Harris FSMA Update PSA 6-13-15

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6/14/15FoodSafetyModernizationActì (FSMA)Linda J. Harris, Ph.D.Specialist in Cooperative ExtensionUC DavisChestnut Growers of America Conference June 13, 2015Thanks to Michelle D. Danyluk, University of Florida for sharing her slidesFSMA updateJune 13, 2015ì Overviewì Produce Safety Ruleì Produce Safety Allianceì Preventive Controls Ruleì Food Safety Preventive Controls Alliance1

6/14/15What is the New Law?ì Food Safety Modernization Act(FSMA)ì Effective Jan 4, 2011ì Biggest change in food safetyregulation since 1938ì Federal Food Drug & Cosmetic ActWhat’s so Historic About the Law?ì Involves development of a new food safetysystemì Broad prevention mandate andaccountabilityì New system of import oversightì Emphasizes partnershipsì Emphasizes farm-to-table responsibilityì Developed through broad coalition2

6/14/15Lawsvs.Regulationsì Lawsì gulationsì Regula7onsì ì DevelopedbyAgenciestofulfillthoselawsSubstan7veì ì FinalRules–HavePowerofLawUseTerm“Shall”ì ì presen7ngcurrentthinkingonAgency’spartGuidanceì UseTerm“Should”ì ì ì ì ì elaw3

ompliance,and ResponseEnhancedPartnershipsImport SafetyInspection,ComplianceandResponseì Mandatedinspec7onfrequencyì Prescribeddependingonriskì NewtoolsforFDAì Mandatoryrecallì Expandedrecordsaccessì Expandedadministra7vedeten7onì Suspensionofregistra7onì Enhancedproducttracingì 3rdpartytes7ng4

6/14/15NewFoodSafetyRegulationsì ProduceSafetyRuleì Preven7veControlsforHumanFoodRuleì ForeignSupplierVerifica7onRuleì Preven7veControlsforAnimalFoodRuleì SanitaryTransportRuleì Inten7onalAdultera7onì tionsì ProduceSafetyRuleGrowersì Preven7veControlsforHumanFoodRuleì ForeignSupplierVerifica7onRuleì Preven7veControlsforAnimalFoodRuleì SanitaryTransportRule5

6/14/15NewFoodSafetyRegulationsì ProduceSafetyRuleì Preven7veControlsforHumanFoodRuleGrowersPackers who packon the farmì ForeignSupplierVerifica7onRuleì Preven7veControlsforAnimalFoodRuleì SanitaryTransportRuleNewFoodSafetyRegulationsì Preven7veControlsforGrowersPackers who packon the farmì ForeignSupplierPackers who packoff the farmì ProduceSafetyRuleHumanFoodRuleVerifica7onRuleì Preven7veControlsforAnimalFoodRuleì SanitaryTransportRule6

6/14/15THE PRODUCESAFETY RULEProduceSafetyRuleì ProposedrulereleasedJanuary2013ì 15,000ini7alcommentsreceivedì SupplementalrulereleasedSeptember2014ì 35,503coveredfarms(est.)7

6/14/15ProduceSafetyRuleì Science- g,packing,andholdingofproduceonfarms.ì Newstandardsinthefollowingmajorareas:ì ì ì ì ì red?ì uceunless ì ì Lessthan (foodsales 500,000)whoselldirectlytoqualifiedendusersì Consumers(anyloca7on)ì Restaurants/retailì In- ‐stateorwithin275milesì Evenifexemptì Packagingorpoint- ‐of- ‐salelabelingrequiredì Nameandaddressofbusiness8

6/14/15START HEREAre yearly TOTAL PRODUCEsales for the farm UNDER 25,000?(average of past 3 years)YESProposed RuleDOES NOT APPLYNOIs SOME of the produce grownspecifically exempt in theproposed rule?YES, one ormoreOnly those produce itemsARE EXEMPTNO, some isnot exemptAre yearly TOTAL FOOD salesfor the farm (exempt and nonexempt produce) OVER 500,000?(average of past 3 years)YESMUST COMPLY with theproposed ruleNONOAre MORE THAN 50% of yearlyTOTAL FOOD sales for the farmto “qualified end-users”(average of past 3 years)YESThe farm IS EXEMPT from theproposed rule (though you stillhave to follow labeling provisionsoutline in original Produce RuleSTART HEREAre yearly TOTAL PRODUCEsales for the farm UNDER 25,000?(average of past 3 years)YESProposed RuleDOES NOT APPLYNOIs SOME of the produce grownspecifically exempt in theproposed rule?NO, some isnot exemptAre yearly TOTAL FOOD salesfor the farm (exempt and nonexempt produce) OVER 500,000?(average of past 3 years)NOYES, one ormoreOnly those produce itemsARE EXEMPTQualified End-Users Consumerof the foodYESMUST COMPLY with theproposedrule Restaurant or retailestablishment withinstate or 275 mile radiusNOAre MORE THAN 50% of yearlyTOTAL FOOD sales for the farmto “qualified end-users”(average of past 3 years)YESThe farm IS EXEMPT from theproposed rule (though you stillhave to follow labeling provisionsoutline in original Produce Rule9

6/14/15Whatis/isnotcovered?ì Coveredì Domes7candimportedproduceì sandvegetables:ì theharvestablepor7on(includingpeels/shells)ì Notcoveredì List“rarelyconsumedraw”ì Producethatiscommerciallyprocessedì ?ì Coveredì Domes7candimportedproduceì sandvegetables:ì stoftheplantsell 100%theof ryourproductfor furtherIf youprocessing(i.e.juice, jam/jelly, canning, etc.) you fallì Notcoveredunder “commerciallyexemptionì List“rarelyprocessed”consumedraw”ì Producethatiscommerciallyprocessedì Musthaverecordsofwhoprocessedit10

6/14/15ExemptProduceRarelyConsumedRawArrowheadCrab applesParsnipsSweet EggplantPinto beansTurnipsAsparagusFigsPlantainsWater chestnutsBeetsGinger rootPotatoesWinter squash (acorn & butternut)Black-eyed peasKalePumpkinYamsBok choyKidney beansRhubarbBrussels sproutsLentilsRutabagaChick-peasLima beansSugar beetCollard greensOkraSweet cornApproachì ac7cesnot“highrisk”commodi7esì Allowsfordifferentprac7cesì Recognizesfurtherprocessesandrarelyconsumedrawì Recognizesnotallwaterorsoilamendmentsarethesameì i.e.,wildlife)11

6/14/15Workertrainingì Allpersonnelhandlingproduceorfood- ‐contactsurfacesorsupervisingthosewhodoì ì ì MAstandardsrelevanttojobì Harvestersneedaddi7onaltrainingì Recognizingcontamina7onì Inspec7ngcontainersandequipmentì Correc7veac7onsì Supervisors(atleastonefarmrep)ì StandardizedPSAcurriculumWorkerhealth&hygieneì Reassignmentofillworkersì Personalcleanlinessì Avoidanimalcontactì Handwashingì Visitorpolicy12

6/14/15Agriculturalwaterì eredproduceorfood- ‐contactsurfacesì Preharvestì irriga7onwaterdirectlyappliedì preparingcropspraysì Harvest/Postharvest(harves7ng/packing/holding)ì ì griculturalwaterì ce,distribu7onsystem,facili7esandequipment).ì WaterQualityProfileì Untreatedsurfacewaterì Minimum20samplesoverminimum2yearsì E.colilevelsin100mlì CalculateGeometricMeanandì Sta7s7calThresholdValueì Calcula7ontoolswillbeavailable13

6/14/15Biologicalsoilamendmentsofanimaloriginì Concernsmaterialthatì Contactscoveredproduceì Contactsproducecontactsurfacesì Poten7allycontaminatesagriculturalwaterBiological soil amendments of animal originFurther guidance expected Raw manure*ì To be further studied.ì 90/120 NOP standard Treatedì Physical/chemical process (validated)ì Composting (prescribed conditions)ì No time interval, BUT: Must meet microbial standard14

6/14/15Domesticatedandwildanimalsì Domes7c/WorkingAnimalsì zeì plantedì WildAnimalIntrusionì oharvestì ipment,tools,andbuildingsì Likelytocontactcoveredproduce:ì ,harves7ng,waxing,cooling,packing,etc.ì orageoffood- ‐contactsurfaces15

6/14/15Equipment,tools,andbuildingsì Designmustallowadequatecleaningandmaintenanceì sì Cleanandsani7zeasnecessaryì Adequatedrainageofdischargeinandnearbuildingsì Restrooms&handwashingfacili7esWhat is expected?ì Preventive controlsì Documentation!ì Worker training, health, and hygieneì Agricultural waterì Biological soil amendments of animal originì Domesticated and wild animalsì Equipment, tools, and buildings16

6/14/15THE PREVENTIVECONTROLS RULEThis section is truncated because it was not covered in the presentation.NewFoodSafetyRegulationsì Preven7veControlsforGrowersPackers who packon the farmì ForeignSupplierPackers who packoff the farmì ProduceSafetyRuleHumanFoodRuleVerifica7onRuleì Preven7veControlsforAnimalFoodRuleì SanitaryTransportRule17

6/14/15PreventiveControlsRuleì Modernizeì CurrentGoodManufacturingPrac7cesRegula7onì Addì ndrisk- ofcGMPsì gula7onsì Replaces21CFRpart110,currentGMPswith21CFRpart117ì Includesalmosteverythingcurrentlyinpart110ì Addspreven7onof“cross- ‐contact”andotherallergencontrols18

6/14/15PreventiveControlsRuleì dsafetyplan,whichwouldincludethefollowing:ì HazardAnalysis;ì RiskbasedPreven7veControls;ì Monitoringprocedures;ì Correc7veac7ons;ì Verifica7on;andì RecordkeepingKeyrequirementsofafoodsafetyplanì nì onì Individual19

6/14/15WhoisaQualifiedIndividual?ì plica7onofriskbasedpreven7vecontrolsì TrainingrecognizedbyFDAì ndardizedtrainingcurriculumì Trainingmustbedocumentedì esì Valida7onofPreven7veControlsì andappropriatenessofcorrec7veac7onsì ReanalysisofFoodSafetyPlan20

6/14/15Summaryì ram,similartotheLGMAandT- ‐GAPsì ThePreven7veControlsRuleissimilartoaHACCP- ‐basedsystemCompliance Dates by Business alLargeSmallV.SmallWater21

6/14/15Compliance Dates by Business argeSmallV.SmallBusinesssizeì Smallbusinessesì 500personsì Verysmallbusinessesì 1Mtotalannualsales)22

6/14/15Trainingì ual”–availableAFTERfinalruleì ProduceSafetyAlliance:ì 2dayworkshopì hVp://producesafetyalliance.cornell.edu/ì FoodSafetyPreven7veControlsAlliance:ì 2.5dayworkshopì hVp://www.iit.edu/ifsh/alliance/Curriculumì Preven7veControlsì Workerhealth,hygiene,andtrainingì SoilAmendmentsì Wildlifeanddomes7canimalsì Produc7onwaterì Postharvestwaterì nell.edu23

6/14/15Curriculumì HARPC- ‐basedfoodsafetyplanì GMPsandotherprerequisiteprogramsì Hazardsì Hazardanalysisì FoodallergenPCì Sanita7onPCì Supplierprogramì Recallplanì Verifica7onandvalida7onì Recordkeepingì Resourcesì FDA’sFSMAWebsiteì ì TradeAssocia7onsforProduceì ì ì ì p://www.pma.com/resources/hot- ‐topics/food- ‐safety- ‐moderniza7on- ews/food safety resource center/food safety moderniza7on act w.im.org/public- ‐policy- ‐and- ‐regula7ons/fsma/Ucfoodsafetyì hVp://ucfoodsafety.ucdavis.edu24

6/14/15 2 What is the New Law? ! Food Safety Modernization Act (FSMA) ! Effective Jan 4, 2011 ! Bi

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