GlobalRegulatoryHarmonizationtoDeliverInnovationtoFarmersGloballyHarmonizedRegulations

thatEmbraceandProgressInnovation2GMOBenefitsandSafety

WellDocumentedHarmonizationBenefits

AcrossStakeholdersProjectOverviewContributionstoeconomicand

environmentalbenefitsStrongsafetyrecordPromotinginnovationandappropriate

resourceallocationProvidingclarityandpredictabilityLeveragingcurrentglobalmomentumCollaborationacrossexpertsinmany

scientificdisciplinesEngagementwithpublicandprivate

sectorstakeholders20YearsofPlantBiotechSuccess3EnvironmentalbenefitsReducedgreenhousegasemissionsImprovedsoilhealthbytillinglessPreservednaturalresourcesFoodsecurityIncreasedyieldsMaintainedyieldsduringdifficultgrowingseasonsSocio-economicbenefitsIncreasedfarmerincomeCreatednewjobsImprovedqualityoflifeSoMuchPotentialinthePipeline...4Newbiotechtechnologies

tobenefitgrowersTriple-stackriceArcticApples(non-browning)InnatePotatoes(protectionagainstbruising)Herbicide&disease-tolerantsoybeansInsect-resistantcottonDrought-tolerantmaizeSalt-tolerant&nutrient-enhancedwheatAphid-resistantwheatLateblight-resistantpotatoDisease-resistantbananaNewbiotechtechnologies

tobenefitconsumersHealthyedibleoils

(notransfat,lowsaturatedfat)GoldenRice(beta-carotene),Iron-RichRiceBiofortifiedsorghum

(highervitaminA,iron&zinc)PinkPineapple(higherlycopene)Transgeniccornline(vitaminbiofortifiedendosperm)Regulatorysystemsgloballyarefailingtodeliverthatinnovation

togrowersandconsumersRegulatorySystemisFailingtoDeliverInnovation5Arethedaysofpredictable,transparent,timely

science-basedregulationsover?Technologydevelopersare

developinganddeliveringinnovationAcceleratedrateofproductintroductionAnOverwhelmed

RegulatorySystem

619952020201549EventsApproved47ExpectedWithlessexperiencedtechnologyprovidersWithmorediverseandnoveltechnologiesTheChallenge–RegulatoryBurdenBeyondDeveloperControl7Source:PhillipsMcDougall2012/CLIMembersUnderDeveloperControl:

TechnologydevelopershaveimprovedandbecomemoreefficientintheR&DandtestingphasesPatentLifetimeR&DPhasesDiscoveryProofofConceptEarlyDevelop-

mentAdvancedDevelop-

mentPre-launchBeyondDeveloperControl:Regulatoryandregistrationtime

andcostshavebothincreased

(50%overpastdecade)CommercialSalesCommercialSalesProductapproval1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25YearsofR&D$130MUSDTheChallenge–RegulatoryBurdenBeyondDeveloperControl8Infact,ittakeslongertogetaGMseedvarietyapprovedthanpharmaceuticalmedicines!OpportunitiesLostDuetoRegulatorySystemChallenges9“TheglobalpipelineofGMcropsoutto2020.”NatureBiotechnology34,31-36(2016),doi:10.1038/nbt.3449Publishedonline08January2016/wp-content/uploads/2015/04/kalaitzandonakes-et-al.-2015-Econ-impact-of-delayed-soybean-innovation_04092015.pdfDelayedinnovationscostfarmersthemostIncomeforIndiancottonfarmersinthe2004/05cropyearwouldhavebeen$70millionhigherwithaccesstoBtcottonvarietiesEachyearofregulatorydelayofadoptionofbiotechbananasinUgandahasbeencalculatedat$179million-$365millioninlostrevenue

forfarmers.In2014itwasestimatedthatIndiahadlostoutonbenefitsofatleast$199millionperyear

inimprovementsinhealthbynotapprovingGoldenRice.HowMightRegulatoryHarmonizationWork?10FutureDefinedataneededforscience-basedriskassessmentofasingletraitproductintendedforfood/feeduseAlignmentacrosspartnersandstakeholdersOutreach/disseminationthroughpublication(s),discussions,andworkshopsDefinitionandimplementationofbestpracticesinstudydesignandreportingAlignmentandimplementationacrossothertypesofproductsorapplicationssuchasstacksorcultivationapprovalsCompositionToxicologyProtein

CharacterizationAllergenicityDietary

ExposureMolecularCharacterization

Alignmentandacceptanceof“right-sized”harmonizeddatapackageforfoodandfeedsafetyassessment

Phase1bPhase1a

Allregulatoryagencies,regardlessofgeography,sharethesamemandate—toensurethehealthyandsafetyofconsumersandprotecttheenvironment–harmonizedregulationsdoesn’tchangethisgoalSafetyremainsthenumberonepriority—todate,therehavebeen

over1,260foodsafetydecisions,across28countries,over20years.

Inallcases,withoutexception,theagenciesarrivedtothesameconclusionofaproductssafety.Doesnotcompromisesafety…KeyConsideration–Safety11CanRegulatoryAgenciesStillGuaranteeSafetyifDataPackagesareHarmonized?12010331234562913377345631613492103119804202321653141Manycountriesaremakingfoodsafetydecisions–oftenaboutthesameproductsorproteinswithmanyyearsofsafeuseTherehavebeenthan1,260foodsafetydecisionsacross28countriesonbiotechcrops–neverwithadifferingconclusion.ILSIResearchFoundation/CropLifeInternational12Therearemultiplemechanismsandpathwaysforharmonizationandstreamliningofregulationsthatdon’tcompromisesovereignty,requireregulatorychangeorsupersedenationaldecisionmakingJoint/simultaneousSharedreviewsRecognitionofdecisionsSafetyassessmentsharingDoesaNationalGovernmentHavetoGiveUpItsRightsorIndependenceWhenItAcceptsGloballyHarmonizedRegulation?13Benefitsofharmonized,pragmaticrequirements:Providesframeworkforemergingregulatorysystemswithoutunnecessaryburdenonagencyresources.Allowscontinuedgrowthinscientificcredibilityofregulatoryassessments.Leveragesextensiveexperienceofriskassessmentandyearsofdatagenerationandsafeusetoensurerequirementsarecommensuratewithrisk.Enablesgovernment/agencyresourcereallocationtowardsotherareas,includingthosewithhigherrisk.Maintainshighrigorofsafetyandsecurityoffoodsupply.Promotesfasterdomesticdeploymentandadoptionforfarmersand

consumersofbeneficialtechnologiestomeetchallengessuchaspests

ornutrition.Createspathtosafetyassessmentsharing,collaboration,andmutualrecognition(furtherstreamliningresources),buildingoncurrentmomentum.BenefitstoRegulators14HarmonizationBenefitsAcrossStakeholders:Regulators:SupportsMomentumTowardsSimplificationandGlobalHarmonization15Simplificationofregistrationsforstacked-traitproductsSafetyassessmentsharingwithgoalofmutualrecognitionSafetyassessmentsharingforfood/feedtoreduceasynchronySimplifiedregistrationsforfamiliartraitsSafetyassessmentsharingwithgoalofmutualrecognitionBenefitsofharmonized,pragmaticrequirements:Reductioninproductdevelopmentcostsandtimelinesenablessmaller/emergingdevelopers,publicsector.Lowerscostbarrierstoworkingonnon-traditionalcropsandtraits,includinghumanitarianefforts.Predictabilityonproductlaunchtimelines,enablingresourcestreamlining,

patentprotection,andbetterdeployment.Educationalopportunitiesfornewerdevelopers,clarityonrequirements,

ensuresonlynecessaryresourcesareexpended.Resourceredirectiontowardsadditionalinnovationsfordevelopersofallsizes.BenefitstoDevelopers16Benefitsofharmonized,pragmaticrequirements:Allowsequalaccessandfasterdeploymenttobeneficial,innovativetechnologiesforgrowersandconsumers.Increasedeconomicgrowthandstabilityresultingfromtechnologybenefitsofreducingproductioncostsandincreasingyield.Higherfarmerincomes+downstreamindustriesHelpsalleviatehunger.LowerfoodpricesSafe,stable,nutritiousfoodsupplyPublichealthbenefitsfromallowingdevelopment

andfasteradoptionofsafer,morenutritioustechnologies.Environmentalbenefitsrealizedfrominnovation

andfasteradoption.BenefitstoConsumers/Public17GlobalDataHar