8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
1/475
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
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
2/475
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
3/475
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/
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
4/475
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
5/475
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
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
6/475
NOTES:
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
7/475
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).
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
1
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
8/475
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.
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
2
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
9/475
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
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
3
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
10/475
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;
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
4
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
11/475
• 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;
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
5
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
12/475
• 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.
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
6
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
13/475
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)
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
7
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
14/475
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
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
8
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
15/475
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
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
9
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
16/475
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;
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
10
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
17/475
• 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;
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
11
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
18/475
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),
°
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
12
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
19/475
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;
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
13
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
20/475
• 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.
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
14
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
21/475
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
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
15
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
22/475
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;
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
16
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
23/475
• 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.
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
17
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
24/475
NOTES:
GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidanceFourthEdition
18
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
25/475
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/
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
26/475
NOTES:
CHAPTER1:GeneralInformation
20
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
27/475
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.
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
21
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
28/475
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.
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
22
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
29/475
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
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
23
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
30/475
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,
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
24
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
31/475
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.”
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
25
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
32/475
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
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
26
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
33/475
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.
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
27
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
34/475
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.
CHAPTER2:ConductingaHazardAnalysisandDevelopingaHACCPPlan
28
8/9/2019 Fish and Fishery Products Hazards and Controls Guidance 508
35/475
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