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What Cabbage Growers Need to Know about FSMA Produce Safety Rule New York State Expo January 19, 2016 Elizabeth A. Bihn, Ph.D. Cornell University
WhatCabbageGrowersNeedtoKnowabout
FSMAProduceSafetyRule
NewYorkStateExpoJanuary19,2016
ElizabethA.Bihn,Ph.D.CornellUniversity
2
Topics
• WhatdoyouwanttoknowabouttheFoodSafetyModernizaLonAct(FSMA)ProduceSafetyRule?
• NiRyGriRyProduceSafetyRuleDetails• ProduceSafetyAllianceTrainingOverview• QuesLonsandDiscussion
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CoveredProduce• Cabbageisacoveredcommodity
– Therearelotsofothercoveredproduceitems,butthisisacabbagesessiondoIfeltitwasoktoskipovertheothers
• Theterm“coveredproduce”isimportanttoknowbecausethisisusedthroughouttherule
A – General Provisions
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QualifiedExempGons1. Duringtheprevious3-yearperiod,morethanhalfofthe
averageannualmonetaryvalueofthefoodthefarmsoldwasdirectlytoqualifiedend-usersa) theconsumerofthefood(consumerdoesnotincludeabusiness);orb) arestaurantorretailfoodestablishmentthatislocated:
i. InthesameStateorthesameIndianreservaLonasthefarmthatproducedthefood;or
ii. Notmorethan275milesfromsuchfarmAND
2. Theaverageannualmonetaryvalueofallfoodthefarmsoldduringthe3-yearperiodprecedingtheapplicablecalendaryearwaslessthan$500,000
A – General Provisions
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ProduceFarmsExemptFromorNotCoveredbytheRule
189,000 Total Produce
Farms 154,000 Exempt/
Not covered
35,000 Covered
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GrowersmaybeexemptfromtheregulaGon,butnotfromthemarketplace.
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FSMAProduceSafetyRuleTimeFrame
Draft Rule Released
Large growers (>$500K) comply - 2 years
Small growers ($250-500K)
comply - 3 years
Very small growers ($25-250K) comply - 4 years
Jan 2013
Nov 2015
Jan 2018
Jan 2019
Jan 2020
Supplemental Notice
Sept 2014 2020 - 2022
Add an additional 2 years to each
business size for compliance with
water criteria
Jan 2016
Effective Date Jan 26, 2016
Dec 2009
Docket
Final Rule Published in
Federal Register
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FoodSafetyPrevenGveControlsforHumanFoodRule
• WillgrowersfallundertworegulaGons?– PrevenGveControlsRule:Focusonthemanufacturing,processing,packingorholdingofhumanfood
– IniLalconcernthatsomegrowerswouldfallintothisregulaLoninaddiLontotheproducerule
– NewdefiniLonsoffarm,sales,holding,andpackingacLviLeshavehelpedtoclarify
Primary Production Farm • An operation under one management in one general,
but not necessarily contiguous, location • Devoted to the growing of crops, the harvesting of
crops, the raising of animals, or any combination of these activities – The definition has been expanded to include
operations that just grow crops and operations that just harvest crops.
Preventive Controls for Human Food rule expands it further to cover two kinds of farming operations: Primary production
Secondary activities
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Primary Production Farm • In addition to these activities, a primary
production farm can: – Pack or hold RACs (regardless of who grew
or raised them) – Manufacture/process, pack, or hold processed
foods so long as: • all such food is consumed on that farm or another
farm under the same management; or • the manufacturing/processing falls into limited
categories
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Secondary Activities Farm • An operation not located on a primary production
farm that is devoted to harvesting, packing, and/or holding RACs.
• The primary production farm(s) that grow, harvest, and/or raise the majority of those RACs must own or jointly own a majority interest in the secondary activities farm.
• The definition also allows certain, limited additional manufacturing/processing, packing, and holding – Same as those for a primary production farm
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FSMAProduceSafetyRuleNiNyGriNyDetails
21CFRParts11,16,and112– Part11:ElectronicRecordsandElectronicSignatures– Part16:RegulatoryHearingBeforetheFDA– Part112:StandardsfortheGrowing,HarvesGng,Packing,andHoldingofProduceforHumanConsumpGon
FederalRegister,Vol.80,No.228,November27,2015DocketNo.FDA2011-N-0921
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Subpartsof21CFRPart112
• A–GeneralProvisions• B–GeneralRequirements• C–Personnel
QualificaLonsandTraining• D–HealthandHygiene• E–AgriculturalWater• F–BiologicalSoil
AmendmentsofAnimalOriginandHumanWaste
• I–DomesLcatedandWildAnimals
• K–Growing,HarvesLng,Packing,andHoldingAcLviLes
• L–Equipment,Buildings,Tools,andSanitaLon
• M–Sprouts• N–AnalyLcalMethods• O–Records• P,Q,R–Variances,
Compliance,andWithdrawalofQualifiedExempLons
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TrainingRequirements:Supervisors
• §112.22(c)AtleastonesupervisororresponsiblepartyforyourfarmmusthavesuccessfullycompletedfoodsafetytrainingatleastequivalenttothatreceivedunderstandardizedcurriculumrecognizedasadequatebytheFDA
C – Personnel Qualifications and Training
The PSA Curriculum will meet this requirement!
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TrainingRequirements:FieldHarvesters
• PersonswhoconductharvestacLviLesmustbetrainedonthefollowing:– RecognizingwhencoveredproducemustnotbeharvestedbecauseofcontaminaLonrisks
– InspecLngharvestcontainersandequipmenttoensurethattheyarefuncLoningproperly,cleanandmaintainedsoasnottobecomeasourceofcontaminaLon
– Correctandreportanyproblemswithharvestcontainersorequipment
C – Personnel Qualifications and Training
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RequiredHygienicPracGces• Maintainpersonalcleanliness• Avoidcontactwithanimalsotherthanworkinganimalsand
takeacLontominimizelikelihoodofcontaminaLonofcoveredproduce
• Ifusinggloves,maintaininanintactandsanitarymannerandreplacewhennecessary
• RemoveorcoverhandjewelrythatcannotbecleanedandsaniLzedwhencoveredproduceismanipulatedbyhand;and
• Donoteat,chewgum,orusetobaccoproductsintheareausedforacoveredacLvity(drinkingbeveragesispermiRed)
• Handwashing(seenextslide)
D – Health and Hygiene
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HandWashingRequirements• Washhandsthoroughlyusingsoap(orothereffecLve
surfactant)andwater,dryhandsthoroughlyusingsingle-servicetowels,sanitarytowelservice,electrichanddryersorotherhanddryingdevices:– BeforestarLngwork– Beforepuongongloves– Aperusingthetoilet– UponreturntotheworkstaLon
aperbreaks– AssoonaspracLcalapertouching
animalsoranimalwaste– AtanyotherLmeworkershandsmay
becomecontaminated
D – Health and Hygiene
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TrainingRequirements:FarmWorkers
• Allpersonnel(includingtemporary,partLme,seasonal,andcontractedpersonnel)whohandlecoveredproduceorfoodcontactsurfaces,orwhoaresupervisorsofsaidpersonnel,mustreceiveadequatetrainingperperson’sduLes,uponhiringandperiodicallythereaper,atleastonceannually
• Trainingmustbeconductedinamannerthatiseasilyunderstoodbypersonnelbeingtrained
C – Personnel Qualifications and Training
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Visitors
• Growersmust:– Makevisitorsawareofthefarm’sfoodsafetypolicies– ProvideaccesstotoiletandhandwashingfaciliLes
• OtherkeyinformaGonforvisitorsshouldinclude:– Areasofthefarmtheyareallowedtovisit– TheimportanceofnotvisiLngthefarmwhenill– Howtowashtheirhands– InstrucLonstokeeppetsathome
§
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UntreatedSoilAmendments• Untreatedbiologicalsoilamendmentsofanimaloriginareconsideredhighrisksincetheyhavenotbeentreatedtoreduceoreliminatepathogens
• Allofthefollowingsoilamendmentswouldbeconsidereduntreated:– Rawmanure– ‘Aged’or‘stacked’manure– Untreatedmanureslurries– Untreatedmanureteas– Agriculturalteaswithsupplementalmicrobialnutrients– Anysoilamendmentmixedwithrawmanure
F – Biological Soil Amendments of Animal Origin and Human Waste
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MinimumApplicaGonIntervals
• TherearecurrentlynoapplicaLonintervalsforrawmanureoutlinedintheProduceSafetyRule
• UntreatedSoilAmendments– FDAiscurrentlypursuingfurtherresearchtosupportapplicaLonintervalsforrawmanure
• TreatedSoilAmendments– 0dayapplicaLonintervalforcomposttreatedbyascienLficallyvalidatedprocess
F – Biological Soil Amendments of Animal Origin and Human Waste
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InspectAgriculturalWaterSourcesandWaterDistribuGonSystems
• Watercanbecontaminatedatthesource,oritcanbecomecontaminatedinthedistribuLonsystem
• MapanddescribeallwaterdistribuLonsystems• WatersourcesanddistribuLonsystemsmustbeinspectedatleastannually
• Keepwatersourcesfreeofdebris,trash,domesLcatedanimals,andotherhazards
§
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WhatWaterMustBeTested?• AgriculturalwaterusedwithadirectwaterapplicaLonmethodtocoveredproduce• AgriculturalwatermeanswaterusedincoveredacLviLesoncoveredproducewherewaterisintendedto,orislikelyto,contactcoveredproduceorfoodcontactsurfaces.
• DirectwaterapplicaGonmethodmeansusingagriculturalwaterinamannerwherebythewaterisintendedto,orislikelyto,contactcoveredproduceorfoodcontactsurfacesduringuseofthewater.
• CoveredproducemeansproducethatissubjecttotheProduceSafetyRule.Theterm“coveredproduce”referstotheharvestableorharvestedpartofthecrop
E – Agricultural Water
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ProducGonWaterQualityCriteria
• ApplytowaterusedwithadirectwaterapplicaLonmethodtocoveredproduce
• EachsourceofproducLonwatermustbetestedtoevaluatewhetheritmeetsthecriteria:o 126orlesscolonyformingunits(CFU)genericE.
coliper100mLwatergeometricmean(GM) ANDo 410orlessCFUgenericE.coliper100mLwater
staLsLcalthresholdvalue(STV)§
Round 2: Slide 17
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GM
(Typical value)
STV
(H
igh-range) GeometricMeansandStaGsGcalThresholdValues
• TestresultsmustbeusedtocalculateGeometricMeansandStaLsLcalThresholdValuestocomparetocriteriaintheFSMAProduceSafetyRule
• Thegeometricmean(GM)isalog-scaleaverage,the“typical”value
• ThestaLsLcalthresholdvalue(STV)isameasureofvariability,theexpected“highrange”value(modeled90%percenLle)
• TheSTViscalculatedusinglog-transformeddataLog(STV)=Average+1.28*StandarddeviaLon
E – Agricultural Water
There will be tools to help you calculate this! Do not panic!
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START:Establishwaterqualityprofile
Atleast20samplesover2-4years
ANNUALLYAFTERSTART:Collectatleast5samplesforanalysisAddto3prioryearsofprofiledatato
createarolling4-yeardataset
IFYOURPROFILEDOESNOTMEETGMORSTVCRITERIA:
AssoonaspracLcableandnolaterthanthefollowingyear,disconLnueuseofthewaterunlessanallowed
correcLvemeasureisapplied
ALLOWEDCORRECTIVEMEASURES:1. ApplyaLmeintervaltoallowdie-
offorremoval2. Re-inspectthewatersystem,
idenLfyproblems,andmakenecessarychanges
3. Treatthewater
IFYOURWATERCHANGES:Ifthewaterqualityprofileno
longerrepresentsthequalityofthewatersource,oryouchange
sources,establishanewprofile
UsingSurfaceWaterQualityProfiles
E – Agricultural Water
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CorrecGveMeasures
• ThreetypesofcorrecLvemeasuresareallowedifyourwatersourcedoesnotmeetwaterqualitycriteria:1. ApplyaLmeinterval
i. In-fielddie-offii. Die-offduringstorageand/orremovalduring
acLviLessuchascommercialwashing2. Re-inspectthewatersystem,idenLfyproblems,and
makenecessarychanges3. Treatthewater
§
Proposed new slide
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• RisksfromproducLonwatermaybereducedbymaximizingtheLmebetweenapplicaLonandharvest
• OnelegalcorrecLvemeasureforwaterqualityisuseofamicrobialdie-offrateof0.5logperdayduringanapplicaLonintervaloffourconsecuLvedaysorless
• 0.5logisapproximately68%• Fourdaysresultsin2-log(99%)calculateddieoff
Thisisimportantifyourini4alwaterqualityprofiledoesnotmeetGMandSTVcriteria!
WaterApplicaGonandTiming
§
Round 2: Slide 19
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TreaGngProducGonWater
• ProducLonwatermaybetreatedifthereisreasontobelievethewaterisnotsafeforitsintendeduse– AnychemicalsusedtotreatwatermustbeEPAregisteredandlabeledforuseinproducLonwater
– Non-chemicaltreatments,calledpesLcidedevicesbyEPA,maybeusediftheyadequatelyreducemicrobialrisks
• Filterunits,UVlightunits,ozonatorunits• YoushouldavoidwatertreatmentsthatmayhavenegaLveenvironmentalandsoilqualityimpacts
• Youmustkeeprecordsofalltreatmentmonitoringdone
§
Round 2: Slide 34
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WaterQualityCriterionforHarvestandPostharvestAcGviGes
• WaterusedforthefollowingmusthavenodetectablegenericE.coliper100mLsample– Directcontactwithcoveredproduceduringoraperharvest
– Directcontactwithfoodcontactsurfaces– Tomakeice– Forhandwashing
• Untreatedsurfacewatermaynotbeusedforthesepurposes
E – Agricultural Water
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KeyWaterQualityVariables
• Qualityatstartofuse– NodetectablegenericE.coliin100mLofsample
• pH– CanimpactsaniLzereffecLveness
• Temperature– MustbemonitoredtominimizepotenLalforinfiltraLon
• Turbidity– Canbeusedtomanagewaterchangeschedule
E – Agricultural Water
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AgriculturalWaterRecords
• Documentresultsofallwatertests• DocumentallmonitoringandacLonstoreducerisks
– AnnualinspecLonofwatersystem– CorrecLvemeasurestaken,ifany
• Die-offand/orremovalbeforeandaperharvest,includingsupporLngcalculaLonsorscienLficinformaLontosupportalternaLvesused
• CorrecLveacLonstakenduringwatersystemre-inspecLon,includingprotecLonofwatersourcesfromcontaminaLon,maintenanceorotherchangestothewaterdistribuLonsystem
• Monitoringofwatertreatments
• ScienLficresearchusedtosupportalternaLveindicators,criteria,orsamplingfrequencies
E – Agricultural Water
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EquipmentandTools• Mustuseequipmentandtoolsthatareofadequatedesign,
construcLon,andworkmanshiptoenablethemtobeadequatelycleanedandproperlymaintained
• Seamsonfoodcontactsurfacesofequipmentandtoolsmustbeeithersmoothlybonded,ormaintainedtominimizeaccumulaLonofdirt,filth,foodparLcles,andorganicmaterialandthusminimizetheopportunityforharborageorgrowthofmicroorganisms
• Mustinspect,maintain,andcleanand,whennecessaryandappropriate,saniLzeallfoodcontactsurfacesofequipmentandtoolsusedincoveredacLviLesasfrequentlyasreasonablynecessarytoprotectagainstcontaminaLonofcoveredproduce
L – Equipment, Buildings, Tools, and Sanitation
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Grazing,WorkingandIntrusiveAnimals
• Ifanimalsmightreasonablycontaminatecoveredproduce,growersmustassessforevidenceofpotenLalcontaminaLon
• IfsignificantevidenceofpotenLalcontaminaLonisfound(suchasobservaLonofanimals,animalexcreta,orcropdestrucLon),theymustevaluatewhethertheproducecanbeharvested
• TakemeasuresreasonablynecessaryduringgrowingtoassistlaterduringharvestwhengrowersmustidenLfy,andnotharvest,coveredproducethatisreasonablylikelytobecontaminatedwithaknownorreasonablyforeseeablehazard
I – Domesticated and Wild Animals
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MixedCropFarms• Ifyougrow,harvest,packorholdexcludedproduceandalso
conductacLviLesoncoveredproduce,andiftheexcludedproduceisnotgrown,harvested,packedorheldinaccordancewiththeProduceSafetyRule,youmusttakemeasuresduringthesecoveredacLviLesto:– Keepcoveredproduceseparatefromexcludedproduce(exceptwhencoveredproduceandexcludedproduceareplacedinthesamecontainerfordistribuLon);and
– AdequatelycleanandsaniLze,asnecessary,anyfoodcontactsurfacesthatcontactexcludedproducebeforeusingsuchfoodcontactsurfacesforcoveredacLviLesoncoveredproduce
K – Growing, Harvesting, Packing, and Holding Activities
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SomeHarvesGngRequirements• Ataminimum,idenLfyingandnotharvesLngcovered
producethatisreasonablylikelytobecontaminatedwithanimalexcretaorthatisvisiblycontaminatedwithanimalexcretarequiresavisualassessmentofthegrowingareaandallcoveredproducetobeharvested
• Mustnotdistributedroppedcoveredproduce.Droppedcoveredproduceiscoveredproducethatdropstothegroundbeforeharvest.Droppedcoveredproducedoesnotincluderootcropsthatgrowunderground(suchascarrots),cropsthatgrowontheground(suchascantaloupe),orproducethatisintenLonallydroppedtothegroundaspartofharvesLng(suchasalmonds).
K – Growing, Harvesting, Packing, and Holding Activities
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Cleaningvs.SaniGzingWhatisthedifferenceandwhydoesitma2er?
• Cleaning:Physicalremovalofdirt(soil)fromsurfacesbyusingcleanwater,soap(detergent),andscrubbing
• SaniGzing:TreatmentofacleanedsurfacewithasaniLzer(suchaschlorine)orothermethod(suchasheatorsteam)toreduceoreliminatemicroorganisms
Importantpoint:YoucannotsaniGzeadirtysurface.
Cleaningalwayscomesfirst!
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CleaningandSaniGzing
K – Growing, Harvesting, Packing, and Holding Activities
Step 4: Apply a sanitizer approved for use on food contact surfaces. Rinsing may be necessary. Let the surface air dry
Step 3: Rinse the surface with clean water, making sure to remove all the detergent and soil
Step 2: Apply an appropriate detergent and scrub the surfaces Step 1: Remove any obvious dirt and debris from
the food contact surface
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TransportaGonRequirements
• Equipmentusedtotransportcoveredproducea)beadequatelycleanedpriortotransporLngproduceandb)adequateforuseintransporLngcoveredproduce
• Useequipmentsuchaspallets,forklips,tractors,andvehiclessuchthattheyareintendedto,orlikelyto,contactcoveredproduce,theymustdosoinamannerthatminimizesthepotenLalforcontaminaLonofcoveredproduceorfoodcontactsurfaceswithknownorreasonablyforeseeablehazards.
L – Equipment, Buildings, Tools, and Sanitation
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PestControlPrograms
• Musttakemeasurestoprotectcoveredproduce,foodcontactsurfaces,andfood-packingmaterialsfromcontaminaLonbypests,includingrouLnemonitoringforpestsasnecessaryandappropriate.
• Forfully-enclosedbuildings,theremustbemeasuresinplacetoexcludepests.
• ForparLally-enclosedbuildings,musttakemeasurestopreventpestsfrombecomingestablishedorremovethem,whenpresent.
L – Equipment, Buildings, Tools, and Sanitation
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ThePSAWebsitehNp://producesafetyalliance.cornell.edu/
• YoucanevenfriendusonFacebook!
• Jointhelistserve!
• Contactus!Elizabeth A. Bihn, Ph.D., Director [email protected], 315.787.2625 Don Stoeckel, Ph.D., Midwest Regional Extension Associate [email protected], 614.634.0884
