CFR 21 Part 117

3/24/2017 eCFRCodeofFederalRegulations
ELECTRONICCODEOFFEDERALREGULATIONS
eCFRdataiscurrentasofMarch22,2017
Title21ChapterISubchapterBPart117
Title21:FoodandDrugs
PART117CURRENTGOODMANUFACTURINGPRACTICE,HAZARDANALYSIS,ANDRISKBASEDPREVENTIVE
CONTROLSFORHUMANFOOD
Contents
SubpartAGeneralProvisions
117.1Applicabilityandstatus.
117.3Definitions.
117.4Qualificationsofindividualswhomanufacture,process,pack,orholdfood.
117.5Exemptions.
117.7ApplicabilityofsubpartsC,D,andGofthisparttoafacilitysolelyengagedinthestorageofunexposedpackaged
food.
117.8ApplicabilityofsubpartBofthisparttotheofffarmpackingandholdingofrawagriculturalcommodities.
117.9Recordsrequiredforthissubpart.
SubpartBCurrentGoodManufacturingPractice
117.10Personnel.
117.20Plantandgrounds.
117.35Sanitaryoperations.
117.37Sanitaryfacilitiesandcontrols.
117.40Equipmentandutensils.
117.80Processesandcontrols.
117.93Warehousinganddistribution.
117.95Holdinganddistributionofhumanfoodbyproductsforuseasanimalfood.
117.110Defectactionlevels.
SubpartCHazardAnalysisandRiskBasedPreventiveControls
117.126Foodsafetyplan.
117.130Hazardanalysis.
117.135Preventivecontrols.
117.136Circumstancesinwhichtheowner,operator,oragentinchargeofamanufacturing/processingfacilityisnot
requiredtoimplementapreventivecontrol.
117.137Provisionofassurancesrequiredunder117.136(a)(2),(3),and(4).
117.139Recallplan.
117.140Preventivecontrolmanagementcomponents.
117.145Monitoring.
117.150Correctiveactionsandcorrections.
117.155Verification.
117.160Validation.
117.165Verificationofimplementationandeffectiveness.
117.170Reanalysis.
117.180Requirementsapplicabletoapreventivecontrolsqualifiedindividualandaqualifiedauditor.
117.190Implementationrecordsrequiredforthissubpart.
SubpartDModifiedRequirements
117.201Modifiedrequirementsthatapplytoaqualifiedfacility.
117.206Modifiedrequirementsthatapplytoafacilitysolelyengagedinthestorageofunexposedpackagedfood.
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117.206Modifiedrequirementsthatapplytoafacilitysolelyengagedinthestorageofunexposedpackagedfood.
SubpartEWithdrawalofaQualifiedFacilityExemption
117.251CircumstancesthatmayleadFDAtowithdrawaqualifiedfacilityexemption.
117.254Issuanceofanordertowithdrawaqualifiedfacilityexemption.
117.257Contentsofanordertowithdrawaqualifiedfacilityexemption.
117.260Compliancewith,orappealof,anordertowithdrawaqualifiedfacilityexemption.
117.264Procedureforsubmittinganappeal.
117.267Procedureforrequestinganinformalhearing.
117.270Requirementsapplicabletoaninformalhearing.
117.274Presidingofficerforanappealandforaninformalhearing.
117.277Timeframeforissuingadecisiononanappeal.
117.280Revocationofanordertowithdrawaqualifiedfacilityexemption.
117.284Finalagencyaction.
117.287Reinstatementofaqualifiedfacilityexemptionthatwaswithdrawn.
SubpartFRequirementsApplyingtoRecordsThatMustBeEstablishedandMaintained
117.301Recordssubjecttotherequirementsofthissubpart.
117.305Generalrequirementsapplyingtorecords.
117.310Additionalrequirementsapplyingtothefoodsafetyplan.
117.315Requirementsforrecordretention.
117.320Requirementsforofficialreview.
117.325Publicdisclosure.
117.330Useofexistingrecords.
117.335Specialrequirementsapplicabletoawrittenassurance.
SubpartGSupplyChainProgram
117.405Requirementtoestablishandimplementasupplychainprogram.
117.410Generalrequirementsapplicabletoasupplychainprogram.
117.415Responsibilitiesofthereceivingfacility.
117.420Usingapprovedsuppliers.
117.425Determiningappropriatesupplierverificationactivities(includingdeterminingthefrequencyofconductingthe
activity).
117.430Conductingsupplierverificationactivitiesforrawmaterialsandotheringredients.
117.435Onsiteaudit.
117.475Recordsdocumentingthesupplychainprogram.
A:21U.S.C.331,342,343,350dnote,350g,350gnote,371,37442U.S.C.243,264,271.
S:80FR56145,Sept.17,2015,unlessotherwisenoted.
EN:Nomenclaturechangestopart100appearat81FR49896,July29,2016.
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SubpartAGeneralProvisions
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117.1Applicabilityandstatus.
(a)Thecriteriaanddefinitionsinthispartapplyindeterminingwhetherafoodis:
(1)Adulteratedwithinthemeaningof:
(i)Section402(a)(3)oftheFederalFood,Drug,andCosmeticActinthatthefoodhasbeenmanufacturedundersuch
conditionsthatitisunfitforfoodor
(ii)Section402(a)(4)oftheFederalFood,Drug,andCosmeticActinthatthefoodhasbeenprepared,packed,or
heldunderinsanitaryconditionswherebyitmayhavebecomecontaminatedwithfilth,orwherebyitmayhavebeen
renderedinjurioustohealthand
(2)Inviolationofsection361ofthePublicHealthServiceAct(42U.S.C.264).
(b)Theoperationofafacilitythatmanufactures,processes,packs,orholdsfoodforsaleintheUnitedStatesifthe
owner,operator,oragentinchargeofsuchfacilityisrequiredtocomplywith,andisnotincompliancewith,section418of
theFederalFood,Drug,andCosmeticActorsubpartC,D,E,F,orGofthispartisaprohibitedactundersection301(uu)
oftheFederalFood,Drug,andCosmeticAct.
(c)Foodcoveredbyspecificcurrentgoodmanufacturingpracticeregulationsalsoissubjecttotherequirementsof
thoseregulations.
[80FR56145,Sept.17,2015,asamendedat81FR3715,Jan.22,2015]
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117.3Definitions.
Thedefinitionsandinterpretationsoftermsinsection201oftheFederalFood,Drug,andCosmeticActapplytosuch
termswhenusedinthispart.Thefollowingdefinitionsalsoapply:
AcidfoodsoracidifiedfoodsmeansfoodsthathaveanequilibriumpHof4.6orbelow.
Adequatemeansthatwhichisneededtoaccomplishtheintendedpurposeinkeepingwithgoodpublichealth
practice.
Affiliatemeansanyfacilitythatcontrols,iscontrolledby,orisundercommoncontrolwithanotherfacility.
Allergencrosscontactmeanstheunintentionalincorporationofafoodallergenintoafood.
Auditmeansthesystematic,independent,anddocumentedexamination(throughobservation,investigation,records
review,discussionswithemployeesoftheauditedentity,and,asappropriate,samplingandlaboratoryanalysis)toassess
anauditedentity'sfoodsafetyprocessesandprocedures.
Battermeansasemifluidsubstance,usuallycomposedofflourandotheringredients,intowhichprincipalcomponents
offoodaredippedorwithwhichtheyarecoated,orwhichmaybeuseddirectlytoformbakeryfoods.
Blanching,exceptfortreenutsandpeanuts,meansaprepackagingheattreatmentoffoodstuffsforanadequatetime
andatanadequatetemperaturetopartiallyorcompletelyinactivatethenaturallyoccurringenzymesandtoeffectother
physicalorbiochemicalchangesinthefood.
Calendardaymeanseverydayshownonthecalendar.
Correctionmeansanactiontoidentifyandcorrectaproblemthatoccurredduringtheproductionoffood,without
otheractionsassociatedwithacorrectiveactionprocedure(suchasactionstoreducethelikelihoodthattheproblemwill
recur,evaluateallaffectedfoodforsafety,andpreventaffectedfoodfromenteringcommerce).
Criticalcontrolpointmeansapoint,step,orprocedureinafoodprocessatwhichcontrolcanbeappliedandis
essentialtopreventoreliminateafoodsafetyhazardorreducesuchhazardtoanacceptablelevel.
Defectactionlevelmeansalevelofanonhazardous,naturallyoccurring,unavoidabledefectatwhichFDAmay
regardafoodproductadulteratedandsubjecttoenforcementactionundersection402(a)(3)oftheFederalFood,Drug,
andCosmeticAct.
Environmentalpathogenmeansapathogencapableofsurvivingandpersistingwithinthemanufacturing,processing,
packing,orholdingenvironmentsuchthatfoodmaybecontaminatedandmayresultinfoodborneillnessifthatfoodis
consumedwithouttreatmenttosignificantlyminimizetheenvironmentalpathogen.Examplesofenvironmentalpathogens
forthepurposesofthispartincludeListeriamonocytogenesandSalmonellaspp.butdonotincludethesporesof
pathogenicsporeformingbacteria.
Facilitymeansadomesticfacilityoraforeignfacilitythatisrequiredtoregisterundersection415oftheFederalFood,
Drug,andCosmeticAct,inaccordancewiththerequirementsofpart1,subpartHofthischapter.
Farmmeansfarmasdefinedin1.227ofthischapter.
FDAmeanstheFoodandDrugAdministration.
Foodmeansfoodasdefinedinsection201(f)oftheFederalFood,Drug,andCosmeticActandincludesraw
materialsandingredients.
Foodallergenmeansamajorfoodallergenasdefinedinsection201(qq)oftheFederalFood,Drug,andCosmetic
Act.
Foodcontactsurfacesarethosesurfacesthatcontacthumanfoodandthosesurfacesfromwhichdrainage,orother
transfer,ontothefoodorontosurfacesthatcontactthefoodordinarilyoccursduringthenormalcourseofoperations.
Foodcontactsurfacesincludesutensilsandfoodcontactsurfacesofequipment.
Fulltimeequivalentemployeeisatermusedtorepresentthenumberofemployeesofabusinessentityforthe
purposeofdeterminingwhetherthebusinessqualifiesforthesmallbusinessexemption.Thenumberoffulltime
equivalentemployeesisdeterminedbydividingthetotalnumberofhoursofsalaryorwagespaiddirectlytoemployeesof
thebusinessentityandofallofitsaffiliatesandsubsidiariesbythenumberofhoursofworkin1year,2,080hours(i.e.,40
hours52weeks).Iftheresultisnotawholenumber,rounddowntothenextlowestwholenumber.
Harvestingappliestofarmsandfarmmixedtypefacilitiesandmeansactivitiesthataretraditionallyperformedon
farmsforthepurposeofremovingrawagriculturalcommoditiesfromtheplacetheyweregrownorraisedandpreparing
themforuseasfood.Harvestingislimitedtoactivitiesperformedonrawagriculturalcommodities,oronprocessedfoods
createdbydrying/dehydratingarawagriculturalcommoditywithoutadditionalmanufacturing/processing,onafarm.
Harvestingdoesnotincludeactivitiesthattransformarawagriculturalcommodityintoaprocessedfoodasdefinedin
section201(gg)oftheFederalFood,Drug,andCosmeticAct.Examplesofharvestingincludecutting(orotherwise
separating)theedibleportionoftherawagriculturalcommodityfromthecropplantandremovingortrimmingpartofthe
rawagriculturalcommodity(e.g.,foliage,husks,rootsorstems).Examplesofharvestingalsoincludecooling,fieldcoring,
filtering,gathering,hulling,shelling,sifting,threshing,trimmingofouterleavesof,andwashingrawagricultural
commoditiesgrownonafarm.
Hazardmeansanybiological,chemical(includingradiological),orphysicalagentthathasthepotentialtocause
illnessorinjury.
Hazardrequiringapreventivecontrolmeansaknownorreasonablyforeseeablehazardforwhichaperson
knowledgeableaboutthesafemanufacturing,processing,packing,orholdingoffoodwould,basedontheoutcomeofa
hazardanalysis(whichincludesanassessmentoftheseverityoftheillnessorinjuryifthehazardweretooccurandthe
probabilitythatthehazardwilloccurintheabsenceofpreventivecontrols),establishoneormorepreventivecontrolsto
significantlyminimizeorpreventthehazardinafoodandcomponentstomanagethosecontrols(suchasmonitoring,
correctionsorcorrectiveactions,verification,andrecords)asappropriatetothefood,thefacility,andthenatureofthe
preventivecontrolanditsroleinthefacility'sfoodsafetysystem.
Holdingmeansstorageoffoodandalsoincludesactivitiesperformedincidentaltostorageofafood(e.g.,activities
performedforthesafeoreffectivestorageofthatfood,suchasfumigatingfoodduringstorage,anddrying/dehydrating
rawagriculturalcommoditieswhenthedrying/dehydratingdoesnotcreateadistinctcommodity(suchas
drying/dehydratinghayoralfalfa)).Holdingalsoincludesactivitiesperformedasapracticalnecessityforthedistributionof
thatfood(suchasblendingofthesamerawagriculturalcommodityandbreakingdownpallets),butdoesnotinclude
activitiesthattransformarawagriculturalcommodityintoaprocessedfoodasdefinedinsection201(gg)oftheFederal
Food,Drug,andCosmeticAct.Holdingfacilitiescouldincludewarehouses,coldstoragefacilities,storagesilos,grain
elevators,andliquidstoragetanks.
Knownorreasonablyforeseeablehazardmeansabiological,chemical(includingradiological),orphysicalhazardthat
isknowntobe,orhasthepotentialtobe,associatedwiththefacilityorthefood.
Lotmeansthefoodproducedduringaperiodoftimeandidentifiedbyanestablishment'sspecificcode.
Manufacturing/processingmeansmakingfoodfromoneormoreingredients,orsynthesizing,preparing,treating,
modifyingormanipulatingfood,includingfoodcropsoringredients.Examplesofmanufacturing/processingactivities
include:Baking,boiling,bottling,canning,cooking,cooling,cutting,distilling,drying/dehydratingrawagricultural
commoditiestocreateadistinctcommodity(suchasdrying/dehydratinggrapestoproduceraisins),evaporating,
eviscerating,extractingjuice,formulating,freezing,grinding,homogenizing,irradiating,labeling,milling,mixing,packaging
(includingmodifiedatmospherepackaging),pasteurizing,peeling,rendering,treatingtomanipulateripening,trimming,
washing,orwaxing.Forfarmsandfarmmixedtypefacilities,manufacturing/processingdoesnotincludeactivitiesthatare
partofharvesting,packing,orholding.
Microorganismsmeansyeasts,molds,bacteria,viruses,protozoa,andmicroscopicparasitesandincludesspecies
thatarepathogens.Thetermundesirablemicroorganismsincludesthosemicroorganismsthatarepathogens,that
subjectfoodtodecomposition,thatindicatethatfoodiscontaminatedwithfilth,orthatotherwisemaycausefoodtobe
adulterated.
Mixedtypefacilitymeansanestablishmentthatengagesinbothactivitiesthatareexemptfromregistrationunder
section415oftheFederalFood,Drug,andCosmeticActandactivitiesthatrequiretheestablishmenttoberegistered.An
exampleofsuchafacilityisafarmmixedtypefacility,whichisanestablishmentthatisafarm,butalsoconducts
activitiesoutsidethefarmdefinitionthatrequiretheestablishmenttoberegistered.
Monitormeanstoconductaplannedsequenceofobservationsormeasurementstoassesswhethercontrol
measuresareoperatingasintended.
Packingmeansplacingfoodintoacontainerotherthanpackagingthefoodandalsoincludesrepackingandactivities
performedincidentaltopackingorrepackingafood(e.g.,activitiesperformedforthesafeoreffectivepackingorre
packingofthatfood(suchassorting,culling,grading,andweighingorconveyingincidentaltopackingorrepacking)),but
doesnotincludeactivitiesthattransformarawagriculturalcommodityintoaprocessedfoodasdefinedinsection201(gg)
oftheFederalFood,Drug,andCosmeticAct.
Pathogenmeansamicroorganismofpublichealthsignificance.
Pestreferstoanyobjectionableanimalsorinsectsincludingbirds,rodents,flies,andlarvae.
Plantmeansthebuildingorstructureorpartsthereof,usedfororinconnectionwiththemanufacturing,processing,
packing,orholdingofhumanfood.
Preventivecontrolsmeansthoseriskbased,reasonablyappropriateprocedures,practices,andprocessesthata
personknowledgeableaboutthesafemanufacturing,processing,packing,orholdingoffoodwouldemploytosignificantly
minimizeorpreventthehazardsidentifiedunderthehazardanalysisthatareconsistentwiththecurrentscientific
understandingofsafefoodmanufacturing,processing,packing,orholdingatthetimeoftheanalysis.
Preventivecontrolsqualifiedindividualmeansaqualifiedindividualwhohassuccessfullycompletedtraininginthe
developmentandapplicationofriskbasedpreventivecontrolsatleastequivalenttothatreceivedunderastandardized
curriculumrecognizedasadequatebyFDAorisotherwisequalifiedthroughjobexperiencetodevelopandapplyafood
safetysystem.
Qualifiedauditormeansapersonwhoisaqualifiedindividualasdefinedinthispartandhastechnicalexpertise
obtainedthrougheducation,training,orexperience(oracombinationthereof)necessarytoperformtheauditingfunction
asrequiredby117.180(c)(2).Examplesofpotentialqualifiedauditorsinclude:
(1)Agovernmentemployee,includingaforeigngovernmentemployeeand
(2)Anauditagentofacertificationbodythatisaccreditedinaccordancewithregulationsinpart1,subpartMofthis
chapter.
Qualifiedenduser,withrespecttoafood,meanstheconsumerofthefood(wherethetermconsumerdoesnot
includeabusiness)orarestaurantorretailfoodestablishment(asthosetermsaredefinedin1.227ofthischapter)that:
(1)Islocated:
(i)InthesameStateorthesameIndianreservationasthequalifiedfacilitythatsoldthefoodtosuchrestaurantor
establishmentor
(ii)Notmorethan275milesfromsuchfacilityand
(2)Ispurchasingthefoodforsaledirectlytoconsumersatsuchrestaurantorretailfoodestablishment.
Qualifiedfacilitymeans(whenincludingthesalesbyanysubsidiaryaffiliateorsubsidiariesoraffiliates,collectively,
ofanyentityofwhichthefacilityisasubsidiaryoraffiliate)afacilitythatisaverysmallbusinessasdefinedinthispart,or
afacilitytowhichbothofthefollowingapply:
(1)Duringthe3yearperiodprecedingtheapplicablecalendaryear,theaverageannualmonetaryvalueofthefood
manufactured,processed,packedorheldatsuchfacilitythatissolddirectlytoqualifiedendusers(asdefinedinthispart)
duringsuchperiodexceededtheaverageannualmonetaryvalueofthefoodsoldbysuchfacilitytoallotherpurchasers
and
(2)Theaverageannualmonetaryvalueofallfoodsoldduringthe3yearperiodprecedingtheapplicablecalendar
yearwaslessthan$500,000,adjustedforinflation.
Qualifiedfacilityexemptionmeansanexemptionapplicabletoaqualifiedfacilityunder117.5(a).
Qualifiedindividualmeansapersonwhohastheeducation,training,orexperience(oracombinationthereof)
necessarytomanufacture,process,pack,orholdcleanandsafefoodasappropriatetotheindividual'sassignedduties.A
qualifiedindividualmaybe,butisnotrequiredtobe,anemployeeoftheestablishment.
Qualitycontroloperationmeansaplannedandsystematicprocedurefortakingallactionsnecessarytopreventfood
frombeingadulterated.
Rawagriculturalcommodityhasthemeaninggiveninsection201(r)oftheFederalFood,Drug,andCosmeticAct.
Readytoeatfood(RTEfood)meansanyfoodthatisnormallyeateninitsrawstateoranyotherfood,includinga
processedfood,forwhichitisreasonablyforeseeablethatthefoodwillbeeatenwithoutfurtherprocessingthatwould
significantlyminimizebiologicalhazards.
ReceivingfacilitymeansafacilitythatissubjecttosubpartsCandGofthispartandthatmanufactures/processesa
rawmaterialorotheringredientthatitreceivesfromasupplier.
Reworkmeansclean,unadulteratedfoodthathasbeenremovedfromprocessingforreasonsotherthaninsanitary
conditionsorthathasbeensuccessfullyreconditionedbyreprocessingandthatissuitableforuseasfood.
Safemoisturelevelisalevelofmoisturelowenoughtopreventthegrowthofundesirablemicroorganismsinthe
finishedproductundertheintendedconditionsofmanufacturing,processing,packing,andholding.Thesafemoisture
levelforafoodisrelatedtoitswateractivity(aw).Anawwillbeconsideredsafeforafoodifadequatedataareavailable
thatdemonstratethatthefoodatorbelowthegivenawwillnotsupportthegrowthofundesirablemicroorganisms.
Sanitizemeanstoadequatelytreatcleanedsurfacesbyaprocessthatiseffectiveindestroyingvegetativecellsof
pathogens,andinsubstantiallyreducingnumbersofotherundesirablemicroorganisms,butwithoutadverselyaffectingthe
productoritssafetyfortheconsumer.
Significantlyminimizemeanstoreducetoanacceptablelevel,includingtoeliminate.
Smallbusinessmeans,forpurposesofthispart,abusiness(includinganysubsidiariesandaffiliates)employingfewer
than500fulltimeequivalentemployees.
Subsidiarymeansanycompanywhichisownedorcontrolleddirectlyorindirectlybyanothercompany.
Suppliermeanstheestablishmentthatmanufactures/processesthefood,raisestheanimal,orgrowsthefoodthatis
providedtoareceivingfacilitywithoutfurthermanufacturing/processingbyanotherestablishment,exceptforfurther
manufacturing/processingthatconsistssolelyoftheadditionoflabelingorsimilaractivityofademinimisnature.
Supplychainappliedcontrolmeansapreventivecontrolforahazardinarawmaterialorotheringredientwhenthe
hazardintherawmaterialorotheringredientiscontrolledbeforeitsreceipt.
Unexposedpackagedfoodmeanspackagedfoodthatisnotexposedtotheenvironment.
Validationmeansobtainingandevaluatingscientificandtechnicalevidencethatacontrolmeasure,combinationof
controlmeasures,orthefoodsafetyplanasawhole,whenproperlyimplemented,iscapableofeffectivelycontrollingthe
identifiedhazards.
Verificationmeanstheapplicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,to
determinewhetheracontrolmeasureorcombinationofcontrolmeasuresisorhasbeenoperatingasintendedandto
establishthevalidityofthefoodsafetyplan.
Verysmallbusinessmeans,forpurposesofthispart,abusiness(includinganysubsidiariesandaffiliates)averaging
lessthan$1,000,000,adjustedforinflation,peryear,duringthe3yearperiodprecedingtheapplicablecalendaryearin
salesofhumanfoodplusthemarketvalueofhumanfoodmanufactured,processed,packed,orheldwithoutsale(e.g.,
heldforafee).
Wateractivity(aw)isameasureofthefreemoistureinafoodandisthequotientofthewatervaporpressureofthe
substancedividedbythevaporpressureofpurewateratthesametemperature.
Writtenproceduresforreceivingrawmaterialsandotheringredientsmeanswrittenprocedurestoensurethatraw
materialsandotheringredientsarereceivedonlyfromsuppliersapprovedbythereceivingfacility(or,whennecessaryand
appropriate,onatemporarybasisfromunapprovedsupplierswhoserawmaterialsorotheringredientsaresubjectedto
adequateverificationactivitiesbeforeacceptanceforuse).
Youmeans,forpurposesofthispart,theowner,operator,oragentinchargeofafacility.
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117.4Qualificationsofindividualswhomanufacture,process,pack,orholdfood.
(a)Applicability.(1)Themanagementofanestablishmentmustensurethatallindividualswhomanufacture,process,
pack,orholdfoodsubjecttosubpartsBandFofthispartarequalifiedtoperformtheirassignedduties.
(2)Theowner,operator,oragentinchargeofafacilitymustensurethatallindividualswhomanufacture,process,
pack,orholdfoodsubjecttosubpartC,D,E,F,orGofthispartarequalifiedtoperformtheirassignedduties.
(b)Qualificationsofallindividualsengagedinmanufacturing,processing,packing,orholdingfood.Eachindividual
engagedinmanufacturing,processing,packing,orholdingfood(includingtemporaryandseasonalpersonnel)orinthe
supervisionthereofmust:
(1)Beaqualifiedindividualasthattermisdefinedin117.3i.e.,havetheeducation,training,orexperience(ora
combinationthereof)necessarytomanufacture,process,pack,orholdcleanandsafefoodasappropriatetothe
individual'sassigneddutiesand
(2)Receivetrainingintheprinciplesoffoodhygieneandfoodsafety,includingtheimportanceofemployeehealthand
personalhygiene,asappropriatetothefood,thefacilityandtheindividual'sassignedduties.
(c)Additionalqualificationsofsupervisorypersonnel.Responsibilityforensuringcompliancebyindividualswiththe
requirementsofthispartmustbeclearlyassignedtosupervisorypersonnelwhohavetheeducation,training,or
experience(oracombinationthereof)necessarytosupervisetheproductionofcleanandsafefood.
(d)Records.Recordsthatdocumenttrainingrequiredbyparagraph(b)(2)ofthissectionmustbeestablishedand
maintained.
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117.5Exemptions.
(a)ExceptasprovidedbysubpartEofthispart,subpartsCandGofthispartdonotapplytoaqualifiedfacility.
Qualifiedfacilitiesaresubjecttothemodifiedrequirementsin117.201.
(b)SubpartsCandGofthispartdonotapplywithrespecttoactivitiesthataresubjecttopart123ofthischapter
(FishandFisheryProducts)atafacilityifyouarerequiredtocomplywith,andareincompliancewith,part123ofthis
chapterwithrespecttosuchactivities.
(c)SubpartsCandGofthispartdonotapplywithrespecttoactivitiesthataresubjecttopart120ofthischapter
(HazardAnalysisandCriticalControlPoint(HACCP)Systems)atafacilityifyouarerequiredtocomplywith,andarein
compliancewith,part120ofthischapterwithrespecttosuchactivities.
(d)(1)SubpartsCandGofthispartdonotapplywithrespecttoactivitiesthataresubjecttopart113ofthischapter
(ThermallyProcessedLowAcidFoodsPackagedinHermeticallySealedContainers)atafacilityifyouarerequiredto
complywith,andareincompliancewith,part113ofthischapterwithrespecttosuchactivities.
(2)Theexemptioninparagraph(d)(1)ofthissectionisapplicableonlywithrespecttothemicrobiologicalhazardsthat
areregulatedunderpart113ofthischapter.
(e)SubpartsCandGdonotapplytoanyfacilitywithregardtothemanufacturing,processing,packaging,orholding
ofadietarysupplementthatisincompliancewiththerequirementsofpart111ofthischapter(CurrentGood
ManufacturingPracticeinManufacturing,Packaging,Labeling,orHoldingOperationsforDietarySupplements)and
section761oftheFederalFood,Drug,andCosmeticAct(SeriousAdverseEventReportingforDietarySupplements).
(f)SubpartsCandGofthispartdonotapplytoactivitiesofafacilitythataresubjecttosection419oftheFederal
Food,Drug,andCosmeticAct(StandardsforProduceSafety).
(g)(1)Theexemptioninparagraph(g)(3)ofthissectionappliestopackingorholdingofprocessedfoodsonafarm
mixedtypefacility,exceptforprocessedfoodsproducedbydrying/dehydratingrawagriculturalcommoditiestocreatea
distinctcommodity(suchasdrying/dehydratinggrapestoproduceraisins,anddrying/dehydratingfreshherbstoproduce
driedherbs),andpackagingandlabelingsuchcommodities,withoutadditionalmanufacturing/processing(suchas
choppingandslicing),thepackingandholdingofwhicharewithinthefarmdefinitionin1.227ofthischapter.Activities
thatarewithinthefarmdefinition,whenconductedonafarmmixedtypefacility,arenotsubjecttotherequirementsof
subpartsCandGofthispartandthereforedonotneedtobespecifiedintheexemption.
(2)Forthepurposesofparagraphs(g)(3)and(h)(3)ofthissection,thefollowingtermsdescribethefoodsassociated
withtheactivity/foodcombinations.Severalfoodsthatarefruitsorvegetablesareseparatelyconsideredforthepurposes
oftheseactivity/foodcombinations(i.e.,coffeebeans,cocoabeans,freshherbs,peanuts,sugarcane,sugarbeets,tree
nuts,seedsfordirectconsumption)toappropriatelyaddressspecifichazardsassociatedwiththesefoodsand/or
processingactivitiesconductedonthesefoods.
(i)Dried/dehydratedfruitandvegetableproductsincludesonlythoseprocessedfoodproductssuchasraisinsand
driedlegumesmadewithoutadditionalmanufacturing/processingbeyonddrying/dehydrating,packaging,and/orlabeling.
(ii)Otherfruitandvegetableproductsincludesthoseprocessedfoodproductsthathaveundergoneoneormoreof
thefollowingprocesses:acidification,boiling,canning,coatingwiththingsotherthanwax/oil/resin,cooking,cutting,
chopping,grinding,peeling,shredding,slicing,ortrimming.Examplesincludefloursmadefromlegumes(suchas
chickpeaflour),pickles,andsnackchipsmadefrompotatoesorplantains.Examplesalsoincludedriedfruitandvegetable
productsmadewithadditionalmanufacturing/processing(suchasdriedappleslicespitted,driedplums,cherries,and
apricotsandsulfitedraisins).Thiscategorydoesnotincludedried/dehydratedfruitandvegetableproductsmadewithout
additionalmanufacturing/processingasdescribedinparagraph(g)(2)(i)ofthissection.Thiscategoryalsodoesnotinclude
productsthatrequiretime/temperaturecontrolforsafety(suchasfreshcutfruitsandvegetables).
(iii)Peanutandtreenutproductsincludesprocessedfoodproductssuchasroastedpeanutsandtreenuts,seasoned
peanutsandtreenuts,andpeanutandtreenutflours.
(iv)Processedseedsfordirectconsumptionincludeprocessedfoodproductssuchasroastedpumpkinseeds,
roastedsunflowerseeds,androastedflaxseeds.
(v)Dried/dehydratedherbandspiceproductsincludesonlyprocessedfoodproductssuchasdriedintactherbsmade
withoutadditionalmanufacturing/processingbeyonddrying/dehydrating,packaging,and/orlabeling.
(vi)Otherherbandspiceproductsincludesthoseprocessedfoodproductssuchaschoppedfreshherbs,choppedor
grounddriedherbs(includingtea),herbalextracts(e.g.,essentialoils,extractscontainingmorethan20percentethanol,
extractscontainingmorethan35percentglycerin),driedherborspiceinfusedhoney,anddriedherborspiceinfused
oilsand/orvinegars.Thiscategorydoesnotincludedried/dehydratedherbandspiceproductsmadewithoutadditional
manufacturing/processingbeyonddrying/dehydrating,packaging,and/orlabelingasdescribedinparagraph(g)(2)(v)of
thissection.Thiscategoryalsodoesnotincludeproductsthatrequiretime/temperaturecontrolforsafety,suchasfresh
herbinfusedoils.
(vii)Grainsincludebarley,dentorflintcorn,sorghum,oats,rice,rye,wheat,amaranth,quinoa,buckwheatand
oilseedsforoilextraction(suchascottonseed,flaxseed,rapeseed,soybeans,andsunflowerseed).
(viii)Milledgrainproductsincludeprocessedfoodproductssuchasflour,bran,andcornmeal.
(ix)Bakedgoodsincludeprocessedfoodproductssuchasbreads,brownies,cakes,cookies,andcrackers.This
categorydoesnotincludeproductsthatrequiretime/temperaturecontrolforsafety,suchascreamfilledpastries.
(x)Othergrainproductsincludeprocessedfoodproductssuchasdriedcereal,driedpasta,oatflakes,andpopcorn.
Thiscategorydoesnotincludemilledgrainproductsasdescribedinparagraph(g)(2)(viii)ofthissectionorbakedgoods
asdescribedinparagraph(g)(2)(ix)ofthissection.
(3)SubpartsCandGofthispartdonotapplytoonfarmpackingorholdingoffoodbyasmallorverysmallbusiness,
and117.201doesnotapplytoonfarmpackingorholdingoffoodbyaverysmallbusiness,iftheonlypackingand
holdingactivitiessubjecttosection418oftheFederalFood,Drug,andCosmeticActthatthebusinessconductsarethe
followinglowriskpackingorholdingactivity/foodcombinationsi.e.,packing(orrepacking)(includingweighingor
conveyingincidentaltopackingorrepacking)sorting,culling,orgradingincidentaltopackingorstoringandstoring
(ambient,coldandcontrolledatmosphere)of:
(i)Bakedgoods(e.g.,breadandcookies)
(ii)Candy(e.g.,hardcandy,fudge,maplecandy,maplecream,nutbrittles,taffy,andtoffee)
(iii)Cocoabeans(roasted)
(iv)Cocoaproducts
(v)Coffeebeans(roasted)
(vi)Gamemeatjerky
(vii)Gums,latexes,andresinsthatareprocessedfoods
(viii)Honey(pasteurized)
(ix)Jams,jellies,andpreserves
(x)Milledgrainproducts(e.g.,flour,bran,andcornmeal)
(xi)Molassesandtreacle
(xii)Oils(e.g.,oliveoilandsunflowerseedoil)
(xiii)Otherfruitandvegetableproducts(e.g.,floursmadefromlegumespitted,driedfruitssliced,driedapplessnack
chips)
(xiv)Othergrainproducts(e.g.,driedpasta,oatflakes,andpopcorn)
(xv)Otherherbandspiceproducts(e.g.,choppedorgrounddriedherbs,herbalextracts)
(xvi)Peanutandtreenutproducts(e.g.,roastedpeanutsandtreenutflours)
(xvii)Processedseedsfordirectconsumption(e.g.,roastedpumpkinseeds)
(xviii)Softdrinksandcarbonatedwater
(xix)Sugar
(xx)Syrups(e.g.,maplesyrupandagavesyrup)
(xxi)Trailmixandgranola
(xxii)Vinegarand
(xxiii)Anyotherprocessedfoodthatdoesnotrequiretime/temperaturecontrolforsafety(e..g.,vitamins,minerals,
anddietaryingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform).
(h)(1)Theexemptioninparagraph(h)(3)ofthissectionappliestomanufacturing/processingoffoodsonafarm
mixedtypefacility,exceptformanufacturing/processingthatiswithinthefarmdefinitionin1.227ofthischapter.
Drying/dehydratingrawagriculturalcommoditiestocreateadistinctcommodity(suchasdrying/dehydratinggrapesto
produceraisins,anddrying/dehydratingfreshherbstoproducedriedherbs),andpackagingandlabelingsuch
commodities,withoutadditionalmanufacturing/processing(suchaschoppingandslicing),arewithinthefarmdefinitionin
1.227ofthischapter.Inaddition,treatmenttomanipulateripeningofrawagriculturalcommodities(suchasbytreating
producewithethylenegas),andpackagingandlabelingthetreatedrawagriculturalcommodities,withoutadditional
manufacturing/processing,iswithinthefarmdefinition.Inaddition,coatingintactfruitsandvegetableswithwax,oil,or
resinusedforthepurposeofstorageortransportationiswithinthefarmdefinition.Activitiesthatarewithinthefarm
definition,whenconductedonafarmmixedtypefacility,arenotsubjecttotherequirementsofsubpartsCandGofthis
partandthereforedonotneedtobespecifiedintheexemption.
(2)Thetermsinparagraph(g)(2)ofthissectiondescribecertainfoodsassociatedwiththeactivity/foodcombinations
inparagraph(h)(3)ofthissection.
(3)SubpartsCandGofthispartdonotapplytoonfarmmanufacturing/processingactivitiesconductedbyasmallor
verysmallbusinessfordistributionintocommerce,and117.201doesnotapplytoonfarmmanufacturing/processing
activitiesconductedbyaverysmallbusinessfordistributionintocommerce,iftheonlymanufacturing/processingactivities
subjecttosection418oftheFederalFood,Drug,andCosmeticActthatthebusinessconductsarethefollowinglowrisk
manufacturing/processingactivity/foodcombinations:
(i)Boilinggums,latexes,andresins
(ii)Chopping,coring,cutting,peeling,pitting,shredding,andslicingacidfruitsandvegetablesthathaveapHless
than4.2(e.g.,cuttinglemonsandlimes),bakedgoods(e.g.,slicingbread),dried/dehydratedfruitandvegetableproducts
(e.g.,pittingdriedplums),driedherbsandotherspices(e.g.,choppingintact,driedbasil),gamemeatjerky,
gums/latexes/resins,othergrainproducts(e.g.,shreddingdriedcereal),peanutsandtreenuts,andpeanutandtreenut
products(e.g.,choppingroastedpeanuts)
(iii)Coatingdried/dehydratedfruitandvegetableproducts(e.g.,coatingraisinswithchocolate),otherfruitand
vegetableproductsexceptfornondried,nonintactfruitsandvegetables(e.g.,coatingdriedplumpieces,driedpitted
cherries,anddriedpittedapricotswithchocolatearelowriskactivity/foodcombinationsbutcoatingapplesonastickwith
caramelisnotalowriskactivity/foodcombination),othergrainproducts(e.g.,addingcarameltopopcornoradding
seasoningstopopcornprovidedthattheseasoningshavebeentreatedtosignificantlyminimizepathogens,peanutsand
treenuts(e.g.,addingseasoningsprovidedthattheseasoningshavebeentreatedtosignificantlyminimizepathogens),
andpeanutandtreenutproducts(e.g.,addingseasoningsprovidedthattheseasoningshavebeentreatedtosignificantly
minimizepathogens))
(iv)Drying/dehydrating(thatincludesadditionalmanufacturingorisperformedonprocessedfoods)otherfruitand
vegetableproductswithpHlessthan4.2(e.g.,dryingcutfruitandvegetableswithpHlessthan4.2),andotherherband
spiceproducts(e.g.,dryingchoppedfreshherbs,includingtea)
(v)Extracting(includingbypressing,bydistilling,andbysolventextraction)dried/dehydratedherbandspiceproducts
(e.g.,driedmint),freshherbs(e.g.,freshmint),fruitsandvegetables(e.g.,olives,avocados),grains(e.g.,oilseeds),and
otherherbandspiceproducts(e.g.,choppedfreshmint,choppeddriedmint)
(vi)FreezingacidfruitsandvegetableswithpHlessthan4.2andotherfruitandvegetableproductswithpHlessthan
4.2(e.g.,cutfruitsandvegetables)
(vii)Grinding/cracking/crushing/millingbakedgoods(e.g.,crackers),cocoabeans(roasted),coffeebeans(roasted),
dried/dehydratedfruitandvegetableproducts(e.g.,raisinsanddriedlegumes),dried/dehydratedherbandspiceproducts
(e.g.,intactdriedbasil),grains(e.g.,oats,rice,rye,wheat),otherfruitandvegetableproducts(e.g.,dried,pitteddates),
othergrainproducts(e.g.,driedcereal),otherherbandspiceproducts(e.g.,choppeddriedherbs),peanutsandtreenuts,
andpeanutandtreenutproducts(e.g.,roastedpeanuts)
(viii)Labelingbakedgoodsthatdonotcontainfoodallergens,candythatdoesnotcontainfoodallergens,cocoa
beans(roasted),cocoaproductsthatdonotcontainfoodallergens),coffeebeans(roasted),gamemeatjerky,
gums/latexes/resinsthatareprocessedfoods,honey(pasteurized),jams/jellies/preserves,milledgrainproductsthatdo
notcontainfoodallergens(e.g.,cornmeal)orthataresingleingredientfoods(e.g.,wheatflour,wheatbran),molasses
andtreacle,oils,otherfruitandvegetableproductsthatdonotcontainfoodallergens(e.g.,snackchipsmadefrom
potatoesorplantains),othergrainproductsthatdonotcontainfoodallergens(e.g.,popcorn),otherherbandspice
products(e.g.,choppedorgrounddriedherbs),peanutortreenutproducts,(providedthattheyaresingleingredient,or
areinformsinwhichtheconsumercanreasonablybeexpectedtorecognizethefoodallergen(s)withoutlabel
declaration,orboth(e.g.,roastedorseasonedwholenuts,singleingredientpeanutortreenutflours)),processedseeds
fordirectconsumption,softdrinksandcarbonatedwater,sugar,syrups,trailmixandgranola(otherthanthosecontaining
milkchocolateandprovidedthatpeanutsand/ortreenutsareinformsinwhichtheconsumercanreasonablybeexpected
torecognizethefoodallergen(s)withoutlabeldeclaration),vinegar,andanyotherprocessedfoodthatdoesnotrequire
time/temperaturecontrolforsafetyandthatdoesnotcontainfoodallergens(e.g.,vitamins,minerals,anddietary
ingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform)
(ix)Makingbakedgoodsfrommilledgrainproducts(e.g.,breadsandcookies)
(x)Makingcandyfrompeanutsandtreenuts(e.g.,nutbrittles),sugar/syrups(e.g.,taffy,toffee),andsaps(e.g.,maple
candy,maplecream)
(xi)Makingcocoaproductsfromroastedcocoabeans
(xii)Makingdriedpastafromgrains
(xiii)Makingjams,jellies,andpreservesfromacidfruitsandvegetableswithapHof4.6orbelow
(xiv)Makingmolassesandtreaclefromsugarbeetsandsugarcane
(xv)Makingoatflakesfromgrains
(xvi)Makingpopcornfromgrains
(xvii)Makingsnackchipsfromfruitsandvegetables(e.g.,makingplantainandpotatochips)
(xviii)Makingsoftdrinksandcarbonatedwaterfromsugar,syrups,andwater
(xix)Makingsugarsandsyrupsfromfruitsandvegetables(e.g.,dates),grains(e.g.,rice,sorghum),othergrain
products(e.g.,maltedgrainssuchasbarley),saps(e.g.,agave,birch,maple,palm),sugarbeets,andsugarcane
(xx)Makingtrailmixandgranolafromcocoaproducts(e.g.,chocolate),dried/dehydratedfruitandvegetableproducts
(e.g.,raisins),otherfruitandvegetableproducts(e.g.,choppeddriedfruits),othergrainproducts(e.g.,oatflakes),peanut
andtreenutproducts,andprocessedseedsfordirectconsumption,providedthatpeanuts,treenuts,andprocessed
seedsaretreatedtosignificantlyminimizepathogens
(xxi)Makingvinegarfromfruitsandvegetables,otherfruitandvegetableproducts(e.g.,fruitwines,applecider),and
othergrainproducts(e.g.,malt)
(xxii)Mixingbakedgoods(e.g.,typesofcookies),candy(e.g.,varietiesoftaffy),cocoabeans(roasted),coffeebeans
(roasted),dried/dehydratedfruitandvegetableproducts(e.g.,driedblueberries,driedcurrants,andraisins),
dried/dehydratedherbandspiceproducts(e.g.,dried,intactbasilanddried,intactoregano),honey(pasteurized),milled
grainproducts(e.g.,flour,bran,andcornmeal),otherfruitandvegetableproducts(e.g.,dried,slicedapplesanddried,
slicedpeaches),othergrainproducts(e.g.,differenttypesofdriedpasta),otherherbandspiceproducts(e.g.,choppedor
grounddriedherbs,driedherborspiceinfusedhoney,anddriedherborspiceinfusedoilsand/orvinegars),peanutand
treenutproducts,sugar,syrups,vinegar,andanyotherprocessedfoodthatdoesnotrequiretime/temperaturecontrolfor
safety(e.g.,vitamins,minerals,anddietaryingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform)
(xxiii)Packagingbakedgoods(e.g.,breadandcookies),candy,cocoabeans(roasted),cocoaproducts,coffeebeans
(roasted),gamemeatjerky,gums/latexes/resinsthatareprocessedfoods,honey(pasteurized),jams/jellies/preserves,
milledgrainproducts(e.g.,flour,bran,cornmeal),molassesandtreacle,oils,otherfruitandvegetableproducts(e.g.,
pitted,driedfruitssliced,driedapplessnackchips),othergrainproducts(e.g.,popcorn),otherherbandspiceproducts
(e.g.,choppedorgrounddriedherbs),peanutandtreenutproducts,processedseedsfordirectconsumption,softdrinks
andcarbonatedwater,sugar,syrups,trailmixandgranola,vinegar,andanyotherprocessedfoodthatdoesnotrequire
time/temperaturecontrolforsafety(e.g.,vitamins,minerals,anddietaryingredients(e.g.,bonemeal)inpowdered,
granular,orothersolidform)
(xxiv)Pasteurizinghoney
(xxv)Roastingandtoastingbakedgoods(e.g.,toastingbreadforcroutons)
(xxvi)Saltingothergrainproducts(e.g.,soynuts),peanutandtreenutproducts,andprocessedseedsfordirect
consumptionand
(xxvii)Siftingmilledgrainproducts(e.g.,flour,bran,cornmeal),otherfruitandvegetableproducts(e.g.,chickpea
flour),andpeanutandtreenutproducts(e.g.,peanutflour,almondflour).
(i)(1)SubpartsCandGofthispartdonotapplywithrespecttoalcoholicbeveragesatafacilitythatmeetsthe
followingtwoconditions:
(i)UndertheFederalAlcoholAdministrationAct(27U.S.C.201etseq.)orchapter51ofsubtitleEoftheInternal
RevenueCodeof1986(26U.S.C.5001etseq.)thefacilityisrequiredtoobtainapermitfrom,registerwith,orobtain
approvalofanoticeorapplicationfromtheSecretaryoftheTreasuryasaconditionofdoingbusinessintheUnited
States,orisaforeignfacilityofatypethatwouldrequiresuchapermit,registration,orapprovalifitwereadomestic
facilityand
(ii)Undersection415oftheFederalFood,Drug,andCosmeticActthefacilityisrequiredtoregisterasafacility
becauseitisengagedinmanufacturing,processing,packing,orholdingoneormorealcoholicbeverages.
(2)SubpartsCandGofthispartdonotapplywithrespecttofoodthatisnotanalcoholicbeverageatafacility
describedinparagraph(i)(1)ofthissection,providedsuchfood:
(i)Isinprepackagedformthatpreventsanydirecthumancontactwithsuchfoodand
(ii)Constitutesnotmorethan5percentoftheoverallsalesofthefacility,asdeterminedbytheSecretaryofthe
Treasury.
(j)SubpartsCandGofthispartdonotapplytofacilitiesthataresolelyengagedinthestorageofrawagricultural
commodities(otherthanfruitsandvegetables)intendedforfurtherdistributionorprocessing.
(k)(1)Exceptasprovidedbyparagraph(k)(2)ofthissection,subpartBofthispartdoesnotapplytoanyofthe
following:
(i)Farms(asdefinedin1.227ofthischapter)
(ii)Fishingvesselsthatarenotsubjecttotheregistrationrequirementsofpart1,subpartHofthischapterin
accordancewith1.226(f)ofthischapter
(iii)Establishmentssolelyengagedintheholdingand/ortransportationofoneormorerawagriculturalcommodities
(iv)Activitiesoffarmmixedtypefacilities(asdefinedin1.227ofthischapter)thatfallwithinthedefinitionoffarm
or
(v)Establishmentssolelyengagedinhulling,shelling,drying,packing,and/orholdingnuts(withoutadditional
manufacturing/processing,suchasroastingnuts).
(2)Ifafarmorfarmmixedtypefacilitydries/dehydratesrawagriculturalcommoditiesthatareproduceasdefined
inpart112ofthischaptertocreateadistinctcommodity,subpartBofthispartappliestothepackaging,packing,and
holdingofthedriedcommodities.CompliancewiththisrequirementmaybeachievedbycomplyingwithsubpartBofthis
partorwiththeapplicablerequirementsforpackingandholdinginpart112ofthischapter.
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117.7ApplicabilityofsubpartsC,D,andGofthisparttoafacilitysolelyengagedinthestorageofunexposed
packagedfood.
(a)ApplicabilityofsubpartsCandG.SubpartsCandGofthispartdonotapplytoafacilitysolelyengagedinthe
storageofunexposedpackagedfood.
(b)ApplicabilityofsubpartD.Afacilitysolelyengagedinthestorageofunexposedpackagedfood,including
unexposedpackagedfoodthatrequirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxin
productionby,pathogensissubjecttothemodifiedrequirementsin117.206foranyunexposedpackagedfoodthat
requirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogens.
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117.8ApplicabilityofsubpartBofthisparttotheofffarmpackingandholdingofrawagricultural
commodities.
Exceptasprovidedby117.5(k)(1),subpartBofthispartappliestotheofffarmpackaging,packing,andholdingof
rawagriculturalcommodities.Compliancewiththisrequirementforrawagriculturalcommoditiesthatareproduceas
definedinpart112ofthischaptermaybeachievedbycomplyingwithsubpartBofthispartorwiththeapplicable
requirementsforpackingandholdinginpart112ofthischapter.
[81FR3956,Jan.25,2016]
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117.9Recordsrequiredforthissubpart.
(a)Recordsthatdocumenttrainingrequiredby117.4(b)(2)mustbeestablishedandmaintained.
(b)TherecordsthatmustbeestablishedandmaintainedaresubjecttotherequirementsofsubpartFofthispart.
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SubpartBCurrentGoodManufacturingPractice
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117.10Personnel.
Themanagementoftheestablishmentmusttakereasonablemeasuresandprecautionstoensurethefollowing:
(a)Diseasecontrol.Anypersonwho,bymedicalexaminationorsupervisoryobservation,isshowntohave,or
appearstohave,anillness,openlesion,includingboils,sores,orinfectedwounds,oranyotherabnormalsourceof
microbialcontaminationbywhichthereisareasonablepossibilityoffood,foodcontactsurfaces,orfoodpackaging
materialsbecomingcontaminated,mustbeexcludedfromanyoperationswhichmaybeexpectedtoresultinsuch
contaminationuntiltheconditioniscorrected,unlessconditionssuchasopenlesions,boils,andinfectedwoundsare
adequatelycovered(e.g.,byanimpermeablecover).Personnelmustbeinstructedtoreportsuchhealthconditionstotheir
supervisors.
(b)Cleanliness.Allpersonsworkingindirectcontactwithfood,foodcontactsurfaces,andfoodpackagingmaterials
mustconformtohygienicpracticeswhileondutytotheextentnecessarytoprotectagainstallergencrosscontactand
againstcontaminationoffood.Themethodsformaintainingcleanlinessinclude:
(1)Wearingoutergarmentssuitabletotheoperationinamannerthatprotectsagainstallergencrosscontactand
againstthecontaminationoffood,foodcontactsurfaces,orfoodpackagingmaterials.
(2)Maintainingadequatepersonalcleanliness.
(3)Washinghandsthoroughly(andsanitizingifnecessarytoprotectagainstcontaminationwithundesirable
microorganisms)inanadequatehandwashingfacilitybeforestartingwork,aftereachabsencefromtheworkstation,and
atanyothertimewhenthehandsmayhavebecomesoiledorcontaminated.
(4)Removingallunsecuredjewelryandotherobjectsthatmightfallintofood,equipment,orcontainers,andremoving
handjewelrythatcannotbeadequatelysanitizedduringperiodsinwhichfoodismanipulatedbyhand.Ifsuchhand
jewelrycannotberemoved,itmaybecoveredbymaterialwhichcanbemaintainedinanintact,clean,andsanitary
conditionandwhicheffectivelyprotectsagainstthecontaminationbytheseobjectsofthefood,foodcontactsurfaces,or
foodpackagingmaterials.
(5)Maintaininggloves,iftheyareusedinfoodhandling,inanintact,clean,andsanitarycondition.
(6)Wearing,whereappropriate,inaneffectivemanner,hairnets,headbands,caps,beardcovers,orothereffective
hairrestraints.
(7)Storingclothingorotherpersonalbelongingsinareasotherthanwherefoodisexposedorwhereequipmentor
utensilsarewashed.
(8)Confiningthefollowingtoareasotherthanwherefoodmaybeexposedorwhereequipmentorutensilsare
washed:eatingfood,chewinggum,drinkingbeverages,orusingtobacco.
(9)Takinganyothernecessaryprecautionstoprotectagainstallergencrosscontactandagainstcontaminationof
food,foodcontactsurfaces,orfoodpackagingmaterialswithmicroorganismsorforeignsubstances(including
perspiration,hair,cosmetics,tobacco,chemicals,andmedicinesappliedtotheskin).
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117.20Plantandgrounds.
(a)Grounds.Thegroundsaboutafoodplantunderthecontroloftheoperatormustbekeptinaconditionthatwill
protectagainstthecontaminationoffood.Themethodsforadequatemaintenanceofgroundsmustinclude:
(1)Properlystoringequipment,removinglitterandwaste,andcuttingweedsorgrasswithintheimmediatevicinityof
theplantthatmayconstituteanattractant,breedingplace,orharborageforpests.
(2)Maintainingroads,yards,andparkinglotssothattheydonotconstituteasourceofcontaminationinareaswhere
foodisexposed.
(3)Adequatelydrainingareasthatmaycontributecontaminationtofoodbyseepage,footbornefilth,orprovidinga
breedingplaceforpests.
(4)Operatingsystemsforwastetreatmentanddisposalinanadequatemannersothattheydonotconstitutea
sourceofcontaminationinareaswherefoodisexposed.
(5)Iftheplantgroundsareborderedbygroundsnotundertheoperator'scontrolandnotmaintainedinthemanner
describedinparagraphs(a)(1)through(4)ofthissection,caremustbeexercisedintheplantbyinspection,extermination,
orothermeanstoexcludepests,dirt,andfilththatmaybeasourceoffoodcontamination.
(b)Plantconstructionanddesign.Theplantmustbesuitableinsize,construction,anddesigntofacilitate
maintenanceandsanitaryoperationsforfoodproductionpurposes(i.e.,manufacturing,processing,packing,andholding).
Theplantmust:
(1)Provideadequatespaceforsuchplacementofequipmentandstorageofmaterialsasisnecessaryfor
maintenance,sanitaryoperations,andtheproductionofsafefood.
(2)Permitthetakingofadequateprecautionstoreducethepotentialforallergencrosscontactandforcontamination
offood,foodcontactsurfaces,orfoodpackagingmaterialswithmicroorganisms,chemicals,filth,andotherextraneous
material.Thepotentialforallergencrosscontactandforcontaminationmaybereducedbyadequatefoodsafetycontrols
andoperatingpracticesoreffectivedesign,includingtheseparationofoperationsinwhichallergencrosscontactand
contaminationarelikelytooccur,byoneormoreofthefollowingmeans:location,time,partition,airflowsystems,dust
controlsystems,enclosedsystems,orothereffectivemeans.
(3)Permitthetakingofadequateprecautionstoprotectfoodininstalledoutdoorbulkvesselsbyanyeffectivemeans,
including:
(i)Usingprotectivecoverings.
(ii)Controllingareasoverandaroundthevesselstoeliminateharboragesforpests.
(iii)Checkingonaregularbasisforpestsandpestinfestation.
(iv)Skimmingfermentationvessels,asnecessary.
(4)Beconstructedinsuchamannerthatfloors,walls,andceilingsmaybeadequatelycleanedandkeptcleanand
keptingoodrepairthatdriporcondensatefromfixtures,ductsandpipesdoesnotcontaminatefood,foodcontact
surfaces,orfoodpackagingmaterialsandthataislesorworkingspacesareprovidedbetweenequipmentandwallsand
areadequatelyunobstructedandofadequatewidthtopermitemployeestoperformtheirdutiesandtoprotectagainst
contaminatingfood,foodcontactsurfaces,orfoodpackagingmaterialswithclothingorpersonalcontact.
(5)Provideadequatelightinginhandwashingareas,dressingandlockerrooms,andtoiletroomsandinallareas
wherefoodisexamined,manufactured,processed,packed,orheldandwhereequipmentorutensilsarecleanedand
provideshatterresistantlightbulbs,fixtures,skylights,orotherglasssuspendedoverexposedfoodinanystepof
preparationorotherwiseprotectagainstfoodcontaminationincaseofglassbreakage.
(6)Provideadequateventilationorcontrolequipmenttominimizedust,odorsandvapors(includingsteamand
noxiousfumes)inareaswheretheymaycauseallergencrosscontactorcontaminatefoodandlocateandoperatefans
andotherairblowingequipmentinamannerthatminimizesthepotentialforallergencrosscontactandforcontaminating
food,foodpackagingmaterials,andfoodcontactsurfaces.
(7)Provide,wherenecessary,adequatescreeningorotherprotectionagainstpests.
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117.35Sanitaryoperations.
(a)Generalmaintenance.Buildings,fixtures,andotherphysicalfacilitiesoftheplantmustbemaintainedinaclean
andsanitaryconditionandmustbekeptinrepairadequatetopreventfoodfrombecomingadulterated.Cleaningand
sanitizingofutensilsandequipmentmustbeconductedinamannerthatprotectsagainstallergencrosscontactand
againstcontaminationoffood,foodcontactsurfaces,orfoodpackagingmaterials.
(b)Substancesusedincleaningandsanitizingstorageoftoxicmaterials.(1)Cleaningcompoundsandsanitizing
agentsusedincleaningandsanitizingproceduresmustbefreefromundesirablemicroorganismsandmustbesafeand
adequateundertheconditionsofuse.Compliancewiththisrequirementmustbeverifiedbyanyeffectivemeans,including
purchaseofthesesubstancesunderaletterofguaranteeorcertificationorexaminationofthesesubstancesfor
contamination.Onlythefollowingtoxicmaterialsmaybeusedorstoredinaplantwherefoodisprocessedorexposed:
(i)Thoserequiredtomaintaincleanandsanitaryconditions
(ii)Thosenecessaryforuseinlaboratorytestingprocedures
(iii)Thosenecessaryforplantandequipmentmaintenanceandoperationand
(iv)Thosenecessaryforuseintheplant'soperations.
(2)Toxiccleaningcompounds,sanitizingagents,andpesticidechemicalsmustbeidentified,held,andstoredina
mannerthatprotectsagainstcontaminationoffood,foodcontactsurfaces,orfoodpackagingmaterials.
(c)Pestcontrol.Pestsmustnotbeallowedinanyareaofafoodplant.Guard,guide,orpestdetectingdogsmaybe
allowedinsomeareasofaplantifthepresenceofthedogsisunlikelytoresultincontaminationoffood,foodcontact
surfaces,orfoodpackagingmaterials.Effectivemeasuresmustbetakentoexcludepestsfromthemanufacturing,
processing,packing,andholdingareasandtoprotectagainstthecontaminationoffoodonthepremisesbypests.The
useofpesticidestocontrolpestsintheplantispermittedonlyunderprecautionsandrestrictionsthatwillprotectagainst
thecontaminationoffood,foodcontactsurfaces,andfoodpackagingmaterials.
(d)Sanitationoffoodcontactsurfaces.Allfoodcontactsurfaces,includingutensilsandfoodcontactsurfacesof
equipment,mustbecleanedasfrequentlyasnecessarytoprotectagainstallergencrosscontactandagainst
contaminationoffood.
(1)Foodcontactsurfacesusedformanufacturing/processing,packing,orholdinglowmoisturefoodmustbeina
clean,dry,sanitaryconditionbeforeuse.Whenthesurfacesarewetcleaned,theymust,whennecessary,besanitized
andthoroughlydriedbeforesubsequentuse.
(2)Inwetprocessing,whencleaningisnecessarytoprotectagainstallergencrosscontactortheintroductionof
microorganismsintofood,allfoodcontactsurfacesmustbecleanedandsanitizedbeforeuseandafteranyinterruption
duringwhichthefoodcontactsurfacesmayhavebecomecontaminated.Whereequipmentandutensilsareusedina
continuousproductionoperation,theutensilsandfoodcontactsurfacesoftheequipmentmustbecleanedandsanitized
asnecessary.
(3)Singleservicearticles(suchasutensilsintendedforonetimeuse,papercups,andpapertowels)mustbestored,
handled,anddisposedofinamannerthatprotectsagainstallergencrosscontactandagainstcontaminationoffood,
foodcontactsurfaces,orfoodpackagingmaterials.
(e)Sanitationofnonfoodcontactsurfaces.Nonfoodcontactsurfacesofequipmentusedintheoperationofafood
plantmustbecleanedinamannerandasfrequentlyasnecessarytoprotectagainstallergencrosscontactandagainst
contaminationoffood,foodcontactsurfaces,andfoodpackagingmaterials.
(f)Storageandhandlingofcleanedportableequipmentandutensils.Cleanedandsanitizedportableequipmentwith
foodcontactsurfacesandutensilsmustbestoredinalocationandmannerthatprotectsfoodcontactsurfacesfrom
allergencrosscontactandfromcontamination.
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117.37Sanitaryfacilitiesandcontrols.
Eachplantmustbeequippedwithadequatesanitaryfacilitiesandaccommodationsincluding:
(a)Watersupply.Thewatersupplymustbeadequatefortheoperationsintendedandmustbederivedfroman
adequatesource.Anywaterthatcontactsfood,foodcontactsurfaces,orfoodpackagingmaterialsmustbesafeandof
adequatesanitaryquality.Runningwateratasuitabletemperature,andunderpressureasneeded,mustbeprovidedinall
areaswhererequiredfortheprocessingoffood,forthecleaningofequipment,utensils,andfoodpackagingmaterials,or
foremployeesanitaryfacilities.
(b)Plumbing.Plumbingmustbeofadequatesizeanddesignandadequatelyinstalledandmaintainedto:
(1)Carryadequatequantitiesofwatertorequiredlocationsthroughouttheplant.
(2)Properlyconveysewageandliquiddisposablewastefromtheplant.
(3)Avoidconstitutingasourceofcontaminationtofood,watersupplies,equipment,orutensilsorcreatingan
unsanitarycondition.
(4)Provideadequatefloordrainageinallareaswherefloorsaresubjecttofloodingtypecleaningorwherenormal
operationsreleaseordischargewaterorotherliquidwasteonthefloor.
(5)Providethatthereisnotbackflowfrom,orcrossconnectionbetween,pipingsystemsthatdischargewastewater
orsewageandpipingsystemsthatcarrywaterforfoodorfoodmanufacturing.
(c)Sewagedisposal.Sewagemustbedisposedofintoanadequateseweragesystemordisposedofthroughother
adequatemeans.
(d)Toiletfacilities.Eachplantmustprovideemployeeswithadequate,readilyaccessibletoiletfacilities.Toiletfacilities
mustbekeptcleanandmustnotbeapotentialsourceofcontaminationoffood,foodcontactsurfaces,orfoodpackaging
materials.
(e)Handwashingfacilities.Eachplantmustprovidehandwashingfacilitiesdesignedtoensurethatanemployee's
handsarenotasourceofcontaminationoffood,foodcontactsurfaces,orfoodpackagingmaterials,byprovidingfacilities
thatareadequate,convenient,andfurnishrunningwateratasuitabletemperature.
(f)Rubbishandoffaldisposal.Rubbishandanyoffalmustbesoconveyed,stored,anddisposedofastominimizethe
developmentofodor,minimizethepotentialforthewastebecominganattractantandharborageorbreedingplacefor
pests,andprotectagainstcontaminationoffood,foodcontactsurfaces,foodpackagingmaterials,watersupplies,and
groundsurfaces.
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117.40Equipmentandutensils.
(a)(1)Allplantequipmentandutensilsusedinmanufacturing,processing,packing,orholdingfoodmustbeso
designedandofsuchmaterialandworkmanshipastobeadequatelycleanable,andmustbeadequatelymaintainedto
protectagainstallergencrosscontactandcontamination.
(2)Equipmentandutensilsmustbedesigned,constructed,andusedappropriatelytoavoidtheadulterationoffood
withlubricants,fuel,metalfragments,contaminatedwater,oranyothercontaminants.
(3)Equipmentmustbeinstalledsoastofacilitatethecleaningandmaintenanceoftheequipmentandofadjacent
spaces.
(4)Foodcontactsurfacesmustbecorrosionresistantwhenincontactwithfood.
(5)Foodcontactsurfacesmustbemadeofnontoxicmaterialsanddesignedtowithstandtheenvironmentoftheir
intendeduseandtheactionoffood,and,ifapplicable,cleaningcompounds,sanitizingagents,andcleaningprocedures.
(6)Foodcontactsurfacesmustbemaintainedtoprotectfoodfromallergencrosscontactandfrombeing
contaminatedbyanysource,includingunlawfulindirectfoodadditives.
(b)Seamsonfoodcontactsurfacesmustbesmoothlybondedormaintainedsoastominimizeaccumulationoffood
particles,dirt,andorganicmatterandthusminimizetheopportunityforgrowthofmicroorganismsandallergencross
contact.
(c)Equipmentthatisinareaswherefoodismanufactured,processed,packed,orheldandthatdoesnotcomeinto
contactwithfoodmustbesoconstructedthatitcanbekeptinacleanandsanitarycondition.
(d)Holding,conveying,andmanufacturingsystems,includinggravimetric,pneumatic,closed,andautomated
systems,mustbeofadesignandconstructionthatenablesthemtobemaintainedinanappropriatecleanandsanitary
condition.
(e)Eachfreezerandcoldstoragecompartmentusedtostoreandholdfoodcapableofsupportinggrowthof
microorganismsmustbefittedwithanindicatingthermometer,temperaturemeasuringdevice,ortemperaturerecording
devicesoinstalledastoshowthetemperatureaccuratelywithinthecompartment.
(f)Instrumentsandcontrolsusedformeasuring,regulating,orrecordingtemperatures,pH,acidity,wateractivity,or
otherconditionsthatcontrolorpreventthegrowthofundesirablemicroorganismsinfoodmustbeaccurateandprecise
andadequatelymaintained,andadequateinnumberfortheirdesignateduses.
(g)Compressedairorothergasesmechanicallyintroducedintofoodorusedtocleanfoodcontactsurfacesor
equipmentmustbetreatedinsuchawaythatfoodisnotcontaminatedwithunlawfulindirectfoodadditives.
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117.80Processesandcontrols.
(a)General.(1)Alloperationsinthemanufacturing,processing,packing,andholdingoffood(includingoperations
directedtoreceiving,inspecting,transporting,andsegregating)mustbeconductedinaccordancewithadequate
sanitationprinciples.
(2)Appropriatequalitycontroloperationsmustbeemployedtoensurethatfoodissuitableforhumanconsumption
andthatfoodpackagingmaterialsaresafeandsuitable.
(3)Overallsanitationoftheplantmustbeunderthesupervisionofoneormorecompetentindividualsassigned
responsibilityforthisfunction.
(4)Adequateprecautionsmustbetakentoensurethatproductionproceduresdonotcontributetoallergencross
contactandtocontaminationfromanysource.
(5)Chemical,microbial,orextraneousmaterialtestingproceduresmustbeusedwherenecessarytoidentify
sanitationfailuresorpossibleallergencrosscontactandfoodcontamination.
(6)Allfoodthathasbecomecontaminatedtotheextentthatitisadulteratedmustberejected,orifappropriate,
treatedorprocessedtoeliminatethecontamination.
(b)Rawmaterialsandotheringredients.(1)Rawmaterialsandotheringredientsmustbeinspectedandsegregated
orotherwisehandledasnecessarytoascertainthattheyarecleanandsuitableforprocessingintofoodandmustbe
storedunderconditionsthatwillprotectagainstallergencrosscontactandagainstcontaminationandminimize
deterioration.Rawmaterialsmustbewashedorcleanedasnecessarytoremovesoilorothercontamination.Waterused
forwashing,rinsing,orconveyingfoodmustbesafeandofadequatesanitaryquality.Watermaybereusedforwashing,
rinsing,orconveyingfoodifitdoesnotcauseallergencrosscontactorincreasethelevelofcontaminationofthefood.
(2)Rawmaterialsandotheringredientsmusteithernotcontainlevelsofmicroorganismsthatmayrenderthefood
injurioustothehealthofhumans,ortheymustbepasteurizedorotherwisetreatedduringmanufacturingoperationsso
thattheynolongercontainlevelsthatwouldcausetheproducttobeadulterated.
(3)Rawmaterialsandotheringredientssusceptibletocontaminationwithaflatoxinorothernaturaltoxinsmust
complywithFDAregulationsforpoisonousordeleterioussubstancesbeforetheserawmaterialsorotheringredientsare
incorporatedintofinishedfood.
(4)Rawmaterials,otheringredients,andreworksusceptibletocontaminationwithpests,undesirable
microorganisms,orextraneousmaterialmustcomplywithapplicableFDAregulationsfornaturalorunavoidabledefectsif
amanufacturerwishestousethematerialsinmanufacturingfood.
(5)Rawmaterials,otheringredients,andreworkmustbeheldinbulk,orincontainersdesignedandconstructedso
astoprotectagainstallergencrosscontactandagainstcontaminationandmustbeheldatsuchtemperatureandrelative
humidityandinsuchamannerastopreventthefoodfrombecomingadulterated.Materialscheduledforreworkmustbe
identifiedassuch.
(6)Frozenrawmaterialsandotheringredientsmustbekeptfrozen.Ifthawingisrequiredpriortouse,itmustbedone
inamannerthatpreventstherawmaterialsandotheringredientsfrombecomingadulterated.
(7)Liquidordryrawmaterialsandotheringredientsreceivedandstoredinbulkformmustbeheldinamannerthat
protectsagainstallergencrosscontactandagainstcontamination.
(8)Rawmaterialsandotheringredientsthatarefoodallergens,andreworkthatcontainsfoodallergens,mustbe
identifiedandheldinamannerthatpreventsallergencrosscontact.
(c)Manufacturingoperations.(1)Equipmentandutensilsandfoodcontainersmustbemaintainedinanadequate
conditionthroughappropriatecleaningandsanitizing,asnecessary.Insofarasnecessary,equipmentmustbetakenapart
forthoroughcleaning.
(2)Allfoodmanufacturing,processing,packing,andholdingmustbeconductedundersuchconditionsandcontrols
asarenecessarytominimizethepotentialforthegrowthofmicroorganisms,allergencrosscontact,contaminationof
food,anddeteriorationoffood.
(3)Foodthatcansupporttherapidgrowthofundesirablemicroorganismsmustbeheldattemperaturesthatwill
preventthefoodfrombecomingadulteratedduringmanufacturing,processing,packing,andholding.
(4)Measuressuchassterilizing,irradiating,pasteurizing,cooking,freezing,refrigerating,controllingpH,orcontrolling
awthataretakentodestroyorpreventthegrowthofundesirablemicroorganismsmustbeadequateundertheconditions
ofmanufacture,handling,anddistributiontopreventfoodfrombeingadulterated.
(5)Workinprocessandreworkmustbehandledinamannerthatprotectsagainstallergencrosscontact,
contamination,andgrowthofundesirablemicroorganisms.
(6)Effectivemeasuresmustbetakentoprotectfinishedfoodfromallergencrosscontactandfromcontaminationby
rawmaterials,otheringredients,orrefuse.Whenrawmaterials,otheringredients,orrefuseareunprotected,theymust
notbehandledsimultaneouslyinareceiving,loading,orshippingareaifthathandlingcouldresultinallergencross
contactorcontaminatedfood.Foodtransportedbyconveyormustbeprotectedagainstallergencrosscontactandagainst
contaminationasnecessary.
(7)Equipment,containers,andutensilsusedtoconvey,hold,orstorerawmaterialsandotheringredients,workin
process,rework,orotherfoodmustbeconstructed,handled,andmaintainedduringmanufacturing,processing,packing,
andholdinginamannerthatprotectsagainstallergencrosscontactandagainstcontamination.
(8)Adequatemeasuresmustbetakentoprotectagainsttheinclusionofmetalorotherextraneousmaterialinfood.
(9)Food,rawmaterials,andotheringredientsthatareadulterated:
(i)Mustbedisposedofinamannerthatprotectsagainstthecontaminationofotherfoodor
(ii)Iftheadulteratedfoodiscapableofbeingreconditioned,itmustbe:
(A)Reconditioned(ifappropriate)usingamethodthathasbeenproventobeeffectiveor
(B)Reconditioned(ifappropriate)andreexaminedandsubsequentlyfoundnottobeadulteratedwithinthemeaning
oftheFederalFood,Drug,andCosmeticActbeforebeingincorporatedintootherfood.
(10)Stepssuchaswashing,peeling,trimming,cutting,sortingandinspecting,mashing,dewatering,cooling,
shredding,extruding,drying,whipping,defatting,andformingmustbeperformedsoastoprotectfoodagainstallergen
crosscontactandagainstcontamination.Foodmustbeprotectedfromcontaminantsthatmaydrip,drain,orbedrawninto
thefood.
(11)Heatblanching,whenrequiredinthepreparationoffoodcapableofsupportingmicrobialgrowth,mustbe
effectedbyheatingthefoodtotherequiredtemperature,holdingitatthistemperaturefortherequiredtime,andthen
eitherrapidlycoolingthefoodorpassingittosubsequentmanufacturingwithoutdelay.Growthandcontaminationby
thermophilicmicroorganismsinblanchersmustbeminimizedbytheuseofadequateoperatingtemperaturesandby
periodiccleaningandsanitizingasnecessary.
(12)Batters,breading,sauces,gravies,dressings,dippingsolutions,andothersimilarpreparationsthatareheldand
usedrepeatedlyovertimemustbetreatedormaintainedinsuchamannerthattheyareprotectedagainstallergencross
contactandagainstcontamination,andminimizingthepotentialforthegrowthofundesirablemicroorganisms.
(13)Filling,assembling,packaging,andotheroperationsmustbeperformedinsuchawaythatthefoodisprotected
againstallergencrosscontact,contaminationandgrowthofundesirablemicroorganisms.
(14)Food,suchasdrymixes,nuts,intermediatemoisturefood,anddehydratedfood,thatreliesprincipallyonthe
controlofawforpreventingthegrowthofundesirablemicroorganismsmustbeprocessedtoandmaintainedatasafe
moisturelevel.
(15)Food,suchasacidandacidifiedfood,thatreliesprincipallyonthecontrolofpHforpreventingthegrowthof
undesirablemicroorganismsmustbemonitoredandmaintainedatapHof4.6orbelow.
(16)Wheniceisusedincontactwithfood,itmustbemadefromwaterthatissafeandofadequatesanitaryqualityin
accordancewith117.37(a),andmustbeusedonlyifithasbeenmanufacturedinaccordancewithcurrentgood
manufacturingpracticeasoutlinedinthispart.
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117.93Warehousinganddistribution.
Storageandtransportationoffoodmustbeunderconditionsthatwillprotectagainstallergencrosscontactand
againstbiological,chemical(includingradiological),andphysicalcontaminationoffood,aswellasagainstdeteriorationof
thefoodandthecontainer.
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117.95Holdinganddistributionofhumanfoodbyproductsforuseasanimalfood.
(a)Humanfoodbyproductsheldfordistributionasanimalfoodwithoutadditionalmanufacturingorprocessingbythe
humanfoodprocessor,asidentifiedin507.12ofthischapter,mustbeheldunderconditionsthatwillprotectagainst
contamination,includingthefollowing:
(1)Containersandequipmentusedtoconveyorholdhumanfoodbyproductsforuseasanimalfoodbefore
distributionmustbedesigned,constructedofappropriatematerial,cleanedasnecessary,andmaintainedtoprotect
againstthecontaminationofhumanfoodbyproductsforuseasanimalfood
(2)Humanfoodbyproductsforuseasanimalfoodheldfordistributionmustbeheldinawaytoprotectagainst
contaminationfromsourcessuchastrashand
(3)Duringholding,humanfoodbyproductsforuseasanimalfoodmustbeaccuratelyidentified.
(b)Labelingthatidentifiesthebyproductbythecommonorusualnamemustbeaffixedtooraccompanyhumanfood
byproductsforuseasanimalfoodwhendistributed.
(c)Shippingcontainers(e.g.,totes,drums,andtubs)andbulkvehiclesusedtodistributehumanfoodbyproductsfor
useasanimalfoodmustbeexaminedpriortousetoprotectagainstcontaminationofthehumanfoodbyproductsforuse
asanimalfoodfromthecontainerorvehiclewhenthefacilityisresponsiblefortransportingthehumanfoodbyproducts
foruseasanimalfooditselforarrangeswithathirdpartytotransportthehumanfoodbyproductsforuseasanimalfood.
[80FR56337,Sept.17,2015]
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117.110Defectactionlevels.
(a)Themanufacturer,processor,packer,andholderoffoodmustatalltimesutilizequalitycontroloperationsthat
reducenaturalorunavoidabledefectstothelowestlevelcurrentlyfeasible.
(b)Themixingofafoodcontainingdefectsatlevelsthatrenderthatfoodadulteratedwithanotherlotoffoodisnot
permittedandrendersthefinalfoodadulterated,regardlessofthedefectlevelofthefinalfood.Forexamplesofdefect
actionlevelsthatmayrenderfoodadulterated,seetheDefectLevelsHandbook,whichisaccessible
athttp://www.fda.gov/pchfruleandathttp://www.fda.gov.
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SubpartCHazardAnalysisandRiskBasedPreventiveControls
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117.126Foodsafetyplan.
(a)Requirementforafoodsafetyplan.(1)Youmustprepare,orhaveprepared,andimplementawrittenfoodsafety
plan.
(2)Thefoodsafetyplanmustbeprepared,oritspreparationoverseen,byoneormorepreventivecontrolsqualified
individuals.
(b)Contentsofafoodsafetyplan.Thewrittenfoodsafetyplanmustinclude:
(1)Thewrittenhazardanalysisasrequiredby117.130(a)(2)
(2)Thewrittenpreventivecontrolsasrequiredby117.135(b)
(3)ThewrittensupplychainprogramasrequiredbysubpartGofthispart
(4)Thewrittenrecallplanasrequiredby117.139(a)and
(5)Thewrittenproceduresformonitoringtheimplementationofthepreventivecontrolsasrequiredby117.145(a)(1)
(6)Thewrittencorrectiveactionproceduresasrequiredby117.150(a)(1)and
(7)Thewrittenverificationproceduresasrequiredby117.165(b).
(c)Records.ThefoodsafetyplanrequiredbythissectionisarecordthatissubjecttotherequirementsofsubpartF
ofthispart.
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117.130Hazardanalysis.
(a)Requirementforahazardanalysis.(1)Youmustconductahazardanalysistoidentifyandevaluate,basedon
experience,illnessdata,scientificreports,andotherinformation,knownorreasonablyforeseeablehazardsforeachtype
offoodmanufactured,processed,packed,orheldatyourfacilitytodeterminewhetherthereareanyhazardsrequiringa
preventivecontrol.
(2)Thehazardanalysismustbewrittenregardlessofitsoutcome.
(b)Hazardidentification.Thehazardidentificationmustconsider:
(1)Knownorreasonablyforeseeablehazardsthatinclude:
(i)Biologicalhazards,includingmicrobiologicalhazardssuchasparasites,environmentalpathogens,andother
pathogens
(ii)Chemicalhazards,includingradiologicalhazards,substancessuchaspesticideanddrugresidues,naturaltoxins,
decomposition,unapprovedfoodorcoloradditives,andfoodallergensand
(iii)Physicalhazards(suchasstones,glass,andmetalfragments)and
(2)Knownorreasonablyforeseeablehazardsthatmaybepresentinthefoodforanyofthefollowingreasons:
(i)Thehazardoccursnaturally
(ii)Thehazardmaybeunintentionallyintroducedor
(iii)Thehazardmaybeintentionallyintroducedforpurposesofeconomicgain.
(c)Hazardevaluation.(1)(i)Thehazardanalysismustincludeanevaluationofthehazardsidentifiedinparagraph(b)
ofthissectiontoassesstheseverityoftheillnessorinjuryifthehazardweretooccurandtheprobabilitythatthehazard
willoccurintheabsenceofpreventivecontrols.
(ii)Thehazardevaluationrequiredbyparagraph(c)(1)(i)ofthissectionmustincludeanevaluationofenvironmental
pathogenswheneverareadytoeatfoodisexposedtotheenvironmentpriortopackagingandthepackagedfooddoes
notreceiveatreatmentorotherwiseincludeacontrolmeasure(suchasaformulationlethaltothepathogen)thatwould
significantlyminimizethepathogen.
(2)Thehazardevaluationmustconsidertheeffectofthefollowingonthesafetyofthefinishedfoodfortheintended
consumer:
(i)Theformulationofthefood
(ii)Thecondition,function,anddesignofthefacilityandequipment
(iii)Rawmaterialsandotheringredients
(iv)Transportationpractices
(v)Manufacturing/processingprocedures
(vi)Packagingactivitiesandlabelingactivities
(vii)Storageanddistribution
(viii)Intendedorreasonablyforeseeableuse
(ix)Sanitation,includingemployeehygieneand
(x)Anyotherrelevantfactors,suchasthetemporal(e.g.,weatherrelated)natureofsomehazards(e.g.,levelsof
somenaturaltoxins).
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117.135Preventivecontrols.
(a)(1)Youmustidentifyandimplementpreventivecontrolstoprovideassurancesthatanyhazardsrequiringa
preventivecontrolwillbesignificantlyminimizedorpreventedandthefoodmanufactured,processed,packed,orheldby
yourfacilitywillnotbeadulteratedundersection402oftheFederalFood,Drug,andCosmeticActormisbrandedunder
section403(w)oftheFederalFood,Drug,andCosmeticAct.
(2)Preventivecontrolsrequiredbyparagraph(a)(1)ofthissectioninclude:
(i)Controlsatcriticalcontrolpoints(CCPs),ifthereareanyCCPsand
(ii)Controls,otherthanthoseatCCPs,thatarealsoappropriateforfoodsafety.
(b)Preventivecontrolsmustbewritten.
(c)Preventivecontrolsinclude,asappropriatetothefacilityandthefood:
(1)Processcontrols.Processcontrolsincludeprocedures,practices,andprocessestoensurethecontrolof
parametersduringoperationssuchasheatprocessing,acidifying,irradiating,andrefrigeratingfoods.Processcontrols
mustinclude,asappropriatetothenatureoftheapplicablecontrolanditsroleinthefacility'sfoodsafetysystem:
(i)Parametersassociatedwiththecontrolofthehazardand
(ii)Themaximumorminimumvalue,orcombinationofvalues,towhichanybiological,chemical,orphysical
parametermustbecontrolledtosignificantlyminimizeorpreventahazardrequiringaprocesscontrol.
(2)Foodallergencontrols.Foodallergencontrolsincludeprocedures,practices,andprocessestocontrolfood
allergens.Foodallergencontrolsmustincludethoseprocedures,practices,andprocessesemployedfor:
(i)Ensuringprotectionoffoodfromallergencrosscontact,includingduringstorage,handling,anduseand
(ii)Labelingthefinishedfood,includingensuringthatthefinishedfoodisnotmisbrandedundersection403(w)ofthe
FederalFood,Drug,andCosmeticAct.
(3)Sanitationcontrols.Sanitationcontrolsincludeprocedures,practices,andprocessestoensurethatthefacilityis
maintainedinasanitaryconditionadequatetosignificantlyminimizeorpreventhazardssuchasenvironmental
pathogens,biologicalhazardsduetoemployeehandling,andfoodallergenhazards.Sanitationcontrolsmustinclude,as
appropriatetothefacilityandthefood,procedures,practices,andprocessesforthe:
(i)Cleanlinessoffoodcontactsurfaces,includingfoodcontactsurfacesofutensilsandequipment
(ii)Preventionofallergencrosscontactandcrosscontaminationfrominsanitaryobjectsandfrompersonneltofood,
foodpackagingmaterial,andotherfoodcontactsurfacesandfromrawproducttoprocessedproduct.
(4)Supplychaincontrols.SupplychaincontrolsincludethesupplychainprogramasrequiredbysubpartGofthis
part.
(5)Recallplan.Recallplanasrequiredby117.139.
(6)Othercontrols.Preventivecontrolsincludeanyotherprocedures,practices,andprocessesnecessarytosatisfy
therequirementsofparagraph(a)ofthissection.Examplesofothercontrolsincludehygienetrainingandothercurrent
goodmanufacturingpractices.
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117.136Circumstancesinwhichtheowner,operator,oragentinchargeofamanufacturing/processingfacility
isnotrequiredtoimplementapreventivecontrol.
(a)Circumstances.Ifyouareamanufacturer/processor,youarenotrequiredtoimplementapreventivecontrolwhen
youidentifyahazardrequiringapreventivecontrol(identifiedhazard)andanyofthefollowingcircumstancesapply:
(1)Youdetermineanddocumentthatthetypeoffood(e.g.,rawagriculturalcommoditiessuchascocoabeans,coffee
beans,andgrains)couldnotbeconsumedwithoutapplicationofanappropriatecontrol.
(2)Yourelyonyourcustomerwhoissubjecttotherequirementsforhazardanalysisandriskbasedpreventive
controlsinthissubparttoensurethattheidentifiedhazardwillbesignificantlyminimizedorpreventedandyou:
(i)Discloseindocumentsaccompanyingthefood,inaccordancewiththepracticeofthetrade,thatthefoodisnot
processedtocontrol[identifiedhazard]and
(ii)Annuallyobtainfromyourcustomerwrittenassurance,subjecttotherequirementsof117.137,thatthecustomer
hasestablishedandisfollowingprocedures(identifiedinthewrittenassurance)thatwillsignificantlyminimizeorprevent
theidentifiedhazard.
(3)Yourelyonyourcustomerwhoisnotsubjecttotherequirementsforhazardanalysisandriskbasedpreventive
controlsinthissubparttoprovideassuranceitismanufacturing,processing,orpreparingthefoodinaccordancewith
applicablefoodsafetyrequirementsandyou:
(ii)Annuallyobtainfromyourcustomerwrittenassurancethatitismanufacturing,processing,orpreparingthefoodin
accordancewithapplicablefoodsafetyrequirements.
(4)Yourelyonyourcustomertoprovideassurancethatthefoodwillbeprocessedtocontroltheidentifiedhazardby
anentityinthedistributionchainsubsequenttothecustomerandyou:
(ii)Annuallyobtainfromyourcustomerwrittenassurance,subjecttotherequirementsof117.137,thatyour
customer:
(A)Willdiscloseindocumentsaccompanyingthefood,inaccordancewiththepracticeofthetrade,thatthefoodis
notprocessedtocontrol[identifiedhazard]and
(B)Willonlyselltoanotherentitythatagrees,inwriting,itwill:
(1)Followprocedures(identifiedinawrittenassurance)thatwillsignificantlyminimizeorpreventtheidentifiedhazard
(iftheentityissubjecttotherequirementsforhazardanalysisandriskbasedpreventivecontrolsinthissubpart)or
manufacture,process,orpreparethefoodinaccordancewithapplicablefoodsafetyrequirements(iftheentityisnot
subjecttotherequirementsforhazardanalysisandriskbasedpreventivecontrolsinthissubpart)or
(2)Obtainasimilarwrittenassurancefromtheentity'scustomer,subjecttotherequirementsof117.137,asin
paragraphs(a)(4)(ii)(A)and(B)ofthissection,asappropriateor
(5)Youhaveestablished,documented,andimplementedasystemthatensurescontrol,atasubsequentdistribution
step,ofthehazardsinthefoodyoudistributeandyoudocumenttheimplementationofthatsystem.
(b)Records.Youmustdocumentanycircumstance,specifiedinparagraph(a)ofthissection,thatappliestoyou,
including:
(1)Adetermination,inaccordancewithparagraph(a)ofthissection,thatthetypeoffoodcouldnotbeconsumed
withoutapplicationofanappropriatecontrol
(2)Theannualwrittenassurancefromyourcustomerinaccordancewithparagraph(a)(2)ofthissection
(3)Theannualwrittenassurancefromyourcustomerinaccordancewithparagraph(a)(3)ofthissection
(4)Theannualwrittenassurancefromyourcustomerinaccordancewithparagraph(a)(4)ofthissectionand
(5)Yoursystem,inaccordancewithparagraph(a)(5)ofthissection,thatensurescontrol,atasubsequentdistribution
step,ofthehazardsinthefoodyoudistribute.
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117.137Provisionofassurancesrequiredunder117.136(a)(2),(3),and(4).
Afacilitythatprovidesawrittenassuranceunder117.136(a)(2),(3),or(4)mustactconsistentlywiththeassurance
anddocumentitsactionstakentosatisfythewrittenassurance.
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117.139Recallplan.
Forfoodwithahazardrequiringapreventivecontrol:
(a)Youmustestablishawrittenrecallplanforthefood.
(b)Thewrittenrecallplanmustincludeproceduresthatdescribethestepstobetaken,andassignresponsibilityfor
takingthosesteps,toperformthefollowingactionsasappropriatetothefacility:
(1)Directlynotifythedirectconsigneesofthefoodbeingrecalled,includinghowtoreturnordisposeoftheaffected
food
(2)Notifythepublicaboutanyhazardpresentedbythefoodwhenappropriatetoprotectpublichealth
(3)Conducteffectivenesscheckstoverifythattherecalliscarriedoutand
(4)Appropriatelydisposeofrecalledfoode.g.,throughreprocessing,reworking,divertingtoausethatdoesnot
presentasafetyconcern,ordestroyingthefood.
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117.140Preventivecontrolmanagementcomponents.
(a)Exceptasprovidedbyparagraphs(b)and(c)ofthissection,thepreventivecontrolsrequiredunder117.135are
subjecttothefollowingpreventivecontrolmanagementcomponentsasappropriatetoensuretheeffectivenessofthe
preventivecontrols,takingintoaccountthenatureofthepreventivecontrolanditsroleinthefacility'sfoodsafetysystem:
(1)Monitoringinaccordancewith117.145
(2)Correctiveactionsandcorrectionsinaccordancewith117.150and
(3)Verificationinaccordancewith117.155.
(b)ThesupplychainprogramestablishedinsubpartGofthispartissubjecttothefollowingpreventivecontrol
managementcomponentsasappropriatetoensuretheeffectivenessofthesupplychainprogram,takingintoaccountthe
natureofthehazardcontrolledbeforereceiptoftherawmaterialorotheringredient:
(1)Correctiveactionsandcorrectionsinaccordancewith117.150,takingintoaccountthenatureofanysupplier
nonconformance
(2)Reviewofrecordsinaccordancewith117.165(a)(4)and
(3)Reanalysisinaccordancewith117.170.
(c)Therecallplanestablishedin117.139isnotsubjecttotherequirementsofparagraph(a)ofthissection.
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117.145Monitoring.
Asappropriatetothenatureofthepreventivecontrolanditsroleinthefacility'sfoodsafetysystem:
(a)Writtenprocedures.Youmustestablishandimplementwrittenprocedures,includingthefrequencywithwhichthey
aretobeperformed,formonitoringthepreventivecontroland
(b)Monitoring.Youmustmonitorthepreventivecontrolswithadequatefrequencytoprovideassurancethattheyare
consistentlyperformed.
(c)Records.(1)Requirementtodocumentmonitoring.Youmustdocumentthemonitoringofpreventivecontrolsin
accordancewiththissectioninrecordsthataresubjecttoverificationinaccordancewith117.155(a)(2)andrecords
reviewinaccordancewith117.165(a)(4)(i).
(2)Exceptionrecords.(i)Recordsofrefrigerationtemperatureduringstorageoffoodthatrequirestime/temperature
controltosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogensmaybeaffirmativerecords
demonstratingtemperatureiscontrolledorexceptionrecordsdemonstratinglossoftemperaturecontrol.
(ii)Exceptionrecordsmaybeadequateincircumstancesotherthanmonitoringofrefrigerationtemperature.
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117.150Correctiveactionsandcorrections.
(a)Correctiveactionprocedures.Asappropriatetothenatureofthehazardandthenatureofthepreventivecontrol,
exceptasprovidedbyparagraph(c)ofthissection:
(1)Youmustestablishandimplementwrittencorrectiveactionproceduresthatmustbetakenifpreventivecontrols
arenotproperlyimplemented,includingprocedurestoaddress,asappropriate:
(i)Thepresenceofapathogenorappropriateindicatororganisminareadytoeatproductdetectedasaresultof
producttestingconductedinaccordancewith117.165(a)(2)and
(ii)Thepresenceofanenvironmentalpathogenorappropriateindicatororganismdetectedthroughtheenvironmental
monitoringconductedinaccordancewith117.165(a)(3).
(2)Thecorrectiveactionproceduresmustdescribethestepstobetakentoensurethat:
(i)Appropriateactionistakentoidentifyandcorrectaproblemthathasoccurredwithimplementationofapreventive
control
(ii)Appropriateactionistaken,whennecessary,toreducethelikelihoodthattheproblemwillrecur
(iii)Allaffectedfoodisevaluatedforsafetyand
(iv)Allaffectedfoodispreventedfromenteringintocommerce,ifyoucannotensurethattheaffectedfoodisnot
adulteratedundersection402oftheFederalFood,Drug,andCosmeticActormisbrandedundersection403(w)ofthe
FederalFood,Drug,andCosmeticAct.
(b)Correctiveactionintheeventofanunanticipatedfoodsafetyproblem.(1)Exceptasprovidedbyparagraph(c)of
thissection,youaresubjecttotherequirementsofparagraphs(b)(2)ofthissectionifanyofthefollowingcircumstances
apply:
(i)Apreventivecontrolisnotproperlyimplementedandacorrectiveactionprocedurehasnotbeenestablished
(ii)Apreventivecontrol,combinationofpreventivecontrols,orthefoodsafetyplanasawholeisfoundtobe
ineffectiveor
(iii)Areviewofrecordsinaccordancewith117.165(a)(4)findsthattherecordsarenotcomplete,theactivities
conducteddidnotoccurinaccordancewiththefoodsafetyplan,orappropriatedecisionswerenotmadeaboutcorrective
actions.
(2)Ifanyofthecircumstanceslistedinparagraph(b)(1)ofthissectionapply,youmust:
(i)Takecorrectiveactiontoidentifyandcorrecttheproblem,reducethelikelihoodthattheproblemwillrecur,evaluate
allaffectedfoodforsafety,and,asnecessary,preventaffectedfoodfromenteringcommerceaswouldbedonefollowinga
correctiveactionprocedureunderparagraphs(a)(2)(i)through(iv)ofthissectionand
(ii)Whenappropriate,reanalyzethefoodsafetyplaninaccordancewith117.170todeterminewhethermodification
ofthefoodsafetyplanisrequired.
(c)Corrections.Youdonotneedtocomplywiththerequirementsofparagraphs(a)and(b)ofthissectionif:
(1)Youtakeaction,inatimelymanner,toidentifyandcorrectconditionsandpracticesthatarenotconsistentwiththe
foodallergencontrolsin117.135(c)(2)(i)orthesanitationcontrolsin117.135(c)(3)(i)or(ii)or
(2)Youtakeaction,inatimelymanner,toidentifyandcorrectaminorandisolatedproblemthatdoesnotdirectly
impactproductsafety.
(d)Records.Allcorrectiveactions(and,whenappropriate,corrections)takeninaccordancewiththissectionmustbe
documentedinrecords.Theserecordsaresubjecttoverificationinaccordancewith117.155(a)(3)andrecordsreviewin
accordancewith117.165(a)(4)(i).
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117.155Verification.
(a)Verificationactivities.Verificationactivitiesmustinclude,asappropriatetothenatureofthepreventivecontroland
itsroleinthefacility'sfoodsafetysystem:
(1)Validationinaccordancewith117.160.
(2)Verificationthatmonitoringisbeingconductedasrequiredby117.140(andinaccordancewith117.145).
(3)Verificationthatappropriatedecisionsaboutcorrectiveactionsarebeingmadeasrequiredby117.140(andin
accordancewith117.150).
(4)Verificationofimplementationandeffectivenessinaccordancewith117.165and
(5)Reanalysisinaccordancewith117.170.
(b)Documentation.Allverificationactivitiesconductedinaccordancewiththissectionmustbedocumentedin
records.
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117.160Validation.
(a)Youmustvalidatethatthepreventivecontrolsidentifiedandimplementedinaccordancewith117.135are
adequatetocontrolthehazardasappropriatetothenatureofthepreventivecontrolanditsroleinthefacility'sfoodsafety
system.
(b)Thevalidationofthepreventivecontrols:
(1)Mustbeperformed(oroverseen)byapreventivecontrolsqualifiedindividual:
(i)(A)Priortoimplementationofthefoodsafetyplanor
(B)Whennecessarytodemonstratethecontrolmeasurescanbeimplementedasdesigned:
(1)Within90calendardaysafterproductionoftheapplicablefoodfirstbeginsor
(2)Withinareasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthe
preparationof)awrittenjustificationforatimeframethatexceeds90calendardaysafterproductionoftheapplicablefood
firstbegins
(ii)Wheneverachangetoacontrolmeasureorcombinationofcontrolmeasurescouldimpactwhetherthecontrol
measureorcombinationofcontrolmeasures,whenproperlyimplemented,willeffectivelycontrolthehazardsand
(iii)Wheneverareanalysisofthefoodsafetyplanrevealstheneedtodoso
(2)Mustincludeobtainingandevaluatingscientificandtechnicalevidence(or,whensuchevidenceisnotavailableor
isinadequate,conductingstudies)todeterminewhetherthepreventivecontrols,whenproperlyimplemented,will
effectivelycontrolthehazardsand
(c)Youdonotneedtovalidate:
(1)Thefoodallergencontrolsin117.135(c)(2)
(2)Thesanitationcontrolsin117.135(c)(3)
(3)Therecallplanin117.139
(4)ThesupplychainprograminsubpartGofthispartand
(5)Otherpreventivecontrols,ifthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)a
writtenjustificationthatvalidationisnotapplicablebasedonfactorssuchasthenatureofthehazard,andthenatureofthe
preventivecontrolanditsroleinthefacility'sfoodsafetysystem.
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117.165Verificationofimplementationandeffectiveness.
(a)Verificationactivities.Youmustverifythatthepreventivecontrolsareconsistentlyimplementedandareeffectively
andsignificantlyminimizingorpreventingthehazards.Todosoyoumustconductactivitiesthatincludethefollowing,as
appropriatetothefacility,thefood,andthenatureofthepreventivecontrolanditsroleinthefacility'sfoodsafetysystem:
(1)Calibrationofprocessmonitoringinstrumentsandverificationinstruments(orcheckingthemforaccuracy)
(2)Producttesting,forapathogen(orappropriateindicatororganism)orotherhazard
(3)Environmentalmonitoring,foranenvironmentalpathogenorforanappropriateindicatororganism,if
contaminationofareadytoeatfoodwithanenvironmentalpathogenisahazardrequiringapreventivecontrol,by
collectingandtestingenvironmentalsamplesand
(4)Reviewofthefollowingrecordswithinthespecifiedtimeframes,by(orundertheoversightof)apreventive
controlsqualifiedindividual,toensurethattherecordsarecomplete,theactivitiesreflectedintherecordsoccurredin
accordancewiththefoodsafetyplan,thepreventivecontrolsareeffective,andappropriatedecisionsweremadeabout
correctiveactions:
(i)Recordsofmonitoringandcorrectiveactionrecordswithin7workingdaysaftertherecordsarecreatedorwithina
reasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)a
writtenjustificationforatimeframethatexceeds7workingdaysand
(ii)Recordsofcalibration,testing(e.g.,producttesting,environmentalmonitoring),supplierandsupplychain
verificationactivities,andotherverificationactivitieswithinareasonabletimeaftertherecordsarecreatedand
(5)Otheractivitiesappropriateforverificationofimplementationandeffectiveness.
(b)Writtenprocedures.Asappropriatetothefacility,thefood,thenatureofthepreventivecontrol,andtheroleofthe
preventivecontrolinthefacility'sfoodsafetysystem,youmustestablishandimplementwrittenproceduresforthe
followingactivities:
(1)Themethodandfrequencyofcalibratingprocessmonitoringinstrumentsandverificationinstruments(orchecking
themforaccuracy)asrequiredbyparagraph(a)(1)ofthissection.
(2)Producttestingasrequiredbyparagraph(a)(2)ofthissection.Proceduresforproducttestingmust:
(i)Bescientificallyvalid
(ii)Identifythetestmicroorganism(s)orotheranalyte(s)
(iii)Specifytheproceduresforidentifyingsamples,includingtheirrelationshiptospecificlotsofproduct
(iv)Includetheproceduresforsampling,includingthenumberofsamplesandthesamplingfrequency
(v)Identifythetest(s)conducted,includingtheanalyticalmethod(s)used
(vi)Identifythelaboratoryconductingthetestingand
(vii)Includethecorrectiveactionproceduresrequiredby117.150(a)(1).
(3)Environmentalmonitoringasrequiredbyparagraph(a)(3)ofthissection.Proceduresforenvironmentalmonitoring
must:
(i)Bescientificallyvalid
(ii)Identifythetestmicroorganism(s)
(iii)Identifythelocationsfromwhichsampleswillbecollectedandthenumberofsitestobetestedduringroutine
environmentalmonitoring.Thenumberandlocationofsamplingsitesmustbeadequatetodeterminewhetherpreventive
controlsareeffective
(iv)Identifythetimingandfrequencyforcollectingandtestingsamples.Thetimingandfrequencyforcollectingand
testingsamplesmustbeadequatetodeterminewhetherpreventivecontrolsareeffective
(v)Identifythetest(s)conducted,includingtheanalyticalmethod(s)used
(vi)Identifythelaboratoryconductingthetestingand
(vii)Includethecorrectiveactionproceduresrequiredby117.150(a)(1).
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117.170Reanalysis.
(a)Youmustconductareanalysisofthefoodsafetyplanasawholeatleastonceevery3years
(b)Youmustconductareanalysisofthefoodsafetyplanasawhole,ortheapplicableportionofthefoodsafetyplan:
(1)Wheneverasignificantchangeintheactivitiesconductedatyourfacilitycreatesareasonablepotentialforanew
hazardorcreatesasignificantincreaseinapreviouslyidentifiedhazard
(2)Wheneveryoubecomeawareofnewinformationaboutpotentialhazardsassociatedwiththefood
(3)Wheneverappropriateafteranunanticipatedfoodsafetyprobleminaccordancewith117.150(b)and
(4)Wheneveryoufindthatapreventivecontrol,combinationofpreventivecontrols,orthefoodsafetyplanasawhole
isineffective.
(c)Youmustcompletethereanalysisrequiredbyparagraphs(a)and(b)ofthissectionandvalidate,asappropriateto
thenatureofthepreventivecontrolanditsroleinthefacility'sfoodsafetysystem,anyadditionalpreventivecontrols
neededtoaddressthehazardidentified:
(1)Beforeanychangeinactivities(includinganychangeinpreventivecontrol)atthefacilityisoperativeor
(2)Whennecessarytodemonstratethecontrolmeasurescanbeimplementedasdesigned:
(i)Within90calendardaysafterproductionoftheapplicablefoodfirstbeginsor
(ii)Withinareasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthe
preparationof)awrittenjustificationforatimeframethatexceeds90calendardaysafterproductionoftheapplicablefood
firstbegins.
(d)Youmustrevisethewrittenfoodsafetyplanifasignificantchangeintheactivitiesconductedatyourfacility
createsareasonablepotentialforanewhazardorasignificantincreaseinapreviouslyidentifiedhazardordocumentthe
basisfortheconclusionthatnorevisionsareneeded.
(e)Apreventivecontrolsqualifiedindividualmustperform(oroversee)thereanalysis.
(f)YoumustconductareanalysisofthefoodsafetyplanwhenFDAdeterminesitisnecessarytorespondtonew
hazardsanddevelopmentsinscientificunderstanding.
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117.180Requirementsapplicabletoapreventivecontrolsqualifiedindividualandaqualifiedauditor.
(a)Oneormorepreventivecontrolsqualifiedindividualsmustdooroverseethefollowing:
(1)Preparationofthefoodsafetyplan(117.126(a)(2))
(2)Validationofthepreventivecontrols(117.160(b)(1))
(3)Writtenjustificationforvalidationtobeperformedinatimeframethatexceedsthefirst90calendardaysof
productionoftheapplicablefood
(4)Determinationthatvalidationisnotrequired(117.160(c)(5))
(5)Reviewofrecords(117.165(a)(4))
(6)Writtenjustificationforreviewofrecordsofmonitoringandcorrectiveactionswithinatimeframethatexceeds7
workingdays
(7)Reanalysisofthefoodsafetyplan(117.170(d))and
(8)Determinationthatreanalysiscanbecompleted,andadditionalpreventivecontrolsvalidated,asappropriatetothe
natureofthepreventivecontrolanditsroleinthefacility'sfoodsafetysystem,inatimeframethatexceedsthefirst90
calendardaysofproductionoftheapplicablefood.
(b)Aqualifiedauditormustconductanonsiteaudit(117.435(a)).
(c)(1)Tobeapreventivecontrolsqualifiedindividual,theindividualmusthavesuccessfullycompletedtraininginthe
developmentandapplicationofriskbasedpreventivecontrolsatleastequivalenttothatreceivedunderastandardized
curriculumrecognizedasadequatebyFDAorbeotherwisequalifiedthroughjobexperiencetodevelopandapplyafood
safetysystem.Jobexperiencemayqualifyanindividualtoperformthesefunctionsifsuchexperiencehasprovidedan
individualwithknowledgeatleastequivalenttothatprovidedthroughthestandardizedcurriculum.Thisindividualmaybe,
butisnotrequiredtobe,anemployeeofthefacility.
(2)Tobeaqualifiedauditor,aqualifiedindividualmusthavetechnicalexpertiseobtainedthrougheducation,training,
orexperience(oracombinationthereof)necessarytoperformtheauditingfunction.
(d)Allapplicabletraininginthedevelopmentandapplicationofriskbasedpreventivecontrolsmustbedocumentedin
records,includingthedateofthetraining,thetypeoftraining,andtheperson(s)trained.
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117.190Implementationrecordsrequiredforthissubpart.
(a)Youmustestablishandmaintainthefollowingrecordsdocumentingimplementationofthefoodsafetyplan:
(1)Documentation,asrequiredby117.136(b),ofthebasisfornotestablishingapreventivecontrolinaccordance
with117.136(a)
(2)Recordsthatdocumentthemonitoringofpreventivecontrols
(3)Recordsthatdocumentcorrectiveactions
(4)Recordsthatdocumentverification,including,asapplicable,thoserelatedto:
(i)Validation
(ii)Verificationofmonitoring
(iii)Verificationofcorrectiveactions
(iv)Calibrationofprocessmonitoringandverificationinstruments
(v)Producttesting
(vi)Environmentalmonitoring
(vii)Recordsreviewand
(viii)Reanalysis
(5)Recordsthatdocumentthesupplychainprogramand
(6)Recordsthatdocumentapplicabletrainingforthepreventivecontrolsqualifiedindividualandthequalifiedauditor.
(b)TherecordsthatyoumustestablishandmaintainaresubjecttotherequirementsofsubpartFofthispart.
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SubpartDModifiedRequirements
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117.201Modifiedrequirementsthatapplytoaqualifiedfacility.
(a)Attestationstobesubmitted.AqualifiedfacilitymustsubmitthefollowingattestationstoFDA:
(1)Anattestationthatthefacilityisaqualifiedfacilityasdefinedin117.3.Forthepurposeofdeterminingwhethera
facilitysatisfiesthedefinitionofqualifiedfacility,thebaselineyearforcalculatingtheadjustmentforinflationis2011and
(2)(i)Anattestationthatyouhaveidentifiedthepotentialhazardsassociatedwiththefoodbeingproduced,are
implementingpreventivecontrolstoaddressthehazards,andaremonitoringtheperformanceofthepreventivecontrolsto
ensurethatsuchcontrolsareeffectiveor
(ii)AnattestationthatthefacilityisincompliancewithState,local,county,tribal,orotherapplicablenonFederalfood
safetylaw,includingrelevantlawsandregulationsofforeigncountries,includinganattestationbasedonlicenses,
inspectionreports,certificates,permits,credentials,certificationbyanappropriateagency(suchasaStatedepartmentof
agriculture),orotherevidenceofoversight.
(b)Procedureforsubmission.Theattestationsrequiredbyparagraph(a)ofthissectionmustbesubmittedtoFDAby
oneofthefollowingmeans:
(1)Electronicsubmission.Tosubmitelectronically,gotohttp://www.fda.gov/furlsandfollowtheinstructions.ThisWeb
siteisavailablefromwherevertheInternetisaccessible,includinglibraries,copycenters,schools,andInternetcafes.
FDAencourageselectronicsubmission.
(2)Submissionbymail.(i)YoumustuseFormFDA3942a.Youmayobtainacopyofthisformbyanyofthefollowing
mechanisms:
(A)Downloaditfromhttp://www.fda.gov/pchfrule
(B)WritetotheU.S.FoodandDrugAdministration(HFS681),5001CampusDr.,CollegePark,MD20740or
(C)Requestacopyofthisformbyphoneat18002167331or3015750156.
(ii)SendapaperFormFDA3942atotheU.S.FoodandDrugAdministration(HFS681),5001CampusDr.,College
Park,MD20740.Werecommendthatyousubmitapapercopyonlyifyourfacilitydoesnothavereasonableaccesstothe
Internet.
(c)Frequencyofdeterminationofstatusandsubmission.(1)Afacilitymustdetermineanddocumentitsstatusasa
qualifiedfacilityonanannualbasisnolaterthanJuly1ofeachcalendaryear.
(2)Theattestationsrequiredbyparagraph(a)ofthissectionmustbe:
(i)SubmittedtoFDAinitially:
(A)ByDecember17,2018,forafacilitythatbeginsmanufacturing,processing,packing,orholdingfoodbefore
September17,2018
(B)Beforebeginningoperations,forafacilitythatbeginsmanufacturing,processing,packing,orholdingfoodafter
September17,2018or
(C)ByJuly31oftheapplicablecalendaryear,whenthestatusofafacilitychangesfromnotaqualifiedfacilityto
qualifiedfacilitybasedontheannualdeterminationrequiredbyparagraph(c)(1)ofthissectionand
(ii)Beginningin2020,submittedtoFDAevery2yearsduringtheperiodbeginningonOctober1andendingon
December31.
(3)Whenthestatusofafacilitychangesfromqualifiedfacilitytonotaqualifiedfacilitybasedontheannual
determinationrequiredbyparagraph(c)(1)ofthissection,thefacilitymustnotifyFDAofthatchangeinstatususingForm
3942abyJuly31oftheapplicablecalendaryear.
(d)TimeframeforcompliancewithsubpartsCandGofthispartwhenthefacilitystatuschangestonotaqualified
facility.Whenthestatusofafacilitychangesfromqualifiedfacilitytonotaqualifiedfacility,thefacilitymustcomplywith
subpartsCandGofthispartnolaterthanDecember31oftheapplicablecalendaryearunlessotherwiseagreedtoby
FDAandthefacility.
(e)Notificationtoconsumers.Aqualifiedfacilitythatdoesnotsubmitattestationsunderparagraph(a)(2)(i)ofthis
sectionmustprovidenotificationtoconsumersastothenameandcompletebusinessaddressofthefacilitywherethe
foodwasmanufacturedorprocessed(includingthestreetaddressorP.O.box,city,state,andzipcodefordomestic
facilities,andcomparablefulladdressinformationforforeignfacilities),asfollows:
(1)Ifafoodpackaginglabelisrequired,thenotificationrequiredbyparagraph(e)ofthissectionmustappear
prominentlyandconspicuouslyonthelabelofthefood.
(2)Ifafoodpackaginglabelisnotrequired,thenotificationrequiredbyparagraph(e)ofthissectionmustappear
prominentlyandconspicuously,atthepointofpurchase,onalabel,poster,sign,placard,ordocumentsdelivered
contemporaneouslywiththefoodinthenormalcourseofbusiness,orinanelectronicnotice,inthecaseofInternetsales.
(f)Records.(1)Aqualifiedfacilitymustmaintainthoserecordsreliedupontosupporttheattestationsthatare
requiredbyparagraph(a)ofthissection.
(2)TherecordsthataqualifiedfacilitymustmaintainaresubjecttotherequirementsofsubpartFofthispart.
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117.206Modifiedrequirementsthatapplytoafacilitysolelyengagedinthestorageofunexposedpackaged
food.
(a)Ifafacilitythatissolelyengagedinthestorageofunexposedpackagedfoodstoresanysuchrefrigerated
packagedfoodthatrequirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxinproduction
bypathogens,thefacilitymustconductthefollowingactivitiesasappropriatetoensuretheeffectivenessofthe
temperaturecontrols:
(1)Establishandimplementtemperaturecontrolsadequatetosignificantlyminimizeorpreventthegrowthof,ortoxin
productionby,pathogens
(2)Monitorthetemperaturecontrolswithadequatefrequencytoprovideassurancethatthetemperaturecontrolsare
consistentlyperformed
(3)Ifthereisalossoftemperaturecontrolthatmayimpactthesafetyofsuchrefrigeratedpackagedfood,take
appropriatecorrectiveactionsto:
(i)Correcttheproblemandreducethelikelihoodthattheproblemwillrecur
(ii)Evaluateallaffectedfoodforsafetyand
(iii)Preventthefoodfromenteringcommerce,ifyoucannotensuretheaffectedfoodisnotadulteratedundersection
402oftheFederalFood,Drug,andCosmeticAct
(4)Verifythattemperaturecontrolsareconsistentlyimplementedby:
(i)Calibratingtemperaturemonitoringandrecordingdevices(orcheckingthemforaccuracy)
(ii)Reviewingrecordsofcalibrationwithinareasonabletimeaftertherecordsarecreatedand
(iii)Reviewingrecordsofmonitoringandcorrectiveactionstakentocorrectaproblemwiththecontroloftemperature
within7workingdaysaftertherecordsarecreatedorwithinareasonabletimeframe,providedthatthepreventivecontrols
qualifiedindividualprepares(oroverseesthepreparationof)awrittenjustificationforatimeframethatexceeds7working
days
(5)Establishandmaintainthefollowingrecords:
(i)Records(whetheraffirmativerecordsdemonstratingtemperatureiscontrolledorexceptionrecordsdemonstrating
lossoftemperaturecontrol)documentingthemonitoringoftemperaturecontrolsforanysuchrefrigeratedpackagedfood
(ii)Recordsofcorrectiveactionstakenwhenthereisalossoftemperaturecontrolthatmayimpactthesafetyofany
suchrefrigeratedpackagedfoodand
(iii)Recordsdocumentingverificationactivities.
(b)Therecordsthatafacilitymustestablishandmaintainunderparagraph(a)(5)ofthissectionaresubjecttothe
requirementsofsubpartFofthispart.
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SubpartEWithdrawalofaQualifiedFacilityExemption
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117.251CircumstancesthatmayleadFDAtowithdrawaqualifiedfacilityexemption.
(a)FDAmaywithdrawaqualifiedfacilityexemptionunder117.5(a):
(1)Intheeventofanactiveinvestigationofafoodborneillnessoutbreakthatisdirectlylinkedtothequalifiedfacility
or
(2)IfFDAdeterminesthatitisnecessarytoprotectthepublichealthandpreventormitigateafoodborneillness
outbreakbasedonconditionsorconductassociatedwiththequalifiedfacilitythatarematerialtothesafetyofthefood
manufactured,processed,packed,orheldatsuchfacility.
(b)BeforeFDAissuesanordertowithdrawaqualifiedfacilityexemption,FDA:
(1)Mayconsideroneormoreotheractionstoprotectthepublichealthormitigateafoodborneillnessoutbreak,
includingawarningletter,recall,administrativedetention,suspensionofregistration,refusaloffoodofferedforimport,
seizure,andinjunction
(2)Mustnotifytheowner,operator,oragentinchargeofthefacility,inwriting,ofcircumstancesthatmayleadFDAto
withdrawtheexemption,andprovideanopportunityfortheowner,operator,oragentinchargeofthefacilitytorespondin
writing,within15calendardaysofthedateofreceiptofthenotification,toFDA'snotificationand
(3)MustconsidertheactionstakenbythefacilitytoaddressthecircumstancesthatmayleadFDAtowithdrawthe
exemption.
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117.254Issuanceofanordertowithdrawaqualifiedfacilityexemption.
(a)AnFDADistrictDirectorinwhosedistrictthequalifiedfacilityislocated(or,inthecaseofaforeignfacility,the
DirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition),oranFDAofficialseniortoeither
suchDirector,mustapproveanordertowithdrawtheexemptionbeforetheorderisissued.
(b)AnyofficerorqualifiedemployeeofFDAmayissueanordertowithdrawtheexemptionafterithasbeenapproved
inaccordancewithparagraph(a)ofthissection.
(c)FDAmustissueanordertowithdrawtheexemptiontotheowner,operator,oragentinchargeofthefacility.
(d)FDAmustissueanordertowithdrawtheexemptioninwriting,signedanddatedbytheofficerorqualified
employeeofFDAwhoisissuingtheorder.
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117.257Contentsofanordertowithdrawaqualifiedfacilityexemption.
Anordertowithdrawaqualifiedfacilityexemptionunder117.5(a)mustincludethefollowinginformation:
(a)Thedateoftheorder
(b)Thename,address,andlocationofthequalifiedfacility
(c)Abrief,generalstatementofthereasonsfortheorder,includinginformationrelevanttooneorbothofthefollowing
circumstancesthatleadsFDAtoissuetheorder:
(1)Anactiveinvestigationofafoodborneillnessoutbreakthatisdirectlylinkedtothefacilityor
(2)Conditionsorconductassociatedwithaqualifiedfacilitythatarematerialtothesafetyofthefoodmanufactured,
processed,packed,orheldatsuchfacility.
(d)Astatementthatthefacilitymusteither:
(1)ComplywithsubpartsCandGofthispartonthedatethatis120calendardaysafterthedateofreceiptofthe
order,orwithinareasonabletimeframe,agreedtobyFDA,basedonawrittenjustification,submittedtoFDA,fora
timeframethatexceeds120calendardaysfromthedateofreceiptoftheorderor
(2)Appealtheorderwithin15calendardaysofthedateofreceiptoftheorderinaccordancewiththerequirementsof
117.264.
(e)AstatementthatafacilitymayrequestthatFDAreinstateanexemptionthatwaswithdrawnbyfollowingthe
proceduresin117.287
(f)Thetextofsection418(l)oftheFederalFood,Drug,andCosmeticActandofthissubpart
(g)Astatementthatanyinformalhearingonanappealoftheordermustbeconductedasaregulatoryhearingunder
part16ofthischapter,withcertainexceptionsdescribedin117.270
(h)Themailingaddress,telephonenumber,emailaddress,andfacsimilenumberoftheFDAdistrictofficeandthe
nameoftheFDADistrictDirectorinwhosedistrictthefacilityislocated(or,inthecaseofaforeignfacility,thesame
informationfortheDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)and
(i)ThenameandthetitleoftheFDArepresentativewhoapprovedtheorder.
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117.260Compliancewith,orappealof,anordertowithdrawaqualifiedfacilityexemption.
(a)Ifyoureceiveanorderunder117.254towithdrawaqualifiedfacilityexemption,youmusteither:
(1)Complywithapplicablerequirementsofthispartwithin120calendardaysofthedateofreceiptoftheorder,or
withinareasonabletimeframe,agreedtobyFDA,basedonawrittenjustification,submittedtoFDA,foratimeframethat
exceeds120calendardaysfromthedateofreceiptoftheorderor
(2)Appealtheorderwithin15calendardaysofthedateofreceiptoftheorderinaccordancewiththerequirementsof
117.264.
(b)Submissionofanappeal,includingsubmissionofarequestforaninformalhearing,willnotoperatetodelayor
stayanyadministrativeaction,includingenforcementactionbyFDA,unlesstheCommissionerofFoodandDrugs,asa
matterofdiscretion,determinesthatdelayorastayisinthepublicinterest.
(c)Ifyouappealtheorder,andFDAconfirmstheorder:
(1)Youmustcomplywithapplicablerequirementsofthispartwithin120calendardaysofthedateofreceiptofthe
order,orwithinareasonabletimeframe,agreedtobyFDA,basedonawrittenjustification,submittedtoFDA,fora
timeframethatexceeds120calendardaysfromthedateofreceiptoftheorderand
(2)Youarenolongersubjecttothemodifiedrequirementsin117.201.
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117.264Procedureforsubmittinganappeal.
(a)Toappealanordertowithdrawaqualifiedfacilityexemption,youmust:
(1)SubmittheappealinwritingtotheFDADistrictDirectorinwhosedistrictthefacilityislocated(or,inthecaseofa
foreignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition),atthemailing
address,emailaddress,orfacsimilenumberidentifiedintheorderwithin15calendardaysofthedateofreceiptof
confirmationoftheorderand
(2)Respondwithparticularitytothefactsandissuescontainedintheorder,includinganysupportingdocumentation
uponwhichyourely.
(b)Inawrittenappealoftheorderwithdrawinganexemptionprovidedunder117.5(a),youmayincludeawritten
requestforaninformalhearingasprovidedin117.267.
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117.267Procedureforrequestinganinformalhearing.
(a)Ifyouappealtheorder,you:
(1)Mayrequestaninformalhearingand
(2)Mustsubmitanyrequestforaninformalhearingtogetherwithyourwrittenappealsubmittedinaccordancewith
117.264within15calendardaysofthedateofreceiptoftheorder.
(b)Arequestforaninformalhearingmaybedenied,inwholeorinpart,ifthepresidingofficerdeterminesthatno
genuineandsubstantialissueofmaterialfacthasbeenraisedbythematerialsubmitted.Ifthepresidingofficerdetermines
thatahearingisnotjustified,writtennoticeofthedeterminationwillbegiventoyouexplainingthereasonforthedenial.
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117.270Requirementsapplicabletoaninformalhearing.
Ifyourequestaninformalhearing,andFDAgrantstherequest:
(a)Thehearingwillbeheldwithin15calendardaysafterthedatetheappealisfiledor,ifapplicable,withina
timeframeagreeduponinwritingbyyouandFDA.
(b)Thepresidingofficermayrequirethatahearingconductedunderthissubpartbecompletedwithin1calendarday,
asappropriate.
(c)FDAmustconductthehearinginaccordancewithpart16ofthischapter,exceptthat:
(1)Theorderwithdrawinganexemptionunder117.254and117.257,ratherthanthenoticeunder16.22(a)ofthis
chapter,providesnoticeofopportunityforahearingunderthissectionandispartoftheadministrativerecordofthe
regulatoryhearingunder16.80(a)ofthischapter.
(2)ArequestforahearingunderthissubpartmustbeaddressedtotheFDADistrictDirector(or,inthecaseofa
foreignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)asprovidedin
theorderwithdrawinganexemption.
(3)Section117.274,ratherthan16.42(a)ofthischapter,describestheFDAemployeeswhopresideathearings
underthissubpart.
(4)Section16.60(e)and(f)ofthischapterdoesnotapplytoahearingunderthissubpart.Thepresidingofficermust
prepareawrittenreportofthehearing.Allwrittenmaterialpresentedatthehearingwillbeattachedtothereport.The
presidingofficermustincludeaspartofthereportofthehearingafindingonthecredibilityofwitnesses(otherthanexpert
witnesses)whenevercredibilityisamaterialissue,andmustincludeaproposeddecision,withastatementofreasons.
Thehearingparticipantmayreviewandcommentonthepresidingofficer'sreportwithin2calendardaysofissuanceof
thereport.Thepresidingofficerwillthenissuethefinaldecision.
(5)Section16.80(a)(4)ofthischapterdoesnotapplytoaregulatoryhearingunderthissubpart.Thepresiding
officer'sreportofthehearingandanycommentsonthereportbythehearingparticipantunder117.270(c)(4)arepartof
theadministrativerecord.
(6)Nopartyshallhavetheright,under16.119ofthischaptertopetitiontheCommissionerofFoodandDrugsfor
reconsiderationorastayofthepresidingofficer'sfinaldecision.
(7)IfFDAgrantsarequestforaninformalhearingonanappealofanorderwithdrawinganexemption,thehearing
mustbeconductedasaregulatoryhearingunderaregulationinaccordancewithpart16ofthischapter,exceptthat
16.95(b)ofthischapterdoesnotapplytoahearingunderthissubpart.Withrespecttoaregulatoryhearingunderthis
subpart,theadministrativerecordofthehearingspecifiedin16.80(a)(1)through(3)and(a)(5)ofthischapterand
117.270(c)(5)constitutestheexclusiverecordforthepresidingofficer'sfinaldecision.Forpurposesofjudicialreview
under10.45ofthischapter,therecordoftheadministrativeproceedingconsistsoftherecordofthehearingandthe
presidingofficer'sfinaldecision.
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117.274Presidingofficerforanappealandforaninformalhearing.
Thepresidingofficerforanappeal,andforaninformalhearing,mustbeanOfficeofRegulatoryAffairsProgram
DirectororanotherFDAofficialseniortoanFDADistrictDirector.
[82FR14146,Mar.17,2017]
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117.277Timeframeforissuingadecisiononanappeal.
(a)Ifyouappealtheorderwithoutrequestingahearing,thepresidingofficermustissueawrittenreportthatincludes
afinaldecisionconfirmingorrevokingthewithdrawalbythe10thcalendardayaftertheappealisfiled.
(b)Ifyouappealtheorderandrequestaninformalhearing:
(1)IfFDAgrantstherequestforahearingandthehearingisheld,thepresidingofficermustprovidea2calendarday
opportunityforthehearingparticipantstoreviewandsubmitcommentsonthereportofthehearingunder117.270(c)(4),
andmustissueafinaldecisionwithin10calendardaysafterthehearingisheldor
(2)IfFDAdeniestherequestforahearing,thepresidingofficermustissueafinaldecisionontheappealconfirming
orrevokingthewithdrawalwithin10calendardaysafterthedatetheappealisfiled.
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117.280Revocationofanordertowithdrawaqualifiedfacilityexemption.
Anordertowithdrawaqualifiedfacilityexemptionisrevokedif:
(a)Youappealtheorderandrequestaninformalhearing,FDAgrantstherequestforaninformalhearing,andthe
presidingofficerdoesnotconfirmtheorderwithinthe10calendardaysafterthehearing,orissuesadecisionrevokingthe
orderwithinthattimeor
(b)Youappealtheorderandrequestaninformalhearing,FDAdeniestherequestforaninformalhearing,andFDA
doesnotconfirmtheorderwithinthe10calendardaysaftertheappealisfiled,orissuesadecisionrevokingtheorder
withinthattimeor
(c)Youappealtheorderwithoutrequestinganinformalhearing,andFDAdoesnotconfirmtheorderwithinthe10
calendardaysaftertheappealisfiled,orissuesadecisionrevokingtheorderwithinthattime.
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117.284Finalagencyaction.
Confirmationofawithdrawalorderbythepresidingofficerisconsideredafinalagencyactionforpurposesof5U.S.C.
702.
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117.287Reinstatementofaqualifiedfacilityexemptionthatwaswithdrawn.
(a)IftheFDADistrictDirectorinwhosedistrictyourfacilityislocated(or,inthecaseofaforeignfacility,theDirector
oftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)determinesthatafacilityhasadequately
resolvedanyproblemswiththeconditionsandconductthatarematerialtothesafetyofthefoodmanufactured,
processed,packed,orheldatthefacilityandthatcontinuedwithdrawaloftheexemptionisnotnecessarytoprotectpublic
healthandpreventormitigateafoodborneillnessoutbreak,theFDADistrictDirectorinwhosedistrictyourfacilityis
located(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyand
AppliedNutrition)will,onhisowninitiativeorontherequestofafacility,reinstatetheexemption.
(b)YoumayaskFDAtoreinstateanexemptionthathasbeenwithdrawnundertheproceduresofthissubpartas
follows:
(1)Submitarequest,inwriting,totheFDADistrictDirectorinwhosedistrictyourfacilityislocated(or,inthecaseofa
foreignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)and
(2)Presentdataandinformationtodemonstratethatyouhaveadequatelyresolvedanyproblemswiththeconditions
andconductthatarematerialtothesafetyofthefoodmanufactured,processed,packed,orheldatyourfacility,suchthat
continuedwithdrawaloftheexemptionisnotnecessarytoprotectpublichealthandpreventormitigateafoodborneillness
outbreak.
(c)Ifyourexemptionwaswithdrawnunder117.251(a)(1)andFDAlaterdetermines,afterfinishingtheactive
investigationofafoodborneillnessoutbreak,thattheoutbreakisnotdirectlylinkedtoyourfacility,FDAwillreinstateyour
exemptionunder117.5(a),andFDAwillnotifyyouinwritingthatyourexemptstatushasbeenreinstated.
(d)Ifyourexemptionwaswithdrawnunderboth117.251(a)(1)and(2)andFDAlaterdetermines,afterfinishingthe
activeinvestigationofafoodborneillnessoutbreak,thattheoutbreakisnotdirectlylinkedtoyourfacility,FDAwillinform
youofthisfinding,andyoumayaskFDAtoreinstateyourexemptionunder117.5(a)inaccordancewiththerequirements
ofparagraph(b)ofthissection.
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SubpartFRequirementsApplyingtoRecordsThatMustBeEstablishedandMaintained
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117.301Recordssubjecttotherequirementsofthissubpart.
(a)Exceptasprovidedbyparagraphs(b)and(c)ofthissection,allrecordsrequiredbythispartaresubjecttoall
requirementsofthissubpart.
(b)Therequirementsof117.310applyonlytothewrittenfoodsafetyplan.
(c)Therequirementsof117.305(b),(d),(e),and(f)donotapplytotherecordsrequiredby117.201.
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117.305Generalrequirementsapplyingtorecords.
Recordsmust:
(a)Bekeptasoriginalrecords,truecopies(suchasphotocopies,pictures,scannedcopies,microfilm,microfiche,or
otheraccuratereproductionsoftheoriginalrecords),orelectronicrecords
(b)Containtheactualvaluesandobservationsobtainedduringmonitoringand,asappropriate,duringverification
activities
(c)Beaccurate,indelible,andlegible
(d)Becreatedconcurrentlywithperformanceoftheactivitydocumented
(e)Beasdetailedasnecessarytoprovidehistoryofworkperformedand
(f)Include:
(1)Informationadequatetoidentifytheplantorfacility(e.g.,thename,andwhennecessary,thelocationoftheplant
orfacility)
(2)Thedateand,whenappropriate,thetimeoftheactivitydocumented
(3)Thesignatureorinitialsofthepersonperformingtheactivityand
(4)Whereappropriate,theidentityoftheproductandthelotcode,ifany.
(g)Recordsthatareestablishedormaintainedtosatisfytherequirementsofthispartandthatmeetthedefinitionof
electronicrecordsin11.3(b)(6)ofthischapterareexemptfromtherequirementsofpart11ofthischapter.Recordsthat
satisfytherequirementsofthispart,butthatalsoarerequiredunderotherapplicablestatutoryprovisionsorregulations,
remainsubjecttopart11ofthischapter.
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117.310Additionalrequirementsapplyingtothefoodsafetyplan.
Theowner,operator,oragentinchargeofthefacilitymustsignanddatethefoodsafetyplan:
(a)Uponinitialcompletionand
(b)Uponanymodification.
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117.315Requirementsforrecordretention.
(a)(1)Allrecordsrequiredbythispartmustberetainedattheplantorfacilityforatleast2yearsafterthedatethey
wereprepared.
(2)Recordsthatafacilityreliesonduringthe3yearperiodprecedingtheapplicablecalendaryeartosupportits
statusasaqualifiedfacilitymustberetainedatthefacilityaslongasnecessarytosupportthestatusofafacilityasa
qualifiedfacilityduringtheapplicablecalendaryear.
(b)Recordsthatrelatetothegeneraladequacyoftheequipmentorprocessesbeingusedbyafacility,includingthe
resultsofscientificstudiesandevaluations,mustberetainedbythefacilityforatleast2yearsaftertheiruseis
discontinued(e.g.,becausethefacilityhasupdatedthewrittenfoodsafetyplan(117.126)orrecordsthatdocument
validationofthewrittenfoodsafetyplan(117.155(b)))
(c)Exceptforthefoodsafetyplan,offsitestorageofrecordsispermittedifsuchrecordscanberetrievedand
providedonsitewithin24hoursofrequestforofficialreview.Thefoodsafetyplanmustremainonsite.Electronicrecords
areconsideredtobeonsiteiftheyareaccessiblefromanonsitelocation.
(d)Iftheplantorfacilityisclosedforaprolongedperiod,thefoodsafetyplanmaybetransferredtosomeother
reasonablyaccessiblelocationbutmustbereturnedtotheplantorfacilitywithin24hoursforofficialreviewuponrequest.
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117.320Requirementsforofficialreview.
AllrecordsrequiredbythispartmustbemadepromptlyavailabletoadulyauthorizedrepresentativeoftheSecretary
ofHealthandHumanServicesforofficialreviewandcopyinguponoralorwrittenrequest.
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117.325Publicdisclosure.
RecordsobtainedbyFDAinaccordancewiththispartaresubjecttothedisclosurerequirementsunderpart20ofthis
chapter.
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117.330Useofexistingrecords.
(a)Existingrecords(e.g.,recordsthatarekepttocomplywithotherFederal,State,orlocalregulations,orforany
otherreason)donotneedtobeduplicatediftheycontainalloftherequiredinformationandsatisfytherequirementsof
thissubpart.Existingrecordsmaybesupplementedasnecessarytoincludealloftherequiredinformationandsatisfythe
requirementsofthissubpart.
(b)Theinformationrequiredbythispartdoesnotneedtobekeptinonesetofrecords.Ifexistingrecordscontain
someoftherequiredinformation,anynewinformationrequiredbythispartmaybekepteitherseparatelyorcombined
withtheexistingrecords.
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117.335Specialrequirementsapplicabletoawrittenassurance.
(a)Anywrittenassurancerequiredbythispartmustcontainthefollowingelements:
(1)Effectivedate
(2)Printednamesandsignaturesofauthorizedofficials
(3)Theapplicableassuranceunder:
(i)Section117.136(a)(2)
(ii)Section117.136(a)(3)
(iii)Section117.136(a)(4)
(iv)Section117.430(c)(2)
(v)Section117.430(d)(2)or
(v)Section117.430(d)(2)or
(vi)Section117.430(e)(2)
(b)Awrittenassurancerequiredunder117.136(a)(2),(3),or(4)mustinclude:
(1)Acknowledgementthatthefacilitythatprovidesthewrittenassuranceassumeslegalresponsibilitytoact
consistentlywiththeassuranceanddocumentitsactionstakentosatisfythewrittenassuranceand
(2)Provisionthatiftheassuranceisterminatedinwritingbyeitherentity,responsibilityforcompliancewiththe
applicableprovisionsofthispartrevertstothemanufacturer/processorasofthedateoftermination.
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SubpartGSupplyChainProgram
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117.405Requirementtoestablishandimplementasupplychainprogram.
(a)(1)Exceptasprovidedbyparagraphs(a)(2)and(3)ofthissection,thereceivingfacilitymustestablishand
implementariskbasedsupplychainprogramforthoserawmaterialsandotheringredientsforwhichthereceivingfacility
hasidentifiedahazardrequiringasupplychainappliedcontrol.
(2)Areceivingfacilitythatisanimporter,isincompliancewiththeforeignsupplierverificationprogramrequirements
underpart1,subpartLofthischapter,andhasdocumentationofverificationactivitiesconductedunder1.506(e)ofthis
chapter(whichprovidesassurancethatthehazardsrequiringasupplychainappliedcontrolfortherawmaterialorother
ingredienthavebeensignificantlyminimizedorprevented)neednotconductsupplierverificationactivitiesforthatraw
materialorotheringredient.
(3)Therequirementsinthissubpartdonotapplytofoodthatissuppliedforresearchorevaluationuse,providedthat
suchfood:
(i)Isnotintendedforretailsaleandisnotsoldordistributedtothepublic
(ii)IslabeledwiththestatementFoodforresearchorevaluationuse
(iii)Issuppliedinasmallquantitythatisconsistentwitharesearch,analysis,orqualityassurancepurpose,thefood
isusedonlyforthispurpose,andanyunusedquantityisproperlydisposedofand
(iv)Isaccompaniedwithdocuments,inaccordancewiththepracticeofthetrade,statingthatthefoodwillbeusedfor
researchorevaluationpurposesandcannotbesoldordistributedtothepublic.
(b)Thesupplychainprogrammustbewritten.
(c)Whenasupplychainappliedcontrolisappliedbyanentityotherthanthereceivingfacility'ssupplier(e.g.,whena
nonsupplierappliescontrolstocertainproduce(i.e.,producecoveredbypart112ofthischapter),becausegrowing,
harvesting,andpackingactivitiesareunderdifferentmanagement),thereceivingfacilitymust:
(1)Verifythesupplychainappliedcontrolor
(2)Obtaindocumentationofanappropriateverificationactivityfromanotherentity,reviewandassesstheentity's
applicabledocumentation,anddocumentthatreviewandassessment.
[80FR56145,Sept.17,201581FR3956,Jan.25,2016]
EDN:At80FR56145,Sept.17,2015,117.405wasadded,effectiveNov.16,2015,exceptforparagraphs
(a)(2).FDAwillpublishadocumentintheFRannouncingtheeffectivedatefortheseparagraphs.
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117.410Generalrequirementsapplicabletoasupplychainprogram.
(a)Thesupplychainprogrammustinclude:
(1)Usingapprovedsuppliersasrequiredby117.420
(2)Determiningappropriatesupplierverificationactivities(includingdeterminingthefrequencyofconductingthe
activity)asrequiredby117.425
(3)Conductingsupplierverificationactivitiesasrequiredby117.430and117.435
(4)Documentingsupplierverificationactivitiesasrequiredby117.475and
(5)Whenapplicable,verifyingasupplychainappliedcontrolappliedbyanentityotherthanthereceivingfacility's
supplieranddocumentingthatverificationasrequiredby117.475,orobtainingdocumentationofanappropriate
verificationactivityfromanotherentity,reviewingandassessingthatdocumentation,anddocumentingthereviewand
assessmentasrequiredby117.475.
(b)Thefollowingareappropriatesupplierverificationactivitiesforrawmaterialsandotheringredients:
(1)Onsiteaudits
(2)Samplingandtestingoftherawmaterialorotheringredient
(3)Reviewofthesupplier'srelevantfoodsafetyrecordsand
(4)Otherappropriatesupplierverificationactivitiesbasedonsupplierperformanceandtheriskassociatedwiththe
rawmaterialorotheringredient.
(c)Thesupplychainprogrammustprovideassurancethatahazardrequiringasupplychainappliedcontrolhas
beensignificantlyminimizedorprevented.
(d)(1)Exceptasprovidedbyparagraph(d)(2)ofthissection,inapprovingsuppliersanddeterminingtheappropriate
supplierverificationactivitiesandthefrequencywithwhichtheyareconducted,thefollowingmustbeconsidered:
(i)Thehazardanalysisofthefood,includingthenatureofthehazardcontrolledbeforereceiptoftherawmaterialor
otheringredient,applicabletotherawmaterialandotheringredients
(ii)Theentityorentitiesthatwillbeapplyingcontrolsforthehazardsrequiringasupplychainappliedcontrol
(iii)Supplierperformance,including:
(A)Thesupplier'sprocedures,processes,andpracticesrelatedtothesafetyoftherawmaterialandother
ingredients
(B)ApplicableFDAfoodsafetyregulationsandinformationrelevanttothesupplier'scompliancewiththose
regulations,includinganFDAwarningletterorimportalertrelatingtothesafetyoffoodandotherFDAcomplianceactions
relatedtofoodsafety(or,whenapplicable,relevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhas
officiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates,andinformation
relevanttothesupplier'scompliancewiththoselawsandregulations)and
(C)Thesupplier'sfoodsafetyhistoryrelevanttotherawmaterialsorotheringredientsthatthereceivingfacility
receivesfromthesupplier,includingavailableinformationaboutresultsfromtestingrawmaterialsorotheringredientsfor
hazards,auditresultsrelatingtothesafetyofthefood,andresponsivenessofthesupplierincorrectingproblemsand
(iv)Anyotherfactorsasappropriateandnecessary,suchasstorageandtransportationpractices.
(2)Consideringsupplierperformancecanbelimitedtothesupplier'scompliancehistoryasrequiredbyparagraph(d)
(1)(iii)(B)ofthissection,ifthesupplieris:
(i)Aqualifiedfacilityasdefinedby117.3
(ii)Afarmthatgrowsproduceandisnotacoveredfarmunderpart112ofthischapterinaccordancewith112.4(a),
orinaccordancewith112.4(b)and112.5or
(iii)Ashelleggproducerthatisnotsubjecttotherequirementsofpart118ofthischapterbecauseithaslessthan
3,000layinghens.
(e)Iftheowner,operator,oragentinchargeofareceivingfacilitydeterminesthroughauditing,verificationtesting,
documentreview,relevantconsumer,customerorothercomplaints,orotherwisethatthesupplierisnotcontrolling
hazardsthatthereceivingfacilityhasidentifiedasrequiringasupplychainappliedcontrol,thereceivingfacilitymusttake
anddocumentpromptactioninaccordancewith117.150toensurethatrawmaterialsorotheringredientsfromthe
supplierdonotcausefoodthatismanufacturedorprocessedbythereceivingfacilitytobeadulteratedundersection402
oftheFederalFood,Drug,andCosmeticActormisbrandedundersection403(w)oftheFederalFood,Drug,and
CosmeticAct.
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117.415Responsibilitiesofthereceivingfacility.
(a)(1)Thereceivingfacilitymustapprovesuppliers.
(2)Exceptasprovidedbyparagraphs(a)(3)and(4)ofthissection,thereceivingfacilitymustdetermineandconduct
appropriatesupplierverificationactivities,andsatisfyalldocumentationrequirementsofthissubpart.
(3)Anentityotherthanthereceivingfacilitymaydoanyofthefollowing,providedthatthereceivingfacilityreviews
andassessestheentity'sapplicabledocumentation,anddocumentsthatreviewandassessment:
(i)Establishwrittenproceduresforreceivingrawmaterialsandotheringredientsbytheentity
(ii)Documentthatwrittenproceduresforreceivingrawmaterialsandotheringredientsarebeingfollowedbythe
entityand
(iii)Determine,conduct,orbothdetermineandconducttheappropriatesupplierverificationactivities,withappropriate
documentation.
(4)Thesuppliermayconductanddocumentsamplingandtestingofrawmaterialsandotheringredients,forthe
hazardcontrolledbythesupplier,asasupplierverificationactivityforaparticularlotofproductandprovidesuch
documentationtothereceivingfacility,providedthatthereceivingfacilityreviewsandassessesthatdocumentation,and
documentsthatreviewandassessment.
(b)Forthepurposesofthissubpart,areceivingfacilitymaynotacceptanyofthefollowingasasupplierverification
activity:
(1)Adeterminationbyitssupplieroftheappropriatesupplierverificationactivitiesforthatsupplier
(2)Anauditconductedbyitssupplier
(3)Areviewbyitssupplierofthatsupplier'sownrelevantfoodsafetyrecordsor
(4)Theconductbyitssupplierofotherappropriatesupplierverificationactivitiesforthatsupplierwithinthemeaning
of117.410(b)(4).
(c)Therequirementsofthissectiondonotprohibitareceivingfacilityfromrelyingonanauditprovidedbyitssupplier
whentheauditofthesupplierwasconductedbyathirdpartyqualifiedauditorinaccordancewith117.430(f)and
117.435.
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117.420Usingapprovedsuppliers.
(a)Approvalofsuppliers.Thereceivingfacilitymustapprovesuppliersinaccordancewiththerequirementsof
117.410(d),anddocumentthatapproval,beforereceivingrawmaterialsandotheringredientsreceivedfromthose
suppliers
(b)Writtenproceduresforreceivingrawmaterialsandotheringredients.(1)Writtenproceduresforreceivingraw
materialsandotheringredientsmustbeestablishedandfollowed
(2)Thewrittenproceduresforreceivingrawmaterialsandotheringredientsmustensurethatrawmaterialsandother
ingredientsarereceivedonlyfromapprovedsuppliers(or,whennecessaryandappropriate,onatemporarybasisfrom
unapprovedsupplierswhoserawmaterialsorotheringredientsaresubjectedtoadequateverificationactivitiesbefore
acceptanceforuse)and
(3)Useofthewrittenproceduresforreceivingrawmaterialsandotheringredientsmustbedocumented.
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117.425Determiningappropriatesupplierverificationactivities(includingdeterminingthefrequencyof
conductingtheactivity).
Appropriatesupplierverificationactivities(includingthefrequencyofconductingtheactivity)mustbedeterminedin
accordancewiththerequirementsof117.410(d).
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117.430Conductingsupplierverificationactivitiesforrawmaterialsandotheringredients.
(a)Exceptasprovidedbyparagraph(c),(d),or(e)ofthissection,oneormoreofthesupplierverificationactivities
specifiedin117.410(b),asdeterminedunder117.410(d),mustbeconductedforeachsupplierbeforeusingtheraw
materialorotheringredientfromthatsupplierandperiodicallythereafter.
(b)(1)Exceptasprovidedbyparagraph(b)(2)ofthissection,whenahazardinarawmaterialorotheringredientwill
becontrolledbythesupplierandisoneforwhichthereisareasonableprobabilitythatexposuretothehazardwillresultin
seriousadversehealthconsequencesordeathtohumans:
(i)Theappropriatesupplierverificationactivityisanonsiteauditofthesupplierand
(ii)Theauditmustbeconductedbeforeusingtherawmaterialorotheringredientfromthesupplierandatleast
annuallythereafter.
(2)Therequirementsofparagraph(b)(1)ofthissectiondonotapplyifthereisawrittendeterminationthatother
verificationactivitiesand/orlessfrequentonsiteauditingofthesupplierprovideadequateassurancethatthehazardsare
controlled.
(c)Ifasupplierisaqualifiedfacilityasdefinedby117.3,thereceivingfacilitydoesnotneedtocomplywith
paragraphs(a)and(b)ofthissectionifthereceivingfacility:
(1)Obtainswrittenassurancethatthesupplierisaqualifiedfacilityasdefinedby117.3:
(i)Beforefirstapprovingthesupplierforanapplicablecalendaryearand
(ii)Onanannualbasisthereafter,byDecember31ofeachcalendaryear,forthefollowingcalendaryearand
(2)Obtainswrittenassurance,atleastevery2years,thatthesupplierisproducingtherawmaterialorother
ingredientincompliancewithapplicableFDAfoodsafetyregulations(or,whenapplicable,relevantlawsandregulationsof
acountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalentto
thatoftheUnitedStates).Thewrittenassurancemustincludeeither:
(i)Abriefdescriptionofthepreventivecontrolsthatthesupplierisimplementingtocontroltheapplicablehazardinthe
foodor
(ii)AstatementthatthefacilityisincompliancewithState,local,county,tribal,orotherapplicablenonFederalfood
safetylaw,includingrelevantlawsandregulationsofforeigncountries.
(d)Ifasupplierisafarmthatgrowsproduceandisnotacoveredfarmunderpart112ofthischapterinaccordance
with112.4(a),orinaccordancewith112.4(b)and112.5,thereceivingfacilitydoesnotneedtocomplywithparagraphs
(a)and(b)ofthissectionforproducethatthereceivingfacilityreceivesfromthefarmasarawmaterialorotheringredient
ifthereceivingfacility:
(1)Obtainswrittenassurancethattherawmaterialorotheringredientprovidedbythesupplierisnotsubjecttopart
112ofthischapterinaccordancewith112.4(a),orinaccordancewith112.4(b)and112.5:
(2)Obtainswrittenassurance,atleastevery2years,thatthefarmacknowledgesthatitsfoodissubjecttosection
402oftheFederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsand
regulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobe
equivalenttothatoftheUnitedStates).
(e)Ifasupplierisashelleggproducerthatisnotsubjecttotherequirementsofpart118ofthischapterbecauseit
haslessthan3,000layinghens,thereceivingfacilitydoesnotneedtocomplywithparagraphs(a)and(b)ofthissectionif
thereceivingfacility:
(1)Obtainswrittenassurancethattheshelleggsproducedbythesupplierarenotsubjecttopart118becausethe
shelleggproducerhaslessthan3,000layinghens:
(2)Obtainswrittenassurance,atleastevery2years,thattheshelleggproduceracknowledgesthatitsfoodissubject
tosection402oftheFederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlaws
andregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedto
beequivalenttothatoftheUnitedStates).
(f)Theremustnotbeanyfinancialconflictsofintereststhatinfluencetheresultsoftheverificationactivitieslistedin
117.410(b)andpaymentmustnotberelatedtotheresultsoftheactivity.
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117.435Onsiteaudit.
(a)Anonsiteauditofasuppliermustbeperformedbyaqualifiedauditor.
(b)IftherawmaterialorotheringredientatthesupplierissubjecttooneormoreFDAfoodsafetyregulations,an
onsiteauditmustconsidersuchregulationsandincludeareviewofthesupplier'swrittenplan(e.g.,HazardAnalysisand
CriticalControlPoint(HACCP)planorotherfoodsafetyplan),ifany,anditsimplementation,forthehazardbeing
controlled(or,whenapplicable,anonsiteauditmayconsiderrelevantlawsandregulationsofacountrywhosefoodsafety
systemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates).
(c)(1)Thefollowingmaybesubstitutedforanonsiteaudit,providedthattheinspectionwasconductedwithin1year
ofthedatethattheonsiteauditwouldhavebeenrequiredtobeconducted:
(i)ThewrittenresultsofanappropriateinspectionofthesupplierforcompliancewithapplicableFDAfoodsafety
regulationsbyFDA,byrepresentativesofotherFederalAgencies(suchastheUnitedStatesDepartmentofAgriculture),
orbyrepresentativesofState,local,tribal,orterritorialagenciesor
(ii)Foraforeignsupplier,thewrittenresultsofaninspectionbyFDAorthefoodsafetyauthorityofacountrywhose
foodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnited
States.
(2)ForinspectionsconductedbythefoodsafetyauthorityofacountrywhosefoodsafetysystemFDAhasofficially
recognizedascomparableordeterminedtobeequivalent,thefoodthatisthesubjectoftheonsiteauditmustbewithin
thescopeoftheofficialrecognitionorequivalencedetermination,andtheforeignsuppliermustbein,andunderthe
regulatoryoversightof,suchcountry.
(d)Iftheonsiteauditissolelyconductedtomeettherequirementsofthissubpartbyanauditagentofacertification
bodythatisaccreditedinaccordancewithregulationsinpart1,subpartMofthischapter,theauditisnotsubjecttothe
requirementsinthoseregulations.
EDN:At80FR56145,Sept.17,2015,117.435wasadded,effectiveNov.16,2015,exceptforparagraph(d).
FDAwillpublishadocumentintheFRannouncingtheeffectivedateforthisparagraph.
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117.475Recordsdocumentingthesupplychainprogram.
(a)TherecordsdocumentingthesupplychainprogramaresubjecttotherequirementsofsubpartFofthispart.
(b)Thereceivingfacilitymustreviewtherecordslistedinparagraph(c)ofthissectioninaccordancewith117.165(a)
(4).
(c)Thereceivingfacilitymustdocumentthefollowinginrecordsasapplicabletoitssupplychainprogram:
(1)Thewrittensupplychainprogram
(2)Documentationthatareceivingfacilitythatisanimporterisincompliancewiththeforeignsupplierverification
programrequirementsunderpart1,subpartLofthischapter,includingdocumentationofverificationactivitiesconducted
under1.506(e)ofthischapter
(3)Documentationoftheapprovalofasupplier
(4)Writtenproceduresforreceivingrawmaterialsandotheringredients
(5)Documentationdemonstratinguseofthewrittenproceduresforreceivingrawmaterialsandotheringredients
(6)Documentationofthedeterminationoftheappropriatesupplierverificationactivitiesforrawmaterialsandother
ingredients
(7)Documentationoftheconductofanonsiteaudit.Thisdocumentationmustinclude:
(i)Thenameofthesuppliersubjecttotheonsiteaudit
(ii)Documentationofauditprocedures
(iii)Thedatestheauditwasconducted
(iv)Theconclusionsoftheaudit
(v)Correctiveactionstakeninresponsetosignificantdeficienciesidentifiedduringtheauditand
(vi)Documentationthattheauditwasconductedbyaqualifiedauditor
(8)Documentationofsamplingandtestingconductedasasupplierverificationactivity.Thisdocumentationmust
include:
(i)Identificationoftherawmaterialorotheringredienttested(includinglotnumber,asappropriate)andthenumberof
samplestested
(ii)Identificationofthetest(s)conducted,includingtheanalyticalmethod(s)used
(iii)Thedate(s)onwhichthetest(s)wereconductedandthedateofthereport
(iv)Theresultsofthetesting
(v)Correctiveactionstakeninresponsetodetectionofhazardsand
(vi)Informationidentifyingthelaboratoryconductingthetesting
(9)Documentationofthereviewofthesupplier'srelevantfoodsafetyrecords.Thisdocumentationmustinclude:
(i)Thenameofthesupplierwhoserecordswerereviewed
(ii)Thedate(s)ofreview
(iii)Thegeneralnatureoftherecordsreviewed
(iv)Theconclusionsofthereviewand
(v)Correctiveactionstakeninresponsetosignificantdeficienciesidentifiedduringthereview
(10)Documentationofotherappropriatesupplierverificationactivitiesbasedonthesupplierperformanceandtherisk
associatedwiththerawmaterialorotheringredient
(11)Documentationofanydeterminationthatverificationactivitiesotherthananonsiteaudit,and/orlessfrequent
onsiteauditingofasupplier,provideadequateassurancethatthehazardsarecontrolledwhenahazardinarawmaterial
orotheringredientwillbecontrolledbythesupplierandisoneforwhichthereisareasonableprobabilitythatexposureto
thehazardwillresultinseriousadversehealthconsequencesordeathtohumans
(12)Thefollowingdocumentationofanalternativeverificationactivityforasupplierthatisaqualifiedfacility:
(i)Thewrittenassurancethatthesupplierisaqualifiedfacilityasdefinedby117.3,beforeapprovingthesupplier
andonanannualbasisthereafterand
(ii)Thewrittenassurancethatthesupplierisproducingtherawmaterialorotheringredientincompliancewith
applicableFDAfoodsafetyregulations(or,whenapplicable,relevantlawsandregulationsofacountrywhosefoodsafety
systemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates)
(13)Thefollowingdocumentationofanalternativeverificationactivityforasupplierthatisafarmthatsuppliesaraw
materialorotheringredientandisnotacoveredfarmunderpart112ofthischapter:
(i)Thewrittenassurancethatsupplierisnotacoveredfarmunderpart112ofthischapterinaccordancewith
112.4(a),orinaccordancewith112.4(b)and112.5,beforeapprovingthesupplierandonanannualbasisthereafter
and
(ii)Thewrittenassurancethatthefarmacknowledgesthatitsfoodissubjecttosection402oftheFederalFood,Drug,
andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsandregulationsofacountrywhosefood
safetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnited
States)
(14)Thefollowingdocumentationofanalternativeverificationactivityforasupplierthatisashelleggproducerthatis
notsubjecttotherequirementsestablishedinpart118ofthischapterbecauseithaslessthan3,000layinghens:
(i)Thewrittenassurancethattheshelleggsprovidedbythesupplierarenotsubjecttopart118ofthischapter
becausethesupplierhaslessthan3,000layinghens,beforeapprovingthesupplierandonanannualbasisthereafter
and
(ii)Thewrittenassurancethattheshelleggproduceracknowledgesthatitsfoodissubjecttosection402ofthe
FederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsandregulationsofa
countrywhosesafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatof
theUnitedStates)
(15)ThewrittenresultsofanappropriateinspectionofthesupplierforcompliancewithapplicableFDAfoodsafety
regulationsbyFDA,byrepresentativesofotherFederalAgencies(suchastheUnitedStatesDepartmentofAgriculture),
orbyrepresentativesfromState,local,tribal,orterritorialagencies,orthefoodsafetyauthorityofanothercountrywhen
theresultsofsuchaninspectionissubstitutedforanonsiteaudit
(16)Documentationofactionstakenwithrespecttosuppliernonconformance
(17)Documentationofverificationofasupplychainappliedcontrolappliedbyanentityotherthanthereceiving
facility'ssupplierand
(18)Whenapplicable,documentationofthereceivingfacility'sreviewandassessmentof:
(i)Applicabledocumentationfromanentityotherthanthereceivingfacilitythatwrittenproceduresforreceivingraw
materialsandotheringredientsarebeingfollowed
(ii)Applicabledocumentation,fromanentityotherthanthereceivingfacility,ofthedeterminationoftheappropriate
supplierverificationactivitiesforrawmaterialsandotheringredients
(iii)Applicabledocumentation,fromanentityotherthanthereceivingfacility,ofconductingtheappropriatesupplier
verificationactivitiesforrawmaterialsandotheringredients
(iv)Applicabledocumentation,fromitssupplier,of:
(A)Theresultsofsamplingandtestingconductedbythesupplieror
(B)Theresultsofanauditconductedbyathirdpartyqualifiedauditorinaccordancewith117.430(f)and117.435
and
(v)Applicabledocumentation,fromanentityotherthanthereceivingfacility,ofverificationactivitieswhenasupply
chainappliedcontrolisappliedbyanentityotherthanthereceivingfacility'ssupplier.
EDN:At80FR56145,Sept.17,2015,117.475wasadded,effectiveNov.16,2015,exceptforparagraphs
(c)(2).FDAwillpublishadocumentintheFRannouncingtheeffectivedatefortheseparagraphs.
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