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Juan Anciso, Ph.D.,Professor and Extension Vegetable SpecialistTexas A&M AgriLife Extension Service

j-anciso@tamu.edu956-968-5581

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TheFoodSafetyModernizationAct(FSMA)

• FSMAincludes:– ProduceSafetyRule– PreventiveControlsforHumanFood– PreventiveControlsforAnimalFood– ForeignSupplierVerificationPrograms– AccreditationofThird-PartyAuditors/CertificationBodies– SanitaryTransportationofHumanandAnimalFood– PreventionofIntentionalContamination/Adulteration

• Focusedonpreventionoffoodsafetyissuesandencompassestheentirefoodsystem

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FSMAProduceSafetyRule

• Firstevermandatoryfederalstandardforgrowing,harvesting,packing,andholdingoffreshproduce

• Somegrowersmaybeeligibleforanexemptionorexcludedbasedon:– Commoditiesgrown(e.g.,rarelyconsumedraw)– Averageannualproducesales– Averageannualfoodsalesandsalesto‘qualifiedendusers’

• Ultimately,All growersshouldunderstandandtakeactiontoreducefoodsafetyrisksonthefarm

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FoodSafetyModernizationActExemptions:1. The proposed rule would not cover farms that have an

average annual value of food sold during the previous three-year period of $25,000 or less.

2. The proposed rule would provide a qualified exemption and modified requirements for farms that meet two requirements: (1) The farm must have food sales averaging less than $500,000 per year during the last three years; and (2) the farm's sales to qualified end-users (must be same state and not more than 275 miles whether consumers, restaurant, or retail) must exceed sales to others.

FDA establishes the following exhaustive list of specific fruits and vegetables that would be Exempt

arrowhead, arrowroot, artichokes, asparagus, beets (roots and tops), black-eyed peas, brussels sprouts, chick-peas, collard greens, crabapples, cranberries, dill, eggplant, figs, ginger root, kidney beans, lentils, lima beans, okra, parsnips, peanuts, pecans, pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga, sugarbeet, sweet corn, sweet potatoes, taro, water chestnuts, winter squash (acorn and butternut squash), and yams.

Covered by this rule. Not Exempt.

almonds, apples, apricots, asian pear, avocados, bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus, cucumbers, curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other melons, mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers (such as bell and hot), pineapple, plums, plumcot, radish, raspberries, scallions, snow peas, spinach, sprouts, strawberries, summer squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, and watermelon

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ProduceSafetyRuleCompliance

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BusinessSizeYearstoComply

AfterEffectiveDate(1-26-16)*

All other businesses(>$500K) 2Smallbusinesses(>$250K-500K) 3Verysmallbusinesses(>$25K-250K) 4*Compliancedatesforcertainaspectsoftheagricultural waterrequirementsallowanadditionaltwoyearsbeyondeachofthesecompliancedates.

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• Youcanpreventandreducerisksonthefarm

• Youknowyourfarmandpracticesbetterthananyone,butyoumaynotknowtheconsequencesofyourcurrentpracticesonfoodsafetyrisks

• Youractionsdirectlyimpactfoodsafetyandthefinancialviabilityofyourfarm

RelevancetotheFarm

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ProduceSafetyBeginsWithYourCommitment

• Identifyingproducesafetyrisksonyourfarm• Supportingtheimplementationoffoodsafetypoliciesandpracticestoreducerisks

• Providingequipmentandfacilitiesnecessarytoimplementpracticesthatreducerisks

• Supportingeffectivefoodsafetytrainingsoeveryonecanactivelybeinvolvedinreducingrisks

• Settingagoodandconsistentexampleonyourfarm

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ProduceSafetyAllianceCurriculum

• CoversbothFSMAProduceSafetyRulerequirementsandmanyproducesafetypracticesincludingGoodAgriculturalPractices(GAPs)

• Atleastonesupervisorfromthefarmmustcompletefoodsafetytrainingatleastequivalenttothestandardizedcurriculum– ThePSAtrainingsatisfiesthisFSMArequirement

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• Keepaneyeoutforthe‘Section- §’symbol– ThisindicatesaspecificFSMAProduceSafetyRulerequirement

ispresentedontheslideorreferredtointheslidenotes• Payattentiontothewords‘must’and‘should’• FSMARegulatoryReferenceTableisprovidedtoalignthe

curriculumwiththeregulation• Glossarytermsareinbold throughout

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MicroorganismsofConcerninFreshProduce

• Bacteria– Salmonella,toxigenic E.coli,Shigella,Listeriamonocytogenes

• Viruses– Norovirus,HepatitisA

• Parasites– Giardialamblia,Cryptosporidiumparvum,Cyclospora cayetanensis

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BacteriaintheFarmEnvironment

• Bacteriaaremicroorganismsthatcanmultiplybothinsideandoutsideofahost

• BacteriaincludepathogenssuchasE.coliO157:H7,Salmonella,andListeriamonocytogenes

• Bacteriacanmultiplyrapidlygiventherightconditions:water,food,andthepropertemperature

• GoodAgriculturalPracticescanreducerisksbyminimizingsituationsthatsupportbacterialsurvivalandgrowth

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Viruses

• Viruses aresmallparticlesthatmultiplyonlyinahost,notintheenvironmentoronproduce

• Contaminationmostoftenlinkedtoanillworkerhandlingfreshproduce(fecal-oralroute)orcontaminatedwater

• Itonlytakesafewvirusparticlestomakesomeoneill

• Canbeverystableintheenvironment

• Preventionisthekeytoreducingviralcontamination

• Limitedoptionsforeffectivesanitizers

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Parasites

• Parasites areprotozoaorintestinalwormsthatcanonlymultiplyinahostanimalorhuman

• Commonlytransmittedbywater

• Canbeverystableintheenvironment;oftennotkilledbychemicalsanitizers

• Cansurviveinthebodyforlongperiodsoftimebeforeevercausingsignsofillness

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HealthImpactsbyPathogenType

*Thetotalalsoincludeschemicalhazardsnotidentifiedinthistable(e.g.,aCurcurbitacin toxinoutbreakassociatedwithsquash).

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ProduceSafetyChallenges

• Freshproduceisoftenconsumedraw(i.e.,notcooked)• Microbialcontaminationonproduceisextremelydifficultto

removeoncepresent– Naturalopenings,stemscars,bruises,cuts– Roughsurfaces,folds,netting

• Contaminationisoftensporadic• Bacteriacanmultiplyonproducesurfacesandinfruitwounds,

providedtherightconditionsarepresent

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ContaminationSources

Produce

Humans

Animals Water

Soil

BuildingsEquipment

Tools

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HowContaminationIsSpread

• HumansWorkerscanspreadpathogenstoproducebecausetheydirectlyhandlefruitsandvegetables.– Improperhealthandhygienepractices

• Lackofadequatetrainingandhandwashingpractices• Lackoforinadequatetoiletfacilities

– Illnessorinjury• Workingwhilesick• Injuriesthatresultinbloodcontactingfreshproduce

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HowContaminationIsSpread

• AnimalsDomesticatedandwildanimalscancarryandtransmithumanpathogenstoproduce.– Fieldintrusionmayresultindirectfecalcontaminationofcropsandfields

– Animalfeeding,rooting,andmovementthroughfieldsmayspreadcontamination

– Animalscancontaminatewatersourcesusedforproduceproduction

– Manurerunoffcancontaminatefields,watersources,andcrops

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HowContaminationIsSpread

• WaterWatercancarryandspreadhumanpathogens,contaminatingentirefieldsorlargeamountsofproduce.– Productionwater

• Irrigation,cropsprays,frostprotection– Postharvestwater

• Fluming,cooling,washing,waxing,cleaning– Unexpectedevents

• Flooding,runoff

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HowContaminationIsSpread

• SoilAmendmentsRawmanureandothersoilamendmentscanbeasourceofcontaminationifnotproperlyhandledandapplied.– Applicationtooclosetoharvest– Improper/incompletetreatment– Improperstorage– Runoff– Windspread– Cross-contaminationduetoimpropersanitationprocedures

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HowContaminationIsSpread

• Surfaces,equipment,tools,andbuildingsAnyuncleansurfacethatcontactsproducecanharborpathogensandserveasasourceofcontamination.– Forexample,nothavinganestablishedscheduleforcleaningorsanitizingfoodcontactsurfaces,includingtools

Facilitymanagementcanalsoimpactrisks– Areasoutsidebuildingsthatarenotkeptmowedorcleancanserveaspestharborageareas

– Standingwaterordebrispresentinthepackinghousecanbecomeasourceofcross-contamination

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Cleaningvs.SanitizingWhatisthedifferenceandwhydoesitmatter?

• Cleaning: Physicalremovalofdirt(soil)fromsurfaceswhichcanincludetheuseofcleanwateranddetergent

• Sanitizing:Treatmentofacleanedsurfacetoreduceoreliminatemicroorganisms

Importantpoint: Youcannotsanitizeadirtysurface.Cleaningalwayscomesfirst!

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StepsTowardsProduceSafety

1 • AssessProduceSafetyRisks

2 • ImplementPractices

3 • MonitorPractices

4 • UseCorrectiveActions

5 • KeepRecords

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AssessingRisks

• Assessyourfarmandpractices– Locationoffarm,fields,andadjacentlandactivitiesthatmayrepresentriskstothecropsyougrow

– Fecalcontaminationriskfromdomesticatedorwildanimals– Useofwaterandmanureincropproduction– Workertrainingprogramsandhygienefacilities– Practicesusedtogrow,harvest,pack,orholdproduceandthetoolsandequipment

– Typicalandatypical(e.g.,flooding)situations

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ImplementingPracticestoReduceRisks

• Focusonpreventingcontamination– Cannotreliablyremovecontamination

• Addressrisksmostlikelytohavethebiggestimpactonproducesafetyfirst

• Mayrequiremodificationofcurrentpracticesandadditionaltrainingforfarmemployees

• Mayrequirecapitalinvestment• Youmayalreadybedoingtherightthing!• Askforhelpandseektrainingifyouareunsure

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GoodAgriculturalPractices(GAPs)

• GAPsprovidesinformationonhowgrowerscancomplywiththeFSMAProduceSafetyRule

• Keyareaswillbereviewedaswellaspracticesthatcanbeimplementedtoreducerisksincluding:– Workertrainingprograms– Watermonitoring,testing,andtreatment– Manureandcompostmanagement– Wildlifeandanimalmonitoring– Sanitationprograms

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StandardOperatingProcedures(SOPs)

• Awrittendocumentdefininghowtocompleteaspecificfoodsafetypractice.

• SOPsinclude:1. Step-by-stepinstructionstoensurethatevenaperson

whohasneverdoneapracticebeforecancompletethepracticecorrectlybyfollowingtheinstructions

2. Locationandnameofanysupplies neededtocompletethepractice

3. Whenandhowoftenthepracticeshouldbecompleted4. Whatrecordsareneeded/necessary

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Monitoring

• Performedonascheduleorduringaspecificactivity

• Allowsyoutoverifypracticesarebeingcompletedproperly

• Helpsidentifyproblemsbeforetheyimpactsafety– FrequenthighgenericE.coli countsinwatertestresults– Evidenceofanimalintrusionandfecalcontamination– Impropercleaningandsanitationpracticesresultingindirtyequipmentandtools

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CorrectiveActions

• Canbeestablishedinadvance– Negativeconsequencesforworkersnot

followingpractices– Plansforaspilledportabletoilet

• Fixproblemsthatareidentifiedduringmonitoring– Restockingtoiletandhandwashingfacilities– Retrainingsupervisorsandfarmworkers

• Mayrequireshortandlongtermplanning– Establishingsanitationprograms(shortterm)– Replacingequipment(longterm)

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Recordkeeping

• Therearemanytemplatesavailable• Recordkeepingshouldbeconvenient,orelseitwillnotgetdone

• Recordsmustbesignedanddatedaftertheyarereviewed

• Keepallrecordsforatleast2years

• Recordkeepingincludesdocumentingpractices,monitoring,andcorrectiveactions

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RecordkeepingBenefits

• Youcanverifypracticesweredone– Anddoneproperly!– Assuresyouthateveryoneisstickingtothefoodsafetypolicies

• Lookfortrendsoroutliersandeliminatepotentialproblems

• Mayberequiredforcertainactivities– Regulatory(i.e.,FSMAProduceSafetyRulerequirements)– Thirdpartyaudits

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RecordkeepingBasics

• Recordscanbehandwritten(pen&paper)orelectronic(handhelddataentryorscanner)

• Investintoolsthatmakeitwork– Clipboards– Penstiedtolongpiecesofstringattachedtoaclipboardwiththerecordkeepinglogs

– Plasticpagesleeves– Ducttape

• Usetechnologytoyouradvantage– Phones,apps,tablets,computersoftware

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RecordkeepingTips

• Establishrecordkeepingschedulesthatmakesensefortherecordkeeperand theaction– Whendoesitneedtoberecorded?

– Whoisinchargeofdocumentingit?

– Howoftendoesitneedtobedocumented?

• Buildrecordkeepingintonormalroutines– Placerecordkeepinglogsinaccessibleareaswithnecessarysupplies(e.g.,pens,paper)

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AFarmFoodSafetyPlan

• GetsyouthinkingaboutYOURfarmandpractices• Keepsyouorganizedsoyoucanfocusyourtimeand

resourcesmoreeffectively• Givesyouaplantofollowandassure

everyoneisinvolved• Documentsyourprogress• Isrequiredbythirdpartauditsand

somebuyers• IsnotrequiredbytheFSMAProduceSafetyRule,butisa

goodidea!

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Summary

• Producesafetyimpactsyourfarm• Microorganismsaretheprimaryproducesafetyconcern

• Yourcommitmentiscriticaltosuccess• Producesafetyincludes:

– Assessingrisks,implementingpractices,monitoringpractices,usingcorrectiveactions,andkeepingrecords

– Providingthenecessaryresourcestogetitdone

• AwrittenFarmFoodSafetyPlanguidesyourproducesafetyefforts