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RulesandStandardsforFoodProcessing

ThispageofferssomedetailsaboutprovidesomedetailsaboutFDAsGMPs,
USDA&FDA'sSSOPs,FDA&USDA'sHACCP,FDA'sFoodSafetyPlans,and
FDA&USDA'sFoodDefensePlans.

TopicsAddressedonthisPage
FDAsGoodManufacturingPractices(21CFRPart110proposedtobe
replacedby21CFRPart117SubpartB)
USDAsOperatingProceduresforEggProcessing(9CFR590.504to
590.575)
FDAsHACCPforJuiceandSeafoodProcessing(21CFRParts120&123)
USDAsSSOPandHACCPforMeatandPoultryProcessing(9CFRParts416
&417)
FDAsFoodSafetyPlanforallotherFoodProcessors(21U.S.C.305gand
proposed21CFRPart117SubpartC)

Introduction
U.S.foodprocessingfirmshavebeensubjecttomanufacturing/processingrulesor
standardsfordecades,butthestandardscontinuetoevolve.Thedevelopmentand
applicationofHazardAnalysisandCriticalControlPoint(HACCP)principlesto
seafood,juice,meatandpoultryprocessinghasbeenasignificanteventsincethe
1990s.Morerecently,CongressexpandeditsperceptionofHACCPprinciplesand
directedthatallotherfoodprocessorsadoptsuchpracticesbydevelopingand
implementingaFoodSafetyPlan.ThispageprovidesabriefoverviewofpastGood
ManufacturingPractices(GMP),SanitaryStandardOperatingProcedures(SSOPs),
HACCPprinciples,andthecomponentsenvisionedtobeincludedinaFoodSafety
Plan.

Overview
FDAhasregulationsspecifyingGoodManufacturingPractices(GMPs)forthefood
processorsthatFDAisresponsibleforregulating(see21CFRPart110headsup,
thisregulationisbeingupdated).GMPsaddressavarietyoftopics.
USDAhassomecomparableregulationsforeggprocessorstheseOperating
Procedures(9CFR590.500590.575)addresstopicssimilartoFDAsGMPs,
butaremorespecificbecausetheeggoperatingproceduresaddressasinglefood
industry.
USDAalsohasSanitaryStandardOperatingProcedures(SSOPs)forthemeat
andpoultryindustries(see9CFRPart416).Again,manyofthetopicsaddressedin
theSSOPsaresimilartotopicsaddressedinFDAsGMPs.

Inaddition,FDAhassomedetailedexpectationsforthejuiceandseafoodindustries
toaugmenttheGMPs(e.g.,21CFR120.6and21CFR123.11)FDAalsorefersto
theseadditionalrequirementsforjuiceandseafoodasSSOPsasourceofpossible
confusion.
FDAhasproposedrevisingitsGMPs(inearly2013).Theserevisions(tobecodified
at21CFRPart117SubpartB21CFRPart110willberemoved),ofcourse,willnot
affectegg,meatandpoultryprocessingwhichareregulatedbyUSDA.Restated,
USDAisnotupdatingtheoperatingproceduresforeggprocessingortheSSOPsfor
meatandpoultryprocessingatthistime(early2014).
FDAhasrequiredjuiceandseafoodprocessorstodevelopandimplementHACCP
plans(21CFRPart120and21CFRPart123,respectively)theseplansare
underpinnedbyGMPs(see21CFR120.5and21CFR123.5)andwillcontinueto
beunderpinnedbythenewestGMPs(thatis,theproposed21CFRPart117Subpart
B)whentheyarefinalized.
Similarly,USDArequiresmeatandpoultryprocessorstohaveHACCPplans(9CFR
Part417)althoughnotexplicitlystatedintheUSDAregulations,onewouldexpecta
relationshipbetweentheprocessorsSSOPsanditsHACCPplan.
Inlate2010/early2011,CongressenactedtheFDAFoodSafetyModernizationActto
requireallFDAfoodprocessors(exceptseafoodandjuiceprocessors)todevelop
andimplementaFoodSafetyPlan(21U.S.C.350g),occasionallydescribedasthe
nextgenerationofHACCP.
PriortotheFoodSafetyModernizationAct,foodprocessorsoverseenbyFDA
(exceptseafoodandjuiceprocessors)werenotrequiredtohaveaHACCP
plan.
Inthefuture,Congresswillallowseafoodandjuiceprocessorstocontinueto
applyexistingHACCPregulationsandplans,ratherthanrequirethose
businessestorevisetheirpracticestoalignwiththerequirementsofaFood
SafetyPlan.
TheFoodSafetyPlanoftheFoodModernizationActhasnoimpactonUSDA,
ortheHACCPrequirementsthatUSDAhasinplaceformeatandpoultry
processors.
FDAproposedregulationsinearly2013forthedevelopmentandimplementationof
FoodSafetyPlans.Whenfinalized,theseregulationswillbecodifiedat21CFRPart
117SubpartC.
Theprimarycomponentsof1)FDAHACCPplansforjuiceandseafoodprocessers,
2)USDAHACCPplansformeatandpoultryprocessors,and3)theFoodSafety
PlansforotherfoodprocessorssubjecttoFDAoversightaresimilar.Therealsoare
somesignificantdifferencesthatwarrantmention.
ThefollowingsectionsprovidesomedetailsaboutGMPs,SSOPs,HACCPandFood
SafetyPlans.

TopicsAddressedinFDAsexistingGMPs
21CFRPart110
FoodprocessingfirmsoverseenbyFDAaresubjecttoGoodManufacturingPractices
(GMP)see21CFRPart110

Formorebackgroundinformation,seeFDAsdocumentonGoodManufacturing
Practices:FoodCGMPModernizationAFocusonFoodSafetyat
http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm207458.htm
GMPsprovidesomedefinitionsfordeterminingwhetherfoodisadulterated(andthus
illegaltosell)becauseithasbeenmanufactured,prepared,packedorheldunder
insanitaryconditions.Moreprecisely,GMPshelpdefinewhether1)foodhasbeen
manufacturedunderconditionsthatitareunfitforfoodor2)foodhasbeenprepared,
packed,orheldunderinsanitaryconditionswherebyitmayhavebecome
contaminatedwithfilth,orwherebyitmayhavebeenrenderedinjurioustohealth(21
CFR110.5).
ThebroadtopicsaddressedinFDAsGMPsinclude:
Personnel:diseasecontrolcleanlinesseducationandtrainingsupervision
Plantandgrounds:groundsplantconstructionanddesign
Sanitaryoperations:generalmaintenancesubstancesusedincleaningand
sanitizingstorageoftoxicmaterialspestcontrolsanitationoffoodcontact
surfacesstorageandhandlingofcleanedportableequipmentandutensils
Sanitaryfacilitiesandcontrols:watersupplyplumbingsewagedisposaltoilet
facilitieshandwashingfacilitiesrubbishandoffaldisposal
Equipmentandutensils
Processesandcontrols:rawmaterialsandotheringredientsmanufacturing
operations
Warehousinganddistribution
GMPsapplytoallfoodprocessorssubjecttoFDAsoversight,includingjuiceand
seafoodprocessorsthataresubjecttoHACCP,aswellasallotherfoodprocessors
whoarebeingmandatedtodevelopFoodSafetyPlans.
InJanuary2013,theFDAproposedaregulationtoreplace21CFRPart110the
proposedregulation(whichhasnotyetbeenfinalizedasofMarch1,2014)wouldbe
codifiedas21CFRPart117SubpartB.

TopicsAddressedinUSDAEggOperatingProcedures
9CFR590.500590.575
USDAFSISoverseesfacilitieswhereshelledeggsarepackedandwhereshelleggs
areprocessedintoeggproducts.See21U.S.C.1034(d).USDAFSIStraditionally
viewedshelleggsafetyasFDA'sresponsibility.However,"[i]nOctober2011,OGC
opinedthatFSIS,throughtheEggProductsInspectionAct(EPIA),doeshave
inspectionauthorityovershelleggs.Thisincludedtheegglayingbarns..."seep.7of
pdfathttp://www.usda.gov/oig/webdocs/50601000123.pdf.
DespitethechangeintheunderstandingofFSIS'roleintheeggindustry,the
followingregulationscontinuetoemphasizeFSISpast,narrowerperspectiveof
overseeingeggprocessing.
TheseOperatingProceduresaremoredetailedthanFDAsGMPs,butspecificityis
possibleinthisFSISregulationbecauseitappliesonlytoeggprocessing.The
regulationaddressesthefollowingtopics:
Premises/facilities,watersupply,drainage,construction,doors,floors,walls,

ceilings,odors,air,drains,dressingrooms,toiletrooms,lavatory
accommodations,handwashingfacilities,facilitiesforcleaningandsanitizing
utensilsandequipment,storageofshells,trash,andotherrefuse
Processingequipmentandutensils:design,construction,materialableto
examine,segregate,andprocesstheproductpermiteasyaccesstoallparts
forcleaningandsanitizing
Generaloperatingprocedures,suchasprocessing,storing,andhandlingof
shelleggs,ingredients,andeggproductspasteurization,heattreatment,
stabilization,andotherprocessesoperatetopreventdeteriorationofproducts
Candlingandtransferroomfacilities,equipmentandoperations
Classificationsofshelleggs
Eggcleaningoperations
Sanitizinganddryingofshelleggspriortobreaking
Breakingroomfacilities&operations
Liquideggcooling&holding
Freezingfacilities&operations
Defrostingfacilities&operations
Sprayprocessdryingfacilities&operations
Sprayprocesspowderdefinitionsandrequirements
Albumenflakeprocessdryingfacilities&operations
Drying,blending,packaging,andheattreatmentroomsandfacilities
Driedeggstorage
Washingandsanitizingroomorarea
Cleaningandsanitizingrequirements
Healthandhygieneofpersonnel
Pasteurizationofliquideggs
Heattreatmentofdriedwhites
Again,theseregulationsarequitespecificbecausetheyapplytooneindustry.

TopicsAddressedinUSDASSOPsforMeatandPoultryProcessing
9CFRPart416
USDAFSIShasregulationsaddressingtheoperationofmeatandpoultryfacilities.
TheregulationsrefertothestandardsasSanitationStandardOperatingProcedures
(SSOPs)eventhoughthetopicsaresimilartothoseaddressedinGMPsandEgg
OperatingProcedures.
Eachofficialestablishmentmustbeoperatedandmaintainedtopreventinsanitary
conditionsandtoensurethattheproductisnotadulterated.Topicsinclude
Groundsandfacilities:groundsandpestcontrolconstructionlightventilation
plumbingsewagedisposalwatersupplyandwater,ice,andsolutionreuse
dressingrooms,lavatories,andtoilets.
Equipmentandutensils:equipmentandutensilsusedforprocessingor
handlingproductoringredientequipmentandutensilsmustbeavailablefor
FSISinspectionreceptaclesforstoringinediblematerial
Sanitaryoperations:foodcontactsurfacesnonfoodcontactsurfaces
cleaningcompounds,sanitizingagents,processingaids,andotherchemicals
productmustbeprotectedfromadulterationduringprocessing,handling,
storage,loading,andunloadingatandduringtransportation
Employeehygiene:cleanlinessclothingdiseasecontrol.

Eachofficialestablishmentshalldevelop,implement,andmaintainwrittenstandard
operatingproceduresforsanitation(SanitationSOP's):
DevelopmentofSanitationSOP's
ImplementationofSOP's
MaintenanceofSanitationSOP's
CorrectiveActions
Recordkeepingrequirements
Agencyverification

AdditionalTopicsaddressedinFDASSOPsforJuiceandSeafood
Processing
21CFR120.6
21CFR123.11
InadditiontocomplyingwithGMPs,theFDAhasaddressedsomespecificissuesfor
juiceandseafoodprocessorsasSSOPs.

JuiceSSOP
Eachjuiceprocessorshallhaveandimplementasanitationstandardoperating
procedure(SSOP)thataddressessanitationconditionsandpracticesbefore,
during,andafterprocessing.TheSSOPshalladdress:
Safetyofthewaterthatcontactsfoodorfoodcontactsurfacesorthatisusedin
themanufactureofice
Conditionandcleanlinessoffoodcontactsurfaces
Preventionofcrosscontaminationfrominsanitaryobjectstofood,food
packagingmaterial,andotherfoodcontactsurfaces
Maintenanceofhandwashing,handsanitizing,andtoiletfacilities
Protectionoffood,foodpackagingmaterial,andfoodcontactsurfacesfrom
adulterationwithlubricants,fuel,pesticides,cleaningcompounds,sanitizing
agents,condensate,andotherchemical,physical,andbiologicalcontaminants
Properlabeling,storage,anduseoftoxiccompounds
Controlofemployeehealthconditions
Exclusionofpestsfromthefoodplant

SeafoodSSOP
Theprocessorshallmonitortheconditionsandpracticesduringprocessingto
ensureconformancewithGMPs
Eachprocessorshallmaintainrecordsthatdocumentmonitoringand
corrections.
Sanitationstandardoperatingprocedurecontrolsmaybeincludedinthe
HACCPplan
Eachseafoodprocessorshouldhaveandimplementawrittensanitation
standardoperatingprocedure
Eachprocessorshallmonitortheconditionsandpracticesduringprocessingto
ensureconformanceGMPs
Eachprocessorshallmaintainrecordsthatdocumentmonitoringandcorrective

actions
Processorsofsmokedandsmokeflavoredfisheryproductsshallincludeintheir
HACCPplanshowtheyarecontrollingthefoodsafetyhazardassociatedwith
theformationoftoxinbyClostridiumbotulinum
ProcessorsshallincludeintheirHACCPplanshowtheyarecontrollingthe
originofthemolluscanshellfishtheyprocesstoensure1)theyonlyprocess
molluscanshellfishharvestedfromgrowingwatersapprovedforharvesting2)
theyacceptonlyshellstockfromaharvesterthatisincompliancewithlicensure
requirementsoriscertified,and3)theyacceptonlycontainersofshucked
molluscanshellfishthatbeartherequiredlabel

TopicsaddressedinFDAProposedGMPrevisions
21CFRPart117SubpartB
Asstatedpreviously,FDAproposedaregulationinearly2013thatwouldupdateits
GMPsbyreplacingthecurrentregulation.
Thelistoftopicsandmuchofthelanguageintheproposed21CFRPart117Subpart
Bisidenticaltothecurrentlanguageof21CFRPart110.Therearesomechanges
buttheyarebestdescribedasclarifyingpaststatementsorreflectingcurrent
practicesandconcernsforexample:
Preventingcrosscontactisemphasizedintheproposedregulation
CurrentsuggestionsonhowtocomplywithsomeregulatorystandardsareNOT
includedintheproposedregulation.

ReviewofHACCPPrinciples
GMPs,OperatingProceduresandSSOPsareonlypartofthestandardsor
expectationsthatfoodprocessorsmustcomplywith.Inthepastseveraldecades,
theconceptofHACCPemerged,wasappliedtosomesectorsofthefoodprocessing
industry,andisevolvingintoFoodSafetyPlans.AbriefreviewoftheHACCP
principlesmayhelpinunderstandingtheapplicationofHACCPandFoodSafety
Plans.
HACCPhasoftenbeendescribedasfoundedonsevenprinciples.Thefollowinglist
iscopiedfromUSDAFoodSafetyandInspectionService,KeyFacts:TheSeven
HACCPPrinciples,revisedJanuary1998at
http://www.fsis.usda.gov/Oa/background/keyhaccp.htm.
Principle1:Conductahazardanalysis.
Plantsdeterminethefoodsafetyhazardsidentifythepreventivemeasuresthe
plantcanapplytocontrolthesehazards.
Principle2:Identifycriticalcontrolpoints.
Acriticalcontrolpoint(CCP)isapoint,step,orprocedureinafoodprocessat
whichcontrolcanbeappliedand,asaresult,afoodsafetyhazardcanbe
prevented,eliminated,orreducedtoanacceptablelevel.Afoodsafetyhazard
isanybiological,chemical,orphysicalpropertythatmaycauseafoodtobe

unsafeforhumanconsumption.
Principle3:Establishcriticallimitsforeachcriticalcontrolpoint.
Acriticallimitisthemaximumorminimumvaluetowhichaphysical,biological,
orchemicalhazardmustbecontrolledatacriticalcontrolpointtoprevent,
eliminate,orreducetoanacceptablelevel.
Principle4:Establishcriticalcontrolpointmonitoringrequirements.
Monitoringactivitiesarenecessarytoensurethattheprocessisundercontrol
ateachcriticalcontrolpoint.FSISisrequiringthateachmonitoringprocedure
anditsfrequencybelistedintheHACCPplan.
Principle5:Establishcorrectiveactions.
Theseareactionstobetakenwhenmonitoringindicatesadeviationfroman
establishedcriticallimit.Thefinalrulerequiresaplant'sHACCPplantoidentify
thecorrectiveactionstobetakenifacriticallimitisnotmet.Correctiveactions
areintendedtoensurethatnoproductinjurioustohealthorotherwise
adulteratedasaresultofthedeviationenterscommerce.
Principle6:Establishrecordkeepingprocedures.
TheHACCPregulationrequiresthatallplantsmaintaincertaindocuments,
includingitshazardanalysisandwrittenHACCPplan,andrecords
documentingthemonitoringofcriticalcontrolpoints,criticallimits,verification
activities,andthehandlingofprocessingdeviations.
Principle7:EstablishproceduresforverifyingtheHACCPsystemisworkingas
intended.
Validationensuresthattheplansdowhattheyweredesignedtodothatis,
theyaresuccessfulinensuringtheproductionofsafeproduct.Plantswillbe
requiredtovalidatetheirownHACCPplans.FSISwillnotapproveHACCP
plansinadvance,butwillreviewthemforconformancewiththefinalrule.
VerificationensurestheHACCPplanisadequate,thatis,workingasintended.
VerificationproceduresmayincludesuchactivitiesasreviewofHACCPplans,
CCPrecords,criticallimitsandmicrobialsamplingandanalysis.FSISis
requiringthattheHACCPplanincludeverificationtaskstobeperformedby
plantpersonnel.VerificationtaskswouldalsobeperformedbyFSISinspectors.
BothFSISandindustrywillundertakemicrobialtestingasoneofseveral
verificationactivities.theoccurrenceoftheidentifiedfoodsafetyhazard.

Subsequently,theseprincipleswereexpandedintoimplementationsteps:
1. AssembleHACCPteam
2. Describeproduct
3. Identifyintendeduse
4. Constructflowdiagram
5. Onsiteconfirmationofflowdiagram
6. Listallpotentialhazardsassociatedwitheachstep,conductahazardanalysis,
andconsideranymeasurestocontrolidentifiedhazards(Principle1)

7. DetermineCriticalControlPoints(Principles2)
8. EstablishcriticallimitsforeachCCP(Principle3)
9. EstablishamonitoringsystemforeachCCP(Principle4)
10. Establishcorrectiveactions(Principle5)
11. Establishverificationprocedures(Principle6)
12. EstablishDocumentationandRecordKeeping(Principle7)
Copiedfromhttp://www.haccporg.eu/food_safety/system.htmlalsosee
http://www.standards.org/standards/listing/haccp

SomeCommonElementsofJuice,Seafood,andMeat&Poultry
HACCP
HACCPregulationsareavailableatthefollowingcitationsconsiderreviewingthese
regulationsasthefollowingmaterialsarestudied.
HACCPforJuiceProcessors:21CFRPart120
HACCPofSeafoodProcessors:21CFRPart123
HACCPforMeatandPoultryProcessors:9CFRPart417
ThefollowingmaterialsareacompilationofconceptsembeddedintheHACCP
regulationsforjuice,seafood,andmeat&poultryprocessors.Eachofthesethree
HACCPregulationsposesomeuniquerequirementsbuttheyalsohaveacoreof
similarities.ThepurposeofthiscompilationistointroduceHACCPbyfocusingon
thecommonalities.
AsonereviewstheHACCPregulationsforjuice,seafood,andmeat&poultry
processors,thefollowingconceptsarecommonamongtheregulations.

Writtenhazardanalysis
Identifyfoodsafetyhazardslikelytooccur
Listof9or10categoriesofhazardstoconsider
Listoffactorsthatcouldimpactthesafetyofafinalfoodproduct,e.g.,
ingredient,processingprocedures,packaging,storage,facility,
equipment,plantsanitation,employeehygiene
Developadetailedflowcharttoidentifyriskstheproductmaybe
exposedto
Reasonableprobabilitythatahazardwilloccurisbasedonexperience
(hasoccurredinthepast),data,scientificreports,etc
Identifycontrol/preventivemeasurestocontrolthesehazards
Reviewcurrentprocesstodetermineifmodificationsareneeded
IdentifyCriticalControlPoints(CCPs)

Considerhazardsarisingfromwithinandoutsidetheplant
Analysisisconductedbyatrainedindividual

WrittenHACCPplan
HACCPplandevelopedandimplemented
Developedbyatrainedindividual
Aplanforeachplantandforeachtypeofproductcangroupproductsintoa
HACCPplanaslongashazards,CCPs,criticallimitsandproceduresare
identical/essentiallythesame
Aplanforeachprocessingprocedure/finalproduct(FSIS)
Listfoodhazardslikelytooccur
ListCCPs
ListCriticalLimits(CLs)foreachCCP
Listprocedure(andfrequency)tomonitorthatoperationsarewithinCLateach
CCP
IncludecorrectiveplanshouldoperationbeoutsidetherangeofCLataCCP
thisassumesthecauseofthedeviationhasbeencorrectlyanticipated
Stopfoodfromenteringcommerce
Causeofdeviationis(identified&)corrected/eliminated(CCPwillbe
undercontrolaftercorrectiveactionhasbeentaken)
Measurestopreventrecurrencehavebeentaken
PredeterminedcorrectiveactionistakenasdescribedinHACCPplan
thisassumesthatcauseofdeviationisidentifiedandthecausealigns
withcauseanticipatedwhenHACCPplanwasdeveloped

Ifcauseofcurrentdeviationdoesnotalignwithpresumedcause,thenbe
certainfoodisnotdistributed,determinethisunanticipatedcause,and
remedythesituationdeterminewhetherHACCPplanneedstobe
modifiedtoaccommodatethisnew/unanticipatedcausefordeviation
Reviewaffectedfoodandtakecorrectiveactiontoassureadulterated
fooddoesnotentercommerce

Validationprocedures
TesttheHACCPplanduringfirstyeartomakesureitisadequate(CCPs,
CLs,monitoring,recordkeeping,correctiveactions&reviewofrecrods)
Test/reassesstheHACCPplanannuallythereafter
Test/reassesstheHACCPplanwhenachangeinprocess,rawmaterials,
productformulation,packaging,distribution,orintendeduseofproduct
hasbeenmade
ReassessHACCPplanwhenchangesoccur
Reassesswhetherthehazardanalysisneedstoberevisedorupdated
whenevertherehasbeenachangeinprocess,rawmaterials,product
formulation,packaging,distribution,orintendeduseofproducthasbeen
made(isthisreassessmentofthehazardanalysisconsideredpartofthe
validationprocedure?)
Thereassessment/validationofhazardanalysisistobeperformed
byatrainedindividual
Verificationprocedure
VerifytheHACCPplanisadequatetocontrolfoodsafetyhazards
Reviewcustomercomplaints

DeterminewhetherthereareadditionalCCPstomonitoralsodetermineif
theCLswerecorrect??
CalibratemonitoringequipmentassumesCLcanbemechanical
measuredatCCPs
Testasampleoftheproducttoassureitisacceptable(FDA)
Observemonitoringandcorrectiveactionstaken(FSIS)
Reviewtherecordstoassure1)monitoringofCLsatCCPshasbeen
conducted,2)thatappropriatecorrectiveactionshavebeentakenwhen
operationswereoutsidetheCLrangeforCCPs,3)thatmonitoring
equipmentwastestedandrecalibratedaccordingtotheHACCPplan.
Recordkeepingsystem
DocumentongoingmonitoringofCLatCCPrecordactual/observed
valuesatCCPs
ReviewthatCLatCCPsarebeingdocumentandthattheCLsarewithin
theacceptablerange
Documentcorrectiveactionsfordeviationsresultingfrombothanticipated
causes(andthusthecorrectiveactionwasalreadyinHACCPplan)and
unanticipatedcauses(andthustherewasnoappropriatecorrectiveaction
alreadyintheHACCPplan)
Verifythatappropriatecorrectiveactionshavebeentaken
Documentthetestingandcalibrationofmonitoringequipmentthatwas
performedtoassurethemonitoringequipmentwasworking
Recordtheresultofanyproducttesting
Verifythatrecordsofproducttestsarecompleteandtestswere
conductedaccordingtofacilitieswrittenprocedures
DocumentSSOPsandtheirimplementation(seejuiceHACCP)
Writtenhazardanalysis
WrittenHACCPplan(withCCPs,CLs,monitoringandverification
procedures)
DocumentthatHACCPsystemhasbeenverified,thatHACCPplanhas
beenvalidated,andthathazardanalysishasbeenvalidated
ReviewrecordsforcompletenesspriortoshippingproductandthatCLs
weremet(FSIS)
PersonwillHACCPtrainingorjobexperiencemay1)develophazardanalysis
andcontrolmeasures,2)developHACCPplan,3)verifyandmonitorHACCP
plan,4)reviewrecords
PersonwithHACCPtraining1)developsHACCPplan,2)reassessand
modifiesHACCPplan,3)reassessandmodifiestheHACCPanalysis,and4)
reviewstherecords.
PersonwithHACCPtrainingtodevelop,reassessandmodifyHACCPplan
Formofrecords,signing&dating,recordretentionarenotdetailedinthissummary.

SomeAdditionalElementsofJuice,SeafoodandMeat&Poultry
HACCP
LackofHACCPplanRENDERStheproductadulterated(seafood)comparedtoLack
ofHACCPplanMIGHTrendertheproductadulterated(FSIS)
Agencyverification(FSIS):reviewHACCPplan,reviewCCPrecords,review

adequacyofcorrectiveactions,reviewCLsreviewrecordsofHACCPsystem,
observe&measureCCPs,collect&analyzesamples,andonsiteobservationsand
recordreview.
HACCPisinadequateifitdoesnotmeetregulatoryrequirements,personnelarenot
performingtasks,businessfailstotakecorrectiveactions,HACCPrecordsarenot
maintained,andadulteratedproductisproducedorshipped(FSIS).
GMPswilldeterminewhethersanitaryconditionsaremet(seafood)

FoodSafetyPlanStatute
21U.S.C.350g
TheFoodSafetyPlan,asenactedbyCongressaspartoftheFDAFoodSafety
ModernizationAct,hasbeendescribedasthenextgenerationofHACCP.This
overviewofthefoodsafetyplanstatuteillustratesseveralHACCPconceptsthatalso
willunderpinfoodsafetyplansinaddition,theoverviewrevealshowtheconceptofa
"foodsafetyplan"extendstheoverallpurposeandideaofHACCP.

UnderaFoodSafetyPlan,theoperatorofafacilityshall
evaluatehazardsthatcouldaffectfoodprocessedorheldbyatthefacility
identifyandimplementpreventivecontrolstosignificantlyminimizeorprevent
theoccurrenceofsuchhazards
provideassurancesthatsuchfoodisnotadulterated
provideassurancesthatsuchfoodisproperlylabelledformajorfoodallergens
monitortheperformanceofthepreventivecontrols,and
maintainrecordsofmonitoringasamatterofroutinepractice.

Theoperatorshalldevelopawrittenhazardanalysisthat
identifiesandevaluatesknownorreasonablyforeseeablehazards,including
biological,chemical,physical,andradiologicalhazards,naturaltoxins,
pesticides,drugresidues,decomposition,parasites,allergens,and
unapprovedfoodandcoloradditivesand
hazardsthatoccurnaturally,ormaybeunintentionallyintroduced
identifiesandevaluateshazardsthatmaybeintentionallyintroduced,
includingbyactsofterrorism.

Theoperatorshallidentifyandimplementpreventivecontrols,includingatcritical
controlpoints,toassurethat
knownorreasonablyforeseeablehazardswillbesignificantlyminimizedor
prevented
anyhazardthatmaybeintentionallyintroducedwillbesignificantlyminimized
orpreventedandaddressed
thefoodprocessedorheldwillnotbeadulteratedormisbrandedrelativeto
majorfoodallergens


Theoperatorofafacilityshallmonitortheeffectivenessofthepreventivecontrols.
Theoperatorofafacilityshallestablishprocedurestoensurethat,ifthepreventive
controlsarenotproperlyimplementedorarefoundtobeineffective
appropriateactionistakentoreducethelikelihoodofrecurrenceofthe
implementationfailure
allaffectedfoodisevaluatedforsafetyand
allaffectedfoodispreventedfromenteringintocommerceiftheoperator
cannotensurethattheaffectedfoodisnotadulteratedormisbrandedrelativeto
majorfoodallergens

Theoperatorofafacilityshallverifythat
thepreventivecontrolsareadequatetocontroltheidentifiedhazards
theoperatorismonitoringtheeffectivenessofpreventivecontrols
theoperatorismakingappropriatedecisionsaboutcorrectiveactions
thepreventivecontrolsareeffectivelyandsignificantlyminimizingorpreventing
theoccurrenceofidentifiedhazards(verificationcanincludetheuseof
environmentalandproducttestingprogramsandotherappropriatemeans)and
thereisdocumented,periodicreanalysisoftheplantoensurethatthefood
safetyplanisstillrelevanttotherawmaterials,conditionsandprocessesinthe
facility,andnewandemergingthreats.

Theoperatorofafacilityshallmaintainrecordsdocumentingthemonitoringofthe
preventivecontrols,instancesofnonconformancematerialtofoodsafety,theresults
oftestingandotherappropriatemeansofverification,instanceswhencorrective
actionswereimplemented,andtheefficacyofpreventivecontrolsandcorrective
actions.
Theoperatorofafacilityshallprepareawrittenplanthatdocumentsanddescribes
theproceduresusedbythefacilitytocomplywiththerequirementsofafoodsafety
plan,includinganalyzingthehazardsandidentifyingthepreventivecontrolsadopted
toaddressthosehazards.Suchwrittenplanandassociatedrecordsshallbemade
promptlyavailabletoFDAuponoralorwrittenrequest.
Theoperatorinchargeofafacilityshallconductareanalysis
wheneverasignificantchangeismadeintheactivitiesconductedatafacilityif
thechangecreatesareasonablepotentialforanewhazard,
wheneverasignificantchangeismadeintheactivitiesconductedatafacilityif
thechangecreatesasignificantincreaseinapreviouslyidentifiedhazard,or
notlessfrequentlythanonceevery3years,whicheverisearlier.
Suchreanalysisshallbecompletedandadditionalpreventivecontrolsneededto
addressthehazardidentifiedshallbeimplementedbeforethechangeinactivitiesat
thefacilityisoperative.Theoperatorshallrevisethewrittenfoodsafetyplanifsuch
asignificantchangeismade,ordocumentthebasisforconcludingthatnoadditional
orrevisedpreventivecontrolsareneeded.
TheFDAmayrequireareanalysistorespondtonewhazardsanddevelopmentsin
scientificunderstanding,includingresultsfromtheDepartmentofHomelandSecurity

biological,chemical,radiological,orotherterrorismriskassessment.

SomeDifferencesbetweenGeneralComponentsofHACCPand
FoodSafetyPlanStatute
TheFoodSafetyPlanstatuteslightlyextendsthelistofhazards
Thestatuteincludesintentionalattacksasahazard
Thestatuteidentifiesthelabelingofmajorfoodallergensasaconcern
Thestatutemandatesareanalysisofthefoodsafetyplannolessoftenthan
everythreeyears
ThestatuteempowersFDAtomandateareanalysisofafoodsafetyplan

OverviewofProposedFoodSafetyRegulation
21CFRPart117SubpartC(proposed)
Addsarecallplanaspartofthefoodsafetyplan
Thehazardevaluationincludesanassessmentoftheseverityofillnessorinjury
shouldthehazardoccur
TheproposedregulationdoesNOTaddressintentionalattacks
Preventivecontrolsaddressprocesscontrols,foodallergencontrols,sanitation
controls,andrecallplan(asalreadymentioned)
Correctiveactionscontinuetodistinguishbetweenanticipatedproblemsand
unanticipatedproblems.
Expandedlistofeventsthattriggerreanalysisofthefoodsafetyplan
Refinedtheresponsibilitiesofthetrainedindividual:preparefoodsafetyplan,
validatepreventivecontrols,reviewrecordsforimplementationand
effectivenessofpreventivecontrols,reviewrecordsforappropriatenessof
correctiveactions,andreanalysisoffoodsafetyplan
Refinedtherequiredrecords:writtenfoodsafetyplans(anditssixrequired
components),monitoringpreventivecontrols,documentcorrectiveactions,

FoodDefense:Assessingvulnerabilitiestoanintentionalattack
withinafoodsystemorinfrastructure
SinceSeptember2001,therehasbeenincreasedfocusontheriskofanintentional
attackontheU.S.foodsystem.Theindustryrecognizedthatthemilitaryassesses
theriskofanintentionalattackonacontinuousbasis.Theprocessusedbythe
militaryisknownasCARVER.Throughoutthe2000s,theU.S.foodindustrystudied
theapplicationofCARVER.TheFoodSafetyModernizationActincorporates
intentionalattackintothedevelopmentandimplementationofaFoodSafetyPlan.
ThissectionreviewsCARVERandbeginstosuggesthowitmightbeincorporated
intoHACCP.ThediscussionalsointroducestheFoodDefenseregulationproposed
byFDAinDecember2013.

Howdoesafoodbusinessbegintoaddresstheriskofanintentionalattackonits
product?Oneideaistoimplementthemilitary'sconceptofCARVER.
SeeFDAwebpageonCARVER+ShockPrimer
"TheCARVERplusShockmethodisanoffensivetargetingprioritizationtoolthat
hasbeenadaptedforuseinthefoodsector.Thistoolcanbeusedtoassessthe
vulnerabilitieswithinasystemorinfrastructuretoanattack.Itallowsyoutothink
likeanattackerbyidentifyingthemostattractivetargetsforattack.Byconducting
suchavulnerabilityassessmentanddeterminingthemostvulnerablepointsin
yourinfrastructure,youcanthenfocusyourresourcesonprotectingyourmost
vulnerablepoints.
"CARVERisanacronymforthefollowingsixattributes(discussedinfurther
detaillater)usedtoevaluatetheattractivenessofatargetforattack:
Criticalitymeasureofpublichealthandeconomicimpactsofanattack
Accessibilityabilitytophysicallyaccessandegressfromtarget
Recuperabilityabilityofsystemtorecoverfromanattack
Vulnerabilityeaseofaccomplishingattack
Effectamountofdirectlossfromanattackasmeasuredbylossinproduction
Recognizabilityeaseofidentifyingtarget
"Inaddition,themodifiedCARVERtoolevaluatesaseventhattribute,the
combinedhealth,economic,andpsychologicalimpactsofanattack,orthe
SHOCKattributesofatarget.
"Theattractivenessofatargetcanthenberankedonascalefromonetotenon
thebasisofscalesthathavebeendevelopedforeachofthesevenattributes.
Conditionsthatareassociatedwithlowerattractiveness(orlowervulnerability)
areassignedlowervalues(e.g.,1or2),whereas,conditionsassociatedwith
higherattractivenessasatarget(orhighervulnerability)areassignedhigher
values(e.g.,9or10).Evaluatingorscoringthevariouselementsofthefood
sectorinfrastructureofinterestforeachoftheCARVERShockattributescan
helpidentifywherewithinthatinfrastructureanattackismostlikelytooccur."
FDAhasnotabandonedtheconceptsthatunderpinCARVER+Shock,buthas
refineditsexplanationoftheconceptsandtheirapplication.SeeFDAresourceson
FoodDefense:
FDAFoodDefensewebbasedinformationdescribingseveralapproachesto
addressingtheconcernofintentionalattacksonthefoodindustry
TheFoodSafetyModernizationActaddsintentionalattacksasariskorhazard
tobeanalyzedaspartofaFoodSafetyPlansee21U.S.C.350iand21U.S.C.
350g(b)(2).
TheFDAshalla)conductavulnerabilityassessmentofthefoodsystem
b)considerthebestavailableunderstandingofuncertainties,risks,costs,
andbenefitsassociatedwithguardingagainstintentionaladulterationof
foodc)determinethetypesofsciencebasedmitigationstrategiesor
measuresthatarenecessarytoprotectagainsttheintentionaladulteration
offoodandd)determinethetime,manner,andforminwhichthese
determinationsaremadepubliclyavailable.
TheFDAshallpromulgateregulationsa)specifyinghowapersonshall
assesswhetherthepersonisrequiredtoimplementmitigationstrategies
toprotectagainstintentionaladulterationoffoodandb)specify
appropriatesciencebasedmitigationstrategiestoprotectthefoodsupply

chainatspecificvulnerablepoints.Theseregulationsshallapplyonlyto
foodforwhichthereisahighriskofintentionalcontamination.
Thissectiondoesnotapplytofarms,exceptforthosethatproducemilk.
FDAProposedFoodDefenseRegulation:SeeFederalRegisterat
https://www.federalregister.gov/articles/2013/12/24/201330373/focused
mitigationstrategiestoprotectfoodagainstintentionaladulteration

USDAFSIS
USDAFSISalsoneedstoconsidertheriskofanintentionalattackagainstthe
meat,poultryandeggindustries.
FoodDefenseandEmergencyResponse
USDAFoodDefensePlanguidesheetforfoodbusinesses

Summary
GoodManufacturingPracticesandSanitaryStandardOperatingProceduresguide
foodprocessorsintheconstructionandoperationoftheirfacilitiestoreducetherisk
ofadulteratedfood.
HazardAnalysis&CriticalControlPointsandFoodSafetyPlansarefoundedonthe
sevenprinciplesofHACCPbuttheFoodSafetyPlanexpandsthescopeofissuesa
foodprocessorisexpectedtoconsiderandaddress,suchasmajorallergens,
preparingarecallplan,andtheriskofanintentionalattackagainstthefoodproduct.
EmailDavid.Saxowsky@ndsu.edu
Thismaterialisintendedforeducationalpurposesonly.Itisnotasubstitutefor
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