IdentifyingSurrogateEnvironmentstoMeetLocalFieldTrialRequirementsContentsofthePresentationWhatisaSurrogate?Whyisthisusefulforregulation?CanweidentifysurrogateenvironmentsforConfinedFieldTrials(CFTs)?(Ithinktheansweris“yes”)UsingasurrogateapproachtosatisfyCFTrequirementsWhatisaSurrogate?Merriam-WebsterDictionary“oneappointedtoactinplaceofanother”“Asubstitute”Inregulation,thisistypicallyasurrogateorganismIntendedtosubstituteforhumansorotherspeciesthataredifficulttotestinthelaboratorySurrogatesinRegulationTheuseofsurrogatespeciesiswellacceptedformanyregulatorypurposesDrugandpharmaceuticalevaluationsChemicalandpesticidetestingRegulatorydecisionmakingwouldnotbepossibleintheseareaswithoutuseofsurrogatesfortestingThisacknowledgestworealitiesYoucan’ttesteverythingdirectlyAlthoughasurrogatewillneverbeidenticaltothespeciesyoucareabout,anappropriatesurrogateisadequatetoensuresafetyIdentifyingSurrogatesforRegulatoryTestingThesurrogatemustbeanappropriatesubstituteforthepurposeofthetestDemonstratesimilaritytothespecies/subjectofinterestShowsimilarresponsesorshareparametersthatarerelevantforthetestresultTherefore,youneedtounderstandyourtestinordertoknowifyouhaveanappropriatesurrogateCanweidentifysurrogateenvironmentsforConfinedFieldTrials(CFTs)?ThesurrogateenvironmentapproachisalreadyappliedintheconductofCFTsSmallscaletrialsareextrapolatedtodrawconclusionsaboutcultivationinamuchlargerenvironmentHowever,manycountriesrequirein-countrytestingtosupportregulatoryassessmentsofGEplantsAlthoughpoliticalboundariesarenotparametersthatinfluencesthetestresultsWhataretherelevantparametersofaCFTenvironment?Ifwewanttoidentifysurrogateenvironments,wefirstneedtounderstandthetestsbeingperformedWhatarewetestinginCFTs?ThenweneedtoconsiderthecharacteristicsoftheenvironmentthatmayinfluencetheresultsofthosetestCFTsarecomparativeassessmentsGEPlantObservationsGrowthRateReproductionPestSuscept.DiseaseSuscept.PhysicalcharacteristicsoftheplantsConventionalComparatorWhatarethecomponentsoftheEnvironment?Biotic:allthelivingthingsMicroorganismsMacroorganismAbioticWeatherClimatePhysicalCharacteristicsConfinedFieldTrialDataDataTypicallyAddressesAgro-phenotypiccharacteristicsCollectedprimarilyforunintendedeffectsassessmentToverifytherearenochangesinreproductiveorgrowthhabitsAllthedataiscomparativeWithoneormorecomparatorsgrowninthesametrialOrtoknownreferencevarietiesDataTypicallydon’taddressBiodiversityinteractionsBioticinteractionsareprettytightlycontrolledunderfieldtrialconditionsPartoftheconfinementprotocolSometimesarthropodsurveysaredone–thesearegenerallylessinformativethanlaboratorydataMostoftheinformativedataforassessingrisktobiodiversityislaboratorydataorfrompublishedliteratureSoanappropriatesurrogateenvironmentShouldbeonewherewewouldexpectpair-wisecomparisonsbetweenaGEcropandtheconventionalparent(orothercomparator)toyieldthesameresults.TheecologyofthesiteshouldnotmatterBecauseitwillbeanagriculturalenvironmentunderconfinementconditionsLimitingbiologicalinteractionDiseasesandpestswillbecontrolledbecausetheyinterferewiththeresultsofthepair-wisecomparisonDemonstratingasimilarphysicalenvironmentshouldbeenoughtoestablishanappropriatesurrogateenvironmentforCFTsDemonstratingSimilarityinthePhysicalEnvironmentIdentifyanappropriatesurrogateenvironmentusingcharacteristicsofthephysicalenvironmentTherearemanywaysyoumightdothis:AnylocationthatcangrowacroparguablysharesphysicalcharacteristicsthatarerelevanttotheresultsofaCFTItmaybeenoughsimplytoknowthatyoucangrowthecropofinterestinbothlocationsAgro-climatesimilarityAmeasureofphysicalcharacteristicsincluding,forexample,growingdegreedays(GDD)seasonality,highandlowtemperaturesetc.ProvidesascientificallydefensiblerationaleforassertingthattheenvironmentsaresubstantiallythesameAgroclimateTherearemanydifferentAgroclimatezonationsavailableWehavechosentousetheGlobalEnvironmentStratification(GEnS)PubliclyavailableZonationishierarchicalBuiltondatafrompubliclyavailablesourcesNotbasedonmathematicalmodelingComparesfavorablewithotherzonations(seevanWartetal.2013)AgroclimateVisualizationUsingtheGlobalEnvironmentStratification(GEnS)UnitesStatesChinaComparingAgroclimatesBoththeUnitedStatesandChinaoccupyprimarilynortherntemperateclimatesFurther,bothcountriesarelargeandgeographicallydiverseIt’snotsurprising,therefore,thatweseethesameagroclimatezonesshowingupinbothcountries.ThisalsoexplainswhyyouseemanyofthesamecropsbeinggrowninbothcountriesSo,youwouldexpecttobeabletoidentifyappropriatesurrogateenvironmentsforCFTtesting.PracticalApplicationRationalplanningfortheconductoffieldtrialsSelectingfieldtrialsitesthatoccupyanagroclimatezonewithrelevanceforcountrieswherefutureriskassessmentswillbeconductedSatisfying“in-country”fieldtrialrequirementswithdatageneratedinsurrogateenvironmentsoutsideofthecountryEitherinoneormultiplecountries/locationswheretrialshavebeenpreviouslyconductedWhatelseisrequired?Regulatoryauthoritymustbeinterested/willingtomeetdatarequirementswithremotelycollecteddataLegalorregulatoryrequirementsarenotalwaysamenabletoascientificrationaleCountriesmayperceivesomeotherbenefittoconductingincountrytrialsIfacountryiswillingtousedatacollectedfromsurrogateenvironments,thosedatamustbecollectedincompliancewithregulatoryrequirementsRequirementsneedtobetransparent,anddeterminedinadvanceSpecific,hypothesisdriventestinginagivenenvironmentmaystillbewarrantedProvidedthereisaplausiblepathwaytoharmandtheexperimentbeingdoneisabletoprovideusefulinformationConclusionsItispossibletoapplyasurrogateapproachtomakeuseofremoteenvironmentstosatisfylocalfieldtrialrequirementsPre-requisitesforusingthesurrogateenvironmentapproach:Establishthattheenvironmentwherethetrialsareconductedisrelevantinthecountrywherethedatais