what cabbage growers need to know about fsma produce safety rule cabbage gro… · 2015 jan 2018...

WhatCabbageGrowersNeedtoKnowabout

FSMAProduceSafetyRule

NewYorkStateExpoJanuary19,2016

ElizabethA.Bihn,Ph.D.CornellUniversity

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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 eab38@cornell.edu, 315.787.2625 Don Stoeckel, Ph.D., Midwest Regional Extension Associate dstoeckel@cornell.edu, 614.634.0884