 1) those which arepasteurized in the final container); and 2) those whichare pasteurized in a kettle (i.e. cooked) and then hotfilled into the final container (e.g.”heat and fill” soupsand sauces). In both cases, ordinarily the heatingprocess must be sufficient to destroy the spores of C.botulinum type E and nonproteolytic types B and F.In neither case is it likely that the heating process willbe sufficient to destroy the spores of C. botulinumtype A and proteolytic types B and F. Therefore, strictrefrigeration control (i.e. at or below 40˚F [4.4˚C])must be maintained during storage and distribution toprevent growth and toxin formation by C. botulinumtype A and proteolytic types B and F, and because ofthe potential survival through the pasteurizationprocess and recovery of spores of nonproteolytic C.botulinum aided by naturally occurring substances,such as lysozyme. In the case of the lysozyme effect,refrigeration serves as a prudent second barrier.

In the second category of products, filling the productinto the final container while it is still hot in acontinuous filling system (i.e. “hot filling”) is alsocritical to the safety of the finished product, because itminimizes the risk of recontamination of the productwith pathogens, including C. botulinum type E andnonproteolytic types B and F. This strategy applies toproducts such as soups and sauces that are filleddirectly from the cooking kettle, where the risk ofrecontamination is minimized. It does not apply toproducts such as crabmeat, lobster meat, or crayfishmeat, or other products that are handled betweencooking and filling. Control of hot filling is coveredin Chapter 18. Chapter 18 also covers other controlsthat may be necessary to prevent recontamination,including controlling container sealing and controllingcontamination of container cooling water. Thesecontrols may be critical to the safety of both catego-ries of products.

Examples of properly pasteurized products are: bluecrabmeat pasteurized to a cumulative lethality of F

185˚F

(F85˚C

) = 31 min., z=16˚F (9˚C); surimi-based prod-ucts, soups, or sauces pasteurized at an internaltemperature of 194˚F (90˚C) for at least 10 minutes.

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In cold-smoked fish, it is important that the productdoes not receive so much heat that the number ofspoilage organisms are significantly reduced. This isbecause spoilage organisms must be present to inhibitthe growth and toxin formation of C. botulinum typeE and nonproteolytic types B and F. This inhibitionis important in cold-smoked fish because the heatapplied during this process is not adequate to weakenthe C. botulinum spores. Control of the temperatureduring the cold-smoking process to ensure survival ofthe spoilage organisms is, therefore, critical to thesafety of the finished product.

The interplay of these inhibitory effects (i.e. salt,temperature, smoke, nitrite) is complex. Control ofthe brining or dry salting process is clearly critical toensure that there is sufficient salt in the finishedproduct. However, preventing toxin formation byC. botulinum type E and nonproteolytic types B andF is made even more complex by the fact that ad-equate salt levels are not usually achieved duringbrining. Proper drying is also critical in order toachieve the finished product water phase salt level(i.e. the concentration of salt in the water portion ofthe fish flesh) needed to inhibit the growth and toxinformation of C. botulinum.

The above described control procedures are coveredin this chapter.

Processors should ordinarily restrict brining, drysalting, and smoking loads to single species and tofish portions of approximately uniform size. Thisminimizes the complexity of controlling the operation.

The combination of inhibitory effects that are presentin smoked and smoke-flavored fish are not adequateto prevent toxin formation by C. botulinum type Aand proteolytic types B and F. Strict refrigerationcontrol (i.e. at or below 40˚F [4.4˚C]) during storageand distribution must be maintained to preventgrowth and toxin formation by C. botulinum type Aand proteolytic types B and F and other pathogensthat may be present in these products (covered in thischapter and Chapter 12).


In some pasteurized surimi-based products, salt incombination with a milder pasteurization process inthe finished product container work to prevent growthand toxin formation by C. botulinum type E andnonproteolytic types B and F. Control of the formula-tion process is clearly critical in these products toensure that there is sufficient salt in the finishedproduct. The formulation controls discussed in thischapter for the production of “pickled” fisheryproducts are also suitable for the control of surimi-based product formulation. Control of the in-con-tainer pasteurization process is also critical. Anexample of a properly pasteurized surimi-basedproduct in which 2.5% salt is present is one that hasbeen pasteurized at an internal temperature of 185˚F(85˚C) for at least 15 minutes. This process may notbe suitable for other types of products, because of theunique formulation and processing involved in themanufacture of surimi-based products.

In-container pasteurization is covered in Chapter 17.Cooking is covered in Chapter 16. Control of refrig-erated storage is covered in this chapter and inChapter 12.

• Control in refrigerated, reduced oxygen packaged“pickled” fish, caviar, and similar products

In “pickled” fish, caviar, and similar products thathave not been preserved sufficiently for them tobe shelf-stable, growth and toxin formation byC. botulinum type E and nonproteolytic types B and Fis controlled by either:

• Adding sufficient salt to produce a water phase saltlevel (i.e. the concentration of salt in the water-portion of the fish flesh) of at least 5 percent;

• Adding sufficient acid to reduce the acidity (pH) to5.0 or below;

• Reducing the amount of moisture that is availablefor growth (water activity) to below 0.97 (e.g., byadding salt or other substances that “bind” theavailable water); or

• Making a combination of salt, pH, and/or wateractivity adjustments that, when combined, prevent thegrowth of C. botulinum type E and nonproteolytictypes B and F (to be established by a scientific study).

Much like smoked products, in some of these prod-ucts the interplay of these inhibitory effects (i.e. salt,water activity, and pH) can be complex. Control ofthe brining, pickling, or formulation steps is, there-fore, critical to ensure that there are sufficientbarriers in the finished product to prevent the growthand toxin formation of C. botulinum type E andnonproteolytic type B and F during storage anddistribution. These control procedures are covered inthis chapter.

Processors should ordinarily restrict brining andpickling loads to single species and to fish portions ofapproximately uniform size. This minimizes thecomplexity of controlling the operation.

The above discussed controls are not sufficient toprevent toxin formation by C. botulinum type A andproteolytic types B and F. Strict refrigeration control(i.e. at or below 40˚F [4.4˚C]) during storage anddistribution must, therefore, be maintained to preventgrowth and toxin formation by C. botulinum type Aand proteolytic types B and F, and other pathogensthat may be present in these products (covered in thischapter).

• Control in refrigerated, reduced oxygen packagedraw, unpreserved fish and unpasteurized, cookedfishery products

For refrigerated, reduced oxygen packaged raw,unpreserved fish (e.g. vacuum packaged fresh fishfillets) and unpasteurized, cooked fishery products(e.g. vacuum packaged, unpasteurized crabmeat,lobstermeat, or crayfish meat), the sole barrier totoxin formation by C. botulinum type E andnonproteolytic types B and F during finished productstorage and distribution is refrigeration. These typesof C. botulinum will grow at temperatures as low as38˚F (3.3C). As was previously stated, maintenanceof temperatures at or below 38˚F (3.3˚C) after theproduct leaves the processor’s control cannot nor-mally be ensured. Time temperature integrators oneach consumer package may be an appropriate meansof providing such control. If you intend to use areduced oxygen packaging technique for theseproducts and you intend to market the productsrefrigerated without time temperature integrators oneach consumer package, you will need to evaluate theeffectiveness of other preventive measures, either


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singularly, or in combination. Such evaluation willusually necessitate the performance of inoculatedpack studies under moderate abuse conditions. Asuitable protocol for the performance of such studiesis contained in a 1992 publication by the NationalAdvisory Committee on Microbiological Criteria forFoods, “Vacuum or modified atmosphere packagingfor refrigerated, raw fishery products.

• Control in frozen, reduced oxygen packaged fisheryproducts

If your product is immediately frozen after process-ing, maintained frozen throughout distribution, andlabeled to be held frozen and to be thawed underrefrigeration immediately before use (e.g. “Impor-tant, keep frozen until used, thaw under refrigerationimmediately before use”), then formation of C.botulinum toxin may not be a significant hazard.

• Control in unrefrigerated (shelf-stable), reducedoxygen packaged fishery products

Examples of shelf-stable, reduced oxygen packagedfishery products are dried fish, acidified fish, cannedfish and salted fish. Because these products aremarketed without refrigeration, either: 1) the sporesof Clostridium botulinum types A,B, E and F must bedestroyed after the product is placed in the finishedproduct container (covered by the low acid cannedfoods regulations, 21 CFR 113); or 2) a barrier, orcombination of barriers, must be in place that willprevent growth and toxin formation by Clostridiumbotulinum types A,B, E and F, and other pathogensthat may be present in the product. Suitable barriersinclude:

• Sufficient salt is added to produce a water phasesalt level (the concentration of salt in the water-portion of the fish flesh) of at least 20 percent(Note: this value is based on the maximum salt levelfor growth of S. aureus.) (covered in this chapter)

• Sufficient salt is added to reduce the water activityto 0.85 or below (covered in this chapter);

• Sufficient acid is added to reduce the pH to 4.6 orbelow (covered by the acidified foods regulations, 21CFR 114);

• The product is dried sufficiently to reduce thewater activity to 0.85 or below (Note: this value isbased on the minimum water activity for growth andtoxin formation of S. aureus,)(covered in Chapter 14).

STEP #11: DETERMINE IF THISPOTENTIAL HAZARD IS SIGNIFICANT.

At each processing step, determine whether “C.botulinum toxin formation” is a significant hazard.The criteria are:

1. Is it reasonably likely that C. botulinum will growand produce toxin during finished product storage anddistribution?

The factors that make C. botulinum toxin formationduring finished product storage and distributionreasonably likely are those that may result in theformation of a reduced oxygen packaging environ-ment. These are discussed in Step #10, under theheading, “Reduced oxygen packaging.”

2.Can the growth and/or toxin production ofC. botulinum, which is reasonably likely to occur, beeliminated or reduced to an acceptable level at thisprocessing step? (Note: If you are not certain of theanswer to this question at this time, you may answer“No.” However, you may need to change this answerwhen you assign critical control points in Step #12.)

“C. botulinum toxin formation” should also beconsidered a significant hazard at any processing stepwhere a preventive measure is, or can be, used toeliminate (or reduce the likelihood of occurrence toan acceptable level) the hazard, if it is reasonablylikely to occur.

Preventive measures for C. botulinum toxin forma-tion during processing can include:

• controlling refrigeration temperatures;• proper icing;• controlling the amount of time that the product is

exposed to temperatures that would permitC. botulinum toxin formation;

• rapidly cooling the fish.



It is important to note that identifying this hazard assignificant at a processing step does not mean that itmust be controlled at that processing step. The nextstep will help you determine where in the process thecritical control point is located.

• Intended use and method of distribution and storage

In determining whether a hazard is significant youshould also consider the intended use and method ofdistribution and storage of the product, which youdeveloped in Step #4. Due to the extremely toxicnature of C. botulinum toxin, it is unlikely that thesignificance of the hazard will be affected by theintended use of your product.

However, if your product is immediately frozen afterprocessing, maintained frozen throughout distribu-tion, and labeled to be held frozen and to be thawedunder refrigeration immediately before use (e.g. “Impor-tant, keep frozen until used, thaw under refrigerationimmediately before use”), then formation of C.botulinum toxin may not be a significant hazard.

STEP #12: IDENTIFY THE CRITICAL CONTROL POINTS (CCP).

For each processing step where “C. botulinum toxinformation” is identified in Column 3 of the HazardAnalysis Worksheet as a significant hazard, determinewhether it is necessary to exercise control at that stepin order to control the hazard. Figure #A-2 (Appen-dix 3) is a CCP decision tree that can be used to aidyou in your determination.

The following guidance will also assist you in deter-mining whether a processing step is a CCP for C.botulinum toxin formation:

1. Is there an acidification step (equilibrium pH of 4.6or below), a drying step or an in-package pasteuriza-tion step (target organism C. botulinum type E andnonproteolytic types B and F) a combination of cookand hot-fill steps (target organism C. botulinum type Eand nonproteolytic types B and F), or a retorting step(commercial sterility) in the process?

a.If there is, you may in most cases identify theacidification step, drying step, pasteurizationstep, cook and hot-fill steps or retorting step as

Preventive measures for C. botulinum toxin formationduring finished product distribution and storage arediscussed in Step #10, under the heading, “Control ofC. botulinum in the finished product.”

List such preventive measures in Column 5 of theHazard Analysis Worksheet at the appropriate process-ing step(s).

Preventive measures of the type just described shouldbe available to most of the “at risk” products describedabove (i.e. vacuum packaged fish, modified atmo-sphere packaged fish, fish packaged in hermeticallysealed containers, fish packed in oil, fish packed indeep containers in which the air is expressed). No-table products for which these preventive measures arenot available include: refrigerated, reduced oxygenpackaged raw, unpreserved fish (e.g. vacuum pack-aged, fresh fish fillets) and reduced oxygen packaged,unpasteurized, cooked fishery products (e.g. vacuumpackaged, unpasteurized crabmeat, lobstermeat, orcrayfish meat). For these products, the sole barrier totoxin formation by C. botulinum type Eand nonproteolytic types B and F during finishedproduct storage and distribution is refrigeration.These types of C. botulinum will grow at temperaturesas low as 38˚F (3.3C). As was previously stated,maintenance of temperatures at or below 38˚F (3.3˚C)after the product leaves the processor’s control cannotnormally be ensured. Time temperature integrators oneach consumer package may be an appropriate meansof providing such control. If you intend to use areduced oxygen packaging technique for these prod-ucts and you intend to market the products refriger-ated without time temperature integrators on eachconsumer package, you will need to evaluate theeffectiveness of other preventive measures, eithersingularly, or in combination. Such evaluation willusually necessitate the performance of inoculated packstudies under moderate abuse conditions.

If the answer to either question 1 or 2 is “Yes” thepotential hazard is significant at that step in theprocess and you should answer “Yes” in Column 3 ofthe Hazard Analysis Worksheet. If none of the criteriais met you should answer “No.” You should record thereason for your “Yes” or “No” answer in Column 4.You need not complete Steps #12 through 18 for thishazard for those processing steps where you haverecorded a “No” or where noted above.


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the CCP(s) for this hazard. Other processingsteps where you have identified “C. botulinumtoxin formation” as a significant hazard will thennot require control and will not need to beidentified as CCPs for the hazard. However, thefollowing products require control of temperatureduring finished product storage and distribution:products pasteurized in the final container to killC. botulinum type E and nonproteolytic types Band F and refrigerated to control the growth ofC. botulinum type A and proteolytic types B andF and other pathogens that may be present (e.g.pasteurized crabmeat, pasteurized surimi); 2)products cooked to kill C. botulinum type E andnonproteolytic types B and F, and then hot filledinto the final container, and then refrigerated tocontrol the growth of C. botulinum type A andproteolytic types B and F, and other pathogensthat may be present; and 3) products dried tocontrol the growth of C. botulinum type E andnonproteolytic types B and F and refrigerated tocontrol the growth of C. botulinum type A andproteolytic types B and F and other pathogensthat may be present. In these cases, you shouldalso identify the finished product storage step asa CCP for the hazard. Such control is covered inthis chapter and in Chapter 12. Additionally,some pasteurized surimi-based products rely ona combination of salt and a relatively mildpasteurization process in the finished productcontainer for the control of C. botulinum type Eand nonproteolytic types B and F. In theseproducts, you should also identify the formulationstep as a CCP for the hazard. Such control iscovered in this chapter under Control StrategyExample 2 – “Pickling.”

Guidance for these C. botulinum toxin controlstrategies is contained in the following locations:

• Chapters 16 and 18, for control of cooking andhot-filling;

• Chapters 17 and 18, for control of pasteurization;• Chapter 14, for control of drying;• Acidified foods regulations, 21 CFR 114, for

control of acidification;• Low acid canned foods regulations, 21 CFR 113,

for control of retorting.

Note: acidification and retorting controls required by21 CFR 113 and 114 need not be included in yourHACCP plan.

b.If there is no acidification step, drying step,pasteurization step, cooking and hot-filling, orretorting step(s) in the process, then decidewhich of the following categories best describesyour product:• smoked or smoke-flavored fish;• “pickled” fish, salted fish and similar products;• other products for which C. botulinum toxin

formation is a significant hazard.

If your product fits into the third category (otherproducts), you will have to establish other preventivemeasures, either singularly, or in combination thatare effective in controlling the hazard, and develop aHACCP plan accordingly.

If your product fits into the first category (smoked orsmoke-flavored fish), you should follow the guidancecontained in the rest of this chapter contained underthe heading “Control Strategy Example 1 – Salting/smoking.”

If your product fits into the second category (“pick-led” fish), you should follow the guidance in the restof this chapter contained under the heading “ControlStrategy Example 2 - Pickling.”

• CONTROL STRATEGY EXAMPLE 1 –SALTING/SMOKING

The following questions apply to salted, smoked, andsmoke-flavored fish:

1. Is the temperature of the heating/smoking processimportant to the safety of the product?

For both cold-smoked and hot-smoked fish productsthe temperature of heating/smoking is critical. Theheating/smoking step for hot-smoked fish must besufficient to damage the spores and make them moresusceptible to inhibition by salt. The smoking stepfor cold-smoked fish must not be so severe that itkills the natural spoilage bacteria. These bacteria arenecessary so that the product will spoil before toxinproduction occurs. It is likely that they will also

produce acid, which will further inhibit C. botulinumgrowth and toxin formation.

For these products you should enter “Yes” in Column6 of the Hazard Analysis Worksheet for the heating/smoking step.

2. Is the water phase salt level and, when permitted,the nitrite level, important to the safety of the product?

For all products in this category the water phase saltlevel is critical to the safety of the product. Nitrite,when permitted, allows a lower level of salt to beused. Salt, and nitrite are the principal inhibitors toC. botulinum type E and nonproteolytic types B andF toxin formation in these products. The water phasesalt level needed to inhibit toxin formation is par-tially achieved during brining or dry salting, andpartially achieved during drying. Control must beexercised over both operations.

You should enter “Yes” in Column 6 of the HazardAnalysis Worksheet for the brining or dry salting stepand the drying step.

3. Is the finished product storage temperature impor-tant to the safety of the product?

Toxin formation by C. botulinum type A and pro-teolytic B and F is not inhibited by salt levels below10%, nor by the combination of inhibitors present inmost smoked or smoke-flavored fish. B. cereus cangrow and form toxin at salt concentrations as high as18%. Therefore, in these products, finished productstorage temperature must be controlled.

In this case, you should enter “Yes” in Column 6 ofthe Hazard Analysis Worksheet for the finishedproduct storage step.

In some cases smoked or smoke-flavored fish arereceived as ingredients for assembly into anotherproduct, such as a salmon pate. In other cases, theyare received simply for storage and further distribu-tion (e.g. by a warehouse). In these cases, thereceiving and storage steps may also require time/temperature controls, and should be designated asCCPs.

The above described control approach is referred toas “Control Strategy Example 1” in Steps #14-18.It is important to note that you may select a controlstrategy that is different from that which is suggestedabove, provided that it assures an equivalent degreeof safety of the product.

Proceed to Step #13 (Chapter 2) or to Step #10 of thenext potential hazard.

• CONTROL STRATEGY EXAMPLE 2 – PICKLING

The following questions apply to “pickled” fish andsimilar products (and to some pasteurized surimi-based products that rely on a combination of salt anda relatively mild pasteurization process in the fin-ished product container for the control of C. botuli-num type E and nonproteolytic types B and F):

1. Is the water phase salt level, water activity, and/orpH level important to the safety of the product?

For all products in this category the water phase saltlevel, water activity, and/or pH level is critical to thesafety of the product, because they are the principleinhibitors to growth and toxin formation by C.botulinum type E and nonproteolytic type B and F.The levels of these inhibitors needed to inhibit toxinformation are achieved during the pickling, brining,or formulation step. Control must be exercised overthe relevant step.

You should enter “Yes” in Column 6 of the HazardAnalysis Worksheet for the pickling, brining, orformulation step, as appropriate.

2. Is the finished product storage temperature impor-tant to the safety of the product?

Unless pickling, brining, or formulation results in awater phase salt level of at least 20% (Note: thisvalue is based on the maximum salt concentration forgrowth of S. aureus), a pH of 4.6 or below, or a wateractivity of 0.85 or below (Note: this value is based onthe minimum water activity for growth of S. aureus),storage and distribution temperature will be critical toensure the safety of the product.


Continued

In this case, you should enter “Yes” in Column 6 ofthe Hazard Analysis Worksheet for the finishedproduct storage step.

In some cases “pickled” fish or similar products arereceived as ingredients for assembly into anotherproduct, such as receipt of bulk “pickled” herring forrepackaging into retail-size containers. In othercases, they are received simply for storage andfurther distribution (e.g. by a warehouse). In thesecases, the receiving and storage steps may alsorequire time/temperature controls, and should bedesignated as CCPs.

The above described control approach is referred toas Control Strategy Example 2" in Steps #14-18. It isimportant to note that you may select a controlstrategy that is different from that which is suggestedabove, provided that it assures an equivalent degreeof safety of the product.

Proceed to Step #13 (Chapter 2) or to Step #10 of thenext potential hazard.

STEP #14: SET THE CRITICAL LIMITS (CL).

For each processing step where “C. botulinum toxinformation” is identified as a significant hazard on theHACCP Plan Form, identify the maximum or mini-mum value to which a feature of the process must becontrolled in order to control the hazard.

You should set the CL at the point that if not met, thesafety of the product is questionable. If you set amore restrictive CL you could, as a result, be re-quired to take corrective action when no safetyconcern actually exists. On the other hand, if you seta CL that is too loose you could, as a result, allowunsafe product to reach the consumer.

As a practical matter it may be advisable to set anoperating limit that is more restrictive than the CL.In this way you can adjust the process when theoperating limit is triggered, but before a triggering ofthe CL would require you to take corrective action.You should set operating limits based on yourexperience with the variability of your operation andwith the closeness of typical operating values to the CL.

Following is guidance on setting critical limits for thecontrol strategy examples discussed in Step #12.

• CONTROL STRATEGY EXAMPLE 1 - SMOKING

For controlling toxin formation by cold smoking:

Critical Limit: The smoker temperature must notexceed 90˚F (32.2˚C).

For controlling toxin formation by hot smoking:

Critical Limit: The internal temperature of the fishmust be maintained at or above 145˚F (62.8˚C)throughout the fish for at least 30 minutes.

For controlling toxin formation by brining, drysalting, and/or drying:

Critical Limit: The minimum or maximum values forthe critical factors of the brining/dry salting, and/ordrying processes established by a scientific study.The critical factors are those that are necessary toassure that the finished product has:• For refrigerated, reduced oxygen packaged

(e.g. vacuum or modified atmospherepackaged) smoked fish or smoke-flavored fish,not less than 3.5 percent water phase salt, or,where permitted, the combination of 3.0percent water phase salt and not less than100 ppm nitrite.

The critical factors may include: brine strength; brineto fish ratio; brining time; brining temperature;thickness, texture, fat content, quality, and species offish; drying time; input/output air temperature,humidity, and velocity; smoke density; drier loading.

• CONTROL STRATEGY EXAMPLE 2 - PICKLING

For controlling toxin formation by pickling,brining, or formulation:

Critical Limit: The minimum or maximum valuesfor the critical factors of the pickling, brining,or formulation process established by ascientific study. The critical factors are thosethat are necessary to assure that the finishedproduct has:


For refrigerated, reduced oxygen packagedfishery products:

• A water phase salt level of at least 5 percent;OR• A pH of 5.0 or below;OR• A water activity of below 0.97;OR• a water phase salt level of at least 2.5% in

surimi-based products, when combined with apasteurization process in the finished productcontainer of 185˚F (85˚C) for at least 15minutes (covered in Chapter 17);

OR• A combination of water phase salt, pH, and/or

water activity that, when combined, havebeen demonstrated to prevent the growth ofC. botulinum type E and nonproteolytic type Band F.

For unrefrigerated (shelf-stable), reduced oxygenpackaged products:

• A water phase salt level of at least 20 percent(based on the maximum salt level for growthof S. aureus;

OR• A pH of 4.6 or below;OR• A water activity of 0.85 or below (based on the

minimum water activity for growth and toxinformation of S. aureus).

The critical factors may include: brine strength; acidstrength; brine/acid to fish ratio; brining/picklingtime; brining/pickling temperature; thickness,texture, fat content, quality, and species of fish.

• CONTROL STRATEGY EXAMPLES 1 & 2

For controlling toxin formation during refriger-ated (not frozen) finished product storage:

Critical Limit: The product must not be exposed to acombination of times and temperatures that willallow growth or toxin formation by C. botulinum orother pathogens that may be present in the product.Refer to the guidance for the control of pathogens

other than C. botulinum provided in the critical limitssection (Step #14) of Chapter 12, which is alsoadequate for the control of C. botulinum.

For controlling toxin formation at receipt of“pickled,” smoked or smoke-flavored fish forstorage or further processing:

Critical Limit: The product must not be exposed to acombination of times and temperatures that willallow growth or toxin formation by C. botulinum orother pathogens that may be present in the product.Refer to the guidance for the control of pathogensother than C. botulinum provided in the critical limitssection (Step #14) of Chapter 12, which is alsoadequate for the control of C. botulinum.

Enter the critical limit(s) in Column 3 of the HACCPPlan Form.

STEP #15: ESTABLISH MONITORINGPROCEDURES.

For each processing step where “C. botulinum toxinformation” is identified as a significant hazard on theHACCP Plan Form, describe monitoring proceduresthat will ensure that the critical limits are consistentlymet.

To fully describe your monitoring program youshould answer four questions: 1) What will bemonitored? 2) How will it be monitored? 3) Howoften will it be monitored (frequency)? 4) Who willperform the monitoring?

It is important for you to keep in mind that thefeature of the process that you monitor and themethod of monitoring should enable you to deter-mine whether the CL is being met. That is, themonitoring process should directly measure thefeature for which you have established a CL.

You should monitor often enough so that the normalvariability in the values you are measuring will bedetected. This is especially true if these values aretypically close to the CL. Additionally, the greaterthe time span between measurements, the moreproduct you are putting at risk should a measurementshow that a CL has been violated.


Following is guidance on establishing monitoringprocedures for the control strategy examples dis-cussed in Step #12. Note that the monitoring fre-quencies that are provided are intended to be consid-ered as minimum recommendations, and may not beadequate in all cases.

What Will Be Monitored?



What: The smoker temperature.


What: The internal temperature at the thickestportion of three of the largest fish in the smokingchamber.


What: The critical aspects of the established brining,dry salting, and/or drying processes. These mayinclude: brine strength; brine to fish ratio;brining time; brining temperature; thickness,texture, fat content, quality, and species of fish;drying time; input/output air temperature,humidity, and velocity; smoke density; drierloading.ORThe water phase salt and, where appropriate,nitrite level of the finished product.



What: The critical aspects of the established pickling,brining, or formulation process. These mayinclude: brine/acid strength; brine/acid to fishratio; brining/pickling time; brine/acidtemperature; thickness, texture, fat content,quality, and species of fish;

ORThe water phase salt, pH, and/or water activity ofthe finished product.



What: The temperature of the cooler;ORThe adequacy of ice or other cooling media.

For controlling toxin formation at receipt ofrefrigerated (not frozen) “pickled,” smoked orsmoke-flavored fish for storage or furtherprocessing:

What: The internal temperature of the fish throughouttransportation;ORThe temperature of the truck or other carrierthroughout transportation;ORFor fishery products with a transit time of fourhours or less: The internal temperature of arepresentative number of containers in the lot attime of delivery;ORThe adequacy of ice or other cooling media attime of delivery.

How Will Monitoring Be Done?



How: Use a digital time/temperature data logger;ORUse a recorder thermometer;ORUse a maximum indicating thermometer;ORUse a high temperature alarm.


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How: Use a digital time/temperature data logger withthree probes.

For controlling toxin formation by brining. drysalting, and/or drying:

How: Monitor the drying time and the input/outputair temperature (as specified by the study) witha temperature recording device or digital time/temperature data logger. The device should beinstalled where it can be easily read and thesensor for the device should be installed toensure that it accurately measures the input/output air temperature;ANDMonitor brine strength with a salinometer;ANDMonitor the brine temperature with a dial ordigital thermometer;ANDMonitor all other critical factors specified bythe study with equipment appropriate for themeasurement;

ORCollect a representative sample of finishedproduct and conduct water phase salt analysis,and, when appropriate, nitrate analysis.

• CONTROL STRATEGY EXAMPLE 2 – PICKLING


How: Monitor brine strength with a salinometer;ANDMonitor acid strength with a pH meter or bytitration;ANDMonitor brine/acid temperature with a dial ordigital thermometer;ANDMonitor all other critical factors specified by thestudy with equipment appropriate for themeasurement;

ORCollect a representative sample of finishedproduct and conduct water phase salt, pH, and/orwater activity analysis.



How: Use a digital time/temperature data logger;ORUse a recorder thermometer;ORUse a high temperature alarm with 24-hourmonitoring;ORMake visual observations of the adequacy ofice or other cooling media in a sufficient numberof containers to represent all of the product.


How: Use a time/temperature integrator for productinternal temperature monitoring during transit;ORUse a digital time/temperature data logger forproduct internal temperature or ambient airtemperature monitoring during transit;ORUse a recorder thermometer for ambient airtemperature monitoring during transit;ORUse a maximum indicating thermometer forambient air temperature monitoring duringtransit;ORUse a dial or digital thermometer for internalproduct temperature monitoring at receipt;ORMake visual observations of the adequacy of iceor other cooling media in a sufficient number ofcontainers to represent all of the product.


How Often Will Monitoring Be Done(Frequency)?



Frequency: Continuous monitoring by the instrumentitself, with visual check of the monitoringinstrument at least once per batch.


Frequency: Continuous monitoring by the instrumentitself, with visual check of the monitoringinstrument at least once per batch.


Frequency: Temperature requirements of the dryingprocess should be monitored continuously by theinstrument itself, with visual check of themonitoring instrument at least once per batch;ANDTime requirements of the drying process shouldbe monitored for each batch;ANDMonitor brine strength at least at the start of thebrining process;ANDMonitor the brine temperature at the start of thebrining process and at least every two hoursthereafter;ANDMonitor the brine to fish ratio at the start of thebrining process;ANDMonitor all other critical factors specified by thestudy as often as necessary to maintain control.

ORWater phase salt and, when appropriate, nitriteshould be determined for each lot or batch offinished product.



Frequency: Monitor brine/acid strength at the startof the brining/pickling/formulation process;ANDMonitor the brine/acid temperature at the start ofthe brining/pickling/formulation process and atleast every two hours thereafter;ANDMonitor the brine/acid to fish ratio at the start ofthe brining/pickling/formulation process;ANDMonitor all other critical factors specified by thestudy as often as necessary to maintain control;

ORWater phase salt, pH, and/or water activityanalysis should be determined for each batch offinished product.



Frequency: Continuous monitoring by the instrumentitself, with visual check of the monitoringinstrument at least once per day;ORFor ice or other cooling media, check at leasttwice per day, or immediately prior to shipment.


Frequency: Each shipment.


181

Who Will Perform the Monitoring?


Who: With recorder thermometers, time/temperature integrators, high temperaturealarms, maximum indicating thermometers, anddigital time/temperature data loggers, monitoringis performed by the equipment itself. However,anytime that such instruments are used, a visualcheck should be made at least once per day(at least once per batch, as appropriate) in orderto ensure that the critical limits have consistentlybeen met. These checks, as well as dialthermometer checks, salinometer checks,pH meter checks, titrations and adequacyof ice or other cooling media checks may beperformed by the receiving employee, theequipment operator, a production supervisor, amember of the quality control staff, or any otherperson who has an understanding of the process,the monitoring procedure, and the critical limits.

Enter the “What,” “How,” “Frequency,” and “Who”monitoring information in Columns 4, 5, 6, and 7,respectively, of the HACCP Plan Form.

STEP #16: ESTABLISH CORRECTIVE AC-TION PROCEDURES.

For each processing step where “C. botulinum toxinformation” is identified as a significant hazard on theHACCP Plan Form, describe the procedures that youwill use when your monitoring indicates that the CLhas not been met.

These procedures should: 1) ensure that unsafeproduct does not reach the consumer; and, 2) correctthe problem that caused the CL deviation. Rememberthat deviations from operating limits do not need toresult in formal corrective actions.

Following is guidance on establishing correctiveaction procedures for the control strategy examplesdiscussed in Step #12.



Corrective Action: Take one or more of thefollowing actions as necessary to regain controlover the operation after a CL deviation:• Make repairs or adjustments to the smoking/

drying chamber;OR• Move some or all of the product to another

smoking/drying chamber;AND

Take one of the following actions to the productinvolved in the critical limit deviation:• Destroy the product;OR• Hold the product until its safety can be

evaluated;OR• Divert the product to a use in which the critical

limit is not applicable (e.g. packaging that isnot hermetically sealed, or low acid cannedfood [LACF] or frozen product);

OR• Divert the product to a non-food use.


Corrective Action: Take one or more of thefollowing actions as necessary to regain controlover the operation after a CL deviation:• Make repairs or adjustments to the heating

chamber;OR• Move some or all of the product to another

heating chamber;AND

Take one of the following actions to the productinvolved in the critical limit deviation:• Destroy the product;OR• Hold the product until its safety can be

evaluated;OR• Reprocess the product;


OR• Divert the product to a use in which the critical

limit is not applicable (e.g. packaging that isnot hermetically sealed, or LACF or frozenproduct);


For controlling toxin formation by brining,dry salting, and/or drying:

Corrective Action: Take one or more of thefollowing actions as necessary to regain controlover the operation after a CL deviation:• Adjust the brine and/or nitrite concentration;OR• Adjust the air velocity or input air temperature

to the drying chamber;OR• Extend the drying process to compensate for a

reduced air velocity or temperature or elevatedhumidity;

ORAdjust the brine strength or brine to fish ratio;

OR• Extend the brining time to compensate for an

improper brine temperature;AND

Take one of the following actions to the productinvolved when there has been a failure tomaintain specified critical factors of the brining,dry salting or drying process:• Destroy the product;OR• Hold the product until it can be evaluated

based on its water phase salt and/or nitratelevel;

OR• Reprocess the product;OR• Divert the product to a use in which the critical



ANDTake one of the following actions to the productinvolved when finished product testing showsthat the water phase salt level and/or nitrite levelis below the critical limit:• Destroy the productOR• Divert the product to a use in which the critical


OR• Divert to a non-food use.



Corrective Action: Take one or more of thefollowing actions as necessary to regain controlover the operation after a CL deviation:• Adjust the brine/acid strength or brine/acid to

fish ratio;OR• Extend the brining/pickling time to compensate

for an improper brine/acid temperature;AND

Take one of the following actions to the productinvolved when there has been a failure tomaintain the specified critical factors of thepickling, brining, or formulation process:• Destroy the product;OR• Hold the product until it can be evaluated

based on its water phase salt, pH, and/or wateractivity level;

OR• Reprocess the product;OR• Divert the product to a use in which the critical




183

ANDTake one of the following actions to the productinvolved when finished product testing showsthat water phase salt is below 5 percent, or thepH is above 5.0, or the water activity is 0.97 orabove, or the intended combination of waterphase salt, pH, and/or water activity has not beenachieved, as appropriate:• Destroy the product;OR• Divert the product to a use in which the critical

limit is not applicable because C. botulinumgrowth in the finished product will becontrolled by some other means(e.g. packaging that is not hermetically sealed,or LACF or frozen product);

OR• Reprocess the product (if reprocessing does not

jeopardize the safety of the product);OR• Divert to a non-food use.



Corrective Action: Take one or several of thefollowing actions as necessary to regain controlover the operation after a CL deviation:• Add ice to the affected productOR• Make repairs or adjustments to the

malfunctioning cooler;OR• Move some or all of the product in the

malfunctioning cooler to another cooler;OR• Freeze the product;

ANDTake one of the following actions to the productinvolved in the critical limit deviation:• Destroy the product;OR• Hold the product until it can be evaluated

based on its total time/temperature exposure;OR• Divert the product to a non-food use.

For controlling toxin formation at receipt ofrefrigerated (not frozen) “pickled,” smoked orsmoke-flavored fish for storage or further process-ing:

Corrective Action: Reject products that do notmeet the time/temperature or adequacy of ice orother cooling media critical limit at receiving;ORHold the product until it can be evaluated basedon its total time/temperature exposure.

ANDDiscontinue use of supplier or carrier untilevidence is obtained that transportation practiceshave changed.

Note: If an incoming lot that fails to meet a receivingcritical limit is mistakenly accepted, and the error islater detected, the following actions should be taken:1) the lot and any products processed from that lotshould be destroyed, diverted to a nonfood use or to ause in which the critical limit is not applicable, orplaced on hold until a food safety evaluation can becompleted; and 2) any products processed from thatlot that have already been distributed should berecalled and subjected to the actions described above.

Enter the corrective action procedures in Column 8 ofthe HACCP Plan Form.

STEP #17: ESTABLISH A RECORDKEEPINGSYSTEM.

For each processing step where “C. botulinum toxinformation” is identified as a significant hazard on theHACCP Plan Form, list the records that will be usedto document the accomplishment of the monitoringprocedures discussed in Step #15. The recordsshould clearly demonstrate that the monitoringprocedures have been followed, and should containthe actual values and observations obtained duringmonitoring.

Following is guidance on establishing a record-keeping system for the control strategy examplesdiscussed in Step #12.




Records: Printout from digital time/temperaturedata logger;ORRecorder thermometer chart;ORRecord showing the results of the maximumindicating thermometer checks;ORRecord showing the results of the hightemperature alarm checks.


Records: Printout from digital time/temperaturedata logger;

ANDSmoking log showing the time that the productreached 145˚F (62.8˚C) and the time that theheating process ended.


Records: Temperature recorder chart or data loggerprintout for drier input/output air temperature;ANDAppropriate records (e.g. processing recordshowing the results of the brine strength andtemperature, brine to fish ratio, size and speciesof fish, time of brining) as necessary todocument the monitoring of the critical factors ofthe brining, dry salting, and/or drying process, asestablished by a study;

ORResults of the finished product water phase saltdetermination, and, when appropriate, nitritedetermination.



Records: Appropriate records (e.g. processingrecord showing the results of the brine/acidstrength and temperature, brine/acid to fish ratio,

size and species of fish, time of brining/pickling)as necessary to document the monitoring of thecritical factors of the brining/pickling process, asestablished by a study;ORResults of the finished product water phase salt,pH, or water activity determinations.



Records: Printout from digital time/temperaturedata logger;ORRecorder thermometer chart;ORStorage record showing the results of the hightemperature alarm checks.


Records: Receiving record showing the results ofthe time/temperature integrator checks;

ORPrintout from digital time/temperature datalogger;ORRecorder thermometer chart;ORReceiving record showing the results of themaximum indicating thermometer checks;ORThe results of internal product temperaturemonitoring at receipt;ANDThe date and time of departure and arrival of thevehicle;ORReceiving record showing the results of the iceor other cooling media checks.

Enter the names of the HACCP records in Column 9of the HACCP Plan Form.


Continued


STEP #18: ESTABLISH VERIFICATIONPROCEDURES.

For each processing step where “C. botulinum toxinformation” is identified as a significant hazard on theHACCP Plan Form, establish verification proceduresthat will ensure that the HACCP plan is: 1) adequateto address the hazard of C. botulinum toxin produc-tion; and, 2) consistently being followed.

Following is guidance on establishing verificationprocedures for the control strategy examples dis-cussed in Step #12.


Verification: Review monitoring, corrective action,and verification records within one week ofpreparation;

ANDProcess establishment (except where finishedproduct water phase salt analysis and, whereappropriate, nitrite analysis is the monitoringprocedure): The adequacy of the brining/drysalting and/or drying process should beestablished by a scientific study. It should bedesigned to consistently achieve a water phasesalt level of: 3.5 percent or 3.0 percent with notless than 100 ppm nitrite for refrigerated,reduced oxygen packaged (e.g. vacuum ormodified atmosphere packaged) smoked fish orsmoke-flavored fish. Expert knowledge ofsalting and/or drying processes is required toestablish such a process. Such knowledge can beobtained by education or experience or both.Establishment of brining/dry salting and dryingprocesses requires access to adequate facilitiesand the application of recognized methods. Thedrying equipment must be designed, operatedand maintained to deliver the established dryingprocess to every unit of product. In someinstances, brining/dry salting and/or dryingstudies will be required to establish minimumprocesses. In other instances, existing literature,which establish minimum processes or adequacyof equipment, are available. Characteristics ofthe process, product, and/or equipment that affect

the ability of the established minimum saltingand/or drying process should be taken intoconsideration in the process establishment. Arecord of the process establishment should bemaintained;

ANDWhen digital time/temperature data loggers,recorder thermometers, or high temperaturealarms are used for in-plant monitoring, checkfor accuracy against a known accurate thermometer(NIST-traceable) at least once per day;

ANDWhen digital time/temperature data loggers orrecorder thermometers are used for monitoring oftransport conditions at receiving, check foraccuracy against a known accurate thermometer(NIST-traceable). Verification should be conductedon new suppliers’ vehicles and at least quarterlyfor each supplier thereafter. Additionalverifications may be warranted based onobservations at receipt (e.g. refrigeration unitsappear to be in poor repair, or readings appear tobe erroneous);

ANDWhen dial or digital thermometers or maximumindicating thermometers are used for monitoring,check for accuracy against a known accuratethermometer (NIST-traceable) when first usedand at least once per year thereafter (Note:Optimal calibration frequency is dependent uponthe type, condition, and past performance of themonitoring instrument);

ANDOther calibration procedures as necessary toensure the accuracy of the monitoring instruments;

ANDFinished product sampling and analysis todetermine water phase salt and, whereappropriate, nitrite analysis at least once everythree months (except where such testing isperformed as part of monitoring).


Verification: Review monitoring, corrective action,and verification records within one week ofpreparation;


ANDProcess establishment (except where finishedproduct water phase salt, pH, or water activityanalysis is the monitoring procedure): Theadequacy of the pickling/brining/formulationprocess should be established by a scientificstudy. For refrigerated, reduced oxygenpackaged products it should be designed toconsistently achieve: a water phase salt level ofat least 5 percent; a pH of 5.0 or below; a wateractivity of below 0.97; a water phase salt level ofat least 2.5% in surimi-based products, whencombined with a pasteurization process in thefinished product container of 185˚F (85˚C) for atleast 15 minutes; or, a combination of salt, pH,and/or water activity that, when combined,prevent the growth of C. botulinum type E andnonproteolytic types B and F (established byscientific study). For unrefrigerated (shelf-stable), reduced oxygen packaged products, itshould be designed to consistently achieve: awater phase salt level of at least 20% (based onthe maximum water phase salt level for growthof S. aureus); a pH of 4.6 or below; or a wateractivity of 0.85 or below (based on the minimumwater activity for growth of S. aureus. Expertknowledge of pickling/brining/formulationprocesses is required to establish such a process.Such knowledge can be obtained by education orexperience or both. Establishment of pickling/brining/formulation processes requires access toadequate facilities and the application ofrecognized methods. In some instances, pickling/brining/formulation studies will be required toestablish minimum processes. In other instances,existing literature, which establish minimumprocesses, are available. Characteristics of theprocess and/or product that affect the ability ofthe established minimum pickling/brining/formulation process should be taken intoconsideration in the process establishment.A record of the process establishment should bemaintained;

ANDWhen digital time/temperature data loggers,recorder thermometers, or high temperaturealarms are used for in-plant monitoring, checkfor accuracy against a known accurat thermometer(NIST-traceable) at least once per day;

ANDWhen digital time/temperature data loggers orrecorder thermometers are used for monitoringof transport conditions at receiving, check foraccuracy against a known accurate thermometer(NIST-traceable). Verification should be conductedon new suppliers’ vehicles and at least quarterlyfor each supplier thereafter. Additionalverifications may be warranted based onobservations at receipt (e.g. refrigeration unitsappear to be in poor repair, or readings appear tobe erroneous);

ANDWhen visual checks of ice or cooling media areused to monitor the adequacy of coolant,periodically measure internal temperatures of theproduct to ensure that the ice or cooling media issufficient to maintain product temperatures at orbelow 40˚F (4.4˚C);

ANDWhen dial thermometers or maximum indicatingthermometers are used for monitoring, check foraccuracy against a known accurate thermometer(NIST-traceable) when first used and at leastonce per year thereafter (Note: Optimalcalibration frequency is dependent upon the type,condition, and past performance of themonitoring instrument);

ANDDaily calibration of pH meters against standardbuffers;

ANDOther calibration procedures as necessary toensure the accuracy of the monitoringinstruments;

ANDFinished product sampling and analysis todetermine water phase salt, pH, or water activitylevel, as appropriate, at least once every three

months (except where such testing is performedas part of monitoring).

Enter the verification procedures in Column 10 of theHACCP Plan Form.

Continued


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easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

TABL

E #1

3-1

Cont

rol S

trat

egy

Exam

ple

1 –

Smok

ing

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f C. b

otul

inum

toxi

n fo

rmat

ion

for a

pro

cess

orof

vac

uum

pac

kage

d ho

t-sm

oked

sal

mon

, usi

ng C

ontro

l Stra

tegy

Exa

mpl

e 1

- Sm

okin

g. I

t is

prov

ided

for

illus

trativ

e pu

rpos

es o

nly.

C. b

otul

inum

toxi

n fo

rmat

ion

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3) f

or o

ther

pot

entia

l haz

ards

(e.g

. aqu

acul

ture

dru

gs, c

hem

ical

con

tam

inan

ts,

para

site

s, g

row

th o

f oth

er p

atho

gens

, sur

viva

l of o

ther

pat

hoge

ns th

roug

h th

e co

ok s

tep,

and

met

al fr

agm

ents

).

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Not

e: T

he c

ritic

al li

mits

in th

is e

xam

ple

are

for i

llust

rati v

e pu

rpos

es o

nly,

and

are

not

rela

ted

to a

ny re

com

men

ded

proc

ess.

(10)

Veri

ficat

ion

•M

inim

um b

rinin

g tim

e6

hour

s

•M

inim

um sa

ltco

ncen

tratio

n of

brin

eat

start

of b

rinin

g 60

osa

limete

r

•M

inim

um ra

tio o

fbr

ine:f

ish 2

:1

•M

axim

um fi

shth

ickne

ss 1

1/2

"

(Not

e: To

pro

duce

am

inim

um w

ater p

hase

salt

level

in th

e loi

n m

uscle

of

3.5%

)

•Le

ngth

of

brin

ing

proc

ess

•Sa

ltco

ncen

tratio

nof

brin

e

•W

eight

of b

rine

(as d

eterm

ined

by v

olum

e)

•W

eight

of f

ish

•Fi

sh th

ickne

ss

•C.

bot

ulin

um to

xin

form

ation

in fi

nish

edpr

oduc

t

Brin

ing

•V i

sual

•Sa

linom

eter

•V i

sual

to m

ark

on ta

nk

•Sc

ale

•Ca

liper

•Pr

oduc

tion

reco

rd

•Pr

oduc

tion

reco

rd

•Pr

oduc

tion

reco

rd

•Pr

oduc

tion

reco

rd

•Pr

oduc

tion

reco

rd

•St

art a

nd en

d of

brin

ing

proc

ess

•St

art o

f brin

ing

proc

ess

•St

art o

f brin

ing

proc

ess

•Ea

ch b

atch

•Ea

ch b

atch

(10

fish)

•Ex

tend

brin

ing

proc

ess

•Ad

d sa

lt

•Ad

d br

ine

•Re

mov

e som

efis

h an

d rew

eigh

•Ho

ld an

dev

aluate

bas

edon

fini

shed

prod

uct w

ater

phas

e salt

analy

sis

•Br

ine r

oom

empl

oyee

•Br

ine r

oom

empl

oyee

•Br

ine r

oom

empl

oyee

•Br

ine r

oom

empl

oyee

•Br

ine r

oom

empl

oyee

• D

ocum

entat

ion

of b

rinin

g/dr

ying

pro

cess

estab

lishm

ent

•Re

view

mon

itorin

g,co

rrecti

veac

tion,

and

verif

icatio

nre

cord

s with

inon

e wee

k of

prep

arati

on

•M

onth

lyca

libra

tion

ofsc

ale

•Qu

arter

ly w

ater

phas

e salt

analy

sis


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(10)

Veri

ficat

ion

TABL

E #1

3-1,

con

tinue

d

Not

e: T

he c

ritic

al li

mits

in th

is e

xam

ple

are

for i

llust

rati v

e pu

rpos

es o

nly,

and

are

not

rela

ted

to a

ny re

com

men

ded

proc

ess.

•M

inim

um ti

me o

pen

vent

2 h

ours

•In

terna

l tem

pera

ture

of

fish

held

at o

r abo

ve14

5˚F

for a

t lea

st 30

min

utes

•Ti

me o

f ope

nve

nt

•In

terna

ltem

pera

ture

of fi

sh an

d tim

eat

that

tempe

ratu

re

•C.

bot

ulin

um to

xin

form

ation

in fi

nish

edpr

oduc

t

Smok

ing/

dryi

ng/

heati

ng•

Visu

al

•Di

gital

data

logg

er w

ithpr

obes

in 3

of

thick

est f

ish in

cold

spot

of

oven

•Pr

oduc

tion

reco

rd

•Da

ta lo

gger

prin

tout

•Sm

okin

g lo

g

•Ea

ch b

atch

•Co

ntin

uous

with

visu

al at

end

ofba

tch

•Ex

tend

dryi

ngpr

oces

s, an

d

•Ho

ld an

dev

aluate

•Ex

tend

heati

ngpr

oces

s, an

d

•M

ake

repa

irs o

rad

justm

ents

toth

e sm

okin

gch

ambe

r, an

d

•Ho

ld an

dev

aluate

•Sm

oker

empl

oyee

•Sm

oker

empl

oyee

•Do

cum

entat

ion

of b

rinin

g/dr

ying

pro

cess

estab

lishm

ent

•Re

view

mon

itorin

g,co

rrecti

veac

tion,

and

verif

icatio

nre

cord

s with

inon

e wee

k of

prep

arati

on

•Da

ilyca

libra

tion

ofda

ta lo

gger

•Qu

arter

ly w

ater

phas

e salt

analy

sis

•M

axim

um co

oler

tempe

ratu

re 4

0˚F

(bas

ed o

n gr

owth

of

vege

tative

path

ogen

s)

•Co

oler

air

tempe

ratu

re•

C. b

otul

inum

toxi

nfo

rmati

on d

urin

gfin

ished

pro

duct

stora

ge

Fini

shed

pro

duct

stora

ge•

Digi

tal d

atalo

gger

•Da

ta lo

gger

prin

tout

•Co

ntin

uous

,wi

th v

isual

once

per d

ay

•Ad

just

or re

pair

cool

er, an

d

•Ho

ld an

dev

aluate

bas

edon

tim

e/tem

pera

ture

of

expo

sure

•Pr

oduc

tion

empl

oyee

•Re

view

mon

itorin

g,co

rrecti

veac

tion,

and

verif

icatio

nre

cord

s with

inon

e wee

k of

prep

arati

on

•Da

ily ch

eck

ofda

ta lo

gger

accu

racy


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

Max

imum

fini

shed

prod

uct p

H in

the l

oin

mus

cle o

f 5.0

Fini

shed

pro

duct

pH in

the l

oin

mus

c le

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

TABL

E #1

3-2

Cont

rol S

trat

egy

Exam

ple

2 –

Pick

ling

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f Clo

stri

dium

bot

ulin

um fo

r a p

roce

ssor

of p

ickl

ed h

errin

g, u

sing

Con

trol S

trate

gy E

xam

ple

2 - P

ickl

ing.

It i

s pr

ovid

ed fo

r illu

stra

tive

purp

oses

onl

y.C

. bot

ulin

um to

xin

form

atio

n m

ay b

e on

ly o

ne o

f sev

eral

sig

nific

ant h

azar

ds fo

r thi

s pr

oduc

t. R

efer

to T

able

s 3-

1, 3

-2, a

nd 3

-3(C

hapt

er 3

) for

oth

er p

oten

tial h

azar

ds (e

.g. h

ista

min

e, c

hem

ical

con

tam

inan

ts, p

aras

ites,

and

met

al fr

agm

ents

).

C. b

otul

inum

toxi

nfo

rmati

on in

fini

shed

prod

uct

Colle

ct sa

mpl

e of

prod

uct f

rom

eac

hpi

cklin

g tan

k at

the e

nd o

f eac

hpi

cklin

g cy

cle a

ndan

alyze

for p

Hus

ing

a pH

mete

r

Analy

tical

resu

ltsEa

ch p

icklin

gtan

k, e

ach

cycle

Cont

inue

pick

ling

proc

ess u

ntil

pHm

eets

the C

L

QC p

erso

nnel

(10)

Veri

ficat

ion

•Da

ilyca

libra

tion

ofpH

mete

r

•Re

vie w

mon

itorin

g,c o

rrec t

ive

actio

n, a

ndve

rific

a tio

nre

cord

s with

inon

e wee

k of

pre p

a ra t

ion

Max

imum

coo

lertem

pera

ture

40˚

F(b

ased

on

grow

th o

fve

getat

ive

path

ogen

s)

Cool

er a

irte

mpe

ratu

reC.

bot

ulin

um to

xin

form

ation

dur

ing

finish

ed p

rodu

ctsto

rage

High

tem

pera

ture

alarm

with

24-

hour

mon

itorin

g

Prod

uctio

n re

cord

with

dail

y ala

rmch

e ck

Cont

inuo

us, w

ithvi

sual

chec

k of

oper

ation

onc

epe

r day

•Ad

just

or re

pair

cool

er, a

nd

•Ho

ld a

ndev

aluate

bas

edon

tim

e/tem

pera

ture

of

expo

sure

Prod

uctio

nem

ploy

e e•

Daily

acc

urac

ych

eck

of h

igh

tempe

ratu

re a

larm

•Re

vie w

mon

itorin

g,c o

rrec t

ive

actio

n, a

ndve

rific

a tio

nre

cord

s with

inon

e wee

k of

pre p

a ra t

ion

Pic k

ling(1

)C

ritic

al C

ontr

olPo

int (

CC

P)

Fini

shed

pro

duct

stora

ge

chapter 13: clostridium botulinum toxin formation...

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