SummaryofChangesIntheFDAFood

Code2013
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ThisSummaryprovidesasynopsisofthetextualchangesfromthe2009FDAFoodCodeandtheSupplementto
the2009FoodCodeChaptersandAnnexestothe2013edition.Theprimaryintentofthisrecordistocapturethe
natureofthechangesratherthantoidentifyeverywordoreditingchange.Thisrecordshouldnotberelied
uponasanabsolutecomparisonthatidentifieseachandeverychange.

General

Numerouseditingchangesweremadethroughoutthedocumentforinternalconsistency,tocorrectsome
errorsinthe2009Codeandforclarification.
Sectionandparagraphnumberslistedrefertothe2009CodeanditsSupplementunlessotherwisenoted.The
numberingsystemwasremovedfromChapter1definitionsinthe2005versionofthisCode.Anexplanation
regardingtherationalecanbefoundinAnnex3,1201.10(B).
UpdatedtheweblinksthroughouttheCodeandAnnexes.
ConvertedseveralTables,charts,andimagesthroughouttheCodetomeetwebaccessibilityrequirements
underSection508oftheRehabilitationActof1973(29U.S.C.794d).Section508mandatesthatallfederal
agencieseliminatethebarriersinaccessingelectronicandinformationtechnology.

Preface
AmendedPrefacesections1,3,5,6,and8toaddupdatedinformationandrevisedatestomakecurrent.

Chapter1PurposeandDefinitions
DeletedEnterohemorrhagicEscherichiacoli(EHEC)asuseofEHECterminologyisoutdated.

AmendedPackagedin(1)todeletethetermsecurelytoavoidundueemphasisonnatureofthepackage
Amended"Packaged"in(2)toremovethephraseorothernondurablecontainertoclarifywhenfoods
packagedatretailneedtobelabeledsothatitreads:"Packaged"doesnotincludewrappedorplacedinacarry
outcontainertoprotectthefoodduringserviceordeliverytotheconsumer,byafoodemployee,uponconsumer
request.

DeletedthetermPotentiallyHazardousFood(Time/TemperatureControlforSafetyFood)(PHF/TCS)and
madeauniversalchangethroughouttheCodetoreplaceitwiththetermTime/TemperatureControlforSafety
Food(TCS).Thedefinitionremainsthesame.
RevisedReducedOxygenPackagingsubparagraph(2)(e),todeletethephraseplacedinahermetically
sealed,impermeablebagandreplaceitwithvacuumpackagedinanimpermeablebagsoitclearlydefinesthe
sousvideprocessasoutlinedinAnnex6(2)(B)(4)(b).Itnowreads:Sousvidepackaging,inwhichraworpartially
cookedfoodisvacuumpackagedinanimpermeablebag,cookedinthebag,rapidlychilled,andrefrigeratedat
temperaturesthatinhibitthegrowthofpsychrotrophicpathogens.

Revised"ShigatoxinproducingEscherichiacoli"(STEC)toreflectcurrentnomenclature.

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Chapter2ManagementandPersonnel
2201.11,2201.12,2201.13

AmendedtoaddnontyphoidalSalmonella(NTS)asoneofthereportableillnessesforactionbythePersonin
ChargeAddedCodelanguagetoaddressemployeehealthcontrolsfortheexclusionandrestrictionof
nontyphoidalSalmonella,andremovalofexclusionandrestrictionfromNTS.

2301.14(H)

Amendedtoclarifythattherequirementtowashhandsbeforedonningglovesisspecifictothebeginningofatask
involvingworkingwithfoodandnotduringthetask.

2301.16(A)(2)

Amendedtoremove(A)(2)(b)(iii)andaddnewsubparagraphs(A)(2)(be)toclarifyandalignthecodifiedtextwith
applicableCFRsandtheFD&CActwithregardtotheuseofhandantisepticsasafoodadditive.

Chapter3Food
3201.16(A)

Amendedtoremoveexisting2009(A)languageinreserveAddednew(A)torecognizearegulatoryauthoritys
abilitytoapprovethesaleofwildmushroomswithinafoodestablishmentandregulatewildmushroomsaccording
totheirLAW.

3301.11(D)

Amendedtorevisesubparagraph(D)(2)toclarifythatParagraph(B)doesnotapplywhereareadytoeatfoodis
addedasaningredienttoanotherfoodthatdoesnotcontainarawanimalfoodandthecombinedproductwillbe
heatedtoatleast63C(145F).

3302.11

Amendedtoremovesubparagraph(A)(3)andrenumberedtheremainingparagraphsas(4)(8).

3304.11

Amendedtoaddanew(C)toclarifythatfoodmaycontactsurfacesoflinensandnapkinsasspecifiedin3
304.13andaddedtermLinenstothetagline.

3304.13

Amendedtoclarifythatnapkinsinthissectionreferstoclothnapkinsandtheyarebydefinitionconsideredlinens.

3304.17
Amendedtorelocatetherequirementregardingthecleaningofreturnablesintothissectionfrom4603.17.

Amended3304.17(A)toclarifyconditionsunderwhichthereuseofreturnablesarepermitted.

Amended3304.17(B)toestablishconditionsunderwhichrefillingofreturnabletakehomecontainersis
permitted.

Amendedtorelocatetheexceptionforfillingafoodspecificcontainerwithabeveragefrom4603.17(B)to3
304.17(C).

Amendedtorenumber3304.17(C)asanew3304.17(D).

Amendedtorelocatetheexceptionforfillingconsumerowned,personaltakeoutcontainersthatarenotfood
specificfrom4603.17(C)to3304.17(E).

3401.14

Amendedtorevise(D)toclarifythatpriortosaleorservice,rawanimalfoodscookedusinganoncontinuous
cookingprocessshallbecookedtoatemperatureandforatimeasspecifiedunder3401.11(A)(C).

3402.11

Amended3402.11(B)toaddanew(2)toclarifythatscallopproductsconsistingsolelyoftheshuckedadductor
muscleareexcludedfromtherequirementsforparasitedestructionandredesignatedexisting(2)(4)tobenew
(3)(5).

3403.11

Amended3403.11(C)toclarifythatthisprovisionappliestoallcommerciallyprocessedTCSfoodsthatare
readytoeat.Previoustextsuggestedthatitappliedonlyimmediatelyuponremovalofthefoodfromasealed
container.

3501.13

Amendedtoaddnew(E)specifyingfrozenfishpackagedusingaROPmethodberemovedfromtheROP
environmenteitherpriortoinitiatingthawingproceduresunderrefrigerationasspecifiedin(A)orpriorto,or
immediatelyuponcompletionof,itsthawingusingproceduresspecifiedin(B)ofthissection.

3501.17

Amendedtoaddnew(F)thatexemptsraw,liveinshellmolluscanshellfishfromdatemarkingandredesignated
former(F)asnew(G).

Amendedexistingsubparagraph3501.17(F)(6)toclarifythattheexemptionfromdatemarkingforshelfstable
dryfermentedsausagesproducedinUSDAregulatedfacilitiesisnotdependentontheproductretainingthe
originalcasingRenumberedexisting(F)(6)asnew(G)(6)asaresultoftheadditionofnew(F).

3502.11

Amendedtorevise(D)tomakeclearthatonlyTCSfoodspreparedunderROPmethodsthatdonotcontrolfor
growthofandtoxinformationbyClostridiumbotulinumandthegrowthofListeriamonocytogenesrequirea
variance.

3502.12

Amended3502.12(B),(D),and(E)leadinparagraphstoreferencenew(F)ofthissection.
Amended3502.12(B)leadinparagraphandsubparagraphs(B)(6)(c),(D)(1),and(E)(2)toreference8
201.14(B)alongwithexistingreferenceto(D).

Amendedsubparagraphs3502.12(B)(3)(b)and(B)(4)todelete14daysandadd30days.

Amended3502.12(B)toaddnewsubparagraph7specifyingthataHACCPplanbeprovidedtotheregulatory
authoritypriortoimplementation.

Amended3502.12(D)leadinparagraphtodeletethewordFOODandreplaceitwiththeterm
Time/TemperaturecontrolforsafetyfoodtoclarifythatthissectionappliestoTCSfood.

Amendedsubparagraph3502.12(D)(2)(b)tospecifyonlythecookingparametersin3401.11(A),(B)and(C)
apply.

Amendedsubparagraph3502.12(D)(2)(e)(ii)toallowforcoldholdingat41Ffor7daysaftercoolingto41F.

Amendedtodeleteexistingsubparagraph3502.12(D)(2)(e)(iii)andamendedsubparagraph3502.12(D)(2)(e)(iv)
torenumberitasthenewsubparagraph(D)(2)(e)(iii).

Amendedtoaddnew(F)toidentifytheconditionsunderwhichaHACCPPlanisnotrequiredforROPTCS
foods.

3602.11

Amended3602.11(B)(2),(3),(5),and(7)toclarifytheinformationthatalabelshouldinclude.

Amendedsubparagraph3602.11(B)(2)toclarifywhatinformationmustbeincludedinthestatementof
ingredients.Thetermsubingredientswasaddedtothissubparagraphtoclarifythatindividualcomponent
ingredientsofamainingredientmustbedisclosedinthestatementofingredients.Thisclarificationhelpstomake
clearthatallindividualingredientsinapackagedfoodwillbedisclosedinthestatementofingredients.

Amendedsubparagraph3602.11(C)(2)toremovecrossreferencetosubparagraph(B)(5)tocorrectlyreferto
whatalabelingdevicesuchasacard,sign,orothermethodofnotificationneedstodeclare.Thischangecorrects
aninadvertenterrorthatwascreatedinthe2005FoodCodewhenanewsubparagraph(B)(5)forfoodallergens
wasaddedandthesubparagraphfornutritionallabelingwasrenumberedto(B)(6),buttheaccompanyingcross
referencein(C)(2)wasnotchangedtocorrectlycrossreference(B)(1),(2),and(6),nutritionallabeling.

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Chapter4Equipment,Utensils,andLinens
4302.13

Amendedthetaglinetoaddmechanicalwarewashing

Amendedtoredesignatetheexistingsectioninto(A)andnew(B)torequiretheavailabilityofirreversible
registeringtemperatureindicators.

4602.11

Amended4602.11(B)tochangethecleaningandsanitizingfrequencyforfoodcontactsurfacesorutensilsthat
areincontactwitharawanimalfoodthatisamajorfoodallergensuchasfish,followedbyothertypesofraw
animalfoods.Withthischange,theexceptiontoexistingsubparagraph(A)(1)foundin(B)nowappliesonlyto
rawmeatandpoultry.

4603.17
Amendedtodelete4603.17andrelocateitsrequirementsinto3304.17.

4802.11

Amended4802.11(C)toclarifythatnapkinsinthissectionreferstoclothnapkinsandtheyarebydefinition
consideredlinensasmentionedin3304.11(C)and3304.13.

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Chapter5Water,Plumbing,andWaste
NoChanges.

Chapter6PhysicalFacilities
NoChanges.

Chapter7PoisonousorToxicMaterials
7204.12

Amended7204.12(A)toredesignate(A)intoaleadinparagraphwithfournewsubparagraphs:Added21
CFR173SecondaryDirectFoodAdditivesPermittedinFoodforHumanConsumptionasnewsubparagraph(A)
(1)AddedGRASingredientsasnewsubparagraph(A)(2)Addedeffectivefoodcontactnotificationsasnew
subparagraph(A)(3)Added40CFR156LabelingRequirementsforPesticidesandDevicesasnew
subparagraph(A)(4)toallowtheuseofotherantimicrobialagentsallowedunderthefoodcontactnotification
programforwashingfruitsandvegetablesaswellasGRASingredientspermittedasantimicrobialsorforgeneral
fooduse.

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Chapter8ComplianceandEnforcement
8201.13

Amended8201.13(B)toaddnewlanguagetohavethefoodestablishmentnotifytheRegulatoryAuthority
throughsubmissionofaHACCPplanthattheywillbeconductingROPoperationsthatconformwithprocedures
in3502.12.

8304.11

Amendedtoaddnew(K)toincludearequirementforthepermitholdertopostasignorplacardnotifyingthe
publicthatinspectionalinformationisavailableforreview.

Annex1ComplianceandEnforcement
NoChanges.

Annex2References
Preface

Amendedtoredesignatenumbersandalphabetize.

2201.12and2201.13
Amendedtoupdatethreereferencesandaddtwentynewreferencesinsupportofincludingpublichealthcontrols
forthecontrolofnontyphoidalSalmonella(NTS)inretailfoodestablishmentsreferencesrenumberedtokeep
alphabeticalformat.

3401.11

Amendedtoredesignatenumbersandalphabetize.

3402.11

Amendedtoaddonenewreference(#6),theFishandFisheryProductsHazardsandControlsGuidance,4th
Edition,April2011,andrenumberedremainingreferences.

3502.12

Amendedtoaddtwonewreferences(#24,and#28)andrenumberedtheremainingreferences.Thenew
referencesareregardingtimetoformationofC.botulinumtoxin.ThesereferencesprovidesupportofthepHof5
limitforthepsychrotrophicstrainsofC.botulinumduetoCodechangestoallowa7daystorageforROPat41F
anda30dayholdforvacuumpackagingandCookChill/SousVideoffoodswithapHof5orless.

4603.17

Amendedtomovereferencefordeleted4603.17tobeunder3304.17sincethetwosectionsweremerged
into3304.17.

6501.111

Amendedtoaddnewreferenceinsupportofthissectiononcontrollingpests.

7204.12

Amendedtoaddnewreferencetoinclude21CFR173.405,SecondaryDirectFoodAdditivesPermittedinFood
forHumanConsumptionSodiumDodecylbenzenesulfonate.

3.SupportingDocuments

AmendedsectionK.GuidanceforRetailFacilitiesRegardingBeefGrindingLogsTrackingSupplier
Information,toupdatewithcurrentUSDA/FSISinformationanddocuments.Theupdateincludesdeleting
existingparagraphs5and6andaddingnewparagraphs5and6Updatedotherexistingparagraphswitheditorial
changes.

Amendedtoaddnewsection,S.CIFORTheCounciltoImproveFoodborneOutbreakResponse(CIFOR)
GuidelinesforFoodborneOutbreakResponse.

Amendedtoaddnewsection,T.CIFORFoodborneIllnessResponseGuidelinesforOwners,Operators,
andManagersofFoodEstablishments(CIFORIndustryGuidelines).

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Annex3PublicHealthReasons/AdministrativeGuidelines
1201.10

Packaged.
AmendedtoaddasectiononPackagedtoclarifywhenfoodspackagedatretailneednotbelabeledandplaced
thetextaftertheFoodEstablishmentandafoodprocessingplantlocatedwithinthesamepremisesofafood
establishmentsectionandbeforetheTCSsection.

22EmployeeHealth

AmendedtoaddadescriptionofnontyphoidalSalmonellabetweenthedescriptionsofNorovirusandSalmonella
Typhi.

AmendedPart22anditsrelatedsubpartsandTables/DecisionTreestobeconsistentwiththechangesin
Chapter2TablesandDecisiontreeswererevisedtomeetaccessibilityrequirementsforwebposting.

AmendedtoupdatethelistofPathogensTransmittedbyFoodContaminatedbyInfectedPersonsWhoHandle
Food,andModesofTransmissionofSuchPathogensfromCDC,effectiveNovember30,2012.

Amendedthepathogendescriptionsinsubpart2201.11tobeconsistentwiththeBadBugBook,2ndEdition,
2012.

2301.14

Amendedtoclarifythatsubparagraph2301.14(H)requireshandwashingimmediatelybefore,during,and
immediatelyafter,theactivitieslisted.

2301.16

AmendedtheAsaFoodAdditiveSectiontoaddanewparagraph4toelaborateonthepriorsanction
requirementsunderthefoodadditiveprovisionintheFederalFood,DrugandCosmeticActasitrelatestothe
substancesinahandantisepticreasonablyexpectedtobecomeacomponentoffoodbasedupontheproducts
intendeduseRenumberedtheexistingparagraph4asanewparagraph5.

3201.11

AmendedtorelocateinformationaboutsafefoodhandlinglabelinstructionsfromAnnex3,3602.11toAnnex3
3201.11.

3201.16

Amendedtodeletelastsentenceinparagraph2reviseparagraph3addnewparagraphs45anddeleteexisting
paragraphs48.

3302.11

Amendedtoremoveparagraph3tobeconsistentwithchangetodeletesubparagraph3302.11(A)(3).

3304.17

Amendedtodescribethepublichealthreasonsforinclusionofanexceptionforreusingandrefillingreturnedtake
homecontainerswithTCSornonTCSfoodRelocatedPHRtextfrom4603.17to3304.17.

3401.14

Amendedtoreviseparagraph6toclarifythatduringthefinalcookingstep,rawanimalfoodscookedusinganon
continuouscookingprocessshallbecookedtoatemperatureandforatimeasspecifiedunder3401.11(A)
(C).

3402.11
Amendedtoupdateparagraph6tobeconsistentwiththeFishandFisheriesProductsHazardsandControls
Guidance,Fourthedition.

Amendedtoaddnewparagraph8toexplainwhytherequirementsforparasitedestructiondonotapplyto
molluscanshellfishandscallopproductsconsistingsolelyoftheshuckedadductormuscle.

3403.11

Amendedtoaddanewparagraph4toprovidethepublichealthreasonforrequiringareheatingtemperaturefor
commerciallyprocessedfoodsthatislowerthanthatforfoodspreparedinthefoodestablishment.

3501.13

AmendedtoaddthreenewparagraphstoaddresstheremovalofROPfrozenfishfromitspackagingbefore
thawingtopreventC.botulinumtoxinformation.

3501.17

AmendedtoremovePHFfromtheTaglinesoitreferencesonlyTCSfood.

Amendedtoaddanewparagraph#13underanewsubheadingShellstockaspublichealthrationalefor
exemptingshellstockfromdatemarking.

Amendedparagraph4undersubheadingofUSDAregulatedproductstoclarifythattheexemptionfromdate
markingforshelfstabledryfermentedsausagesproducedinUSDAregulatedfacilitiesisnotdependentonthe
productretainingtheoriginalcasing.

3502.11

AmendedwithaneditorialchangetomakeacorrectioninthetitleofChart1toaccuratelycrossreference3
502.11ratherthan3501.11.

3502.12

Amendedtheentireannexsectiontoreorganizetheinformationaccordingtodifferentconceptspresentedinthe
Annex,addedsubheadings,andrevisedcertaintextwithintheexistingparagraphs,suchthatchangesare:

Intheintroductoryparagraphs,
amendedparagraph1toaddinformationaboutsafetyconcernswhenspoilageorganismsareinhibited,and
amendedparagraph2todeleteinformationaboutoxygentransferrateandaddinformationaboutother
waysoxygenisrestrictednotjustbythepackaging.
Amendedtextunderthenewsubheading,ROPwithTwoBarriers,
inparagraph2,toprovideexamplesoffoodsthathavehighlevelsofcompetingorganismsandexplained
whytherefrigeratedshelflifetimewasincreasedfrom14calendardaysto30calendardaysforvacuum
packagedROPfood,and
inparagraph3,toaddressnontime/temperaturecontrolforsafetyfoodexplainingwhythesefoodsdonot
requireavarianceorHACCPPlanforROP.
Amendedthefirstsentenceinparagraph1underthenewsubheading,ROPandCheese,toremoveNaturally
fermentedatthestartofthesentence.
Amendedtextunderthenewsubheading,ROPwithOneBarrier(CookChillandSousVide),
inparagraph1tochangethefouroptionstothreeoptionsforinhibitinggrowthforcook/chill,sousvide
processing,and
 inparagraph2,tochangethe38Fcoldholdingtemperaturenotedto41F,tobeconsistentwiththe
changesmadeinsubparagraph3502.12(D)(2)(e).Amendedtextunderthenewsubheading,The
RelationshipBetweenTimeandROP,toaddnewtextthatprovidesinformationregardingshorttermROP
storageandexemptionfromaHACCPPlan.
Amendedtextunderthenewsubheading,HACCPPlanswithROP,
inparagraph1toaddinformationonsubmittingaHACCPPlantotheregulatoryauthority,and
inparagraph2toclarifyinformationforwhenanoperatorsubmitsanapplicationforavariance.
Amendedtextunderthenewsubheading,ROPwithFish,forinternalconsistency.

3602.11

Amendedtoreorganizetheentirepublichealthreasonsandincludenewsubheadingtitlesremovedoutdated
informationfromthefoodallergenlabelingsubsectionincludedinformationaboutastaxanthin,acoloradditive
usedinsalmonidfishunderitsnewsubheadingNewcrossreferencecreatedin3602.11todirectthereaderto
3201.11underthenewsafehandlinginstructionssubheading.

Amendedtoclarifywhyfoodheldunderthedirectcontroloftheoperatorisexemptfromthelabelingrequirements
in3602.11,whilefoodenclosedinacontainerorwrappingandplacedondisplayforconsumerselfserviceis
subjecttothelabelingrequirementsunder3602.11.

Addedpublichealthrationaletoexplaintheimportanceofhavinganaccuratelistoffoodingredientsonthe
label.Twoexampleswereprovidedtoillustratethemethodthatfoodestablishmentsmayusetolisttheingredients
onthelabel.

4101.15

Amendedparagraph1andaddednewparagraph2toaddinformationaboutzincandzincpoisoning

4302.13

Amendedtochangethetaglineandtoaddanewparagraph2withthepublichealthrationaleforthenew4
302.13(B).

4602.11

Amendedtoaddnewparagraphs5and6toclarifythatfoodcontactsurfacesofequipmentandutensilsthathave
contactedarawanimalfoodthatisamajorfoodallergensuchasrawfishmustbecleanedandsanitizedpriorto
contactingdifferenttypesofrawanimalfoods.

4603.17

RemovedAnnex3,4603.17andrelocatedthepublichealthreasonstextfrom4603.17to3304.17.

7204.12

Amendedtoupdateweblinkinparagraph1,reviseparagraph3andaddanewparagraph4thatspeaksto
allowingfoodadditivesandfoodcontactsubstancesaswellassubstancesgenerallyrecognizedassafe(GRAS)
thatarepermittedunderFDAsregulationsforwashingfruitsandvegetables.

8304.11

Amendedtoaddnewpublichealthreasonstoexplaintheintentofaddinginnew(K)arequirementtoposta
sign/placardnotifyingthepublicthatinspectionalinformationisavailableforreview.

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