Fish and Fishery Products Hazards and Controls Guidance 508

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    Fish and Fishery Products Hazards and Controls Guidance Fourth 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 and Controls Guidance FourthEdition–April2011

     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  

     Youmaysubmitelectronicorwrittencomments regardingthisguidanceatanytime.Submit electroniccommentsto http://www.regulations.   gov . SubmitwrittencommentstotheDivision ofDocketsManagement(HFA-305),Foodand DrugAdministration,5630FishersLane,Rm. 1061,Rockville,MD20852.Allcomments shouldbeidentifiedwiththedocketnumber listedinthenoticeofavailabilitythatpublishes

    inthe Federal Register.

    U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforFoodSafetyandAppliedNutrition  (240)402-2300

     April2011

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

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    TableofContents:FishandFisheryProductsHazardsandControlsGuidance

    Guidance for the Industry:FishandFisheryProductsHazardsandControlsGuidance................................1 

    CHAPTER 1:GeneralInformation.......................................................................................................19  CHAPTER 2:ConductingaHazardAnalysisandDevelopingaHACCPPlan..........................................21 

    CHAPTER 3:PotentialSpecies-RelatedandProcess-RelatedHazards.....................................................29  

    CHAPTER 4:PathogensFromtheHarvestArea...................................................................................75 

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

    CHAPTER 6:NaturalToxins ............................................................................................................99 

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

    CHAPTER 8:OtherDecomposition-RelatedHazards .........................................................................153

    CHAPTER 9:EnvironmentalChemicalContaminantsandPesticides......................................................155 

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

    CHAPTER 11:AquacultureDrugs.....................................................................................................183 

    CHAPTER 12: PathogenicBacteriaGrowthandToxinFormation(OtherThanClostridiumbotulinum)  asaResultofTimeandTemperatureAbuse.................................................................209  

    CHAPTER 13:ClostridiumbotulinumToxinFormation.........................................................................245  

    CHAPTER 14:PathogenicBacteriaGrowthandToxinFormationasaResultofInadequateDrying .........293 

    CHAPTER 15:StaphylococcusaureusToxinFormationinHydratedBatterMixes..................................309  

    CHAPTER 16:PathogenicBacteriaSurvivalThroughCookingorPasteurization ..................................... 315

    CHAPTER 17: PathogenicBacteriaSurvivalThroughProcessesDesignedtoRetain  RawProductCharacteristics ....................................................................................... 331

    CHAPTER 18: IntroductionofPathogenicBacteriaAfterPasteurizationand  SpecializedCookingProcesses .................................................................................345 

    CHAPTER 19: UndeclaredMajorFoodAllergensandCertainFoodIntoleranceCausingSubstances  andProhibitedFoodandColorAdditives ....................................................................355 

    CHAPTER 20:MetalInclusion..........................................................................................................385  

    CHAPTER 21:GlassInclusion..........................................................................................................395 

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

    APPENDIX 2:SampleProductFlowDiagram.....................................................................................411 

    APPENDIX 3:CriticalControlPointDecisionTree...............................................................................413 

    APPENDIX 4:BacterialPathogenGrowthandInactivation..................................................................417 

    APPENDIX 5:FDAandEPASafetyLevelsinRegulationsandGuidance................................................439  

    APPENDIX 6:JapaneseandHawaiianVernacularNamesforFishEatenRaw......................................443  

    APPENDIX 7: BacterialandViralPathogensofGreatestConcerninSeafoodProcessing PublicHealthImpacts..................................................................................................451 

    APPENDIX 8:ProceduresforSafeandSanitaryProcessingandImportingofFishandFisheryProducts...455  

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    NOTES:

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    GuidancefortheIndustry:FishandFisheryProductsHazardsandControlsGuidance FourthEdition

    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

    Thisguidanceisintendedtoassistprocessors offishandfisheryproductsinthedevelopment oftheirHazardAnalysisCriticalControlPoint (HACCP)plans.Processorsoffishandfishery

    productswillfindinformationinthisguidance thatwillhelpthemidentifyhazardsthatare associatedwiththeirproducts,andhelpthem formulatecontrolstrategies.Theguidancewill helpconsumersandthepublicgenerallyto understandcommercialseafoodsafetyinterms ofhazardsandtheircontrols.Theguidancedoes notspecificallyaddresssafehandlingpracticesby consumersorbyretailestablishments,although manyoftheconceptscontainedinthisguidance areapplicabletoboth.Thisguidanceisalso

    intendedtoserveasatooltobeusedbyfederal andstateregulatoryofficialsintheevaluationof HACCPplansforfishandfisheryproducts.

    FDA’sguidance