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3/24/2017 FoodSafetyModernizationAct(FSMA)>FSMAFinalRuleonProduceSafety

FSMAFinalRuleonProduceSafety
StandardsfortheGrowing,Harvesting,Packing,andHoldingofProducefor
HumanConsumption
ProduceSafetyStandardsundertheFSMAMainPage(/Food/GuidanceRegulation/FSMA/ucm304045.htm)

ViewtheFinalRuleContentsintheFederalRegisterNotice
(https://www.federalregister.gov/articles/2015/11/27/201528159/standardsforthegrowingharvesting
packingandholdingofproduceforhumanconsumption)
BelowisafactsheetprovidedbyFDA.

AbouttheFinalRule
FederalRegisterNotice(https://www.federalregister.gov/articles/2015/11/27/201528159/standardsforthegrowing
harvestingpackingandholdingofproduceforhumanconsumption)
DocketFolderFDA2011N0921(http://www.regulations.gov/#!docketDetailD=FDA2011N0921)
Questions&Answers(/Food/GuidanceRegulation/FSMA/ucm247559.htm#Produce_Rule)
CoverageandExemptions/ExclusionsFlowchart(ColorPDF:95KB)
(/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf)
CoverageandExemptions/ExclusionsFlowchart(Black&WhitePDF:67KB)
(/downloads/Food/GuidanceRegulation/FSMA/UCM479592.pdf)
HowDidFDAEstablishRequirementsforWaterQualityandTestingofIrrigationWater?
(/Food/GuidanceRegulation/FSMA/ucm472501.htm)
WhattheProduceSafetyRuleMeansforConsumers(/Food/GuidanceRegulation/FSMA/ucm472503.htm)
PrintFriendlyFactSheet(PDF:405KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM472887.pdf)

RelatedGuidance
DraftGuidanceforIndustry:CompliancewithandRecommendationsforImplementationoftheStandardsforthe
Growing,Harvesting,Packing,andHoldingofProduceforHumanConsumptionforSproutOperations
(/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm510578.htm)
DraftGuidanceforIndustry:DescribingaHazardThatNeedsControlinDocumentsAccompanyingtheFood,as
RequiredbyFourRulesImplementingFSMA
(/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm524553.htm)

PublicMeetings&Webinars
WebinarontheFinalRule(/Food/GuidanceRegulation/FSMA/ucm471649.htm)November2015

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SupplementalNoticesofProposedRulemaking(/Food/GuidanceRegulation/FSMA/ucm418878.htm)November13,
2014
EnvironmentalImpactStatementfortheProposedRule(/Food/GuidanceRegulation/FSMA/ucm428460.htm)February
10,2015

SupportingMaterial
5StepsTowardWorkingwithFDAonHumanandAnimalFoodGuidanceDocuments
(/Food/GuidanceRegulation/FSMA/ucm538623.htm)
CaseStudy:FoodSafetyGuidelinesforCantaloupes(/Food/GuidanceRegulation/FSMA/ucm538601.htm)
FDAConsideringSimplifyingAgriculturalWaterStandards(/Food/GuidanceRegulation/FSMA/ucm546089.htm)
FinalEnvironmentalImpactStatement(EIS)(/Food/GuidanceRegulation/FSMA/ucm396564.htm)
FinalRegulatoryImpactAnalysis(/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm472310.htm)
RecordofDecision(/downloads/Food/GuidanceRegulation/FSMA/UCM470746.pdf)
AdditionalInformationonRawManure(/Food/GuidanceRegulation/FSMA/ucm482426.htm)
TestingMethodologiesforE.coliO157:H7andSalmonellaspeciesinSpentSproutIrrigationWater(orSprouts)
(PDF:622KB)(/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM467055.pdf)
TestingMethodologyforListeriaspeciesorL.monocytogenesinEnvironmentalSamples(PDF:109KB)
(/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM467056.pdf)
FinalQualitativeAssessmentofRisktoPublicHealthFromOnFarmContaminationofProduce(PDF:986KB)
(/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM470780.pdf)

AdditionalInformation
AudiooftheIndustryCallConcerningtheFinalRuleNovember13,2015(MP3:12MB)
(/downloads/Food/GuidanceRegulation/FSMA/UCM473502.mp3)
ConstituentUpdate:FDAProvides$21.8MilliontoStatesforProduceSafety
(/Food/NewsEvents/ConstituentUpdates/ucm519760.htm)
ConstituentUpdate:HowtoWorkwithFDAonFoodGuidanceDocuments
(/Food/NewsEvents/ConstituentUpdates/ucm538434.htm)
TranscriptoftheIndustryCallConcerningtheFinalRuleNovember13,2015(PDF:109KB)
(/downloads/Food/GuidanceRegulation/FSMA/UCM473503.pdf)
ConstituentUpdate:FDAReleasesGroundbreakingRulesonProduceandImportedFoodstoModernizeand
StrengthenFoodSafetySystem(/Food/NewsEvents/ConstituentUpdates/ucm472505.htm)
ConsumerUpdate:5WaysNewFDARulesWillMakeYourFoodsSafer
(/ForConsumers/ConsumerUpdates/ucm459072.htm)
SproutSafetyAlliance(/Food/GuidanceRegulation/FSMA/ucm293429.htm)
ProduceSafetyAlliance(http://producesafetyalliance.cornell.edu/)
(http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
VideoBlog:ComingTogethertoTalkAboutFSMA(http://blogs.fda.gov/fdavoice/index.php/2015/06/coming
togethertotalkaboutfsma/)

ContactUs
HowtoContactFDAaboutFSMA(/Food/GuidanceRegulation/FSMA/ucm459719.htm)(TechnicalAssistanceNetwork)

TranslationsofthisFactSheet
Arabic(PDF:218KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480534.pdf)

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm 2/9
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Chinese(Simplified)(PDF:358KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480536.pdf)
Chinese(Traditional)(PDF:515KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM482189.pdf)
French(PDF:143KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480538.pdf)
FrenchExemptions/ExclusionsFlowchart(PDF:75KB)
(/downloads/Food/GuidanceRegulation/FSMA/UCM487250.pdf)
FrenchExemptionsandVariance(PDF:74KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM490299.pdf)
Hindi(PDF:211KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480540.pdf)
Italian(PDF:159KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480543.pdf)
Japanese(PDF:566KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480544.pdf)
Korean(PDF:317KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480545.pdf)
Portuguese(PDF:163KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480546.pdf)
Russian(PDF:206KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480547.pdf)
Spanish(PDF:74KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480548.pdf)
SpanishExemptions/ExclusionsFlowchart(PDF:75KB)
(/downloads/Food/GuidanceRegulation/FSMA/UCM487283.pdf)
SpanishExemptionsandVariance(PDF:74KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM490298.pdf)
Thai(PDF:304KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM480549.pdf)

Inthisfactsheet:

Introduction
KeyRequirements
Exemptions
Variances
ComplianceDates
EnvironmentalImpactStatement
AssistancetoIndustry

Introduction
TheFDAFoodSafetyModernizationAct(FSMA)ProduceSafetyruleisnowfinal,andtheearliestcompliancedates
forsomefarmsbeginoneyearaftertheeffectivedateofthefinalrule(seeComplianceDatesbelow).Therule
establishes,forthefirsttime,sciencebasedminimumstandardsforthesafegrowing,harvesting,packing,andholding
offruitsandvegetablesgrownforhumanconsumption.

ThisrulewasfirstproposedinJanuary2013.Inresponsetoinputreceivedduringthecommentperiodandduring
numerouspublicengagementsthatincludedpublicmeetings,webinars,listeningsessions,andvisitstofarmsacrossthe
country,theFDAissuedasupplementalnoticeofproposedrulemakinginSeptember2014.Theproposedrevisions
weredesignedtomaketheoriginallyproposedrulemorepractical,flexible,andeffective.

Thefinalruleisacombinationoftheoriginalproposalandrevisionsoutlinedinthesupplementalproposal,with
additionalchangesasappropriate.ThedefinitionoffarmandrelatedtermswererevisedinthefinalPreventive
ControlsforHumanFoodrule(/Food/GuidanceRegulation/FSMA/ucm334115.htm),andthesamedefinitionsof

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thosetermsareusedinthisruletoestablishproducesafetystandards.Operationswhoseonlyactivitiesarewithinthe
farmdefinitionarenotrequiredtoregisterwithFDAasfoodfacilitiesandthusarenotsubjecttothepreventivecontrols
regulations.

Foroperationsthatmeetthefarmdefinition,exemptionsandmodifiedrequirementsfortheProduceSafetyare
explainedinExemptionsandVariancesandintheCoverageandExemptions/Exclusionsflowchart(PDF:
95KB)(/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf).

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KeyRequirements
1.AgriculturalWater

Waterquality:Thefinalruleadoptsthegeneralapproachtowaterqualityproposedinthesupplementalrule,with
somechanges.Thefinalruleestablishestwosetsofcriteriaformicrobialwaterquality,bothofwhicharebasedon
thepresenceofgenericE.coli,whichcanindicatethepresenceoffecalcontamination.
NodetectablegenericE.coliareallowedforcertainusesofagriculturalwaterinwhichitisreasonablylikelythat
potentiallydangerousmicrobes,ifpresent,wouldbetransferredtoproducethroughdirectorindirectcontact.
Examplesincludewaterusedforwashinghandsduringandafterharvest,waterusedonfoodcontactsurfaces,
waterusedtodirectlycontactproduce(includingtomakeice)duringorafterharvest,andwaterusedforsprout
irrigation.Theruleestablishesthatsuchwaterusemustbeimmediatelydiscontinuedandcorrectiveactionstaken
beforereuseforanyofthesepurposesifgenericE.coliisdetected.Theruleprohibitsuseofuntreatedsurface
waterforanyofthesepurposes.
Thesecondsetofnumericalcriteriaisforagriculturalwaterthatisdirectlyappliedtogrowingproduce(otherthan
sprouts).Thecriteriaarebasedontwovalues,thegeometricmean(GM)andthestatisticalthreshold(STV).The
GMofsamplesis126orlessCFUofgenericE.coliper100mLofwaterandtheSTVofsamplesis410CFUor
lessofgenericE.coliin100mLofwater.
TheGMisanaverage,andthereforerepresentswhatiscalledthecentraltendencyofthewaterquality
(essentially,theaverageamountofgenericE.coliinawatersource).
STVreflectstheamountofvariabilityinthewaterquality(indicatingE.colilevelswhenadverseconditions
comeintoplaylikerainfallorahighriverstagethatcanwashwasteintoriversandcanals).Althoughthisis
anoversimplification,itcanbedescribedasthelevelatwhich90percentofthesamplesarebelowthevalue.
TheFDAisexploringthedevelopmentofanonlinetoolthatfarmscanusetoinputtheirwatersampledataand
calculatethesevalues.
ThesecriteriaaccountforvariabilityinthedataandallowforoccasionalhighreadingsofgenericE.coliin
appropriatecontext,makingitmuchlesslikely(ascomparedtotheoriginallyproposedcriteriaforthiswater
use)thatafarmwillhavetodiscontinueuseofitswatersourceduetosmallfluctuationsinwaterquality.
Thesecriteriaareintendedasawatermanagementtoolforuseinunderstandingthemicrobialqualityof
agriculturalwaterovertimeanddeterminingalongtermstrategyforuseofwatersourcesduringgrowing
produceotherthansprouts.
Ifthewaterdoesnotmeetthesecriteria,correctiveactionsarerequiredassoonasispracticable,butnolater
thanthefollowingyear.Farmerswithagriculturalwaterthatdoesnotinitiallymeetthemicrobialcriteriahave
additionalflexibilitybywhichtheycanmeetthecriteriaandthenbeabletousethewaterontheircrops.These
optionsinclude,forexample:
Allowingtimeforpotentiallydangerousmicrobestodieoffonthefieldbyusingacertaintimeintervalbetween
lastirrigationandharvest,butnomorethanfourconsecutivedays.

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Allowingtimeforpotentiallydangerousmicrobestodieoffbetweenharvestandendofstorage,ortobe
removedduringcommercialactivitiessuchaswashing,withinappropriatelimits.
Treatingthewater.
Testing:Thefinalruleadoptsthegeneralapproachtotestinguntreatedwaterusedforcertainpurposesproposedin
thesupplementalnotice,withsomechanges.Therulestillbasestestingfrequencyonthetypeofwatersource(i.e.
surfaceorgroundwater).
Intestinguntreatedsurfacewaterconsideredthemostvulnerabletoexternalinfluencesthatisdirectlyapplied
togrowingproduce(otherthansprouts),theFDArequiresfarmstodoaninitialsurvey,usingaminimumof20
samples,collectedascloseasispracticabletoharvestoverthecourseoftwotofouryears.Theinitialsurvey
findingsareusedtocalculatetheGMandSTV(thesetwofiguresarereferredtoasthemicrobialwaterquality
profile)anddetermineifthewatermeetstherequiredmicrobialqualitycriteria.
Aftertheinitialsurveyhasbeenconducted,anannualsurveyofaminimumoffivesamplesperyearis
requiredtoupdatethecalculationsofGMandSTV.
Thefivenewsamples,plusthepreviousmostrecent15samples,createarollingdatasetof20samplesforuse
inconfirmingthatthatthewaterisstillusedappropriatelybyrecalculatingtheGMandSTV.
Foruntreatedgroundwaterthatisdirectlyappliedtogrowingproduce(otherthansprouts),theFDArequires
farmstodoaninitialsurvey,usingaminimumoffoursamples,collectedascloseasispracticabletoharvest,
duringthegrowingseasonoroveraperiodofoneyear.TheinitialsurveyfindingsareusedtocalculatetheGM
andSTVanddetermineifthewatermeetstherequiredmicrobialqualitycriteria.
Aftertheinitialsurveyhasbeenconducted,anannualsurveyofaminimumofonesampleperyearisrequired
toupdatethecalculationsofGMandSTV.
Thenewsample,plusthepreviousmostrecentthreesamples,createarollingdatasetoffoursamplesforuse
inconfirmingthatthatthewaterisstillusedappropriatelybyrecalculatingtheGMandSTV.
ForuntreatedgroundwaterthatisusedforthepurposesforwhichnodetectablegenericE.coliisallowed,the
FDArequiresfarmstoinitiallytesttheuntreatedgroundwateratleastfourtimesduringthegrowingseasonor
overaperiodofoneyear.Farmsmustdeterminewhetherthewatercanbeusedforthatpurposebasedonthese
results.
IfthefourinitialsampleresultsmeetthenodetectablegenericE.colicriterion,testingcanbedoneonce
annuallythereafter,usingaminimumofonesample.Farmsmustresumetestingatleastfourtimesper
growingseasonoryearifanyannualtestfailstomeetthemicrobialqualitycriterion.
Thereisnorequirementtotestagriculturalwaterthatisreceivedfrompublicwatersystemsorsuppliesthatmeet
requirementsestablishedintherule(providedthatthefarmhasPublicWaterSystemresultsorcertificatesof
compliancedemonstratingthatthewatermeetsrelevantrequirements),orifthewateristreatedincompliance
withtherulestreatmentrequirements.

2.BiologicalSoilAmendments

RawManure:TheFDAisconductingariskassessmentandextensiveresearchonthenumberofdaysneeded
betweentheapplicationsofrawmanureasasoilamendmentandharvestingtominimizetheriskofcontamination.
(Asoilamendmentisamaterial,includingmanure,thatisintentionallyaddedtothesoiltoimproveitschemicalor
physicalconditionforgrowingplantsortoimproveitscapacitytoholdwater.)
Atthistime,theFDAdoesnotobjecttofarmerscomplyingwiththeUSDAsNationalOrganicProgramstandards,
whichcallfora120dayintervalbetweentheapplicationofrawmanureforcropsincontactwiththesoiland90
daysforcropsnotincontactwiththesoil.Theagencyconsidersadherencetothesestandardsaprudentstep
towardminimizingthelikelihoodofcontaminationwhileitsriskassessmentandresearchisongoing.

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Thefinalrulerequiresthatuntreatedbiologicalsoilamendmentsofanimalorigin,suchasrawmanure,mustbe
appliedinamannerthatdoesnotcontactcoveredproduceduringapplicationandminimizesthepotentialfor
contactwithcoveredprdouceafterapplication.
StabilizedCompost:Microbialstandardsthatsetlimitsondetectableamountsofbacteria(includingListeria
monocytogenes,Salmonellaspp.,fecalcoliforms,andE.coli0157:H7)havebeenestablishedforprocessesusedto
treatbiologicalsoilamendments,includingmanure.Theruleincludestwoexamplesofscientificallyvalidcomposting
methodsthatmeetthosestandards.Stabilizedcompostpreparedusingeitherofthesemethodsmustbeappliedina
mannerthatminimizesthepotentialforcontactwithproduceduringandafterapplication.

3.Sprouts

Thefinalruleincludesnewrequirementstohelppreventthecontaminationofsprouts,whichhavebeenfrequently
associatedwithfoodborneillnessoutbreaks.Sproutsareespeciallyvulnerabletodangerousmicrobesbecauseof
thewarm,moistandnutrientrichconditionsneededtogrowthem.
Between1996and2014,therewere43outbreaks,2,405illnesses,and171hospitalizations,and3deaths
associatedwithsprouts,includingthefirstdocumentedoutbreakofListeriamonocytogenesassociatedwith
sproutsintheUnitedStates.
Requirementsspecifictosproutsinclude,forexample:
Takingmeasurestopreventtheintroductionofdangerousmicrobesintoorontoseedsorbeansusedfor
sprouting,inadditiontotreatingseedsorbeansthatwillbeusedforsprouting(orrelyingonpriortreatmentbythe
seed/beangrower,distributor,orsupplierwithappropriatedocumentation).
Testingofspentsproutirrigationwaterfromeachproductionbatchofsprouts,orinprocesssproutsfromeach
productionbatch,forcertainpathogens.Sproutscannotbeallowedtoentercommerceuntilitisascertainedthat
theserequiredpathogentestresultsarenegative.
Testingthegrowing,harvesting,packingandholdingenvironmentforthepresenceofListeriaspeciesorListeria
monocytogenes.
Takingcorrectiveactionsifspentsproutirrigationwater,sprouts,and/oranenvironmentalsampletestspositive.
Sproutoperationswillhavelesstimetocomeintocompliancewiththerulethanfarmsgrowingotherproduce.They
willhaveonetothreeyearstocomplybasedonthesizeoftheiroperation,withnoadditionaltimetomeetthewater
requirements.

4.DomesticatedandWildAnimals

Theruleaddressesconcernsaboutthefeasibilityofcomplianceforfarmsthatrelyongrazinganimals(suchas
livestock)orworkinganimalsforvariouspurposes.Itestablishesthesamestandardsfortheseanimalsasitdoesfor
intrusionbywildanimals(suchasdeerorferalswine).Farmersarerequiredtotakeallmeasuresreasonably
necessarytoidentifyandnotharvestproducethatislikelytobecontaminated.
Ataminimum,thisrequiresallcoveredfarmstovisuallyexaminethegrowingareaandallcoveredproducetobe
harvested,regardlessoftheharvestmethodused.
Inaddition,undercertaincircumstancestherulerequiresfarmstodoadditionalassessmentduringthegrowing
season,andifsignificantevidenceofpotentialcontaminationbyanimalsisfound,totakemeasuresreasonably
necessarytoassistlaterduringharvest.Suchmeasuresmightinclude,forexample,placingflagsoutliningthe
affectedarea.
Althoughthefinalruledoesnotrequireestablishingwaitingperiodsbetweengrazingandharvest,theFDA
encouragesfarmerstovoluntarilyconsiderapplyingsuchintervalsasappropriateforthefarmscommoditiesand
practices.Theagencywillconsiderprovidingguidanceonthispracticeinthefuture,asneeded.

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Aswasstatedinthesupplementalnotice,farmsarenotrequiredtoexcludeanimalsfromoutdoorgrowingareas,
destroyanimalhabitat,orclearbordersaroundgrowingordrainageareas.Nothingintheruleshouldbeinterpreted
asrequiringorencouragingsuchactions.

5.WorkerTrainingandHealthandHygiene

Requirementsforhealthandhygieneinclude:
Takingmeasurestopreventcontaminationofproduceandfoodcontactsurfacesbyillorinfectedpersons,for
example,instructingpersonneltonotifytheirsupervisorsiftheymayhaveahealthconditionthatmayresultin
contaminationofcoveredproduceorfoodcontactsurfaces.
Usinghygienicpracticeswhenhandling(contacting)coveredproduceorfoodcontactsurfaces,forexample,
washinganddryinghandsthoroughlyatcertaintimessuchasafterusingthetoilet.
Takingmeasurestopreventvisitorsfromcontaminatingcoveredproduceand/orfoodcontactsurfaces,for
example,bymakingtoiletandhandwashingfacilitiesaccessibletovisitors.
Farmworkerswhohandlecoveredproduceand/orfoodcontactsurfaces,andtheirsupervisors,mustbetrainedon
certaintopics,includingtheimportanceofhealthandhygiene.
Farmworkerswhohandlecoveredproduceand/orfoodcontactsurfaces,andtheirsupervisors,arealsorequiredto
haveacombinationoftraining,educationandexperiencenecessarytoperformtheirassignedresponsibilities.This
couldincludetraining(suchastrainingprovidedonthejob),incombinationwitheducation,orexperience(e.g.,work
experiencerelatedtocurrentassignedduties).

6.Equipment,ToolsandBuildings

Theruleestablishesstandardsrelatedtoequipment,toolsandbuildingstopreventthesesources,andinadequate
sanitation,fromcontaminatingproduce.Thissectionoftherulecovers,forexample,greenhouses,germination
chambers,andothersuchstructures,aswellastoiletandhandwashingfacilities.
oRequiredmeasurestopreventcontaminationofcoveredproduceandfoodcontactsurfacesinclude,forexample,
appropriatestorage,maintenanceandcleaningofequipmentandtools.

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Exemptions
Theruledoesnotapplyto:

Producethatisnotarawagriculturalcommodity.(Arawagriculturalcommodityisanyfoodinitsrawornaturalstate)
ThefollowingproducecommoditiesthatFDAhasidentifiedasrarelyconsumedraw:asparagusblackbeans,great
Northernbeans,kidneybeans,limabeans,navybeans,andpintobeansgardenbeets(rootsandtops)andsugar
beetscashewssourcherrieschickpeascocoabeanscoffeebeanscollardssweetcorncranberriesdatesdill
(seedsandweed)eggplantsfigshorseradishhazelnutslentilsokrapeanutspecanspeppermintpotatoes
pumpkinswintersquashsweetpotatoesandwaterchestnuts
Foodgrains,includingbarley,dentorflintcorn,sorghum,oats,rice,rye,wheat,amaranth,quinoa,buckwheat,and
oilseeds(e.g.cottonseed,flaxseed,rapeseed,soybean,andsunflowerseed)
Producethatisusedforpersonaloronfarmconsumption
Farmsthathaveanaverageannualvalueofproducesoldduringthepreviousthreeyearperiodof$25,000orless

Theruleprovidesanexemptionforproducethatreceivescommercialprocessingthatadequatelyreducesthepresence
ofmicroorganismsofpublichealthsignificance,undercertainconditions.

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Therulealsoprovidesaqualifiedexemptionandmodifiedrequirementsforcertainfarms.

Tobeeligibleforaqualifiedexemption,thefarmmustmeettworequirements:
Thefarmmusthavefoodsalesaveraginglessthan$500,000peryearduringthepreviousthreeyearsand
Thefarmssalestoqualifiedendusersmustexceedsalestoallotherscombinedduringthepreviousthreeyears.
Aqualifiedenduseriseither(a)theconsumerofthefoodor(b)arestaurantorretailfoodestablishmentthatis
locatedinthesamestateorthesameIndianreservationasthefarmornotmorethan275milesaway.
Afarmwiththequalifiedexemptionmuststillmeetcertainmodifiedrequirements,includingdisclosingthenameand
thecompletebusinessaddressofthefarmwheretheproducewasgrowneitheronthelabeloftheproduceoratthe
pointofpurchase.Thesefarmsarealsorequiredtoestablishandkeepcertaindocumentation.
Afarmsqualifiedexemptionmaybewithdrawnasfollows:
Ifthereisanactiveinvestigationofanoutbreakoffoodborneillnessthatisdirectlylinkedtothefarm,or
IfFDAdeterminesitisnecessarytoprotectthepublichealthandpreventormitigateanoutbreakbasedon
conductorconditionsassociatedwiththefarmthatarematerialtothesafetyofthefarmsproducethatwouldbe
coveredbytherule.
BeforeFDAissuesanordertowithdrawaqualifiedexemption,theagency:
Mayconsideroneormoreotheractionstoprotectpublichealth,includingawarningletter,recall,administrative
detention,refusaloffoodofferedforimport,seizureandinjunction.
Mustnotifytheowner,operator,oragentinchargeofthefarm,inwriting,ofthecircumstancesthatmayleadFDA
towithdrawtheexemption,provideanopportunityforresponsewithin15calendardaysofreceiptofthe
notification,andconsideractionstakenbythefarmtoaddresstheissuesraisedbytheagency.
Awithdrawnexemptionmaybereinstatedif(asapplicable):
TheFDAdeterminesthattheoutbreakwasnotdirectlylinkedtothefarm,and/or
TheFDAdeterminesthattheproblemswithconductorconditionsmaterialtothesafetyofthefoodproducedor
harvestedatthefarmhavebeenadequatelyresolved,andcontinuedwithdrawaloftheexemptionisnot
necessarytoprotectpublichealthorpreventormitigateanoutbreakoffoodborneillness.

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Variances
Therulealsopermitsstates,tribes,orforeigncountriesfromwhichfoodisimportedintotheU.S.tosubmitapetition,
alongwithsupportinginformation,toFDArequestingavariance(s)fromoneormoreoftherequirementsofthisrule.

Theruleenablesastate,tribe,orcountry,ifitconcludesthatmeetingoneormoreoftherulesrequirementswould
beproblematicinlightoflocalgrowingconditions,torequestvariancestothoserequirements.Thestate,tribe,or
foreigncountrymustdemonstratethattherequestedvarianceisreasonablylikelytoensurethattheproduceisnot
adulteratedandprovidesthesamelevelofpublichealthprotectionasthecorrespondingrequirement(s)intherule.
Thefinalrulemakesitclearthatfederallyrecognizedtribesmaysubmitavariancepetition.
Therequestforavariancemustbesubmittedbyacompetentauthority,meaningapersonororganizationthatisthe
regulatoryauthorityforfoodsafetyforthestate,tribe,orforeigncountry.
Aforeigngovernmentdoesnotneedtohaveasystemsrecognitionarrangementorequivalenceagreementwiththe
FDAtoobtainavariance.
Thevariancerequestmustincluderelevantandscientificallyvalidinformationspecifictotheproduceoractivity.
Informationcouldrelatetocrops,climate,soil,geographyorenvironment,aswellasthepracticesofthatparticular

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region.
Examplesoftypesofvariancesthatmaybegrantedincludeavariancefromtheagriculturalwatermicrobialquality
criteriaforwaterusedduringgrowingcoveredproduce(otherthansprouts)usingadirectwaterapplicationmethod,
avariancefromthemicrobialdieoffrateusedtodeterminethetimeintervalbetweenthelastirrigationandharvest
and/ortheaccompanyingmaximumtimeintervalandavariancefromtheapproachorfrequencyforwatertestingfor
waterusessubjecttotherulesmicrobialqualitycriteria.

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ComplianceDates
Compliancedatesforcoveredactivities,exceptforthoseinvolvingsprouts,aftertheeffectivedateofthefinalruleare:

Verysmallbusinesses,thosewithmorethan$25,000butnomorethan$250,000inaverageannualproducesales
duringthepreviousthreeyearperiod:fouryears
Smallbusinesses,thosewithmorethan$250,000butnomorethan$500,000inaverageannualproducesales
duringthepreviousthreeyearperiod:threeyears
Allotherfarms:twoyears
Thecompliancedatesforcertainaspectsofthewaterqualitystandards,andrelatedtestingandrecordkeeping
provisions,allowanadditionaltwoyearsbeyondeachofthesecompliancedatesfortherestofthefinalrule

Compliancedatesformodifiedrequirementsforfarmseligibleforaqualifiedexemptionare:

Forlabelingrequirement(ifapplicable):January1,2020
Forretentionofrecordssupportingeligibilityforaqualifiedexemption:Effectivedateofthefinalrule
Forallothermodifiedrequirements:
Verysmallbusinesses,fouryearsaftertheeffectivedateofthefinalrule
Smallbusinesses,threeyearsaftertheeffectivedateofthefinalrule

Compliancedatesforcoveredactivitiesinvolvingsproutsaftertheeffectivedateofthefinalruleare:

Verysmallbusinesses:threeyears
Smallbusinesses:twoyears
Allotherfarms:oneyear

Formoreinformation,seeComplianceDateExtensionsandClarificationsforFSMAFinalRules
(/Food/GuidanceRegulation/FSMA/ucm517545.htm).

backtotop

EnvironmentalImpactStatement
TheFDAhasalsoreleasedtheFinalEnvironmentalImpactStatement(EIS)
(/Food/GuidanceRegulation/FSMA/ucm396564.htm),whichplacestheProduceSafetyruleinthecontextofitslikely
impactontheenvironment,includinghumanhealthandsocioeconomiceffects.TheDraftEISwaspublishedinJanuary
2015.TheFDAconsideredpubliccommentssubmittedinthetwomonthsthatfollowedindraftingtheFinalEIS.The
FDAconsideredthefindingsoftheFinalEISinfinalizingtheproducerule.

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm 9/9

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