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    Fish and Fishery ProductsHazards and Controls GuidanceFourth Edition – APRIL 2011

    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    PUBLIC HEALTH SERVICE

    FOOD AND DRUG ADMINISTRATION

    CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

    OFFICE OF FOOD SAFETY

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    Fish and Fishery Products Hazards andControls GuidanceFourthEdition–April2011

     Additional copies may be purchased from:

     Florida Sea Grant IFAS - Extension Bookstore

    University of Florida

     P.O. Box 110011

    Gainesville, FL 32611-0011

    (800) 226-1764

    Or

    www.ifasbooks.com 

    Or you may download a copy from:

    http://www.fda.gov/FoodGuidances  

     Youmaysubmitelectronicorwrittencommentsregardingthisguidanceatanytime.Submitelectroniccommentsto http://www.regulations.  gov . SubmitwrittencommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,Rm.1061,Rockville,MD20852.Allcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishes

    inthe Federal Register.

    U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforFoodSafetyandAppliedNutrition (240)402-2300

     April2011

    http://www.ifasbooks.com/http://www.fda.gov/FoodGuidanceshttp://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/http://www.fda.gov/FoodGuidanceshttp://www.ifasbooks.com/

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    TableofContents:FishandFisheryProductsHazardsandControlsGuidance

    Guidance for the Industry:FishandFisheryProductsHazardsandControlsGuidance................................1

    CHAPTER 1:GeneralInformation.......................................................................................................19 CHAPTER 2:ConductingaHazardAnalysisandDevelopingaHACCPPlan..........................................21

    CHAPTER 3:PotentialSpecies-RelatedandProcess-RelatedHazards.....................................................29  

    CHAPTER 4:PathogensFromtheHarvestArea...................................................................................75

    CHAPTER 5:Parasites......................................................................................................................91

    CHAPTER 6:NaturalToxins ............................................................................................................99 

    CHAPTER 7:Scombrotoxin(Histamine)Formation .............................................................................113

    CHAPTER 8:OtherDecomposition-RelatedHazards .........................................................................153

    CHAPTER 9:EnvironmentalChemicalContaminantsandPesticides......................................................155

    CHAPTER 10:Methylmercury..........................................................................................................181

    CHAPTER 11:AquacultureDrugs.....................................................................................................183

    CHAPTER 12: PathogenicBacteriaGrowthandToxinFormation(OtherThanClostridiumbotulinum) asaResultofTimeandTemperatureAbuse.................................................................209  

    CHAPTER 13:ClostridiumbotulinumToxinFormation.........................................................................245  

    CHAPTER 14:PathogenicBacteriaGrowthandToxinFormationasaResultofInadequateDrying .........293 

    CHAPTER 15:StaphylococcusaureusToxinFormationinHydratedBatterMixes..................................309  

    CHAPTER 16:PathogenicBacteriaSurvivalThroughCookingorPasteurization ..................................... 315

    CHAPTER 17: PathogenicBacteriaSurvivalThroughProcessesDesignedtoRetain RawProductCharacteristics ....................................................................................... 331

    CHAPTER 18: IntroductionofPathogenicBacteriaAfterPasteurizationand SpecializedCookingProcesses .................................................................................345 

    CHAPTER 19: UndeclaredMajorFoodAllergensandCertainFoodIntoleranceCausingSubstances andProhibitedFoodandColorAdditives ....................................................................355 

    CHAPTER 20:MetalInclusion..........................................................................................................385  

    CHAPTER 21:GlassInclusion..........................................................................................................395

    APPENDIX 1:Forms.......................................................................................................................405  

    APPENDIX 2:SampleProductFlowDiagram.....................................................................................411

    APPENDIX 3:CriticalControlPointDecisionTree...............................................................................413

    APPENDIX 4:BacterialPathogenGrowthandInactivation..................................................................417

    APPENDIX 5:FDAandEPASafetyLevelsinRegulationsandGuidance................................................439  

    APPENDIX 6:JapaneseandHawaiianVernacularNamesforFishEatenRaw......................................443  

    APPENDIX 7: BacterialandViralPathogensofGreatestConcerninSeafoodProcessingPublicHealthImpacts..................................................................................................451

    APPENDIX 8:ProceduresforSafeandSanitaryProcessingandImportingofFishandFisheryProducts...455  

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    GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition

    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.

    I. INTRODUCTION

    ThisguidanceisintendedtoassistprocessorsoffishandfisheryproductsinthedevelopmentoftheirHazardAnalysisCriticalControlPoint(HACCP)plans.Processorsoffishandfishery

    productswillfindinformationinthisguidancethatwillhelpthemidentifyhazardsthatareassociatedwiththeirproducts,andhelpthemformulatecontrolstrategies.Theguidancewillhelpconsumersandthepublicgenerallytounderstandcommercialseafoodsafetyintermsofhazardsandtheircontrols.Theguidancedoesnotspecificallyaddresssafehandlingpracticesbyconsumersorbyretailestablishments,althoughmanyoftheconceptscontainedinthisguidanceareapplicabletoboth.Thisguidanceisalso

    intendedtoserveasatooltobeusedbyfederalandstateregulatoryofficialsintheevaluationofHACCPplansforfishandfisheryproducts.

    FDA’sguidancedocuments,includingthisguidance,donotestablishlegallyenforceableresponsibilities.Instead,guidancedescribethe Agency’scurrentthinkingonatopicandshouldbeviewedonlyasrecommendations,unless

    specificregulatoryorstatutoryrequirementsare

    cited.Theuseoftheword should inAgency

    guidancemeansthatsomethingissuggestedorrecommended,butnotrequired.

    II. DISCUSSION

    A.ScopeandLimitations

    Thecontrolstrategiesandpracticesprovidedinthisguidancearerecommendationstothefish

    andfisheryproductsindustryunlesstheyarerequiredbyregulationorstatute.ThisguidanceprovidesinformationthatwouldlikelyresultinaHACCPplanthatisacceptabletoFDA.Processorsmaychoosetouseothercontrolstrategies,aslongastheycomplywiththerequirementsoftheapplicablefoodsafetylawsandregulations.However,processorsthatchosetouseothercontrolstrategies(e.g.,criticallimits)shouldscientificallyestablishtheiradequacy.

    Theinformationcontainedinthetablesin

    Chapter3andinChapters4through21provideguidancefordeterminingwhichhazardsare“reasonablylikelytooccur”inparticularfishandfisheryproductsunderordinarycircumstances.However,thetablesshouldnotbeusedseparatelyforthispurpose.Thetableslistpotentialhazardsforspecificspeciesandfinishedproducttypes.Thisinformationshouldbecombinedwiththeinformationinthesubsequentchapterstodeterminethelikelihoodofoccurrence.

    Theguidanceisnotasubstitutefortheperformanceofahazardanalysisbyaprocessoroffishandfisheryproducts,asrequiredbyFDA’sregulations.Hazardsnotcoveredbythisguidancemayberelevanttocertainproductsundercertaincircumstances.Inparticular,processorsshouldbealerttoneworemergingproblems(e.g.,theoccurrenceofnaturaltoxinsinfishnotpreviouslyassociatedwiththattoxin).

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     FDAannounceditsadoptionoffinalregulationstoensurethesafeandsanitaryprocessingoffishandfisheryproductsinthe Federal Register ofDecember18,1995(60FR65096)(hereinafterreferredtoastheSeafoodHACCPRegulation).Thisguidance,theSeafoodHACCPRegulation(21CFR123),andtheControlofCommunicableDiseasesregulation(21CFR1240)applytoallaquaticanimallife,otherthanbirdsandmammals,usedasfoodforhumanconsumption.Forexample,inadditiontofreshandsaltwaterfinfishandcrustaceans,thisguidanceappliestoechinodermssuchasseacucumbersandseaurchins;reptilessuchasalligatorsandturtles;amphibianssuchasfrogs;andtoallmollusks,includinglandsnails(escargot).Italsoappliestoextractsandderivativesoffish,suchaseggs(roe),oil,cartilage,andfishproteinconcentrate.Inaddition,thisguidanceappliestoproductsthataremixturesoffishandnon-fishingredients,suchastunasandwichesandsoups.Appendix8,§123.3,liststhedefinitionsfor“fish”and“fisheryproduct”usedintheSeafoodHACCPRegulation.

    Thisguidancecoverssafetyhazardsassociated withfishandfisheryproductsonly.Itdoesnotcovermosthazardsassociatedwithnon-fisheryingredients(e.g.,Salmonella enteritidis

    inraweggs).However,wheresuchhazardsarepresentedbyafisheryproductthatcontainsnon-fisheryingredients,controlmustbeincludedintheHACCPplan(§123.6).Processorsmayusetheprinciplesincludedinthisguidanceforassistanceindevelopingappropriatecontrolsforthesehazards.

    ThisguidancedoesnotcoverthehazardassociatedwiththeformationofClostridiumbotulinum (C. botulinum)toxininlow-acidcannedfoods(LACFs)orshelf-stableacidifiedfoods.MandatorycontrolsforthishazardarecontainedintheThermallyProcessedLow- AcidFoodsPackagedinHermeticallySealedContainersregulation(hereinafterreferredtoastheLACFRegulation,21CFR113)andthe AcidifiedFoodsregulation(21CFR114).Suchcontrolsmaybe,butarenotrequiredtobe,includedinHACCPplansfortheseproducts.

    ThisguidancedoesnotcoverthesanitationcontrolsrequiredbytheSeafoodHACCPRegulation.However,themaintenanceofasanitationmonitoringprogramisanessentialprerequisitetothedevelopmentofaHACCPprogram.Whensanitationcontrolsarenecessaryforfoodsafety,butarenotincludedinasanitationmonitoringprogram,theymustbeincludedintheHACCPplan(21CFR123.6).

    Thisguidancedoesnotdescribecorrectiveactionorverificationrecords,becausetheserecordsarenotrequiredtobelistedintheHACCPplan.Nonetheless,suchrecordsmustbemaintained, whereapplicable,asrequiredin§123.7and§123.8.Additionally,thisguidancedoesnotrestatethegeneralrequirementsforrecordsthatareset

    outin§123.9(a).

    ThisguidancedoesnotcoverreassessmentoftheHACCPplanand/orthehazardanalysisorreviewofconsumercomplaints,asmandatedby§123.8.

    Thisguidancealsodoesnotprovidespecificguidancetoimportersoffishandfisheryproductsforthedevelopmentofrequiredimporterverificationprocedures.However,theinformationcontainedinthetext,and,inparticular,inAppendix5(“FDAandEPASafety

    LevelsinRegulationsandGuidance”),shouldproveusefulforthispurpose.

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    B.ChangesinThisEdition

    Followingisasummaryofthemostsignificantchangesinthiseditionoftheguidancedocument.Inadditiontousingthissummarylist, youshouldcarefullyreviewthechaptersthatare

    applicabletoyourproductandprocess.

     The information contained throughout this

    guidance document is changed as follows:

    Theelementsofacontrolstrategy(i.e.,criticallimits,monitoringprocedures,correctiveactionprocedures,recordkeepingsystem,andverificationprocedures)arenowconsolidatedforeachcontrolstrategy.Inmostcases,anexampleofaHACCPplanfollowsthediscussionofeachcontrolstrategy;

     Abibliographyisnowlocatedattheendofmostchapters.Referenceshavebeenaddedanddeletedformanyofthechapters;

    • InformationonthemechanicsofcompletingaHACCPplan,previouslyrepeatedinChapters4through21,isnowcontainedinChapter2;

    • Informationonthepotentialpublichealthconsequences(i.e.,illnessorinjury)ofseafoodsafetyhazardsisnowprovided;

    • Recommendationsforspecificjobpositionsarenolongerlistedfor“Whoshouldperformthemonitoring?”inChapters4through21;

    •  Additionalinformationisnowprovidedontheperformanceofaccuracychecksandcalibrationoftemperature-indicatingdevices(e.g.,thermometers)andtemperature-recordingdevices(e.g.,recordingthermometers);and

    • ReferenceisnolongermadetotheintendedissuancebyFDAofguidanceon

    thedevelopmentofSanitationStandardOperatingProcedures(SSOPs)andsanitationmonitoringorguidanceonthedevelopmentofimporterverificationprocedures.

     The recommendations in Chapter 2 for

    conducting a hazard analysis and developing a

    HACCP plan are changed as follows:

    •  Additionalinformationthatisbroadlyapplicabletothesetasks,alsocontainedinthecompaniondocumenttothisguidance,“HACCP:HazardAnalysisCriticalControlPointTrainingCurriculum,”developedbytheSeafoodHACCPAllianceforTrainingandEducation,isnowincluded.

     The information in Chapter 3 for identifying

    potential species-related and process-related

    hazards is changed as follows:

    • Informationisnowprovidedonhowillicitspeciessubstitutioncanimpactontheidentificationofpotentialspecies-relatedhazards.

     The information contained in Table 3-2

    (“Potential Vertebrate Species-Related

    Hazards”) is changed as follows:

    • Thereareseveralscientificnamechangestoreflectchangesintaxonomicconventions;

    •  Aholehole( Kuhlia spp.)isnolongerlistedashavingapotentialciguaterafishpoisoning(CFP)hazard;

    •  AmberjackorYellowtail,Aquacultured(Seriola lalandi ),isnolongerlistedashavingapotentialCFPhazard;

    • Barramundi( Lates calcarifer )isnowlistedasaspeciesthatisaquacultured;

    • BasaorBocourti( Pangasius bocourti )isnowlistedasaspeciesinU.S.commerce;

    • Bass,Sea( Dicentrarchus labrax )isnowlistedasaspeciesthatisaquacultured;

    • Bata( Labeo bata)isnowlistedasaspeciesinU.S.commerce;

    • Bream( Abramis brama)isnowlistedasaspeciesthatisaquacultured;

    • Caparari( Pseudoplatystoma tigrinum)isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • Carp( Barbonymus spp., Hypophthalmichthysnobilis, andCarassius carassius )isnowlistedasaspeciesinU.S.commerce;

    • Carp( Hypophthalmichthys nobilis and

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    Carassius carassius )isnowlistedasaspeciesthatisaquacultured;

    • Cascarudo(Callichthys callichthys )isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • Characin( Leporinus obtusidens )isnowlistedasaspeciesinU.S.commerce;

    • Charal(Chirostomajordani)isnowlistedasaspeciesinU.S.commerce;

    • Chiring( Apocryptes bato)isnowlistedasaspeciesinU.S.commerce;

    • ClariasFish,orWalkingClariasFish(Clariasanguillaris and Clarias gariepinus ),isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish,andisnow

    listedasaspeciesthatisaquacultured;• Cobia( Rachycentron canadum)isnowlisted

    asaspeciesthatisaquacultured;

    • Coroata( Platynematichthys notatus )isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • CurimbataorGuramata( Prochilodus lineatus )isnowlistedasaspeciesinU.S.commerce;

    • Cusk-eel( Brotula clarkae )isnowlistedasaspeciesinU.S.commerce;

    Dace( Rhinichthys spp.)isnowlistedasaspeciesthatisaquacultured;

    • Eel,Moray( Muraena retifera),isnolongerlistedashavingapotentialCFPhazard;

    • Featherback( Notopterus notopterus )isnowlistedasaspeciesinU.S.commerce;

    • Flathead( Platycephalus conatus )isnowlistedasaspeciesinU.S.commerce;

    • FlatwhiskeredFish( Pinirampus pirinampu)isnowlistedasamarketnameforaspecies

    previouslyreferredtoascatfish;• Frog( Rana spp.)isnowlistedashavinga

    parasitehazard;

    • Gillbacker,orGilleybaka( Aspistor parkeri ),isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • Goatfish( Mulloidichthys vanicolenis )isnowlistedasaspeciesinU.S.commerce;

    • Goatfish( Mulloidichthys spp., Pseudupeneus spp., and Upeneichthys lineatus )isnolongerlistedashavingapotentialCFPhazard;

    • Goby( Neogobius melanostomus )isnowlistedasaspeciesinU.S.commerce;

    • Grouper( Anyperodon spp., Caprodon schlegelii,and Diplectrum formosum)isnolongerlistedashavingapotentialCFPhazard;

    • Grouper,orCoralGrouper( Plectropomus spp.),isnowlistedasaspeciesinU.S.commerce;

    • Grouper,orJewfish( Epinephelus itajara),isnolongerlistedasahavingapotentialCFPhazard;

    Herring,orSeaHerring,orSild(Clupea spp.),isnolongerlistedashavingapotentialscombrotoxin(histamine)hazardassociated withitsroe;

    • Hind( Epinephelus drummondhayi )isnolongerlistedashavingapotentialCFPhazard;

    •  Jack(Carangoides bartholomaei )isnowlistedashavingapotentialCFPhazard;

    •  Jack(Selene spp., Urapsis secunda, andOligoplites saurus )isnolongerlistedashavingapotentialCFPhazard;

    •  JackorCrevalle( Alectis indicus )isnolongerlistedashavingapotentialCFPhazard;

    •  JackorRoosterfish( Nematistius pectoralis )isnolongerlistedashavingapotentialCFPhazard;

    •  Jobfish( Aprion spp.)isnowlisted,and Aprion virescens isdeletedbecauseitisincludedin Aprion spp.;

    •  Jobfish( Aphareus spp., Aprion spp., and Pristipomoides spp.)isnolongerlistedashavingapotentialscombrotoxin(histamine)hazard;

    • Kahawai( Arripis spp.)isnolongerlistedashavingapotentialCFPhazard;

    • Loach(Somileptus gongota)isnowlistedasaspeciesinU.S.commerce;

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     • Mackerel,narrow-barredSpanish(Scomberomorus commerson),isnowlistedashavingapotentialCFPhazard;

    • Menhaden( Brevoortia spp. and Ethmidiummaculatum)isnowlistedashaving

    apotentialscombrotoxin(histamine)hazardforproductsintendedfordirecthumanconsumptionofthemuscleandforaqueouscomponents,suchasfishproteinconcentrates,thataretobeusedasfoodadditives.Itisalsolistedashavingapotentialenvironmentalchemicalcontaminantandpesticidehazardwhenthefoodproductsareintendedforhumanconsumption,suchasoilextractsusedasdietaryingredients;

    • OreoDory( Neocyttus spp.)isnowlistedasaspeciesinU.S.commerce;

    • OreoDory(Pseudocyttus spp.)isnowlisted,and Pseudocyttus maculates isdeletedbecauseitisincludedin Pseudocyttus spp;

    • PangasiusorShortbarbel( Pangasiusmicronemus )isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • Parrotfish( Bolbometopon spp.)isnowlistedasaspeciesinU.S.commerce;

    • PiramutabaorLaulaoFish( Brachyplatystomavaillanti )isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • Puffer( Fugu spp., nowTakifugu spp.)isnowlistedasanaquaculturedspecies;

    • Puffer(Sphoeroides annulatus, Sphoeroidesnephelus, Sphoeroides spengleri,andSphoeroides testudineus, Tetraodon spp.)isnowlistedasaspeciesinU.S.commerce;

    • Puffer( Fugu spp., nowTakifugu spp.)isnow

    listedashavingapotentialParalyticShellfishPoisoning(PSP)hazard;

    • Rita( Rita rita)isnowlistedasaspeciesinU.S.commerce;

    • Rohu( Labeo rohita)isnowlistedasaspeciesinU.S.commerce;

    • Sailfish( Istiophorus platypterus )isnowlistedasaspeciesinU.S.commerce;

    • Salmonandroe(wild)(freshwater)(Oncorhynchus spp. andSalmo salar )isnowlistedashavingapotentialparasitehazard;

    • Scad(Trachurus spp.)isnowlistedashavingapotentialscombrotoxin(histamine)hazard;

    • ScadorHorseMackerel(Trachurus trachurus)isnowlistedasamarketnameforaspeciespreviouslyreferredtoasonlyscad;

    • Shad( Alosa spp.)isnolongerlistedashavingapotentialscombrotoxin(histamine)hazardassociatedwithitsroe;

    • Shad,Hilsa(Tenualosa ilisha),isnowlistedasaspeciesinU.S.commerce;

    • Snapper( Etelis spp.and Pristipomoides spp.)isnolongerlistedashavingapotentialCFP

    hazard;• Snapper( Pristipomoides spp.)isnolonger

    listedashavingapotentialscombrotoxin(histamine)hazard;

    • Snapper(Symphorus nematophorus )isnowlistedashavingapotentialCFPhazard;

    • Sorubim,orSurubi( Pseudoplatystomacorruscans ),isnowlistedasamarketnameforaspeciespreviouslyreferredtoascatfish;

    • Spearfish(Tetrapturus spp.)isnowlistedas

    havingapotentialscombrotoxin(histamine)hazard;

    • Squirrelfish( Holocentrus spp.)isnolongerlistedashavingapotentialCFPhazard;

    • SutchiorSwai( Pangasius hypophthalmus )arenowlistedasmarketnamesforaspeciespreviouslyreferredtoascatfishandarenowlistedasspeciesthatareaquacultured;

    • Tang( Naso spp.)isnowlistedasaspeciesinU.S.commerce;

    Tang(Tenthis spp.)isnolongerlisted.• Tang( Zebrasoma spp.)isnolongerlistedas

    ahavingapotentialCFPhazard;

    • Tigerfish( Datnioides microlepis and Datnioides polota)isnowlistedasaspeciesinU.S.commerce;

    • Tinfoil( Barbonymus altus )isnowlistedasaspeciesinU.S.commerce;

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    • Trahira( Hoplias malabaricus )isnowlistedasaspeciesinU.S.commerce;

    • Triggerfish(Canthidermis sufflamenand Melichthys niger )isnolongerlistedashavingapotentialCFPhazard;

    • Tuna(Thunnus spp.)isnowlistedasagenusthatisaquacultured;

    • Turbot(Scophthalmus maximus,now Psettamaxima)isnowlistedasaspeciesthatisaquacultured;

    • Turtle( Malaclemys spp., Chelydra spp., Apalone spp., and Trachemys spp.)isnowlistedasaspeciesinU.S.commerce;

    • Turtle,Aquacultured( Malaclemys spp.,Chelydra spp., Apalone spp., and Trachemys

     spp.),isnowlistedasaspeciesinU.S.commerce;

    • Unicornfish(Naso unicornis )isnowlistedasaspeciesinU.S.commerce;

    •  Weakfish(Cynoscion spp.)isnowlistedashavingapotentialenvironmentalchemicalcontaminantandpesticidehazard;

    •  Weakfish,orBangamary( Macrodon ancylodon),isnowlistedasamarketnameforaspeciespreviouslyreferredtoasonlyweakfish;

     WhiskeredFish( Arius spp.)isnowlistedasamarketnameforaspeciespreviouslyreferredtoasseacatfish;

    •  WhiskeredFish,orGafftopsailFish( Bagremarinus ),isnowlistedasamarketnameforaspeciespreviouslyreferredtoasseacatfish;

    •  WhiskeredFish,orHardheadWhiskeredFish( Ariopsis felis ),isnowlistedasamarketnameforaspeciespreviouslyreferredtoasseacatfish;

    •  Wrasse(Cheilinus undulatus )isnowlistedasaspeciesinU.S.commerce;

    •  YellowtailAmberjack(Seriola lalandi )isnowlistedasaspeciesthatisaquaculturedandisnolongerlistedashavingapotentialCFPhazard;

    • Zander(Sander lucioperca)isnowlistedasaspeciesthatisaquacultured.

     The information contained in Table 3-3

    (“Potential Invertebrate Species-Related

    Hazards”) is changed as follows:

    • Thereareseveralscientificnamechangestoreflectchangesintaxonomicconventions;

    •  Abalone( Haliotis spp.)isnowlistedashavinganaturaltoxinhazard;

    • Conch( Lambis lambis )isnowlistedasaspeciesinU.S.commerce;

    • Crab,allspeciesarenowlistedashavingapotentialenvironmentalchemicalcontaminantandpesticidehazard;

    • Crab,Blue(Callinectes sapidus ),isnowlistedasaspeciesthatisaquacultured;

    • Crab,JapaneseFreshwater(Geothelphusa

    dehaani ),isnowlistedasaspeciesinU.S.commerce;

    • Crab,Sheep( Loxorhynchus grandis ),isnowlistedasaspeciesinU.S.commerce;

    • Crab,Swamp(Scylla serrata),isnowlistedasaspeciesinU.S.commerce;

    • Murex,orMerex( Murex brandaris ),isnowlistedasaspeciesinU.S.commerce;

    • Oyster(Spondylus spp.)isnowlistedasaspeciesinU.S.commerce;

    • SeaSquirt(Styela spp.)isnowlistedasaspeciesinU.S.commerce;

    • Shrimp( Pleoticus muelleri )isnowlistedasaspeciesinU.S.commerce;

    • Snail,Moon( Polinices spp.),isnowlistedasaspeciesinU.S.commerce;

    •  Whelk( Busycon spp.)isnowlistedashavingapotentialnaturaltoxinhazard.

     The information contained in Table 3-4

    (“Potential Process-Related Hazards”) is

    changed as follows:

    • Fishoilisnowlistedasafoodcategory;

    • Changeshavebeenmadetobeconsistent withchangesinChapters13,16,and17.

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     The recommendations in Chapter 4 for the

    control of pathogens from the harvest area are

    changed as follows:

     The recommendations in Chapter 6 for the

    control of natural toxins are changed as follows:

    • Hydrostaticpressure,individualquickfreezing(IQF)withextendedstorage,

    andirradiationarenowidentifiedasprocessesthataredesignedtoretainrawproductcharacteristicsandthatcanbeusedtoreduceVibrio vulnificus (V.vulnificus )andVibrio parahaemolyticus (V. parahaemolyticus )tonon-detectablelevels;

    • Itisnowrecognizedthatatagonacontainerofshellstock(in-shellmolluscanshellfish)receivedfromanotherdealerneednotidentifytheharvester;

    • Criticallimitsrelatingtocontrolofpathogen

    growthpriortoreceiptofrawmolluscanshellfishbytheprimaryprocessorarenowlinkedtomonitoringthetimethattheshellfishareexposedtoair(i.e.,byharvestorrecedingtide)ratherthantothetimethattheshellfishareharvested;

    • ReferenceisnowmadetotheroleoftheFederal,state,tribal,territorialandforeigngovernmentshellfishcontrolauthoritiesindeterminingwhetherthehazardofV. parahaemolyticus isreasonablylikelytooccurinrawmolluscanshellfishandinthedevelopmentofaV. parahaemolyticus controlplanthatwilldictate,atleasttosomeextent,thenatureofthecontrolsforthispathogeninHACCPplans;

    • Thecontrolstrategyexamplesarerestructuredforimprovedclarity:oneforsourcecontrols(e.g.,tagging,labeling,sourcewaters,harvesterlicensure,andrawconsumptionadvisory)andasecondfortimefromharvesttorefrigerationcontrols.

     The recommendations in Chapter 5 for thecontrol of parasites are changed as follows:

    • Itisnowrecognizedthattheparasitehazardmaybereasonablylikelytooccurinfishraisedinfreshwatercontaininglarvaeofpathogenicliver,lungandintestinalflukesbecausetheseparasitesenterthefishthroughtheskinratherthaninthefood.

    •  AzaspiracidPoisoning(AZP)isnowdescribed,andanactionlevelof0.16mg/kgisnowprovided;

    • Informationregardingpotentialmolluscanshellfishtoxins,pectenotoxins(PTXs)andyessotoxins(YTXs),isnowprovided,althoughFDAhasnospecificexpectationsforcontrolofYTXs;

    •  AnexampleofaHACCPplanisnowprovidedforcontrolofnaturaltoxinsinmolluscanshellfish;

    • TheactionlevelforDiarrheticShellfishPoisoning(DSP)isnowlistedas0.16ppmtotalokadaicacidequivalents;

    •  ActionlevelsforCFParenowlistedas0.01ppbforPacificciguatoxinand0.1ppbforCaribbeanciguatoxin;

    • Itisnownotedthatin2008,FDAadvisedagainsttheconsumptionoflobstertomalleybecauseunusuallyhighlevelsofPSPtoxins weredetectedinthatorganinlobsterscaughtinthewatersofNewEnglandduringaredtideevent;

    • CFPisnowdescribedasbeingassociated

     withconsumptionoftoxin-contaminatedfishfoundintropicalorsubtropicalareasaroundtheworldbetween35°northlatitudeand35°southlatitude,particularlytheCaribbeanSea,PacificOcean,andIndianOceanandintheFlowerGardenBanksareainthenorthernGulfofMexico;

    • Gempylotoxinisnowdescribedasbeingassociatedwithorangeroughy(Hoplostethusatlanticus)andoreodory(Allocyttusspp.,Pseudocyttusspp.andNeocyttusspp.)althoughinlesseramountsthanescolar.

     The recommendations in Chapter 7 for the

    control of scombrotoxin (histamine) formation

    are changed as follows:

    • Informationisnowprovidedaboutthepotentialforscombrotoxin(histamine)

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    formationinproductsliketunasaladthathavebeenallowedtobecomerecontaminatedandthensubjectedtotimeandtemperatureabuse;

    • Therecommendationsregardingon-board

    chillingofscombrotoxin-formingspeciesoffisharenowlistedasfollows:

    Fishexposedtoairorwatertemperaturesabove83°F(28.3°C)shouldbeplacedinice,orinrefrigeratedseawater,iceslurry,orbrineof40°F(4.4°C)orless,assoonaspossibleduringharvest,butnotmorethan6hoursfromthetimeofdeath,or

    °

    Fishexposedtoairandwatertemperaturesof83°F(28.3°C)orlessshouldbeplacedinice,orinrefrigeratedseawater,iceslurry,orbrineof40°F(4.4°C)orless,assoonaspossibleduringharvest,butnotmorethan9hoursfromthetimeofdeath,or

    °

    Fishthataregilledandguttedbeforechillingshouldbeplacedinice,orinrefrigeratedseawater,iceslurry,orbrineof40°F(4.4°C)orless,assoonaspossibleduringharvest,butnotmorethan12hoursfromthetimeofdeath,or

    °

    Fishthatareharvestedunderconditionsthatexposedeadfishtoharvestwatersof65°F(18.3°C)orlessfor24hoursorlessshouldbeplacedinice,refrigeratedseawater,iceslurry,orbrineof40°F(4.4°C)orless,assoonaspossibleafterharvest,butnotmorethanthetimelimitslistedabove,withthetimeperiodstarting whenthefishleavethe65°F(18.3°C)orlessenvironment;

    °

    • Cautionsarenowprovidedthathandlingpracticesandprocessingcontrolsthatarerecommendedassuitableforpreventingtheformationofscombrotoxinmaynotbesufficienttopreventfishfromsufferingqualityorshelf-lifedegradation(i.e.,decomposition)inawaythatmayotherwiserenderitadulteratedundertheFederalFood,Drug,andCosmeticAct;

    • Theloweranteriorportionoftheloinisnowidentifiedasthebestplacetocollectasamplefromlargefishforhistamineanalysis;

    • Fermenting,pickling,smoking,anddryingarenowidentifiedaslikelycriticalcontrol

    points(CCPs)forthishazard;•  Whenfisharecheckedforinternal

    temperatureatoff-loading,itisnowrecommendedthat:

    ° Forfishheldicedorrefrigerated(notfrozen)onboardthevesselandoff-loadedfromthevesselbytheprocessor24ormorehoursafterdeath,theinternaltemperatureshouldbe40°F(4.4°C)orbelow,

    ORForfishheldicedorrefrigerated(notfrozen)onboardthevesselandoff-loadedfromthevesselbytheprocessorfrom15tolessthan24hoursafterdeath,theinternaltemperatureshouldbe50°F(10°C)orbelow,

    °

    OR

    Forfishheldicedorrefrigerated(notfrozen)onboardthevesselandoff-

    loadedfromthevesselbytheprocessorfrom12tolessthan15hoursafterdeath,theinternaltemperatureshouldbe60°F(15.6°C)orbelow;

    °

    • Therecommendedlevelatwhichalotshouldberejectedbasedonsensoryexaminationwhen118fishareexaminedisnowcorrectedtobenomorethan2fishtocoincidewiththegoaloflessthan2.5%decompositioninthelot;

    • Itisnowrecommendedthatthenumberof

    fishsubjectedtosensoryexaminationbeincreasedifthereislikelytobegreaterthannormalvariabilityinthelot,andthatonlyonespeciesconstitutealotforsamplingpurposes;

    •  Whenhistamineanalysisisperformedasacorrectiveaction,itisnowrecommendedthatanyfishfoundtoexceedtheinternal

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    temperatureatreceivingcriticallimitbeincludedinthesample;

    •  Whenthesensorycriticallimithasnotbeenmet,itisnowrecommendedthattheprocessorperformhistamineanalysis

    ofaminimumof60fish,collectedrepresentativelyfromthroughoutthelot,includingallfishinthelotthatshowevidenceofdecomposition,andrejectthelotifanyfisharefoundwithahistaminelevelgreaterthanorequalto50ppm;

    • Subdividingandretestingforhistamineisnolongerrecommendedafteraninitialfailedhistaminetest;

    • Itisnowrecommendedthatemployeeswhoconductsensoryscreeningreceiveadequate

    training;

    • Itisnowrecommendedthatforshipmentsofscombrotoxin-formingspeciesreceivedundericeonopen-bedtrucksbecheckedforbothsufficiencyoficeandinternalproducttemperature;

    • Itisnowrecommendedthatshipmentsofscombrotoxin-formingspeciesreceivedundergelpacksbecheckedforbothadequacyofgelpacksandinternalproducttemperature;

    • Itisnowrecommendedthatifonlytheinternaltemperatureoffishischeckedatreceiptbyasecondaryprocessorbecausethetransittimeisnomorethan4hours,calculationoftransittimeshouldincludealltimeoutsideacontrolledtemperatureenvironment;

    • Itisnowrecommendedthatifonlytheinternaltemperatureoffishischeckedatreceiptbyasecondaryprocessorbecausethetransittimeisnomorethan4hours,

    atemperature-indicatingdevice(e.g.,athermometer)shouldbeusedtodetermineinternalproducttemperaturesinaminimumof12fish,unlesstherearefewerthan12fishinalot,inwhichcaseallofthefishshouldbemeasured;

    •  Whenchecksofthesufficiencyoficeorchemicalcoolingmedia,suchasgelpacks,

    orinternalproducttemperaturesareusedatreceiptoffishfromanotherprocessor,itisnowrecommendedthatthenumberofcontainersexaminedandthenumberofcontainersinthelotberecorded;

    Controlofscombrotoxin(histamine)formationduringprocessingandstoragearenowprovidedasseparatecontrolstrategyexamples,andexamplesofHACCPplansarenowprovidedforbothstrategies;

    • Theextendedexposuretimesduringprocessing(morethan12hours,cumulatively,ifanyportionofthattimeisattemperaturesabove70°F(21.1°C);ormorethan24hours,cumulatively,aslongasnoportionofthattimeisattemperaturesabove

    70°F(21.1°C))previouslyrecommendedforfishthathavebeenpreviouslyfrozenarenowalsorecommendedforfishthathavebeenpreviouslyheattreatedsufficientlytodestroyscombrotoxin-formingbacteriaandaresubsequentlyhandledinamannerwherethereisanopportunityforrecontaminationwithscombrotoxin-formingbacteria;

    • Itisnowacknowledgedthatitmaybepossibletocontrolscombrotoxinformation

    duringunrefrigeratedprocessingusingacriticallimitthatistimeofexposureonly(i.e.,notemperaturecomponent),ifitisdevelopedwithanassumptionthatworst-casetemperatures(e.g.,inexcessof70°F(21.1°C))mayoccur;

    • Chemicalcoolants(e.g.,gelpacks)arenolongerrecommendedforcontroloftemperatureduringin-plantstorage;

    • Forcontroloftimeandtemperatureduringrefrigeratedstorage,itisnownotedthatcriticallimitsthatspecifyacumulativetimeandtemperatureofexposuretotemperaturesabove40°F(4.4°C)arenotordinarilysuitablebecauseofthedifficultyindetermining whenspecificproductshaveenteredandleftthecoolerandthetimeandtemperatureexposurestowhichtheyweresubjected.However,theremaybecircumstanceswhere

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    thisapproachissuitable.Itisalsonotedthatminorvariationsincoolertemperaturemeasurementscanbeavoidedbysubmergingthesensorforthetemperature-recordingdeviceinaliquidthatmimicsthecharacteristicsoftheproduct;

    • High-temperaturealarmsarenolongerrecommendedformonitoringtemperaturesincoolersorprocessingareas;

    •  Whentheadequacyoficeisestablishedasthecriticallimitforrefrigeratedstorage,itisnowrecommendedthatmonitoringbeperformedwithsufficientfrequencytoensurecontrolratherthanatleasttwiceperday.

     The recommendations in Chapter 8 related

    to other decomposition-related hazards are

    changed as follows:

    • ItisnownotedthatFDAhasreceivedconsumercomplaintsconcerningillnessesassociatedwiththeconsumptionofdecomposedsalmon,attributabletotheproductioninthefishoftoxinsotherthanhistamine(e.g.,biogenicamines,suchasputrescineandcadaverine);

    • Itisnownotedthattherearealsosomeindicationsthatchemicalsformedwhenfats

    andoilsinfoodsoxidizemaycontributetolong-termdetrimentalhealtheffects.

     The recommendations in Chapter 9 for the

    control of environmental chemical contaminants

    and pesticides are changed as follows:

    • Toxicelementguidancelevelsforarsenic,cadmium,lead,andnickelarenolongerlisted;

    • Tolerancelevelsforendothallanditsmonomethylesterinfishandcarbarylinoystersarenowlisted;

    • Thecollectionofsoilsamplesfromaquacultureproductionsitesisnolongerlistedasapreventivemeasure;

    •  AnexampleofaHACCPplanisnowprovidedforcontrolofenvironmentalchemicalcontaminantsinmolluscanshellfish;

    •  Whentestingforenvironmentalchemicalcontaminantsandpesticidesisusedasthecontrolmeasure,itisnowrecommendedthattheadequacyofthetestingmethodsandequipmentbeverifiedperiodically(e.g.,bycomparingresultswiththoseobtainedusinganAssociationofOfficialAnalyticalChemists(AOAC)orequivalentmethod,orbyanalyzingproficiencysamples).

    Chapter 10, which covers the control of

    methylmercury, has been rewritten to

    acknowledge that FDA is receiving comments

    on a draft quantitative risk assessment

    for methylmercury, which may result in a

    reassessment of its risk management strategies.

     The recommendations in Chapter 11 for thecontrol of aquaculture drugs are changed as

    follows:

    • Thepotentialforthishazardtooccurduringtransportationoflivefishisnowrecognized,andrecommendedcontrolsareprovided;

    •  Anexplanationofextra-labeluseofdrugsisnowprovided,andalistofdrugsprohibitedforextra-labeluseisnowlisted;

    • FDAhighenforcementpriorityaquaculture

    drugsarenowlisted;•  Aquaflor®TypeAMedicatedArticle

    (florfenicol)isnowlistedasanapproveddrugforcatfishandsalmonids;

    •  Aquaflor®CA1isnowlistedasanapproveddrugforcatfishorinfingerlingtofoodfishasthesolerationfor10consecutivedays.

    • 35%PEROX-AID®(hydrogenperoxide)isnowlistedasanapproveddrugforfreshwater-rearedsalmonidsandfreshwater-

    rearedcoolwaterfinfishandchannelcatfish;• Terramycin®200forFish(oxytetracycline

    dihydrate)TypeC,isnowlistedasanapproveddrugforcatfish,salmonids;andlobster;

    • OxyMarine™,OxytetracyclineHClSolublePowder-343,Terramycin-343,TETROXYAquaticisnowlistedasanapproveddrugforallfinfishfryandfingerlingsasanaidinidentification;

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    • Quarterlyrawmaterial,in-process,orfinishedproducttestingisnowrecommendedasaverificationstepforcontrolstrategiesinvolvingreviewofsuppliers’certificatesatreceiptofrawmaterials,reviewofrecordsofdruguseatreceiptofrawmaterials,andon-farmvisits;

    •  Whentestingforaquaculturedrugsisusedasthecontrolmeasure,itisnowrecommendedthattheadequacyofthetestingmethodsandequipmentbeverifiedperiodically(e.g.,bycomparingresultswiththoseobtainedusinganAOACorequivalentmethod,orbyanalyzingproficiencysamples).

     The recommendations in Chapter 12 for the

    control of pathogenic bacteria growth and

    toxin formation (other than C. botulinum) as

    a result of time and temperature abuse are

    changed as follows:

    • ItisnowrecognizedthatV. vulnificus ,V. parahaemolyticus ,andVibrio cholaraenon-O1andnon-0139aregenerallyassociatedwithmarineandestuarinespeciesoffishandmaynotbereasonablylikelytooccurinfreshwaterspeciesornon-fishery

    ingredients,unlesstheyhavebeencross-contaminated;

    • Itisnowclarifiedthatproductsthatarepartiallycookedtosetthebatterorbreadingorstabilizetheproductshape(e.g.,fishballs,shrimpeggrolls,andbreadedfishportions)arenotconsideredtobereadytoeat;

    • InformationisnowprovidedonthedeterminationofCCPsforproductsthatareacombinationofraw,ready-to-eatandcooked,ready-to-eatfisheryingredients;

    • Controloftimeandtemperatureabuseatreceipt,duringcoolingaftercooking,duringunrefrigeratedprocessing,andduringrefrigeratedstorageandprocessingarenowprovidedasfourseparatecontrolstrategyexamples.ExamplesofHACCPplansarenowprovidedforallfourstrategies;

    • Forcontroloftransitconditionsatreceiptofready-to-eatfishorfisheryproductsdeliveredrefrigerated(notfrozen),itisnowrecommendedthatalllotsbeaccompaniedbytransportationrecordsthatshowthatthefishwereheldatorbelowanambientorinternaltemperatureof40°F(4.4°C)throughouttransitor,fortransittimesof4hoursorless,thattheinternaltemperatureofthefishattimeofreceiptwasatorbelow40°F(4.4°C);

    • Forcontroloftimeandtemperatureduringrefrigeratedstorageandrefrigeratedprocessing,itisnownotedthatcriticallimitsthatspecifyacumulativetimeandtemperatureofexposuretotemperatures

    above40°F(4.4°C)arenotordinarilysuitablebecauseofthedifficultyindetermining whenspecificproductshaveenteredandleftthecoolerandthetimeandtemperatureexposurestowhichtheyweresubjected.However,theremaybecircumstanceswherethisapproachissuitable.Itisalsonotedthatminorvariationsincoolertemperaturemeasurementscanbeavoidedbysubmergingthesensorforthetemperature-recordingdeviceinaliquidthatmimicsthe

    characteristicsoftheproduct;• Itisnowrecommendedthatifonlythe

    internaltemperatureofthefisheryproductischeckedatreceipt,becausethetransittimeisnomorethan4hours,calculationoftransittimeshouldincludealltimeoutsideacontrolledtemperatureenvironment;

    • Itisnowrecommendedthatifonlytheinternaltemperatureofproductischeckedatreceiptbyasecondaryprocessorbecausethetransittimeisnomorethan4hours,atemperature-indicatingdevice(e.g.,athermometer)shouldbeusedtodetermineinternalproducttemperaturesinaminimumof12containers(e.g.,cartonsandtotes),unlesstherearefewerthan12containersinalot,inwhichcaseallofthecontainersshouldbemeasured;

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     Alternatively,exposuretime(i.e.,timeatinternaltemperaturesabove50°F(10°C)butbelow135ºF(57.2ºC))shouldbelimitedto4hours,aslongasnomorethan2ofthosehoursarebetween70°F(21.1°C)and135ºF(57.2ºC),

     

    •  Whenchecksofthesufficiencyoficeorchemicalcoolingmedia,suchasgelpacks,orinternalproducttemperaturesareusedatreceiptoffishfromanotherprocessor,itisnowrecommendedthatthenumberofcontainersexaminedandthenumberofcontainersinthelotberecorded;

    • Chemicalcoolants(e.g.,gelpacks)arenolongerrecommendedforcontroloftemperatureduringin-plantstorage;

    • Recommendedcumulativeexposuretimesandtemperatures(i.e.,criticallimits)arenowlistedasfollows:

    For raw, ready-to-eat products:

    Ifatanytimetheproductisheldatinternaltemperaturesabove70°F(21.1°C),exposuretime(i.e.,timeatinternaltemperaturesabove50°F(10°C)butbelow135ºF(57.2ºC))shouldbelimitedto2hours(3hoursifStaphylococcus aureus (S. aureus )istheonlypathogenofconcern),

    °

    OR

    OR

    Iftheproductisheldatinternaltemperaturesabove50°F(10°C),butneverabove70°F(21.1°C),exposuretimeatinternaltemperaturesabove50°F(10°C)shouldbelimitedto5hours(12hoursifS.

    aureus istheonlypathogenofconcern),

    °

    OR

    Theproductisheldatinternaltemperaturesbelow50°F(10°C),

    °

    OR

     Alternatively,theproductisheldatambientairtemperaturesbelow50°F(10°C)throughoutprocessing;

    For cooked, ready-to-eat products:

    Ifatanytimetheproductisheldatinternaltemperaturesabove80°F(27.2°C),exposuretime(i.e.,timeatinternaltemperaturesabove50°F(10°C)butbelow135ºF(57.2ºC))shouldbelimitedto1hour(3hoursifS.aureusistheonlypathogenofconcern),

    °

    OR

     Alternatively,ifatanytimetheproductisheldatinternaltemperaturesabove

    80°F(26.7°C),exposuretime(i.e.,timeatinternaltemperaturesabove50°F(10°C)butbelow135ºF(57.2ºC))shouldbelimitedto4hours,aslongasnomorethan1ofthosehoursisabove70°F(21.1°C),

    OR

    Ifatanytimetheproductisheldatinternaltemperaturesabove70°F(21.1°C),butneverabove80°F(26.7°C),

    exposuretimeatinternaltemperaturesabove50°F(10°C)shouldbelimitedto2hours(3hoursifS. aureus istheonlypathogenofconcern),

    °

    OR

     Alternatively,iftheproductisneverheldatinternaltemperaturesabove80°F(26.7°C),exposuretimesatinternaltemperaturesabove50°F(10°C)shouldbelimitedto4hours,aslongasnomorethan2ofthose

    hoursareabove70°F(21.1°C),OR

    Iftheproductisheldatinternaltemperaturesabove50°F(10°C),butneverabove70°F(21.1°C),exposuretimeatinternaltemperaturesabove50°F(10°C)shouldbelimitedto5hours(12hoursifS.aureus istheonlypathogenofconcern),

    °

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    OR

    Theproductisheldatinternaltemperaturesbelow50°F(10°C),

    °

    OR

     Alternatively,theproductisheldatambientairtemperaturesbelow50°F(10°C)throughoutprocessing;

    • High-temperaturealarmsarenolongerrecommendedformonitoringtemperaturesincoolersorprocessingareas;

    •  Whentheadequacyoficeisestablishedasthecriticallimitforrefrigeratedstorage,itisnowrecommendedthatmonitoringbeperformedwithsufficientfrequencytoensurecontrolratherthanatleasttwiceperday;

    • Itisnowrecommendedthatmonitoringshipmentsreceivedundergelpacksincludebothadequacyofgelpacksandinternalproducttemperature.

     The recommendations in Chapter 13 for the

    control of C. botulinum toxin formation are

    changed as follows:

    • InformationisnowprovidedonTime-TemperatureIndicator(TTI)performanceandsuitability;

    •  AcontrolstrategyisnowprovidedforapplicationofTTIsoneachofthesmallestpackageunits(i.e.,theunitofpackagingthat willnotbedistributedanyfurther,usuallyconsumerorend-userpackage),whererefrigerationisthesolebarriertopreventtoxinformation;

    • Itisnolongerrecommendedthatconsiderationbegiventowhetherthefinishedproductwillbestoredand

    distributedfrozenwhendeterminingwhetherthehazardissignificant.Acontrolstrategyisnowprovidedtoensurethatfrozenproductsareproperlylabeledwhenfreezingisthesolebarriertopreventtoxinformation;

    • Processorsarenowadvisedtotakeparticularcareindeterminingthesafetyofapackagingmaterialforaproductinwhich(1)the

    spoilageorganismshavebeeneliminatedorsignificantlyreducedbysuchprocessesashighpressureprocessingand(2)refrigerationisthesolebarriertotoxinformation.Thegenerallyrecommended10,000cc/m 2 /24hoursat24ºCoxygentransmissionratesmaynotbesuitableinthiscase;

    • High-temperaturealarmsarenolongerrecommendedformonitoringtemperaturesincoolersorprocessingareas;

    • Chemicalcoolants(e.g.,gelpacks)arenolongerrecommendedforcontroloftemperatureduringin-plantstorage;

    •  Whentheadequacyoficeisestablishedasthecriticallimitforrefrigeratedstorage,itisnowrecommendedthatmonitoring

    beperformedwithsufficientfrequencytoensurecontrolratherthanatleasttwiceperday;

    • Itisnowrecommendedthatawaterphasesaltlevelof20%beachievedinshelf-stable,reducedoxygenpackagedproductsinwhichsaltistheonlybarriertopathogenicbacteriagrowthandtoxinformation;

    • Itisnowrecommendedthatmonitoringshipmentsreceivedundergelpacksinclude

    bothadequacyofgelpacksandinternalproducttemperature;

    • Itisnowrecommendedthatifonlytheinternaltemperatureofthefisheryproductischeckedatreceipt,becausethetransittimeisnomorethan4hours,calculationoftransittimeshouldincludealltimeoutsideacontrolledtemperatureenvironment;

    • Itisnowrecommendedthatifonlytheinternaltemperatureofproductischeckedatreceiptbyasecondaryprocessorbecause

    thetransittimeisnomorethan4hours,atemperature-indicatingdevice(e.g.,athermometer)shouldbeusedtodetermineinternalproducttemperaturesinaminimumof12containers(e.g.,cartonsandtotes),unlesstherearefewerthan12containersinalot,inwhichcaseallofthecontainersshouldbemeasured;

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    •  Acontrolstrategyexampleisnowprovidedforreceiptbyasecondaryprocessorofrefrigeratedreducedoxygenpackagedproductsthatmaybestoredandfurtherdistributedorusedasaningredientforfurtherprocessing;

    • Itisnowclarifiedthatbriningtimeshouldbemonitoredduringtheprocessingofsmokedfish;

    • Itisnowrecommendedthatbrinebetreatedtominimizemicrobialcontaminationorbeperiodicallyreplacedasagoodmanufacturingpracticecontrol.

     The recommendations in Chapter 14 for the

    control of pathogenic bacteria growth and

    toxin formation as a result of inadequatedrying are changed as follows:

    • Itisnolongerrecommendedthatconsiderationbegiventowhetherthefinishedproduct willbestoredanddistributedfrozen(inthecaseofreducedoxygenpackagedproducts)orrefrigerated(inthecaseofaerobicallypackagedproducts)whendeterminingwhetherthehazardissignificant.Acontrolstrategytoensurethatrefrigerateddriedproductsareproperlylabeledwhenrefrigerationisthesole

    barriertotoxinformationisnowprovided.AcontrolstrategytoensurethatfrozenproductsareproperlylabeledwhenfreezingisthesolebarriertotoxinformationisnowprovidedinChapter13.

     The recommendations in Chapter 15 for the

    control of S. aureus toxin formation in hydrated

     batter mixes are changed as follows:

    • ThenumberofS. aureus organismsnormallyneededtoproducetoxinisnowlistedas

    500,000to1,000,000pergram;• High-temperaturealarmsarenolonger

    recommendedformonitoringtemperaturesinprocessingareas.

     The recommendations in Chapter 16 for the

    control of pathogenic bacteria survival through

    cooking are changed as follows:

    • Theseparatechaptersthatpreviouslycoveredpathogensurvivalthroughcookingandpathogensurvivalthroughpasteurizationarenowcombined;

    • Pasteurizationisnowdefinedasaheat

    treatmentappliedtoeliminatethemostresistantpathogenofpublichealthconcernthatisreasonablylikelytobepresentinfood;

    • InformationisnowprovidedforanoptiontomonitorEnd-PointInternalProductTemperature,insteadofcontinuoustimeandtemperaturemonitoringduringcookingorpasteurization,whenascientificstudyhasbeenconductedtovalidatethatitwillprovidea6Dprocessforthetargetpathogen;

    • Forsurimi-basedproducts,soups,orsauces,thefollowingpasteurizationprocessisnowrecommended:aminimumcumulative,totallethalityofF194°F(F90°C)=10minutes, wherez=12.6°F(7°C)fortemperatureslessthan194°F(90°C),andz=18°F(10°C)fortemperaturesabove194°F(90°C);

    • Fordungenesscrabmeat,thefollowingpasteurizationprocessisnowrecommended:aminimumcumulativetotallethalityofF

    194°F

    (F90°C)=57minutes,wherez=15.5°F(8.6°C);• Informationconcerninglevelsof Listeria

    monocytogenes ( L. monocytogenes )infoodsisnowupdatedbasedonthefinalFDA/U.S.DepartmentofAgriculture L. monocytogenesriskassessment.

    Chapter 17 is a new chapter that contains

    guidance for the control of pathogen survival

    through processes designed to retain raw

    product characteristics, including high

    hydrostatic pressure processing, mild heat

    processing, IQF with extended frozen storage,

    and irradiation. At present, the chapter applies

    exclusively to the processing of molluscan

    shellfish products for which there is a desire

    to retain raw product characteristics. However,

    these technologies may have other applications

    as well.

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     The recommendations in Chapter 18 for the

    control of the introduction of pathogenic

     bacteria after pasteurization and specialized

    cooking processes are changed as follows:

    • Itisnolongerrecommendedthatconsideration

    begiventowhetherthefinishedproduct willbestoredanddistributedfrozenwhendeterminingwhetherthehazardissignificant. AcontrolstrategytoensurethatfrozenproductsareproperlylabeledwhenfreezingisthesolebarriertopreventC. botulinumtoxinformationisnowprovidedinChapter13.

    • Theuseofsulfitingagentsinconchmeatisnowidentifiedasareasonablylikelyhazard.

     The recommendations in Chapter 20 for the

    control of metal inclusion are changed as

    follows:

     The recommendations in Chapter 19 for the

    control of undeclared food allergens and

    intolerance substances and prohibited food

    and color additives are changed as follows:•  Additionalexplanatorymaterialonfood

    allergensisnowincluded,withinformationontheFoodAllergenLabelingandConsumerProtectionActof2004anditsimpactonpreventivecontrolsforallergens;

    •  Additionalinformationisnowprovidedonthefactorstobeconsideredinjudgingwhenthepresenceofcertainfoodintolerancesubstancesandprohibitedfoodandcoloradditivesisorisnotreasonablylikelytooccur,suchasthehistoricaluseofthesubstanceandtheexpectedlevelofsulfitingagentintheformulatedfinishedfood;

    •  Additionalinformationisnowprovidedonregulatoryrequirementsforfoodadditives.

    • Correctiveactionsarenowexpandedtoincludestepsthatshouldbetakentoregaincontrolovertheoperationafteracriticallimitdeviation,forconsistencywithguidanceintheotherchapters;

    • Itisnowrecommendedthatfinishedproductlabelsbecheckedattimeoflabelingratherthanattimeoflabelreceiving;

    • Itisnowrecommendedthatfinishedproducttestingbeincludedasaverificationstep whenreviewofsuppliers’labelingisusedasamonitoringprocedureforthepresenceofsulfitingagents;

    • Foreignobjectslessthan0.3inch(7mm)arenowidentifiedashavingapotentialforcausingtraumaorseriousinjurytopersonsinspecialriskgroups,suchasinfants,surgerypatients,andtheelderly;

    •  Additionalinformationoncalibrationand validationofelectronicmetaldetectorsisnowprovided;

    •  Wiremeshbasketsarenolongerusedasanexampleofanunlikelysourceofmetal

    fragments;• Therecommendedcriticallimitforthemetal

    detectionorseparationcontrolstrategyhasbeenexpandedtoread,“Allproductpassesthroughanoperatingmetaldetectionorseparationdevice,”and“Nodetectablemetalfragmentsinaproductpassingthroughthemetaldetectionorseparationdevice.” Asaresult,therecommendedmonitoringproceduresarealsoexpandedsothattheynowaredesignedtoalsoensurethattheprocessesareinplaceandoperating;

    • Itisnowrecommendedthatwhenmetalfragmentsarefoundinaproductbyametaldetectororseparatedfromtheproductstreambymagnets,screens,orotherdevices,thesourceofthefragmentislocatedandcorrected.

     The recommendations in Chapter 21 for the

    control of glass inclusion are changed as follows:

    • Thischapterisnolongeridentifiedasadraft;

    • Theuseofx-raydetectiondevicesisnolongerrecommendedasareliablemethodforcontrollingglassinclusion;

    • Therecommendedcriticallimitfortheglasscontainercleaningandvisualinspectioncontrolstrategyhasbeenexpandedtoread,“Allcontainerpassthroughanoperatingglasscontainerinspectionorcleaning

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    process,”and“NodetectableglassfragmentsinglasscontainerspassingtheCCP.”Asaresult,therecommendedmonitoringproceduresarealsoexpandedsothattheynowaredesignedtoalsoensurethattheprocessesareinplaceandoperating;

    • Themonitoringproceduresfortheglasscontainercleaningandvisualinspectioncontrolstrategynowincludearecommendationthatarepresentativesampleofthecleanedorinspectedcontainersbeexaminedatthestartofprocessing,every4hoursduringprocessing,attheendofprocessing,andafteranybreakdowns;

    • Itisnowrecommendedthatmonitoringforthepresenceofglassbeperformedatthe

    startofeachproductiondayandaftereachshiftchange.

    • Itisnowrecommendedthatarepresentativesampleofcleanedorinspectedglasscontainersbeexamineddaily,atthestartofprocessing,every4hoursduringprocessing,attheendofprocessing,andafteranybreakdowns.

     The Hazard Analysis Worksheet in Appendix

    1 has been changed for consistency with the

     worksheet in the “HACCP: Hazard AnalysisCritical Control Point Training Curriculum,”

    developed by the Seafood HACCP Alliance for

     Training and Education.

     The recommendations in Appendix 4 for

     bacterial pathogen growth and inactivation are

    changed as follows:

    • RecommendedsummarycumulativeexposuretimesandtemperaturesarenowlistedasdescribedaboveforChapter12;

    • ThemaximumwaterphasesaltlevelforgrowthofCampylobacter jejuni isnowlistedas1.7%;

    • Themaximumlevelofacidity(pH)forgrowthofpathogenicstrainsof Escherichiacoli ( E. coli )isnowlistedas10;

    • Themaximumrecommendedcumulative

    exposuretimesfor Bacillus cereus arenowlistedasfollows:5daysattemperaturesof39.2to43°F(4to6°C);1dayattemperaturesof44to59°F(7to15°C);6hoursattemperaturesof60to70°F(16to21°C);and3hoursattemperaturesabove70°F(21°C);

    • Themaximumcumulativeexposuretimesfor E. coli, Salmonella,andShigella spp.arenowlistedasfollows:2daysfortemperaturesfromtheirminimumgrowthtemperature41.4to50°F(10°C);5hoursfortemperaturesof51to70°F(11to21°C);and2hoursfortemperaturesabove70°F(21°C);

    • Themaximumcumulativeexposuretimesfor Listeria monocytogenes arenowlistedasfollows:7daysfortemperaturesof31.3

    to41ºF(-0.4to5ºC);1dayfortemperaturesof42to50°F(6to10°C);7hoursfortemperaturesof51to70°F(11to21°C);3hoursfortemperaturesof71to86°F(22to30°C);and1hourfortemperaturesabove86°F(30°C);

    • ThemaximumcumulativeexposuretimesforVibrio cholerae ,V. vulnificus ,andV. parahaemolyticus arenowlistedasfollows:21daysfortemperaturesfromtheirminimum

    growthtemperatureto50°F(10°C);6hoursfortemperaturesof51to70°F(11to21°C);2hoursattemperaturesof71to80°F(22to26.7°C);and1hourattemperaturesabove80°F(26.7°C),withthelasttemperaturerangeapplyingonlytocooked,ready-to-eatproducts.

     The safety levels listed in Appendix 5, Table

     A-5, “FDA and EPA Safety Levels in Regulations

    and Guidance,” are changed as follows:

    • Toxicelementguidancelevelsforarsenic,

    cadmium,lead,andnickelarenolongerlisted;

    • Tolerancelevelsforendothallanditsmonomethylesterinfishandcarbarylinoystersarenowlisted;

    •  AtolerancelevelforFlorfenicolinchannelcatfishandfreshwater-rearedsalmonidsisnowlisted;

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    • Thetoleranceforoxytetracyclineisnowcorrectedtoapplytoallfinfishandlobster;

    • Thetoleranceforsulfamerazineisnowcorrectedtoapplytotrout;

    •  Alistofdrugsprohibitedforextra-labeluse

    isnowprovided;• V. parahaemolyticus andV. vulnificus levels

    arenowlistedforpost-harvestprocessedmolluscanshellfish.

     Appendix 6 no longer lists food allergens. It

    now contains a table of Japanese and Hawaiian

     vernacular names and their corresponding U.S.

    market names.

     Appendix 7 no longer lists the bibliography. It

    now contains information regarding the publichealth impacts of bacterial and viral pathogens

    of greatest concern in seafood processing.

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    NOTES:

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    CHAPTER1:GeneralInformation

    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.

    THEGUIDANCE

    ThisisthefourtheditionoftheFoodandDrug Administration’s(FDA’s)“FishandFisheryProductsHazardsandControlsGuidance.”ThisguidancerelatestoFDA’sFishandFisheryProductsregulation(calledtheSeafoodHACCPRegulation,21CFR123,inthisguidancedocument)andtheControlofCommunicableDiseasesregulation,21CFR1240,thatrequireprocessorsoffishandfisheryproductstodevelopandimplementHACCPsystemsfortheiroperations.Thosefinalregulationswerepublishedinthe Federal RegisteronDecember18,1995,andbecameeffectiveonDecember18,1997.ThecodifiedportionoftheregulationsisincludedinAppendix8.

    Thisguidanceisbeingissuedasacompanion

    documentto“HACCP:HazardAnalysisCriticalControlPointTrainingCurriculum,”whichwasdevelopedbytheSeafoodHACCPAllianceforTrainingandEducation.TheAllianceisanorganizationoffederalandstateregulators,includingFDA,academia,andtheseafoodindustry.FDArecommendsthatprocessorsoffishandfisheryproductsusethetwodocumentstogetherinthedevelopmentofaHACCPsystem.

    ThisguidancedocumentwillbemaintainedontheFDA.GOVwebsite,whichshouldbeconsultedforsubsequentupdates.

    Copiesofthetrainingdocumentmaybepurchasedfrom:

    Florida Sea GrantIFAS-ExtensionBookstore

    UniversityofFloridaP.O.Box110011Gainesville,FL32611-0011(800)226-1764

    Or

    www.ifasbooks.com 

    Oryoumaydownloadacopyfrom:

    http://www.fda.gov/FoodGuidances  

    CHAPTER1:GeneralInformation

    19

    http://www.ifasbooks.com/http://www.fda.gov/FoodGuidanceshttp://www.fda.gov/FoodGuidanceshttp://www.ifasbooks.com/

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    NOTES:

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    CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan

    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 discussan 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.

    THEHACCPPLANFORM

    Thisguidancedocumentisdesignedtowalk youthroughaseriesof18stepsthatwillyieldacompletedHazardAnalysisCriticalControlPoint(HACCP)plan.AblankHACCPPlanFormis

    containedinAppendix1.Notethatthisisatwo-pageform,withthesecondpagetobeusedif yourprocesshasmorecriticalcontrolpointsthancanbelistedononepage.TheProceduresfortheSafeandSanitaryProcessingandImportingofFishandFisheryProductsregulation,21CFR123(hereinafter,theSeafoodHACCPRegulation),requiresthatyouprepareaHACCPplanforfishandfisheryproductsthatyouprocessiftherearesignificantfoodsafetyhazardsassociatedwiththeproducts.Theregulationdoesnotrequirethatyou

    usetheformincludedinAppendix1.However,usingthisstandardizedformmayhelpyoudevelopanacceptableplanandwillexpediteregulatoryreview.AseparateHACCPplanshouldbedevelopedforeachlocationwherefishandfisheryproductsareprocessedandforeachkindoffishandfisheryproductprocessedatthatlocation.YoumaygroupproductstogetherinasingleHACCPplanifthefoodsafetyhazardsandcontrolsarethesameforallproductsinthegroup.

    THEHAZARDANALYSISWORKSHEET

    InordertocompletetheHACCPPlanForm, youwillneedtoperformaprocesscalledhazardanalysis.TheSeafoodHACCPRegulationrequiresthatallseafoodprocessorsconduct,

    orhaveconductedforthem,ahazardanalysistodeterminewhethertherearefoodsafetyhazardsthatarereasonablylikelytooccurintheirproductandtothepreventivemeasuresthataprocessorcanapplytocontrolthosehazards(21CFR123.6(a)).FDAhasfoundthattheuseofastandardizedHazardAnalysisWorksheetassistswiththisprocess.AblankHazardAnalysis WorksheetiscontainedinAppendix1.Notethatthisisalsoatwo-pageform,withthesecondpagetobeusedifyourprocesshasmoreprocessing

    stepsthancanbelistedononepage.TheSeafoodHACCPRegulationdoesnotrequirethatthehazardanalysisbekeptinwriting.However,FDAexpectsthatawrittenhazardanalysiswillbeusefulwhenyouperformmandatoryHACCPplanreassessmentsandwhenyouareaskedbyregulatorstojustifywhycertainhazardswereor werenotincludedinyourHACCPplan.

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    THESTEPS PRELIMINARYSTEPS

    FollowingisalistofthestepsthatthisguidanceusesinHACCPplandevelopment:

    STEP1:Providegeneralinformation.

    • Preliminary Steps

    Providegeneralinformation;°Describethefood;°Describethemethodofdistributionand°storage;

    Identifytheintendeduseandconsumer;°Developaflowdiagram.°

    • Hazard Analysis Worksheet

    SetuptheHazardAnalysisWorksheet;°Identifypotentialspecies-relatedhazards;

    ° Identifypotentialprocess-relatedhazards;°Understandthepotentialhazard;°Determinewhetherthepotentialhazard°issignificant;

    Identifycriticalcontrolpoints.°• HACCP Plan Form

    SetuptheHACCPPlanForm;°Setcriticallimits;°Establishmonitoringprocedures:

    ° •  What,

    • How,

    • Frequency,

    •  Who;

    Establishcorrectiveactionprocedures;°Establisharecordkeepingsystem;°Establishverificationprocedures.°

    Recordthenameandaddressofyourprocessing

    facilityinthespacesprovidedonthefirstpageofboththeHazardAnalysisWorksheetandtheHACCPPlanForm(Appendix1).

    STEP2:Describethefood.

    IdentifythemarketnameorLatinname(species)ofthefisherycomponent(s)oftheproduct.

     Examples:

    • Tuna (Thunnus albacares);

    • Shrimp (  Pandals spp.);

    •  Jack mackerel (Trachurus spp.).

    Fullydescribethefinishedproductfood.

     Examples:

    •  Individually quick frozen, cooked, peeled

     shrimp;

    •  Fresh tuna steaks;

    •  Frozen, surimi-based, imitation king crab

    legs;

    •  Fresh, raw drum, in-the-round;

    •  Raw shrimp, in-shell;•  Raw, shucked clams;

    •  Fresh seafood salad, with shrimp and blue

    crabmeat;

    •  Frozen, breaded pollock sticks;

    •  Frozen crab cakes.

    Describethepackagingtype.

     Examples:

    • Vacuum-packaged plastic bag;

     Aluminum can;•  Bulk, in wax-coated paperboard box;

    •  Plastic container with snap lid.

    RecordthisinformationinthespaceprovidedonthefirstpageofboththeHazardAnalysis WorksheetandtheHACCPPlanForm.

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    STEP3:Describethemethodofdistributionandstorage.

    Identifyhowtheproductisdistributedandstoredafterdistribution.

     Examples:• Stored and distributed frozen;

    •  Distributed on ice and then stored under

    refrigeration or on ice.

    RecordthisinformationinthespaceprovidedonthefirstpageofboththeHazardAnalysis WorksheetandtheHACCPPlanForm.

    STEP4:Identifytheintendeduseandconsumer.

    Identifyhowtheproductwillbeusedbytheenduserorconsumer.

     Examples:

    • To be heated (but not fully cooked) and

     served;

    • To be eaten with or without further cooking;

    • To be eaten raw or lightly cooked;

    • To be fully cooked before consumption;

    • To be further processed into a heat and serve

     product.

    Identifytheintendedconsumeroruseroftheproduct.Theintendedconsumermaybethegeneralpublicoraparticularsegmentofthepopulation,suchasinfantsortheelderly.Theintendedusermayalsobeanotherprocessorthat willfurtherprocesstheproduct.

     Examples:

    •  By the general public;

    •  By the general public, including some

    distribution to hospitals and nursing homes;•  By another processing facility.

    RecordthisinformationinthespaceprovidedonthefirstpageofboththeHazardAnalysis WorksheetandtheHACCPPlanForm.

    STEP5:Developaflowdiagram.

    Thepurposeofthediagramistoprovideaclear,simpledescriptionofthestepsinvolvedintheprocessingofyourfisheryproductanditsassociatedingredientsasthey“flow”fromreceipt

    todistribution.Theflowdiagramshouldcoverallstepsintheprocessthatyourfirmperforms.Receivingandstoragestepsforeachoftheingredients,includingnon-fisheryingredients,shouldbeincluded.Theflowdiagramshouldbe verifiedon-siteforaccuracy.

    FigureA-1(Appendix2)isanexampleofaflowdiagram.

    HAZARDANALYSISWORKSHEET

    STEP6:SetuptheHazardAnalysisWorksheet.

    Recordeachoftheprocessingsteps(fromtheflowdiagram)inColumn1oftheHazard AnalysisWorksheet.

    STEP7:Identifythepotentialspecies-relatedhazards.

    Biological,chemical,andphysicalhazardscanaffectthesafetyoffisheryproducts.Somefoodsafetyhazardsareassociatedwiththeproduct(e.g.,thespeciesoffish,thewayinwhichthefishisraisedorcaught,andtheregionofthe worldfromwhichthefishoriginates).Thesehazardsareintroducedoutsidetheprocessingplantenvironmentbefore,during,orafterharvest.Thisguidancereferstotheseas“speciesrelatedhazards.”Otherfoodsafetyhazardsareassociatedwiththewayinwhichtheproduct

    isprocessed(e.g.,thetypeofpackaging,themanufacturingsteps,andthekindofstorage).Thesehazardsareintroducedwithintheprocessingplantenvironment.Thisguidancereferstotheseas“process-relatedhazards.”TheyarecoveredinStep8.

    FindinTable3-2(Chapter3)orTable3-3(Chapter3)themarketname(Column1)or

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     Latinname(Column2)oftheproductthatyouidentifiedinStep2.UseTable3-2forvertebrates(animalswithbackbones)suchasfinfish.UseTable3-3forinvertebrates(animalswithoutbackbones)suchasshrimp,oysters,crabs,andlobsters.Determinewhetherthespecieshasapotentialspecies-relatedhazardbylookingfora“√”mark(orone-orthree-lettercodesforanaturaltoxin)intheright-handcolumnsofthetable.Ifitdoes,recordthepotentialspecies-relatedhazard(s)inColumn2oftheHazard AnalysisWorksheet,ateveryprocessingstep.

    Tables3-2and3-3includethebestinformationcurrentlyavailabletoFDAconcerninghazardsthatarespecifictoeachspeciesoffish.Youshoulduse yourownexpertise,orthatofoutsideexperts,as

    necessary,toidentifyanyhazardsthatmaynotbeincludedinthetable(e.g.,thosethatmaybeneworuniquetoyourregion).Youmayalreadyhaveeffectivecontrolsinplaceforanumberofthesehazardsaspartofyourroutineortraditionalhandlingpractices.Thepresenceofsuchcontrolsdoesnotmeanthatthehazardisnotsignificant.Thelikelihoodofahazardoccurringshouldbejudgedintheabsenceofcontrols.Forexample,thefactthatscombrotoxin(histamine)developmentinaparticularspeciesoffishhasnotbeennoted

    maybetheresultof(1)theinabilityofthefishtoproducehistamineor(2)theexistenceofcontrolsthatarealreadyinplacetopreventitsdevelopment(e.g.,harvestvesseltimeandtemperaturecontrols).Inthefirstcase,thehazardisnotreasonablylikelytooccur.Inthesecondcase,thehazardisreasonablylikelytooccur,andthecontrolsshouldbeincludedintheHACCPplan.

    STEP8:Identifypotentialprocess-relatedhazards.

    FindinTable3-4(Chapter3)thefinishedproductfood(Column1)andpackagetype(Column2)thatmostcloselymatchtheinformationthatyoudevelopedinSteps2and3.Recordthepotentialhazard(s)listedinthetableforthatproductinColumn2oftheHazardAnalysisWorksheet,ateveryprocessingstep.

     YoumayneedtoincludepotentialhazardsformorethanonefinishedproductfoodcategoryfromTable3-4,whichwillhappenwhenyourproductfitsmorethanonedescription.Forexample,ifyoucookshrimpanduseittoprepareafinishedproductsalad,youshouldlookatboththe“cookedshrimp”andthe“salads…preparedfromready-to-eatfisheryproducts”categoriesinTable3-4,Column1.PotentialhazardsfrombothfinishedproductfoodcategoriesapplytoyourproductandshouldbelistedinColumn2oftheHazardAnalysisWorksheet.

    Table3-4includesthebestinformationcurrentlyavailabletoFDAconcerninghazardsthatarerelatedtospecificprocessingtechniques.Youshoulduseyourownexpertise,orthatofoutside

    expertsasnecessary,toidentifyanyhazardsthatmaynotbeincludedinthetable(e.g.,thosethatareneworuniquetoyourphysicalplant,equipment,orprocess).

    STEP9:Understandthepotentialhazard.

    Consultthehazardsandcontrolschaptersofthisguidancedocument(Chapters4through7,9,and11through21)foreachofthepotentialhazardsthatyouenteredinColumn2ofthe

    HazardAnalysisWorksheet.ThesechaptersofferguidanceforcompletingyourhazardanalysisanddevelopingyourHACCPplan.Eachchaptercontainsasection,“UnderstandthePotentialHazard,”thatprovidesinformationaboutthesignificanceofthehazard,theconditionsunder whichitmaydevelopinafisheryproduct,andmethodsavailabletocontrolthehazard.

    STEP10:Determinewhetherthepotentialhazardissignificant.

    NarrowthelistofpotentialhazardsthatyouenteredinColumn2oftheHazardAnalysis Worksheettothosethataresignificantor,inotherwords,“reasonablylikelytooccur.”TheSeafoodHACCPRegulationdefinesafoodsafetyhazardthatisreasonablylikelytooccuras“oneforwhichaprudentprocessorwouldestablishcontrolsbecauseexperience,illnessdata,

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     scientificreports,orotherinformationprovideabasistoconcludethatthereisareasonablepossibilitythatitwilloccurintheparticulartypeoffishorfisheryproductbeingprocessedintheabsenceofthosecontrols.”

    Thehazardsandcontrolschaptersofthisguidance(Chapters4through7,9,and11through21)eachcontainasection,“Determine WhetherthisPotentialHazardIsSignificant,”thatprovidesinformationabouthowtoassessthesignificanceofpotentialhazards.Youshouldevaluatethesignificanceofapotentialhazardindependentlyateachprocessingstep.Itmaybesignificantatonestepbutnotatanother.Apotentialhazardissignificantattheprocessingorhandlingstepif(1)itisreasonablylikelythat

    thehazardcanbeintroducedatanunsafelevelatthatprocessingstep;or(2)itisreasonablylikelythatthehazardcanincreasetoanunsafelevelatthatprocessingstep;or(3)itissignificantatanotherprocessingorhandlingstepanditcanbeprevented,eliminated,orreducedtoanacceptablelevelatthecurrentprocessingorhandlingstep.Whenevaluatingthesignificanceofahazardataprocessingstep,youshouldconsiderthemethodofdistributionandstorageandtheintendeduseandconsumerofthe

    product,whichyoudevelopedinSteps3and4.

    Ifyoudeterminethatapotentialhazardissignificantataprocessingstep,youshouldanswer“Yes”inColumn3oftheHazardAnalysis Worksheet.Ifyoudeterminethatapotentialhazardisnotsignificantataprocessingstep,youshouldanswer“No”inthatcolumn.Youshouldrecordthereasonforyour“Yes”or“No”answerinColumn4.YouneednotcompleteSteps11through18forahazardforthoseprocessing

    stepswhereyouhaverecordeda“No.”Itisimportanttonotethatidentifyingahazardassignificantataprocessingstepdoesnotmeanthatitmustbecontrolledatthatprocessingstep.Step11willhelpyoudeterminewhereintheprocessthecriticalcontrolpointislocated.

    STEP11:Identifycriticalcontrolpoints.

    ForeachprocessingstepwhereasignificanthazardisidentifiedinColumn3oftheHazard AnalysisWorksheet,determinewhetheritisnecessarytoexercisecontrolatthatstep

    inordertocontrolthehazard.FigureA-2(Appendix3)isacriticalcontrolpoint(CCP)decisiontreethatcanbeusedtoaidyouin yourdetermination.

    Thehazardsandcontrolschaptersofthisguidance(Chapters4through7,9,and11through21)eachcontainasection,“IdentifyCriticalControlPoints(CCPs),”whichprovidesinformationaboutwherecontrolshouldbeexercised.Eachchapterdiscussesoneormore

    “controlstrategyexample(s)”forhowthehazardcanbecontrolled,becausethereareoftenmore waysthanonetocontrolahazard.CCP(s)foronecontrolstrategyexampleoftendifferfromthoseofanotherexampleforthesamehazard.Thecontrolstrategiescontainpreventivemeasureinformation.Recordthepreventivemeasure(s)inColumn5oftheHazardAnalysisWorksheetforeach“Yes”answerinColumn3.

    Foreverysignificanthazard,theremustbeatleastoneCCPwherethehazardiscontrolled(21CFR123.6(c)(2)).Insomecases,controlmaybenecessaryatmorethanoneCCPforasinglehazard.Inothercases,aprocessingstepmaybeaCCPformorethanonehazard.CCPsarepointsintheprocess(i.e.,processingsteps) wheretheHACCPcontrolactivitieswilloccur.ControlactivitiesataCCPcaneffectivelyprevent,eliminate,orreducethehazardtoanacceptablelevel(21CFR123.3(b)).

    IfyoudeterminethataprocessingstepisaCCP

    forasignificanthazard,youshouldenter“Yes”inColumn6oftheHazardAnalysisWorksheet.If youdeterminethataprocessingstepisnotaCCPforasignificanthazard,youshouldenter“No”inthatcolumn.YouneednotcompleteSteps12through18forahazardforthoseprocessingsteps whereyouhaverecordeda“No.”

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    HACCPPLANFORM

    STEP12:SetuptheHACCPPlanForm.

    Findtheprocessingstepsthatyouhaveidentified

    asCCPsinColumn6oftheHazardAnalysis Worksheet.RecordthenamesoftheseprocessingstepsinColumn1oftheHACCPPlanForm.Enterthehazard(s)forwhichtheseprocessingstepswereidentifiedasCCPsinColumn2oftheHACCPPlanForm.ThisinformationcanbefoundinColumn2oftheHazardAnalysis Worksheet.

    CompleteSteps13through18foreachofthesignificanthazards.Thesestepsinvolvesettingcriticallimits,establishingmonitoringprocedures,

    establishingcorrectiveactionprocedures,establishingarecordkeepingsystem,andestablishingverificationprocedures.

    STEP13:Setcriticallimits.

    ForeachprocessingstepwhereasignificanthazardisidentifiedontheHACCPPlanForm,identifythemaximumorminimumvalueto whichaparameteroftheprocessmustbecontrolledinordertocontrolthehazard.Each

    controlstrategyexampleprovidedinthehazardsandcontrolschaptersofthisguidance(Chapters4through7,9,and11through21)eachcontainasection,“SetCriticalLimits,”thatprovidesinformationaboutappropriatecriticallimitsforeachofthecontrolstrategyexample(s)discussed.

     Youshouldsetacriticallimitatsuchavaluethatifitisnotmet,thesafetyoftheproductmaybequestionable.Ifyousetamorerestrictivecriticallimit,youcould,asaresult,berequiredtotakecorrectiveactionwhennosafetyconcernactuallyexists.Ontheotherhand,ifyousetacriticallimitthatistooloose,youcould,asaresult,allowanunsafeproducttoreachtheconsumer.

     Asapracticalmatter,itmayalsobeadvisabletosetanoperatinglimitthatismorerestrictivethanthecriticallimit.Inthisway,youcanadjusttheprocesswhentheoperatinglimitisnot

    met,butbeforeacriticallimitdeviationwouldrequireyoutotakecorrectiveaction.Youshouldsetoperatinglimitsbasedonyourexperience withthevariabilityofyouroperationandwiththeclosenessoftypicaloperatingvaluestothecriticallimit.

    Considerthatthecriticallimitshoulddirectlyrelatetotheparameterthatyouwillbemonitoring.Forexample,ifyouintendtomonitorthetemperatureofthewaterinthecookerandthespeedofthebeltthatcarriestheproductthroughthecooker(becauseyouhavedeterminedthatthesefactorsresultinthedesiredinternalproducttemperatureforthedesiredtime),youshouldspecifywatertemperatureandbeltspeedascriticallimits,nottheinternal

    temperatureoftheproduct.

    Enterthecriticallimit(s)inColumn3oftheHACCPPlanForm.

    STEP14:Establishmonitoringprocedures.

    ForeachprocessingstepwhereasignificanthazardisidentifiedontheHACCPPlanForm,describemonitoringproceduresthatwillensurethatcriticallimitsareconsistentlymet(21CFR123.6(c)(4)).Thehazardsandcontrolschapters

    ofthisguidancedocument(Chapters4through7,9,and11through21)eachcontainasection,“EstablishMonitoringProcedures,”thatprovidesinformationaboutappropriatemonitoringproceduresforeachofthecontrolstrategyexample(s)discussed.

    Tofullydescribeyourmonitoringprogram,youshouldanswerfourquestions:(1)Whatwillbemonitored?(2)Howwillmonitoringbedone?(3)Howoftenwillmonitoringbedone(frequency)?and(4)Whowilldothemonitoring?

    Itisimportantforyoutokeepinmindthatthemonitoringprocessshoulddirectlymeasuretheparameterforwhichyouhaveestablishedacriticallimit.Thenecessaryfrequencyofmonitoringisdependentuponthecircumstances.Continuousmonitoringisalwaysdesirable,andinsomecasesnecessary.Inothercases,itmaynotbenecessaryorpractical.Youshouldmonitor

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     oftenenoughthatthenormalvariabilityinthe valuesyouaremeasuringwillbedetected.Thisisespeciallytrueifthesevaluesaretypicallyclosetothecriticallimit.Additionally,thegreaterthetimespanbetweenmeasurements,themoreproductsyouareputtingatriskshouldameasurementshowadeviationfromacriticallimithasoccurred,becauseyoushouldassumethatthecriticallimithadnotbeenmetsincethelast“good”value.Evenwithcontinuousmonitoring,thepaperorelectronicrecordofthecontinuousmonitoringshouldbeperiodicallycheckedinordertodeterminewhetherdeviationsfromthecriticallimithaveoccurred.Thefrequencyofthatcheckshouldbeatleastdaily,andmorefrequentifrequiredinorderto

    implementanappropriatecorrectiveaction.Enterthe“What,”“How,”“Frequency,”and“Who”monitoringinformationinColumns4,5,6,and7,respectively,oftheHACCPPlanForm.

    STEP15:Establishcorrectiveactionprocedures.

     AcorrectiveactionmustbetakenwheneverthereisadeviationfromacriticallimitataCCP(21CFR123.7((a)).Foreachprocessingstepwhere

    asignificanthazardisidentifiedontheHACCPPlanForm,describetheproceduresthatyou willusewhenyourmonitoringindicatesthatthecriticallimithasnotbeenmet.NotethattheSeafoodHACCPRegulationdoesnotrequirethatyoupredetermineyourcorrectiveactions. Youmayinsteadelecttofollowtheprescribedcorrectiveactionprocedureslistedat21CFR123.7(c).However,apredeterminedcorrectiveactionhasthefollowingadvantages:(1)Itprovidesdetailedinstructionstotheprocessing

    employeethatcanbefollowedintheeventofacriticallimitdeviation;(2)itcanbepreparedatatimewhenanemergencysituationisnotcallingforanimmediatedecision;and(3)itremovestheobligationtoreassesstheHACCPplaninresponsetoacriticallimitdeviation.

    Thehazardsandcontrolschaptersofthisguidance(Chapters4through7,9,and11

    through21)eachcontainasection,“EstablishCorrectiveActionProcedures,”thatprovidesinformationaboutappropriatecorrectiveactionproceduresforeachofthecontrolstrategyexample(s)discussed.Anappropriatecorrectiveactionproceduremustaccomplishtwogoals:(1)ensurethatanunsafeproductdoesnotreachtheconsumerand(2)correcttheproblemthatcausedthecriticallimitdeviation(21CFR123.7).Ifthecorrectiveactioninvolvestestingthefinishedproduct,thelimitationsofthesamplingplanshouldbeunderstood.Becauseoftheselimitations,microbiologicaltestingisoftennotasuitablecorrectiveaction.TheSeafoodHACCPRegulationrequiresthatcorrectiveactionsbefullydocumentedinrecords(21CFR123.7(d)).Notethatifacriticallimitdeviationoccursrepeatedly,theadequacyofthatCCPforcontrollingthehazardshouldbereassessed.Rememberthatdeviationsfromoperatinglimitsdonotneedtoresultinformalcorrectiveactions.

    EnterthecorrectiveactionproceduresinColumn8oftheHACCPPlanForm.

    STEP16:Establisharecordkeepingsystem.

    ForeachprocessingstepwhereasignificanthazardisidentifiedontheHACCPPlanForm,listtherecordsthatwillbeusedtodocumenttheaccomplishmentofthemonitoringproceduresdiscussedinStep14(21CFR123.9(a)(2)).

    Thehazardsandcontrolschaptersofthisguidance(Chapters4through7,9,and11through21)eachcontainasection,“EstablishaRecordkeepingSystem,”thatprovidesinformationaboutappropriaterecordsforeachofthecontrolstrategyexample(s)discussed.Recordsmustdocumentmonitoringofthe

    CCPandshallcontaintheactualvaluesandobservationsobtainedduringmonitoring(21CFR123.6(b)(7))TheSeafoodHACCPRegulationlistsspecificrequirementsaboutthecontentoftherecords(21CFR123.9(a)).

    EnterthenamesoftheHACCPmonitoringrecordsinColumn9oftheHACCPPlanForm.

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    STEP17:Establishverificationprocedures.

    ForeachprocessingstepwhereasignificanthazardisidentifiedontheHACCPPlanForm,describetheverificationproceduresthatwillensurethattheHACCPplanis(1)adequateto

    addressthehazardand(2)consistentlybeingfollowed(21CFR123.6(c)(6)).

    Thehazardsandcontrolschaptersofthisguidance(Chapters4through7,9,and11through21)eachcontainasection,“EstablishVerificationProcedures,”thatprovidesinformationaboutappropriateverificationactivitiesforeachofthecontrolstrategyexample(s)discussed.Theinformationcoversvalidationoftheadequacyofcriticallimits(e.g.,processestablishment);

    calibration(includingaccuracychecks)ofCCPmonitoringequipment;performanceofperiodicend-productandin-processtesting;andreviewofmonitoring,correctiveaction,andverificationrecords.NotethattheSeafoodHACCPRegulationdoesnotrequireproducttesting(21CFR123.8(a)(2)(iii)).However,itcanbeausefultool,especiallywhencoupledwitharelativelyweakmonitoringprocedure,suchasrelianceuponsuppliers’certificates.

     WhencalibrationoranaccuracycheckofaCCPmonitoringinstrumentshowsthattheinstrumentisnotaccurate,youshouldevaluatethemonitoringrecordssincethelastinstrumentcalibrationtodeterminewhethertheinaccuracywouldhavecontributedtoacriticallimitdeviation.Forthisreason,HACCPplanswithinfrequentcalibrationoraccuracycheckscanplacemoreproductsatriskthanthosewithmorefrequentchecksshouldaproblemwithinstrumentaccuracyoccur.

    EntertheverificationproceduresinColumn10of

    theHACCPPlanForm.

    STEP18:CompletetheHACCPPlanForm.

     Whenyouhavefinishedthesestepsforallsignificanthazardsthatrelatetoyourproduct, youwillhavecompletedtheHACCPPlanForm. YoushouldthensignanddatethefirstpageoftheHACCPPlanForm.Thesignaturemustbe

    thatofthemostresponsibleindividualon-siteat yourprocessingfacilityorahigherlevelofficial(21CFR123.6(d)(1)).ItsignifiesthattheHACCPplanhasbeenacceptedforimplementationby yourfirm.

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    CHAPTER3:PotentialSpecies-RelatedandProcess-RelatedHazards

    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