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inorDerortheexcitingnewgenerationcropswex19veallbeenhearingabouttoreachthearmtheymustx1rstpassthroughtheregulatoryprocesswhichespeciallyortheapprovalonewbiotechtraitshasbecomeevenmorecomplicatedintheUnitedStatesoverthepastewyears.x1cNotmuchhaschangedsince2009weareinaprettysimilarplaceintermsotheamountotimeittakestobringaproductthroughtheregulatoryprocessx1dsaysAndyLaVignepresidentandCEOotheAmericanSeedTradeAssociationwhichhasprovidedthevoiceortheseedindustryintheregula-toryprocessdebateoverthelastewyears.Onaverageittakesabouttwotothreeyearstogetaprod-uctthroughtheapprovalsprocesssaysLaVignebutrecentlegalchallengestocertainbiotechproductscausetheregulatorypro-cesstogetboggeddown.x1cUnitedStatesAgricultureSecretaryTomVilsackmentionedchangingPart340regulationswhichessentiallygovernsthederegulationobiotechproductsx1dexplainsLaVigne.x1cOurhopeisthattheadministrationrecognizestheconstraintsonthesystemandmakesitaprioritytomodiythesystemtoavoidthelegalmattersaswellasimproveex1ciencies.x1dPublicPerceptionItx19snotthejoboregulatoryagenciesintheUnitedStatestox1csellx1dtheproductstheyapprovetothegeneralpublicbutitistheirresponsibilitytotellacompellingstoryaboutwhytheyhaveapprovedthem.ItheyailtodothatasrecentlitigationsintheUnitedStatesaroundRoundupReadyalalaandsugarbeetshasshowntherewillbeabacklashopublicopinionparticularlyaroundnewbiotechtraits.x1cIbelievethatpublicper-ceptionwouldbebetterinormedbyknowinghowregulatorsuseascience-basedapproachtounderstandandlookatproductsx1dsaysPhilipMillerglobalregulatoryleadorMonsanto.Howeverasweatherextremessuchasfoodsanddroughtstakeatollonglobalcropyieldstheyalsoinfatetheweeklygrocerybill.Thatinturnstartstoinfuencepublicopinionaboutthingslikebiotechnologywhichisocusingonanewgenerationotraitstomaketomorrowx19scropsmoredrought-tolerantorwaterex1cient.Theseandotherproductsarelikelytobeindemandnotjustorgrowerscontendingwithwatershortagesandotherchal-lengesbutalsoconsumerswhoseperceptionsarebeginningtochangeastheeconomicimpactsotheseproblemsareelt.Thereisalsoacreepingrecognitionthatthesenewtechnolo-ManeuvexcingthxcoughxdheregulaxdoxcyMazeTheu.s.regx17latoryx15yx15temremainx15thegoldx15tandardbx17ttherecentdrivetointrodx17cenewgeneticallyenhancedcropx15tofeedagrowingpopx17lationix15px17ttingx17nrelentingprex15x15x17reonboththeregx17latoryx15yx15temandthex15eedindx17x15try.4seeDWorLDgiesarequitedierentromthex1rstgenerationogeneticallymodix1edproductswhichocusedonresistancetoherbicidesorinsects.x1cIntermsosomethinglikedroughttoleranceIthinkthereisrealpublicawarenessandIthinkwewillseethisinourwal-letswhenwegotothegrocerystorex1dsaysAndrewReedheadoregulatoryaairsatBASF.x1cCropsthathavebettertolerancetomedium-levelstressandcanstillyieldwellwillresonatewiththegeneralpublic.Traitslikethatareabitclosertotheconsumerthanherbicidetolerance.x1dIncreasinglyComplexAlthoughthecourtshaveupheldtheUnitedStatesDepartmentoAgriculturex19sdecisiontoderegulatecertainbiotechcropsthelegalbattleshavetakenatollonitsresources.x1cTherehasbeenaseriesolitigationsbycriticsobiotechquestioningthedecisionstoapprovebiotechcropswhichhaveconsumedtheUSDAx19sregulatoryagenciesx19resourcesx1dsaysMiller.x1cThathasbeenoneotheactorsthathasledtotheslowingdownotheapprovalprocessintheUnitedStates.x1dAnotheractorlengtheningapprovaltimelinesisasignix1-cantincreaseinnewproductsbeingsubmittedbymorecompa-nies.x1cOneothethingsthathasbeencriticalhasbeenmakingsurethattheUSDAhastheresourcingitneedstohandlethatgrowthininnovationthatwillbenex1ttheU.S.growerx1dhesays.LaVignesayssomeadditionalresourceshavebeenallo-catedtothebiotechnologyregulatorysystemoverthepastcoupleoyearsbutgiventhecurrenteconomicsituationhebelievesresourceswillcontinuetobetightorallprogramsorawhileyet.Asproductsandtechnologiesbecomemorecomplexrequirementsarebecomingmorerigorous.x1cTherearemorelink-agesbetweentraitstherex19smorestackingotraitsx1dsaysThomasKlevornoContextNetwork.x1cWhenacompanystackstwopes-ticidally-activegenesinaplanttherex19sthepotentialoranewapprovalprocess.Itx19slikeanewproductmixinaormulationsotheEPAgetsinvolved.Thatcouldmaketheapprovalprocessmorecomplicatedaswell.x1dOneothebigquestionsacingtheindustrysaysKlevorniswhetherregulatoryagenciesmaybeginaspartoinsectresist-ancestrategiestomovetowardshavingcompaniesdemonstratewhetheronegeneisasgoodorbetterthananothergeneor