university of maryland –jifsan- 5f...system to highly rigorous systems (for example, iso 10725...

University of Maryland –JIFSAN-

University of Maryland –JIFSAN- Laboratory Capacity Building Needs at FSSAI.

Janie Dubois, PhD

University of Maryland, JIFSAN June 15, 2017


Table of Contents

Objectives of Laboratory Capacity Building ......................................................................................................................... 3Methodology .......................................................................................................................................................................... 3FSSAI Laboratory Capacity Building Prioritization ............................................................................................................. 6

1- Information Dossier ....................................................................................................................................................... 62- Capacity Building Choice Set ....................................................................................................................................... 93- Define Decision Criteria and Weights ......................................................................................................................... 104- Information Cards ........................................................................................................................................................ 105- Selection of Priorities .................................................................................................................................................. 10

Conclusions .......................................................................................................................................................................... 13Appendix 1: Participants in discussions for prioritization ................................................................................................... 14Appendix 2: Information Cards ........................................................................................................................................... 15


LaboratoryCapacityBuildingNeedsatFSSAI

ObjectivesofLaboratoryCapacityBuildingTheobjectiveoftheGFSPprogramforlaboratorycapacitybuildingistodeveloptrainingresourcesforlong-termimpact.Weaimtodevelopskillswheretheyareneededandverifythattheskillsareacquiredthroughproficiencytesting.Finally,wewanttosupportthereproductionoftrainingworkshopandtheimplementationofsustainabletrainingresourcestoensureimpactinthelongterm.

MethodologyInordertodesignahumanresourcescapacitybuildingplanwithFSSAI,weneededtounderstandthestructureofthefoodcontrolsystemandtheplaceoflaboratories.Furthermore,weconsideredtheexpansionofinfrastructurearoundthecountrythatisongoingaresultofagapanalysisperformedinternallyin2015(outcomesreportedinthe16thMeetingofCentralAdvisoryCommitteeofFSSAIonFebruary3rd,2016)following(largely)the“Maggienoodle”problem.Thisevaluationneededtobeperformedwithina2-monthperiodandwithoutvisitsinIndia.Toolsused:

• AnonlinesurveyofparticipantsinGFSPtraining• Mediasurvey(deskwork)• InformalinterviewsparticipantsinGFSPtraining(facetofacemeetings)• Additionalinformalinterviewswithstakeholders(facetoface)• ThelistofpersonsinvolvedanddatesofmeetingsisavailableinAppendix1.

ThemethodologyusedforprioritizationwasdevelopedaspartofanAsiaPacificEconomicCooperation(APEC)projectundertheFoodSafetyCooperationForum'sPartnershipTrainingInstituteNetwork(PTIN)in2013.ThelaboratorycollaborationprograminAPECconsistsoffivecriticalcomponents:

1. Accreditation.EstablishingorleveragingexistingLabAccreditation/QualityAssurancemeasures.ThisincludessharingSOPs,bestpractices,identifyingscopeofaccreditationandrecommendingsourcesforgapanalysis.Laboratoriescanrangefromnoqualityassurancesystemtohighlyrigoroussystems(forexample,ISO10725accredited).Currentlaboratorystatuswilldictateneedsassessment.

2. ProficiencyTesting(PT).Thisincludestheidentificationofprogramsandleveragingofavailableresourcesandreferencematerials.Whileusuallyincludedunderlaboratoryaccreditation/qualityassurance,itisseparatedtoemphasizetheimportanceofparticipationinaPTprogram.PTsamplesareadirectmeasurefordemonstratingtestingcompetency.

3. Training.Utilizingcurrentprograms,includinggovernmentsponsoredtrainingcourses,andinternationaltraininglaboratories,amongothers.Trainingwillcoverscreeningandconfirmatorytesting.Prerequisitescanbesatisfiedbydevelopingweb-basedmodulesorthroughexistingtrainingmaterialavailablefromgovernmentagenciesandotherorganizations.

4. LaboratoryInfrastructure.Thisincludesrecommendationsforcurrentandnewtechnologiesandequipmentutilizedbyregulatorylaboratories.Basedoncurrenttestingmethodologies,guidancecanbeprovidedastowhatequipment,standardsandreagentsaremostsuitablefortestmethods.Althoughflexibilityinmethodselectionexists,eventually,equipmentplatformsfortestingwillharmonize.

5. Methods.Thisincludessharingcurrentfoodtestingmethods(microbiologicalandchemical)andmethodvalidationprotocols,aswellasparticipationincollaborativestudies.Methodvalidationcriteriacanalsobecapturedunderlaboratoryaccreditation/qualityassurancebutisincludedheretohighlighttheimportanceofmethods,theirintendeduseandperformance.


APEC Food Safety Cooperation Forum Tool Facingthechallengeofinvestinginasingleactivityeachyear,itwasobviousthatthetaskofselectingsuchactivitydemandedanevaluationofmanyfactorsthatwerenotseenasequallyimportantbydifferentstakeholdersandacrosstheregion.Tothiseffect,aScientificandTechnicalAdvisoryGroup(STAG)wasgatheredintheSpring2013todevelopatoolfortheprioritizationoflaboratorycapacitybuildingactivitiesthatcouldbeusedindependentlybynationalorregionalgovernmentsorstakeholdersgroupstodecidetheirownprioritiesforinvestments.A“mini-STAG”reflectedthepublic-privatepartnershipmodelofthePTINandwascomposedofexpertsfromUSDA(Dr.CharlesPixleyandDr.EmilioEsteban,Mrs.CathyMcKinnel,Ms.KellyMcCormickandMrs.FaniaYangarber),U.S.FDA(Dr.ElizabethCalvey,Dr.PalmerOrlandi,Mr.CarlSciacchitano),academia(Dr.JanieDubois,UniversityofMarylandJIFSAN),andindustry(Dr.DeAnnBeneshof3M,Dr.WayneWargoofAbbottNutrition).Theteamdevelopedacapacityassessmenttooltoenableabetterunderstandingofcurrentanddesiredcapacity.ThedrafttoolwaspresentedanddiscussedataSTAGmeetinginNovember2012inWashingtonDC.Itwasagreedthateconomieswouldvolunteertoconductapilotapplicationoftheprioritizationtooltosupportfurtherdevelopment.ChileandChinawereannouncedasthepiloteconomiesattheAPECSOMIImeetinginIndonesiainApril2013.Therewerestrongimperativestoavoidduplicatingexistingresourcesinthisproject,soassessmentandprioritizationtoolsusedbyinternationalorganizationwereinvestigatedbyJIFSAN(UniversityofMaryland’sJointInstituteforFoodSafetyandAppliedNutrition),theprogramimplementationorganization.TheWorldOrganizationforAnimalHealthToolfortheEvaluationofPerformanceofVeterinaryServices(OIEPVS)toolwasselectedasagoodmodelforassessment,andtheMultiCriteriaDecisionAnalysisdevelopedtoprioritizeSanitaryandPhytoSanitarycapacitybuildingneedsattheStandardsandTradeDevelopmentFacility(STDF)couldbetailoredtofitthepurposeofprioritizationforlaboratorycapacity.Moreinformationmaybefoundusingtheselinks:OIEPVS1andSTDFP-IMA2.FrameworkforPrioritizationTheobjectiveofthedecisionframeworkistoprovideatransparenttooltoprioritizelaboratorycapacitybuildingactivitiesandtheunderlyingfoodsafetyissues.ThedevelopmentisbasedonworkbyHensonandMasakuredetailedinthedocument“EstablishingPrioritiesforSPSCapacity-building:AGuidetoMulti-CriteriaDecision-Making”3fromnowonreferredtoas“theGuide”.AsexplainedintheGuide,“theframeworkisdesignedforapplicationtochoicesbetweenrelativelylargenumbersofoptionsthatcandiffermarkedlyintheircharacteristicsandtheassociatedflowofcostsandbenefitsovertime,includingvariouselementsoffoodsafety,(…).Further,itpermitsprioritiestobedefinedonthebasisofmultiplecriteriawhichmightbemeasuredinadisparatemannerandassigneddifferingweights.”Theframeworkisdesignedusingsevenstages.Stage1:CompileInformationDossierTheinformationdossierisacollectionofinformationthatshouldbeusedtodefinecapacitybuildingoptionsandrankthem.Itincorporateseconomic,trade,healthandotherrelevantdata.Forthissection,

1 http://www.oie.int/support-to-oie-members/pvs-evaluations/oie-pvs-tool/ 2 http://www.standardsfacility.org/sites/default/files/P-IMA_Guide_EN.pdf 2 http://www.standardsfacility.org/sites/default/files/P-IMA_Guide_EN.pdf 3 http://sasec.asia/uploads/events/2014/tfweek-2014/am/stdf-establishing-priorities.pdf


thelistofindicatorsdevelopedbyregulatorsandindustryfortheAPECworkwasusedhereasthebasisforcomparisonofoptions.ThehierarchyoffactorsandcriteriausedforcomparisonisillustratedinFigure2andbrieflydescribedbelow.

Publichealthimpactisanindicatorthatwillbemeasuredusingtwocriteria:Thepotentialtopreventillnessandtheneedtoaddressanoutbreak.Thedatausedtoevaluatethesecriteriashallinclude

• Aquantitative,orsemi-quantitativeevaluationofthediseaseburdenthatmaybeaddressedbytheoption(i.e.isthereahealthproblem?)

• Datafromtheregion(ideally)abouttheimpactoftheoptionondiseaseburden(i.e.hasthisshownanimpactondiseaseburdensomewhere?)

• Dataontheextentofacurrentoutbreakandthelikelihoodthatitwillberesolvedwithouttheapplicationoftheoption(i.e.willthisoptionatleastpositivelyinfluencetheresolutionoftheoutbreak)Difficultyofimplementationisanindicatorofthelikelihoodthattheoptionwillactuallybeappliedifitisfoundtobeapriority.Criteriaforthisevaluationaddressmanagementbuy-in,availabilityofpersonnel,aqualitativeevaluationofthechancesthattheoptionwill

notyieldthedesiredoutcome(i.e.solvethefoodsafetyissueitismeanttoaddress),andaqualitativemeasureofalignmentwiththeoverallstrategy.Thelattercriterionisessentialtoensurethattheresourcesneededfortherealizationofthecapacitybuildingoptionwillbeavailableandforlongenoughtobeabletoreachthedesiredoutcome.Tradeimpactisanindicatorthatcanbemeasuredwithtwocriteria:Tradeexpansionpotential(openingnewmarkets)andtradelossthatwillberegainedasaresultofthisoptionbeingappliedandsuccessful.Thesecriteriaarebestrepresentedbyquantitativedata(inU.S.dollarstofacilitatediscussionsacrosseconomies).Inthecaseofthisactivity,weusedtradelossinformationfromstatisticspublishedbytheUSandEUonimportrejection.Finally,thecostsassociatedwiththeoptionaremeasuredquantitativelyanddividedintothetwocategoriesofinitialinvestmentandimplementation(andcontinuousapplication)oftheoption.Thesecondcategoryshallbeevaluatedonaper-yearbasisconsideringtheloadofsamplesnowandinthefuture,thesavingsresultingfromswitchingtothisoptionifitreplacesanotheroptionandothersimilarfactors.Inthisparticularactivity,theongoinginfrastructuredevelopmentofFSSAIwasconsideredanimportantfactorandthecostsassociatedwiththisplanwereperceivedasalreadyincurred.Stage2:DefineChoiceSetThesecondstageoftheprioritizationactivityistodefineasetofcapacitybuildingoptions.Inthecurrentexercise,onlylaboratorycapacitybuildingoptionsrelatedtodevelopinghumanresources(i.e.training).ThecompletesetdevelopedintheAPECprojectwasproposed,buttheparticipantsrefinedtheoptions.Duringtheconversations,participantswereaskedquestionsaboutthedifferentoptionsandweregiventheopportunitytodiscussthemcasually.

Figure1:Indicatorsandcriteriatocompareoptions.


Stage3:DefineDecisionCriteriaandWeightsDecisioncriteria,indicatorstheimportanceofeach,whichwilltranslateintotheirweights,wereorganicallyselectedthroughthepilotworkinAPECandappliedherewithconsiderationofthecontext,especiallyasitrelatestoFSSAIinfrastructureexpansionplans.Stage4:ConstructionofInformationCardsTheinformationcardsarethegatheringplaceforalltheinformationbrieflyintroducedbefore,whereeachindicatorandcriteriaareevaluatedforeachoption.Thecriteriaencompassbothquantitativeandqualitativedata,andthediscussionsthatledtotheinformationincludedinthecardsalsoconsideredthelevelofconfidencefeltabouttheinformationbytheimplementer(JIFSAN).Stages5-7concerntheanalysisofthisinformation,eithermanuallyofusingstatisticalsoftware,anddecisions.Statisticalsoftwareismoreappropriatewhendetailedinformationabouthealthimpact,availableresources,costsandtradevaluesareconsidered.Theshortperiodallocatedforthisprioritizationactivitydidnotpermitacompilationofdetailedinformationthereforeasimplemanualanalysiswaspreferred.

FSSAILaboratoryCapacityBuildingPrioritization

1-InformationDossier 1.1FoodControlSysteminIndiaThestructureofthefoodcontrolsystemisbasedontheFoodSafetyandStandardsActof2006.TheFoodSafetyandStandardsAuthority(FSSAI)isresponsibleforthecontrolofdomesticandimportedfoods.ItsCommissionerofFoodSafetyappointsfood-testinglaboratories,whichplayrolesinathree-levelsystem.BothpublicandprivatelyownedlaboratoriesmaybecomeFSSAInotifiedlaboratories,butReferralLaboratoriesarepartoftheFSSAI.TypesofFSSAINotifiedLaboratories:

Level1:FoodProductsStandardsandFoodAdditivesLevel2:Contaminants,ToxinsandResiduesReferral:R&Dcapabilities,trainingfacilities,analyticalcapacityandinvestigation

Finally,allFSSAInotifiedlaboratoriesmustbeaccreditedbytheNationalAccreditationBoardforTestingandCalibration(NABL)accordingtothestandardISO17025.1.2RecurringProblemsatExportasanIndicatorThisprioritizationislargelybasedonopinionsfromanalysts.However,beyondinterviewswithanalystsintheFSSAIjurisdiction,itisusefultolookattradedatatoevaluatethetypesoflaboratoryteststhatwouldrespondtothegreatestsourcesofimportrejections.Rejectionofexportedcommoditiesistypicallyindicativeofproblemsthatarewidespreadinthedomesticproductionaswell.ExportrejectionsfromtheEuropeanUnionwereusedtoprioritizethefirststepoftheprojectinIndia,wherepesticideresidues,veterinarydrugsandmycotoxinswereselected.USFDAimportrejectiondatafrom2005to2013wasevaluatedbytheUSDAEconomicResearchServiceandtheyidentifiedthatthemainproblemswithIndianfoodcommoditiespresentedforimportationintotheUnitedStateswereSalmonellacontamination,pesticideresiduesandthepresenceoffilth.Thisdatadoesnotincludemeatandpoultry,forwhichthereisessentiallynotradebetweenthetwocountries.SimilarinformationwascompiledbyUNIDOfortheUSandEUfor2002-2008inaworkingpaperentitled" WhatdoBorder


RejectionstellusaboutTradeStandardsComplianceofDevelopingCountries?"4andreproducedinFigures1and2.

Figure1:LargestsourcesofimportrejectionsofIndiancommoditiesbytheEU2002-2008.

Figure2:LargestsourcesofimportrejectionsofIndiancommoditiesbytheUS2002-2008.Acloserlookatrejectionsandimportalertsfrom2016indicatesthatspices,processedfoodandfeed,rice,seafoodandproduceshowthemostproblems(table1).Shipmentrejectionsindicatetherejectionofindividualconsignments,whileimportalertsindicatethattheFDAsuggeststhatparticularcommoditiesimportedbyspecificfirmsnotbeacceptedforimportwithoutevidenceprovidedbythefirmthattheproductscomply.Soanimportalertmaylist1firm,or50firms.Putsimply,importalertsareindicativeofrecurringproblems,asopposedtorejectedshipmentswhichconcernonlyoneshipmentatatime.

4https://www.unido.org/fileadmin/user_media/Services/Industrial_Competitiveness/Trade_Capacity_Building/rejection_analysis.PDF


Table1:ImportalertsandrejectiondataforIndiancommoditiesbyUSFDA(2016).Notethattherewerenoimportalertsonrice.1.3RelevantIssuesIdentifiedin2015ThereviewofthefoodcontrolsystemconductedinternallyinFSSAIin2015islargelyreportedintheminutesofthe16thMeetingofCentralAdvisoryCommitteeofFSSAIonFebruary3rd,2016.Theobservationsrelatedtolaboratories,whileintheprocessofbeingaddressed,arestillrelevant:

• Lackofadequatehumanresources• Outdatedinfrastructure• Shortageofreagentsandsuppliestocarryouttests• Moststatelaboratoriesarenotfullyfunctionalandcannotperformallthreewingsofmandate

(chemical,microbiologicalandheavymetalsanalyses)• Financialconstraintsinmostofthestatelaboratories

Highsampleload Lackofappropriateequipmentforcontaminantsandsampleload StatelabshavelittletonocapacityinmicrobiologyFirst,laboratorieslacksufficientnumbersoftrainedanalystsandscientiststoreviewthedata.Theyoftenoperateininadequateinfrastructurethatcannotsupporttheinstallationofthelaboratoryequipmentneededtotestagainstmodernstandards.ThemediawidelyreportedthatmostlaboratoriesattheStatelevelcannotperformalloftheirfunctionsduetotheinfrastructureandstaffshortcomings.Statelaboratories(especially)arenotadequatelyfundedtopurchasethesuppliestheyneedtohandlethesamplethroughputexpectedfromthem.Itisnotclearthatthenewpartialcentralcontroloffundswillresolvethisissuebecauseofanoverallunderfundingofthefunctions.Finally,themediaalsoreportsthatfocusofmostlaboratorieshasbeenchemicalcontaminants,butthechangingdemographics(moreready-to-eatfoodsinurbancenters,lesstimetocook,lesstraditionalfoodsthatareboiledforlongperiods)willveryrapidlyemphasizethedeficienciesinthecapacitytotestformicrobialpathogensinfood.1.4OpinionsofAnalystsandManagers


JIFSAN,onbehalfoftheGFSP’sLaboratoryCapacityBuildingProgramconductedashortreviewofprioritycapacitybuildingneedsinfoodcontrollaboratoriesinthe3monthsbetweenthefirstGFSP-sponsoredtraininginSingapore,andthismeeting.

a. PerceptionofSupportWefirstaskedanalystshowtheyfeltabouttheirworkandtheirlaboratories.Mostanalysts(theexceptionbeinginreferrallabs)feelisolatedintheirlaboratory;theyfeelthattheydonothaveagroupofpeersthattheycanreachouttowhentheyneedsupport.Analystsalsofeelthattheworkloadisdisproportionalwiththeinfrastructureandequipment.Longhours,farbeyondthe“normalworkday”areneededtomeetthesamplethroughputdemand.

b. PerceptionofSkillsIntermsoftechnicalskills,wefoundanalystsconfidentabouttheirskillsandalsorealisticaboutthescopeoftheirtechnicalskills.Adifferenceitseenbetweenhighlyskilledanalystsandnewerrecruitsintermsoftheirpriorities.Lowerskilledanalystsshowastrongdesiretolearnandincreaseboththebreadthskillsandtheirnetworkofpeers,whilethe(oftenmoresenior)highlyskilledanalystsfeelsomewhatfrustratedbyalackofinclusionofscientistsinmanagementdecisions.Theyalsofocustheirconcernsonthemissionoftheirlaboratorywhenaskedaboutgrowthandfeelthatthelackofinfrastructureandlatesttechnologiesispreventingthemfromachievingtheirgoals.Thisindicatesthatthedesirefortrainingisaverypersonaloneamongneweranalystsandlackoftrainingopportunitiesfortheirstaffnotperceivedasaroadblockbythemanagerswhoaremoreconcernedwithinfrastructures.Managersfeelthatprovidedtheinstruments,theywillbeabletotraintheiranalysts.Thereviewdidnotdiveintotheindividuallaboratoryneedsinmicrobiologyinlargepartbecausetheintervieweesinpubliclabswereallchemists.Nevertheless,wewishedtolookintotheneedsinmicrobiologyinordertoplancapacitybuildingactivitiesinthemediumterm,soweinitiateddiscussionsinthegroupsandaninterviewwithanAdvisortoFSSAI.Wealsousedthetradedata,morespecificallythereasonsforimportrejectionsrelatedtomicrobiology.

2-CapacityBuildingChoiceSetThesecondstageoftheprioritizationactivityistodefineasetofworkforcecapacitybuildingoptionstoprioritize.ThelistcompiledbytheAPECgroupforgeneralusewasconsideredadequate:

• Screening(rapid)methodsformycotoxins• Confirmationmethodsformulti-mycotoxins• Methodsformulti-residuesofveterinarydrugs• Methodsformulti-residuetestingofpesticides• Non-targetedcontaminantsanalysis• Screeningmethodsforindustrialchemicals• Advancedmassspectrometry(forcontaminants)• Validationofchemicalmethods(includingmatrixextension)• Generalfoodmicrobiologytraining• Rapid(molecular)methodsforfoodmicrobiology(rtPCR-based)• WholegenomesequencingtoreplacePFGE(PulseNetforoutbreaks)• Screeningmethodsinfoodmicrobiology• Methodsforthedeterminationoffilth• MethodsforthedeterminationofSalmonella• MethodsforthedeterminationofE.coli(STEC)• Validationofmicrobiologicalmethods


3-DefineDecisionCriteriaandWeightsThecriteriaofpublichealthimpact,easeofimplementation,tradeimpactandcostsasdefinedintheAPECprojectwereusedwithoutchanges.Weightsforthecriteriawerenotpredefinedandallcriteriawereconsideredequal.

4-InformationCardsAninformationcardisthecollectionofdata,discussionpointsandrelevantinformationabouteachoptiononthechoiceset.Theinformationisbydefinitionbiasedbytheparticipantsinaconsultation,whominthiscasewerealmostexclusivelychemicalanalysts.ThetradeimpactinformationwasalsolimitedtotradewiththeEUandUS.Finally,thecostandeaseofimplementationwereapproachedfromaGFSPperspective,whereweconsideredbothin-countryresourcesandaccesstoGFSPpartners.TheinformationcardsforeachoptionareavailableinAppendix2.

5-SelectionofPriorities PhaseofthelaboratorycapacitybuildingprojectattheGFSPfocusedonchemicalanalysisandaddressedthetopicsofmethodsofdeterminationforpesticides,mycotoxinsandveterinarydrugsinfood.TheyareidentifiedinTable2.PrioritiesforPhase2ofLaboratoryCapacityBuilding:1-Chemistry

• Screeningmethodsforindustrialchemicalresiduesinfood• Advancedtraininginmassspectrometry(forcontaminantresiduesinfood)• Trainingonmethodvalidation,includingmatrixextension

2-Microbiology• Traininginrapid(focusonmolecular)methodsformicrobialcontaminantsinfood• MethodsofdeterminationofSalmonellainfood• Standardmethodsforthedeterminationoffilth

Theseprioritiesweredeterminedbasedonthescoresobtainedusingthemulti-criteriadecisionanalysisdescribedabove.Table2summarizesthescores.


Table2:Scoreandselectionofprioritiesforphase2oftheGFSPproject.

LaboratoryCapacityBuildingOptionsTotalscore

ProposedPhase1-2

"Chemistry" Screeningmethodsformycotoxins 10-$ Confirmationmethodsformulti-mycotoxins 14-$ Phase1Methodsformulti-residuesofveterinarydrugs 12-$ Phase1Methodsformulti-residuetestingofpesticides 15-$ Phase1Non-targetedcontaminantsanalysis 6-$ Screeningmethodsforindustrialchemicals 12-$ Phase2Advancedmassspectrometry(forcontaminants) 12-$ Phase2Validationofchemicalmethods(incl.matrixextension) 11-$ Phase2

"Microbiology" Generalfoodmicrobiologytraining 9-$ Rapid(molecular)methodsforfoodmicrobiology(rtPCR-based) 11-$$ Phase2WholegenomesequencingtoreplacePFGE 8-$ Screeningmethodsinfoodmicrobiology 11-$$ Methodsforthedeterminationoffilth 12-$ Phase2MethodsforthedeterminationofSalmonella 13-$ Phase2MethodsforthedeterminationofE.coli(STEC) 11-$ Validationofmicrobiologicalmethods 5-$

RationalefortheSpecificTrainingNeedsinChemistryThescoresobtainedintheevaluationofoptionsareusedtodeterminepriorities.ThethreeprioritiesaddressedinthefirstphaseoftheGFSP-FSSAIprojectareindicatedinthetableandcorrespondtosomeofthehighestscoringoptions.Theadditionaltrainingneedsemphasizedbytheparticipantsincludedbothanalyticalmethodsandskillstousethedatageneratedbythesemethods,atopicthatwasraisedaspartofthemethodvalidationoption.Thereisadesiretobeabletoreviewdataforconformanceasameansofaccessingpromotions,butalsoadesirebyhigher-levelmanagerstousethedatainriskanalysistodevelopIndianstandardsfordomesticfoods.Theseaspectswerenotpartofthecriteriaforselection,butareworthmentioninghere.Analystsalsoindicatedthattheydidnotknowof,orcompletelyunderstand,thesamplingplansthatleadtothesamplestheyreceiveinthelaboratories,whichinturnleadsthemtoquestionhowrepresentativethesamplesare.Methodsvalidationwouldincludethesubjectofsampling.Finally,benchanalystsdonotfeelconfidentaboutwritingStandardOperatingProceduresandwishtorelyonSOPswrittenbyothers.WhilethisprocessworkswellinhighlyhierarchicalorganizationssuchasFSSAIanditsreferrallabs,itisasignificanthurdleforsmallerorganizationslikeStatelaboratories.PrivatesectorlaboratoriesdidnotsharetheneedfortraininginQAorscientificprinciples.Thesetopicsweredeemedpartofthemethodsvalidationoption.Theprinciplesoftheanalyticaltechniquesaswellasthebiochemistryofthecommoditiesandfoodsthemselveswereconsideredaneedthatmaybefulfilledwithliterature,butanalystsdon’tknowwheretofindit.Weincludedthesetopicsintheoptionofadvancedmassspectrometrytraining.


Asameansofcomparisonforthedemandplacedontheanalysts,wecanlookattheUSandEUsystems.IntheUS,regulatorylaboratoriesalmostexclusivelytestagriculturalcommodities…CommoditiesarerelativelysimplerwitheitherhighwaterORhighfatcontent,acidoralkalinepH,andaneedtotestforeitherpesticidesorveterinarydrugsforexample.IntheEU,alargenetworkofreferencelaboratoriesisheavilyfundedtodevelopandseetothevalidationanddeploymentoffit-for-purposemethods.TheIndiansystem,whichhasalargecomponentoftestingonfinishedfoods,requiresanalyststotestcomplexfoodproductscombiningmanyagriculturalcommoditiesandconsequentlyrequiringtestingformanyclassesofcontaminants.AnalystsfeltthattheIndiansystemwassimilartotheEUwhentheFSSAImethodsmanualwasprescriptiveandverydetailed,butthatthecurrentmanualdoesn’tprovidethemwiththemethodsthattheyneed.SinceWesternscientistswholargelydonotdealwithfinishedfoodspublishmostanalyticalmethodsinthepeer-reviewedliterature,thereisverylittleinformationavailableonmethodsadaptationforcomplexmatrices.Thishadalargeinfluenceonthedesiretoseetheoptionofmethodsvalidationgetimplemented.SpecificTrainingNeedsinMicrobiologySimilarlytotheobservationinchemistry,microbiologicallabsfeelthatthefoodcontrolsystemwillnotbeabletomeetthesamplethroughputneedswithtraditionalmicrobiologicalmethods,supportingthehigherscoreobtainedfortheoptionoftraininginrapidmolecular-basedmethods.ThisprivatelaboratoriesmentionedalreadybeingequippedwithmolecularmethodsandlooktomoveintowholegenomesequencinginthefuturetomatchthedataavailableintheWestforoutbreakinvestigation(asafee-for-servicetoexporters).ThepublichealthlaboratoriesseetheglobalPulseNetsystemmovingtoWholeGenomeSequencing,butitisstillnotperceivedasessential(amongthegroupinterviewed).Interestingly,filthanalysiswasatopreasonforimportrejection,butintervieweesdidnotbelievetheseanalysesaredoneintheirlaboratories.FilthanalysisandSalmonellascoredhighbecauseofthetradeconcernsandeaseofimplementation,whilethisgroupdidnotrecognizeahighpublichealthimpact.Theneedsidentifiedwere:1.Screening(rapid)methodsbasedonmoleculartesting2.Adaptedconfirmationmethods,probablyusingtraditionalselectiveculturemethods(tokeepcostslow)andtheorganismofgreaterinterestforinitialtraining:Salmonella -WholegenomesequencinginReferralLabsforoutbreakinvestigation3.FilthanalysistoreducetradeimpactSpecificNeedsinLaboratoryOperationsSupportLastbutnotleast,analystsraisedtheissuesassociatedwithmoderninstrumentmaintenance.Whileanalystsdonotfeelitshouldbetheirjobtomaintaininstruments,theydowishtohaveaccesstotrainedengineerswhowouldperformthismaintenanceforthem.Skillsforbasictroubleshootingshouldbedevelopedateachlaboratory,andanalystsfeelthatcentrallylocatedresourcescouldsupportformorecomplexissues.Tobeclear,analystsrealizethatinternalsupportcannotreplaceserviceengineersfromthevendorsforrepairs,buttheyfeelthatthein-houseserviceshoulddealwithwhatisperceivedinWesternlabsasin-housemaintenance.FinallyStatelabsespeciallyfeelthatthedevelopmentandmaintenanceofasourcingsystemforreagentsandkitswouldhelpmeetworkloadrequirementbyavoidingdowntime.Amongthemanyadvantagesperceivedbyanalysts,avoidingdowntimeduetodelaysindeliveries,loweringcostsandalsoaligningmethodswithotherlabsthroughthedecision-makingprocessofselectingwhattokeepininventorywereveryimportanttothem.


ConclusionsLaboratorytrainingneedsarebroadinscope,butanalystsnowfeelthattheexpertiseisavailableinIndiainmanyareasofneed(especiallythoseaddressedinphase1oftheGFSP-FSSAIproject),andonlyrequirestobemanagedforeffectivedeploymentacrossagenciesandlaboratoriesthroughtrain-the-trainerprograms.Asetofthreeadditionaltrainingtopicswasselectedtoproposeforthesecondphaseoftheprojectbasedontherelevancetobothtradeandhealth,andingeneral,thedifficultyofimplementationwasnotperceivedasahurdle.Therewasnotanequivalentconfidenceintheavailabilityoftrainersinmicrobiology,butitcouldbeduetotheinterviewpoolthatwascomposedlargelyofchemistsandafewlaboratorymanagers.Discussionsindicatedthatanalystswantmorenetworkingopportunitiesandmoderninstrumentstomeetthedesiredsampleload.Analystswantmorestandardmethodsfitforthecommoditiestheyaregiven(especiallyforprocessedfoods).Finally,asupportsystemintermsofinstrumentmaintenanceandprocurementwassuggestedthatcouldfacilitatetheexpansionoftheFSSAIportfolioofanalyses.


Appendix1:Participantsindiscussionsforprioritization

Date:December9,2016 GroupdiscussionMr.M.A.Sreenivasa CSIR-CentralFoodTechnologicalResearchInstitue,MysoreMrs.ArunaBandil FoodSafety&StandardsAuthorityofIndia,DelhiMr.SurenderSinghRaghav FSSAI,GhaziabadMr.HemantKulkarni StatePublicHealthLaboratory,PuneDr.Rajesh.R ExportInspectionAgency,KolkotaDr.PritiAmritkar EnvirocareLabsPvtLtd,ThaneDr.ArchnaTiwari FoodSafety&StandardsAuthorityofIndia,Delhi

Dr.AparnaPharandeAshwamedhEngineers&Consultants-LaboratoryServicesDivision,Nashik

Dr.DebaduttaMishra CentralFoodLaboratory(FSSAI),KolkataDr.CherukuriSreenivasaRao Director,NationalInstituteofPlantHealthManagement,Hyderabad

Date:April27,2017 GroupdiscussionDr.SatyenKumarPanda IndianCouncilofAgriculturalResearch,CochinDr.AnoopA.Krishnan ExportInspectionAgency,KolkataDr.PrasannaKumarPatil CentralInstituteofBrackishWaterAquaculture,ChennaiAnupamGogoi Govt.ofAssam,StatePublicHealthLaboratory,GuwahatiMs.KanikaAggarwal FoodSafety&StandardsAuthorityofIndia,NewDelhDr.RakeshKumarTirpude FoodandDrugLaboratory,Mumbai

Date:April28,2017 Privatemeeting

Dr.BhaskarNarayanADVISOR,FOODSAFETY&STANDARDSAUTHORITYOFINDIA(FSSAI),NEWDELHI

Dr.ShrinivasJoshi WatersPvtLtd,Bangalore

Date:June1,2017 GroupdiscussionMr.ZavierT.V. SpiceBoardQualityEvaluationLaboratory,KochiDr.PrasannaVasu CFTRI,MysoreMs.Vanajakshi CFTRI,MysoreSri.ChabungbamSanajaobaMeitei StatePublicHealth,ManipurDr.ChetanT.P. StateFoodLaboratory,BangaloreMs.SharadaH.Roddammanavar StateFoodLaboratory,BangaloreMs.AjiniA.S. CEPCILaboratory,KollamDr.JayrajsinhSarvaiya GujaratForensicScienceUniversity,GandhinagarMs.KavithaM. FSSAI,NewDelhiSri.BalamuraliKrishnaKondapalli IntertekPvtLtd,HyderabadMs.ElizabethM.Gomes BangaloreTestingLaboratoryPvtLtd,BangaloreDr.D.P.Gurumoorthi ScientificFoodTestingServices(P)Ttd,ChennaiManoranjanKumar StateFoodandDrugTestingLaboratory,RudrapurDr.SagarUtture TUVSUDSouthAsia,Bangalore


Appendix2:InformationCardsEachoptionwasdiscussedandprosandconswerenoted.Ascore,between1and5,wasassignedbasedonthecomments,where1islowand5ishighpriority."Chemistry"Option1:Screeningmethodsformycotoxins

Criteria Information Score

PublicHealthImpact

-Low:Foundinspices,butreducedbycooking(presumably)-Manydeathsin1970sbutnorecentoutbreaks-Lowinstaplefoodrice

2

EaseofImplementation

Screeningnotcommoninlabs,mostlyconfirmationandquantitationWouldnotbeveryexpensivetostartscreening,trainingpartnersandfacilitiesareavailable.

5

TradeImpact

-PrioritycauseofrejectsinEU,butscreeninginsufficientintrade,requireconfirmation-Couldhelpprioritizeuseofresourcesforconfirmation

3

Costs(trainingonly)

-Lowbecauseofeaseandkitsarecheap low

Option2:Confirmationmethodsformycotoxins


PublicHealthImpact

-Sameasscreening 4


EasybecausepartofFSSAIinfrastructureplanandtrainingpartnersandfacilitiesavailable

5

TradeImpact

-PrioritycauseofrejectsinEU 5

Costs(trainingonly)

-Lowbecauseofeaseandinfrastructureresourcesalreadyallocated low


Option3:Methodsformulti-residueofveterinarydrugs


PublicHealthImpact

-Unknown,althoughfearsofantimicrobialresistancewarrantbettercontrolofveterinarydruguse

2


-EasybecausepartofFSSAIinfrastructureplanandtrainingpartnersandfacilitiesavailable-Mediumbecausemethodsnotcommonforprocessedfoods

5

TradeImpact


Costs(trainingonly)


Option4:Methodsformulti-residueofpesticides


PublicHealthImpact

-Veryhighforapplicators,farmingfamilies-Greatfearofmisuseduetolackofeducation-Greatfearduetocasualmarketingpractices(unlabeledcontainers,dosageunspecified,etc)

5


-EasybecausepartofFSSAIinfrastructureplanandtrainingpartnersandfacilitiesavailable-Mediumbecausemethodsnotcommonforprocessedfoods

5

TradeImpact


Costs(trainingonly)



Option5:Non-targetedcontaminantsanalysis


PublicHealthImpact

-Medium:Importantfearfromeducatedpopulationbut"over-rated"-Lowdon'tfeelthatpeoplegetsickfromunknowns

2


-DifficultbecausenoFSSAIfacilityisequipped,buttrainingcouldbeeasybecausetrainingpartnersandfacilitiesareavailable-Difficultbecauseofmatrixvarietypresentedtolabs,methodsnotadapted

1

TradeImpact

-LowbecausecompletelyunexpectedsubstancesarenotsuchabigconcerninIndia-Alsobecauseweknowwhatwewanttolookforsowecouldusetargetedtests-Highbecausefeellikeitwouldhelpbuildtrust

3

Costs(trainingonly)

-Lowbecauseofavailabletrainingpartnersandfacilities low

Option6:Screeningmethodsforindustrialchemicals


PublicHealthImpact

-Low,notperceivedaslargeproblem(likeChina)-High,wouldliketoknowifitisaproblem-Highbecausetechniquesreallyincludesallchemicalcontaminants,notjustindustrial

4


-Easybecausepartofinfrastructureplan-Hardbecausenotmanylaboratorieshavespecialistsinindustrialchemicals(analystsdon'tknowwhattheyshouldlookfor)-Easybecauseitalsoworksforpest.,vet.drugs,additives,etc.

5

TradeImpact

-LowinEUandUS-Highbecauseoffearthatifsomeonestartslooking,theymayfindit-Highbecausemayreduceproblemswithagric.contaminants

3

Costs(trainingonly)



Option7:Advanced mass spectrometry (for contaminants)


PublicHealthImpact

-Mediumbecausemethodscanbeappliedalready 3


-Easybecausepartofinfrastructureplan-Easybecauseaccesstotrainingpartners

5

TradeImpact

-MediumsincetouchesonproblemsinEUandUS-Highbecauseoffearthatunknownproblemmayexist

4

Costs(trainingonly)


Option7:Validationofchemicalmethods(includingmatrixextension)


PublicHealthImpact

-Lowbecausewecanusevalidatedmethods

2


-Easy,justclassroomtrainingandmanytrainingpartnersavailableforvalidationpart-Mediumbecauseneedtoaddressdifferentmatrices,buteasybecauseexpertiseisavailable

5

TradeImpact

-Lowbecausewecanusevalidatedmethods-Highbecausevalidatedmethodsdon'tworkforallmatrices,especiallyprocessedfoods

4

Costs(trainingonly)

-LowbecauseofavailabletrainingpartnersandinfrastructurewithinFSSAIdevelopmentplan

low


"Microbiology":Option1:GeneralFoodMicrobiology


PublicHealthImpact

-Lowforgeneralfoodmicrobiology-Notsurewhatitmeans-Feelthereareplentyoffoodmicrocoursesinuniversities

1


-Highbecauseverybasicandplentyoftrainingpartnersavailable-Lowbecausetoogeneraltogettimefortraining

3

TradeImpact

-Low,toobasictohaverelevancewithtrade-HighbecauselotsofrejectionsinUSandEUbecauseofmicrobiology-HighifindustrywasthetargetinsteadofFSSAI

5

Costs(trainingonly)

-Lowbecauseofease low

Option2:Rapid(molecular)methodsforfoodmicrobiology


PublicHealthImpact

-Medium,don'tfeelsomanypeoplegetsickinIndia 3


-Hard,veryfewlabshaveequipment,notsureitisininfrastructureplan-Easybecausetrainingpartnersareavailable

3

TradeImpact

-HighbecauseofEUandUSrejections-Hightoacceleratereleaseofexports

5

Costs(trainingonly)

-Lowbecauseofavailabilityoftrainingpartners medium


Option3:WholegenomesequencingtoreplacePFGE(PulseNetforoutbreaks)


PublicHealthImpact

-Highwhenanoutbreakhappens-Notsurehowoftenoutbreakshappen-Currenttoolsmaybeenough(?)(notrightgrouptodiscuss)

4


-LowbecauseinstrumentationnotavailableandnotpartofFSSAIinfrastructureplan-Trainingpartnersavailable,butfacilitiesabroadonly

2

TradeImpact

-Norightgrouptoask-Perceivedashighifcan"clear"Indiaascauseofoutbreak...-Perceivedasmediumtocreatetrustinsystem

2

Costs(trainingonly)

-Highbuthastobeabroad,facilitiesnotavailableforreproductions

high

Option4:Screeningmethodsinfoodmicrobiology


PublicHealthImpact

-Highasapreventativemeasure,especiallyforcities-Lowbecauseallfoodiscooked-Lowbecausepeopledon'tseemtogetsickfromfoodinIndia

4


-Highbecausemanylabshavefacilitiesforscreeningmethods-Highbecausemanytrainingpartnersavailable-Lowbecausereferencestrainsnotavailable

4

TradeImpact

-Unknown,seemstovaguetohavemeasurableimpact-Notrightaudienceforthisquestion-CouldbehighifaddressesUSandEUrejections

3

Costs(trainingonly)

-Lowbecausemanylabsandtrainingpartnersavailable-Highbecausereferencestrainsarenotavailableandaredifficulttoimport

medium


Option5:Methodsfordeterminationoffilth


PublicHealthImpact

-Low,peopledon'tknowwhatfilthis-Indiansareusedtowashingcommodities,expectphysicalcontaminants

2


-Highbecausetrainingpartnersavailable-Highbecauserequires"usual"equipmentlikemicroscopes

5

TradeImpact

-HighbecauseofrejectionsfromUS 5

Costs(trainingonly)

-Lowbecauseofavailabilityoftrainingpartnersandnorequirementforspecialequipment

low

Option6:MethodsfordeterminationofSalmonella


PublicHealthImpact

-Highforcitieswherepeopleeachdifferently-Highforchildren-Lowbecausemosttraditionalfoodiscooked

4


-Highbecauselabsexistwhodothesetests-Lowbecauselabsareoverloaded,notimefortraining-Highbecausetrainingpartnersareavailable-Lowifweneedalotofreferencestrains

4

TradeImpact

-HighbecauseofrejectionsfromUS 5

Costs(trainingonly)

-LowbecauseofavailabilityoftrainingpartnersandfacilitiesavailableinIndia

low


Option7:MethodsfordeterminationofE.coli


PublicHealthImpact

-Highforcitieswherepeopleeachdifferently-LowbecausemanyIndiansarevegetarian-Lowbecausetraditionalfoodiscooked

2


-Highbecauselabsexistwhodothesetests-Lowbecauselabsareoverloaded,notimefortraining-Highbecausetrainingpartnersareavailable-Lowifweneedalotofreferencestrains

4

TradeImpact

-HighbecauseofrejectionsfromUS-High,wethinkitisagrowingprobleminaquaculture

5

Costs(trainingonly)

-LowbecauseofavailabilityoftrainingpartnersandfacilitiesavailableinIndia

low

Option8:Validationofmicrobiologicalmethods


PublicHealthImpact

-Lowbecausewecanusevalidatedmethods 1


-Highbecauseclassroomtrainingandtrainingpartnersavailable-Lowbecauselabsdon'thavestatisticiansonstaff

3

TradeImpact

-Lowbecausewecanusevalidatedmethods-(Notrightgrouptoask,notawareoflackofmethods)

1

Costs(trainingonly)

-Lowbecauseonlyclassroom

low

university of maryland –jifsan- 5f...system to highly rigorous systems (for example, iso 10725...

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