Important Consideraons for Sustainability, Social ulity and Ethical Assessment of Late

Blight Resistant GM Potato

Biosafety Report 2016/01

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BiosafetyReport2016/01

GenØk-CentreforBiosafety,Tromsø,Norway

November2016

ImportantConsiderationsforSustainability,SocialutilityandEthicalAssessmentofLateBlightResistantGMPotato

Writtenby:FrøydisGillundandAnneIngeborgMyhr

GenØk–CentreforBiosafety,Forskningsparken,PB.6418,9294Tromsø,NorwayTel.:+4777646620-post@genok.no–http://www.genok.com

Coverphotos:©panoramarx(adobestock.com),©alkerk(adobestock.com),©RuudMorijn

(adobestock.com),HowardF.Schwartz(ColoradoStateUniversity)

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Fundedby:TheELSAprogramintheNorwegianResearchCouncil,projectnumber:220621.Publicationdate:Reportstatus:OpenaccessComments/feedbackonthereport:Wewelcomefeedbackonthisreport.Ifyouhaveanycomments,pleasefeelfreetocontactAnneIngeborgMyhrat:anne.myhr@genok.noHowtocitethereport:Gillund,F.andMyhr,A.I.(2016)ImportantConsiderationsforSustainability,SocialutilityandEthicalAssessmentofLateBlightResistantGMPotato,BiosafetyReport01/16,GenØk-CentreforBiosafety,Tromsø,NorwayThereportcanbedownloadedfrom:http://genok.no/radgiving/rapporter/

GenØk–CentreforBiosafety(www.genok.no)isanindependentresearchinstitutefoundedin1998and located in Tromsø, Norway. GenØk is engaged in the field of biosafety and geneecologyresearchonmodernbiotechnology,nanotechnology,syntheticbiologyandothertechnologiesemergingfromthese.This institutionalsoworksoncapacitybuildingandadvisoryactivitiesrelatedtobiosafety.GenØkfocusesonaprecautionary,holisticandinterdisciplinaryapproachtobiosafety.In2007,GenØkwasappointednationalcompetencecenteronbiosafetybyNorwegianauthorities.

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TableofContentsSummary.................................................................................................................................................41. Introduction....................................................................................................................................51.1. LateblightresistantGMpotato......................................................................................................51.2. Theregulatorycontext....................................................................................................................61.3. Outlineofthereport.......................................................................................................................72. ImportantConsiderationswhenAssessingSocialUtility................................................................8DoestheLBRGMpotatocontributetosolveanimportantproblemforNorwegianpotatoproducers?8IsthereademandfortheLBRGMpotatoamongNorwegianpotatoproducersandconsumers?........9WhatarethealternativeapproachestobreedforlateLBRpotatovarieties?.....................................103. Importantconsiderationswhenassessingcontributiontosustainabledevelopment.................11IstheresistanceoftheGMpotatodurableovertime?.........................................................................11DoestheLBRGMpotatoreducetheneedforfungicidestocontrolLBovertime?...............................12IstheLBRGMpotatosafeforhumanhealthandtheenvironmentovertime?....................................13DoestheprofitabilityoffarmerswhocultivateLBRGMpotatoimproveovertime?...........................14DoesthecultivationofLBRGMpotatoaffectopportunitiesforco-existencebetweenGM,conventionalandorganicpotatoproduction,andthediversityofcommercialpotatovarietiesavailabletofarmers?............................................................................................................................154. Importantconsiderationsforanassessmentofethicaljustifiability............................................16DoescultivationofLBRGMpotatoaffectfarmers’,manufacturers’andconsumers’freedomtochoosedifferentpotatovarietiescultivatedunderdifferentproductionsystems?...............................16IstheLBRGMpotatoavailableforfurtherbreedingandresearch?.....................................................175. Conclusionsandrecommendationsforfurtherresearch.............................................................17References.............................................................................................................................................19

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SummaryThis Biosafety Report intends to contribute to ongoing efforts to translate the criteria concerningsustainability,ethicaljustifiabilityandsocialutilityintheNorwegianGeneTechnologyActintomoreconcrete terms. It does sobypresenting tenassessmentquestions that are important to considerwhenassessingwhether lateblight resistant (LBR)geneticallymodified (GM)potatocontributes tosustainability,benefitssocietyandisethicallyjustifiableinaNorwegianagriculturalcontext.Lateblightisthemostdevastatingdiseaseonpotatoesglobally.Currentcontrolmeasuresinconventionalpotatoproductionare largelybasedon chemical treatmentwith fungicides that is costly, both forpotatoproducersandtheenvironment.Ifsuccessful,cultivatingLBRGMpotatomayresultinareductionoffungicideapplicationstocontrolthelateblightdiseaseinpotatoproduction.Hence,LBRGMpotatoisclaimed to be one of the first GM plants that have the potential to solve a serious problem forNorwegianandEuropeanfarmers.Thetenassessmentquestionsrelatingtosocialutility,sustainabilityandethicaljustifiabilitythatarepresentedanddiscussedinthisreportare:

1. Does the LBR GM potato contribute to solve an important problem for Norwegian potatoproducers?

2. IsthereademandfortheLBRGMpotatoamongNorwegianpotatoproducersandconsumers?3. WhatarethealternativeapproachestobreedforLBRpotatovarieties?4. IstheGMpotatoplant’sLBRdurableovertime?5. DoestheLBRGMpotatoreducetheneedforfungicidestocontrolLBovertime?6. IstheLBRGMpotatosafeforhumanhealthandtheenvironmentovertime?7. DoestheprofitabilityoffarmerswhocultivatetheLBRGMpotatoimproveovertime?8. DoestheLBRGMpotatoaffectopportunitiesforco-existencebetweenGM,conventionaland

organic potato production, and the diversity of commercial potato varieties available tofarmers?

9. DoestheLBRGMpotatoaffectfarmers’,manufacturers’andconsumers’freedomtochoosedifferentpotatovarietiescultivatedunderdifferentproductionsystems?

10. IstheLBRGMpotatoavailableforfurtherbreedingandresearch?The reporthighlightsuncertainties associatedwith theseassessmentquestions, suggests areas forfurtherresearchandstrategiesformonitoring.Thereportiswrittenaspartofathree-yearresearchproject(2013-2016)fundedbytheELSAprogramoftheNorwegianResearchCouncil(projectnumber:220621).Theprojectintendstoexamine,throughparticipatoryanddeliberativeassessmentmethodologies,potentialethical,socialandsustainabilityaspects from cultivating and marketing LBR GM potato in Norway. The report draws on insightsgenerated during stakeholder discussions and public meetings on this topic, as well as review ofrelevantliterature.

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1. IntroductionThis Biosafety Report outlines issues that are important to considerwhen assessing sustainability,socialutilityandethicalimplicationsofcultivatinglateblightresistant(LBR)geneticallymodified(GM)potato in Norway. It intends to contribute to the operationalization of the criteria relating tosustainable development, ethical justifiability and benefit to society in the Norwegian GeneTechnologyAct(1993),andbuildsontheeffortsmadebytheNorwegianBiotechnologyAdvisoryBoardintranslatingthesecriteriaintomoreconcreteterms(NorwegianBiotechnologyAdvisoryBoard2009,2011,2014).ThereportpresentstenassessmentquestionsthatareparticularlyrelevanttoconsiderwhenassessingcultivationofLBRGMpotatoinaNorwegianagriculturalcontext.Thereportpointstoknowledgegapsanduncertaintiesassociatedwiththeseassessmentquestions,suggestsareasforfurtherresearchandstrategiesformonitoring.

1.1. LateblightresistantGMpotatoThispotatohasbeengeneticallymodifiedtoincreaseitsresistancetopotatolateblight.Potatolateblight,causedbyafungus-likeorganismcalledPhytophthorainfestans,isthemostdevastatingpotatodiseaseworldwide.Currentcontrolmeasuresinconventionalpotatoproductionarelargelybasedonchemical treatmentwith fungicides that is costly,both forpotatoproducersand theenvironment.Improvinghostplantresistanceisconsideredthemostsustainablewaytocontrollateblight(Rietmanetal.2012;WhiteandShaw2010),but classical introgressionbreeding for lateblight resistance ischallengingforseveralreasons:

(i) Thepotatohasaverycomplexgenetics(highlyheterozygousandpolyploid),whichcreatescrossing barriers and makes it difficult to transfer traits from wild Solanum ssp. tocommercialpotatovarieties

(ii) Desirabletraits,suchaslateblightresistance,areoftenassociatedwithundesirabletraits,whichmustberemovedthroughseveralgenerationsofbackcrosses to thecommercialpotatovariety(linkagedrag)

(iii) Thepotatoispropagatedvegetativelyandthereproductivefertilityisoftenlimited(iv) P. infestans has a very high evolutionary potential and can therefore easily adapt and

overcomehostplantresistance.ExperiencefromcultivatingLBRpotatoeshasthereforeshownthatthepotatoplant’sresistanceiseasilybrokenoncethepotatoesareputintolarge-scalecommercialproduction.

ItisarguedthattheGMapproachenablesmoreefficientlateblightresistancebreedingthanclassicalintrogressionbreeding,asthisapproachenablesresearcherstointroduceseveralresistancegenesinelitepotatovarieties.Hence,thisapproachisexpectedtoresultinpotatoeswithmoredurablelateblightresistancethatalsoperformwellforotherdesiredqualities(Haverkortetal.2016).Thegenes introduced in LBRGMpotatoare called resistance (R) genesandarederived fromwildpotatospecies(Solanumssp.)foundinCentralandSouthAmerica.TheseRgenesrecognizeP.infestans

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andpreventinfection,therebyprovidewildpotatowithnaturalresistancetopotatolateblight.Morethan 20 R genes have so far been identified and are available for transformation (Rodewald andTrognitz2013).ItispossibletodevelopLBRGMpotatothatonlyharborgenesfromnaturallycrossablerelatives.ThesetypeofGMplantsarecalledcisgenicplants.SeveralEuropeanresearchteamsarecurrentlydevelopinglateblightresistantGMpotatoesthatharboruptothreedifferentRgeneswhicharetestedinfieldtrialsindifferentpartsofEurope(EuropeanCommission2016).TheAmericancompanyJ.R.SimplothasalsodevelopedthreevarietiesofLBRGMpotatoandapprovalforcultivationintheUSisexpectedby the end of 2016 (Simplot 2016). Other US based research environments and the InternationalPotato Centre in Peru (CIP) are also developing LBR GM potato (Halterman Lab 2015, WisconsinUniversity2012,CornellUniversity2013,InternationalPotatoCenter2014),andtheydocarryoutfieldtrialstakingplaceindevelopingcountries.

1.2. TheregulatorycontextTheNorwegianGeneTechnologyAct(1993)regulatestheproductionanduseofgeneticallymodifiedorganisms(GMOs)(GeneTechnologyAct1993).ItstipulatesthatapprovalscanbegrantedinNorwayifitisdemonstratedthattheproductionoruseoftheGMOdoesnothavedetrimentaleffectstotheenvironmentorhumanhealth,representsabenefittosociety,contributestosustainabledevelopmentandisethicallyjustifiable.

Theterms“sustainabledevelopment”,“benefittosociety”and“ethicaljustifiability”arecomplexandcan be interpreted differently in the context of GMOs. The interpretations used for this BiosafetyReportisinspiredbytheworkofscholars(RosendalandMyhr2009,Catacora-Vargas2014),thathasspecificallyanalyzedthesecriteriaforGMOriskassessmentinaNorwegiancontext,anddoalsodrawon the Norwegian Biotechnology Advisory Board’s contributions on how to operationalize theassessmentcriteria(NorwegianBiotechnologyAdvisoryBoard2009,2011,2014).Societalutilityreferstopublicwelfareconsiderations.IssuesrelevantforaGMOassessmentincludeproduction-relatedissues(e.g.accesstoseeds,profitabilityforfarmersandbenefitsharing),socialandjustificationconsiderationsonaglobal level(e.g.equitybetweentheGlobalNorthandSouth),andsocietalneedanddemand(e.g.publicacceptabilityanddemand,andwhethertheGMOcontributestosolveanimportantproblem).

Sustainable development is interpreted according to theWorld Commission on Environment andDevelopment’s(WCED)1987definition,whichreferstothepossibilityofpeopletomeettheirneedswithout compromising theability for futuregenerations tomeet theirownneeds (WCED1987). Itimpliestoconsiderenvironmental/ecological,societalandeconomicimpactsofGMOs,takingalongtermandglobalperspective(i.e.consideringimpactsintheproducercountry).EthicaljustifiabilityrelatestowhethertheGMOcontributestothecommongoodandisinlinewiththeethicalvaluesonwhichsocietyisfunded.AssessingethicaljustifiabilityimpliestoconsiderwhethertheGMOrespectsorinfringeseco-ethicalvalues(e.g.theintegrityandintrinsicvalueofnatureandecological balance) and commonly shared anthropocentric values (e.g. well-being, autonomy,solidarity, equity and justice). It involves a situational analysis in which alternatives to the GMOapproach are identified, and a consideration for how the impactedpartieswill be affected by thedifferentalternatives.

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The Precautionary principle regulates actions associated with uncertainty and is an underlyingprincipleforGMOregulationsinNorway.ItcomesintoplaywhenthereisscientificuncertaintyandreasonabledoubtconcerningadverseeffectswiththeadoptionanduseofaGMO.Theprinciple isconsidered a key issue in a sustainability assessment, as this involves considering long-termperspectives,global,environmentalandhealthimpactsthatareoftenassociatedwithuncertainty.

1.3. OutlineofthereportThis report presents ten assessment questions that are consider particularly relevant to evaluateethical, social and sustainability implications related to the specific case of LBR GM potato in aNorwegianagriculturalcontext:

1. Does the LBR GM potato contribute to solve an important problem for Norwegian potatoproducers?

2. IsthereademandfortheLBRGMpotatoamongNorwegianpotatoproducersandconsumers?3. WhatarethealternativeapproachestobreedforLBRpotatovarieties?4. IstheGMpotatoplant’sLBRdurableovertime?5. DoestheLBRGMpotatoreducetheneedforfungicidestocontrolLBovertime?6. IstheLBRGMpotatosafeforhumanhealthandtheenvironmentovertime?7. DoestheprofitabilityoffarmerswhocultivatetheLBRGMpotatoimproveovertime?8. DoestheLBRGMpotatoaffectopportunitiesforco-existencebetweenGM,conventionaland

organic potato production, and the diversity of commercial potato varieties available tofarmers?

9. DoestheLBRGMpotatoaffectfarmers’,manufacturers’andconsumers’freedomtochoosedifferentpotatovarietiescultivatedunderdifferentproductionsystems?

10. IstheLBRGMpotatoavailableforfurtherbreedingandresearch?Thepotential impactscausedby theLBRGMpotatoplant itself (throughout thewholeproductionchain)anditsproductionsystem,shouldbetakenintoaccountinanassessmentofthesequestions.Thisconcernspotentialimpactsthroughoutthewholeproductionchainandbytheproductionsystemitislikelytobecultivatedunder.Furthermore,theLBRGMpotatoshouldbecomparedtoitsclosestgeneticrelative,cultivatedinthesameagro-ecologicalsystemandtakingthestrategiesusedtocontrollate blight in conventional potato production at the time of the evaluation into account as this iscurrentlythedominatingproductionforminNorway.Thedevelopmentoftheseassessmentquestionsdrawsondiscussionwithkeystakeholdersinpotatoproduction inNorway(Gillundetal.2014,2015,2016),andonareviewofrelevant literature.Thequestionsaregroupedaccordingtotheassessmentcriteriatheyareconsideredmostrelevantfor.Asthese criteria are interlinked, many of the assessment questions are relevant for more than onecriteria.Importantly,thelistofassessmentquestionsisnotexhaustiveandthereportdoesnotintendtoanswerthesuggestedassessmentquestions.Rather,thereportintendstopresentinformationthatthat are of relevance for these questions, also areas characterized by uncertainties are highlighttogetherwithsuggestionsfortopicsthatneedsfurtherresearch.

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2. ImportantConsiderationswhenAssessingSocialUtility

DoestheLBRGMpotatocontributetosolveanimportantproblemforNorwegianpotatoproducers?Potato lateblight isconsideredoneofthemostsevereproblemsforNorwegianpotatoproduction(Sæthre et al. 2006,Gillund et al. 2016). The disease has becomemore aggressive during the lastdecadeandmightincreasefurtherwithclimatechange,asmorerainfallispredictedduringgrowingseasons creating more favorable conditions for fungal diseases in general (Cooke et al. 2011).Additionally,P.infestansmayremaininthesoilintheformofoosporesthatarebetterpreservedatcoldtemperatures.ThismayexplainthefactthatinfectionsfromoosporesarecommoninNorway,and are resulting in outbreaks of the disease earlier in the growing season aswell as longer timeperiodsforprevalenceofthediseaseinthesoil(Cookeetal.2011).ThemostcommonsourcesforlateblightinNorwayareinfectedtubers(seedtubersorvolunteers)andP.infestansoosporesinthesoil.Thediseasespreadsquicklyfrompotatoplanttopotatoplantintheformoffungalsporescarriedbywindandrain. Infectedpotatoplantsthatarenottreatedwilleventuallydie.Moreover,infectedtubersbecomebrown,unattractiveandthequalityistolowthatitcanbeconsumedasfoodorfeed.ThemostwidelycultivatedpotatovarietiesinNorwayarenotveryresistanttolateblight.Moreresistantpotatovarietiesareavailable,butthesearenotwidelycultivatedinNorwayorEuropeastheyaregenerallynotconsideredtoperformsufficientlywellforotherproductrelatedqualities(Cookeetal.2011).Current control measures in conventional potato products largely rely on spraying with syntheticfungicidesthroughoutthegrowingseason.AbouthalfofthetotalfungicideapplicationsinNorwegianagricultureareusedtocontrolpotatolateblight(Plantevernleksikonet2011).Thediseaseisthemostimportant factor for reduced yield and quality in organic potato production (Agropub 2015). TheannuallossesassociatedwithlateblightinNorwayareestimatedtobearound55–65millionNOK.Theseestimations includecostsassociatedwithbuyingandapplying fungicides (48,5millionNOK),yieldloss(5-14millionNOKdependingonseverityoflateblightinfections)andinspection,researchandadvisoryservice(3,3millionNOK)(Sæthreetal.2006).Knowledgegapsandresearchneeds:

TodescribetheseverityofthelateblightprobleminNorway,werecommendupdatedstatisticaldataon:

• TheprevalenceofthelateblightdiseaseindifferentpotatoproducingregionsinNorway• Economic losses caused by the disease (e.g. control measures, yield loss and monitoring

strategies)• Other important costs and losses associatedwithpotatoproduction (e.g. losses causedby

otherimportantpotatodiseasesorotherfactorscontributingtoyieldlossorreducedquality)

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IsthereademandfortheLBRGMpotatoamongNorwegianpotatoproducersandconsumers?Conventional LBR potato varieties are notwidely adopted by Norwegian potato producers, partlybecause they are not considered to perform sufficiently well for other qualities. It is thereforereasonabletoassumethatthere isademandforLBRpotatovarieties,whichalsoperformwell forotherpropertiesappreciatedbyfarmers,processingindustriesandconsumers.CultivatingLBRpotatovarietiesmayalsocontributetomeetthegoalofreduceddependencyonchemicaltreatmentofplantdiseases in Norwegian agriculture (NorwegianMinistry of Agriculture and Food 2016), and satisfyconsumerdemandsforfoodproducedwithoutchemicals.Atpresentfarmersalsouseconsiderabletimeduringthegrowthseasontomonitortheirpotatocropsfor lateblight infestations,henceLBRpotato varieties may improve farmers’ psychological well-being as they will be relieved from theconcernthattheircropwillbeseverelydamaged(Gillundetal.2016).WhetheritisademandforgeneticallymodifiedLBRpotatois,however,arguablydependentonpublicacceptanceofGMfoodingeneral.Empiricalresearchonconsumer’sacceptanceofGMfoodinNorwayislimitedandoutdated.Still,reluctancetowardsGMfoodtendstobethedominantattitudeamongNorwegianconsumers(HviidNielsen2012).Forinstance,theNetworkforGMOfreeFoodandFeedinNorwayworksforarestrictiveapproachtoGMOsinNorwayandrepresentsabroadrangeofinterestorganizations, including farmerunionsandoneof the largest foodchains inNorway (CoopNorge)(http://gmofrimat.no/).Consumersurveyshave,however,shownthattheyoungersegmentoftheNorwegianpopulationaremorewillingtoacceptGMfoodiftheyfindthattheproducthasclearbenefits,particularlyrelatedtolessuseofsyntheticchemicalsforpestanddiseaseprotection(Magnusetal.2009).Diseasespecificity(i.e.lateblightresistance)wasfoundtomatterlittleforconsumersupportinasurveyonattitudestoGMpotatoamongUSconsumers(McComasetal.2014).LBRGMpotatomaybedevelopedascisgenicpotatoes (e.g. only harboring genes from crossable relatives or the same species), and it may beexpected that consumerswill bemorepositive to this approach (Haverkort et al. 2009). The2010Eurobarometer survey does support this hypothesis as it indicates consumers are more positivetowardscisgenicGMplants(Gaskelletal.2011).SimilarattitudesarefoundinastudythatcomparesconsumeracceptanceamongUSandEuropeancitizens,thoughthisstudyshowsthereisasignificantdifferencebetweentheUSAandcountriesinEurope,withatwiceashighacceptancelevelofcisgenicplantsintheUSA(LuskandRozan2006).AnotherconsumersurveycarriedoutinEuropefindsthatconsumersconsidercisgenicplantsasGMandstill favor forexample labellingof sucha technique(Kronbergeretal.2013).

Photo:©juniart/adobestock.com

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Knowledgegapsandresearchneeds:TodescribethepotentialdemandofLBRGMpotatoinNorwaywerecommendconsumersurveysthatparticularlyinvestigates:

• Attitudes to LBR GM potato among different segments of the Norwegian population andinterestedparties(e.g.consumers,farmersandpotatoretailers)

• Attitudes to cisgenic LBR potato in particular in the Norwegian population and amonginterestedparties

WhatarethealternativeapproachestobreedforlateLBRpotatovarieties?DevelopingLBRpotatovarietiesthroughclassicalintrogressionbreedingisconsideredchallengingandlaborious(Vleeshouwersetal.2011).Still, italsohasadvantages:WhiletheGMapproachcurrentlycanonlyexploitqualitativeresistancemechanisms,bothquantitativeandqualitativeLBRmechanismscanbeexploitedthroughclassicalbreeding.QualitativeresistanceisconferredbyasingleRgeneandresultsincompleteresistancetothosestrainsofthepathogenthatarerecognisedbythespecificRgene.QuantitativeresistanceismediatedbymultiplegeneswhicheachgivespartialresistancetoabroadrangeofP. infestansstrains(KouandWang2010).Qualitativeresistanceisconsideredtobemore durable, but has been difficult to exploit in breeding programs as the genes underlying thisresistancearestilllargelyunknown,andbecauseitismorecomplicatedtobreedfortraitscontrolledbymultiplegenes(Duetal.2013).Despite the challenges associated with classical introgression breeding for LBR, ongoing potatobreeding programs in Europe using such approaches, including marker assisted breeding, showpromisingresults.OnesuchexampleisBioimpuls,apotatobreedingprograminitiatedbyresearchersattheLouisBolkInstituteandWageningenURwhoareworkingtogetherwithbreedingcompaniesandfarmer-breederstodeveloprobustcultivarsthatareresistanttoP.infestans(Almekindersetal.2014).ThecultivarsBionicaandTolucaarewellknownexamplesoftraditionallybredLBRresistantcultivarspossessingR genes fromdifferentwildpotato species (Lammerts vanBuerenet al. 2008,Haverkort et al. 2009). Similarly, researchers at the French National Institute for AgriculturalResearch (INRA) aims to develop LBR potato cultivars exploiting both qualitative and quantitativeresistance(Marhadouretal.2013).TheSárváriresearchtrust,basedinScotland,hasbeenbreedingforLBRpotatoessince2002andhasdevelopeddifferentSarpocultivars.Amongthem,SarpoMiraiscurrentlyconsideredtobeoneofthemostlateblightresistantcultivarinEurope(WhiteandShaw2010,Rietmanetal.2012).InNorway,researchersatGraminorcarryoutpotatobreeding.TheyhavebredvarietiessuchasOdiniaandTrollthatarequiteresistanttolateblight.Still,manyoftheselateblight resistant potato varieties are not widely cultivated as they are not considered to performsufficientlywell forotherqualitiesappreciatedbyfarmersandconsumers.Norwegianstakeholdershavearguedthatbreedingfor lateblightresistance isnotprioritized intraditionalpotatobreedingprogramsto theextent that it couldhavebeen.This ispartlyexplainedby the fact that fungicidescurrentlycontrollateblighteffectively.Thecurrentfungicidesthatareusedtocontrollateblightareconsidered to be less harmful for human health than most herbicides and especially insecticides(Gillundetal.2016).

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Knowledgegapsandresearchneeds:Tomapoutpossiblealternativeapproachestobreedfor lateblightresistance.Thiseffortneedstoincludesresearchthatintendstoidentify:

• CurrentbreedingeffortsandapproachesforLBR,particularlyinNorwayandEurope• TheprioritygiventoLBRinpotatobreedingprograms,particularlyinNorwayandEurope• PossiblyotherpotatobreedingapproachesforLBRthatareunderdevelopment

3. Importantconsiderationswhenassessingcontributiontosustainabledevelopment

IstheresistanceoftheGMpotatodurableovertime?Amainchallengewithbreedingforlateblightresistanceistodevelopcultivarsthatareresistanttolateblightovertime.This isbecauseP. infestanshasaremarkablecapacitytorapidlyadapttoandovercomeresistanthostplants(Fry2008).SingleRgenesthathavebeenintroducedtocommercialpotatovarieties throughtraditional introgressionbreedinghasconsequentlybeendefeatedshortlyafter the potato varieties have been put in commercial production (Vleeshouwers et al. 2011).ResearchersdevelopingLBRGMpotatotrytoovercomethischallengebyaddingupseveralsingleRgenes(e.g.genestacking)intheGMpotato.Theyexpectthatthisapproachwillmaketheresistancemoredurable(Zhuetal.2012,Jonesetal.2014,Kwang-Ryongetal.2014,Haverkortetal.2016).Fieldtrialswith stacked LBRGMpotato events showpromising results (Haverkort et al. 2016), still it isdifficulttopredicthowlongtheresistanceactuallywilllastandthisanswercanonlybegivenafterthepotatoisputinlarge-scaleproductionandcultivatedovertime.TostrengthenthedurabilityofLBRGMpotato,itisrecommendedthattheP.infestanspopulationismonitoredintheareawheretheGMpotatoiscultivatedtodetectifanyoftheRgenesofacertainGMpotatovarietyarebrokenbythepathogen.Furthermore,strategiestohaltvirulencedevelopmentintheP.infestanspopulationneedtobeestablishedpriortolargescalecultivation(Haesaertetal.2015). The genetic diversity of the Nordic P. infestans population is particularly high and thisstrengthens the adaptive potential of the pathogen (Brurberg et al. 2011). Hence, resistancemanagement and monitoring is particularly important in a Norwegian context. When developing

Photo:©RuudMorijn/adobestock.com

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monitoringandresistancemanagementstrategiesitisalsoimportanttoclarifyresponsibilitiesaswellasthedistributionofthecostsforcarryingoutthesetasks.Oneproposed strategy for resistancemanagement is to apply reduceddose ratesof fungicides toprevent breakthrough of the entire R gene stack, if monitoring shows presence of virulence toindividualRgenesascomponentsofRgenestacks(Haesaertetal.2015).Anotherproposedstrategytoprolongthepotatoplantsresistanceistodevelop“dynamicGMpotatocultivars”thatconsistsofLBRGMpotatoplantswherethecompositionofthesetofRgenesdifferswhileallotherpropertiesareexactly the same.The idea is to change the setofR genesexpressedby theGMpotatoeventbetweenthegrowingseasonsorindifferentpartsofthesamepotatofield(Haverkortetal.2016).Knowledgegapsandresearchneeds:To furtheradvancebreedingprograms fordurableLBRpotatovarieties it is important tocarryoutbasicresearchon:

• ThemolecularmechanismsunderlyingtheobservedLBR• ThemechanismsandevolutionofthevirulencedevelopmentintheP.infestanspopulation

To develop a plan for integrated LB control,monitoring and resistancemanagement. This can forexamplebecarriedoutby:

• WorkshoptoevaluateriskforvirulencedevelopmentintheNordicP.infestanspopulationsand suggest a resistancemanagement program. The participants in this workshop shouldinclude experts on evolutionary genetics, quantitative population genetics, resistanceevolutionandfungaldiseases,aswellaspotatoproducers,andagriculturaladvisors.

DoestheLBRGMpotatoreducetheneedforfungicidestocontrolLBovertime?It is calculated that growing the LBRGMpotato can reduce theneed for fungicidesby 80%whenincludedaspartofa crop-specific integratedpestmanagement (IPM)strategy (CollierandMullins2010,Haverkortetal.2016).SomesprayingmaybeneededtowardstheendofthegrowingseasontopreventLBattacksonsenescingGMpotatoplantssincetheydonotconferthesamelevelofLBR(Jonesetal.2014),andsomesprayingisalsoproposedasastrategytohaltvirulencedevelopmentwithinthepathogen population (Haesaert et al. 2015). The extent to which cultivation of LBR GM reducesfungicidedependsonwhetherandtowhatdegreetheGMplantpossessesresistanceinthefoliage,thetubersorboth.TherearestudiesindicatethattheLBRGMpotatomayconferbothfoliarandtuberresistance,whileotherstudiesindicatethecontrary(Haltermanetal.2008,Kirketal.2001,Parketal.2005,PlattandTai1998).Importantly,thepotentialofLBRGMpotatotoreducefungicideuseinthelong rundependson thedurability of the resistanceof the LBRGMpotato. Knowledge about theexpected durability of the LBR GM potato togetherwith strategies to strengthen the durability isthereforehighlyrelevantfortheassessmentofthefungiciderequirementovertime.Knowledgegapsandresearchneeds:ToevaluatetheextenttowhichcultivationofLBRGMpotatoreducesfungicideuse(inconcentrationsornumbersofapplications),itisimportanttocarryoutfieldtrialstoidentify:

• FungiciderequirementsforcultivatingLBRGMpotatounderdifferentclimaticconditionsandduringallphasesofthegrowingseason.

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• Tissue-specificexpressionofRgenesandtowhatextenttheyconferLBRindifferentpartsofthepotatoplant

• How secondary pests responds to a) reduced spraying against P. infestans, and b) lessprevalenceofP.infestans.

IstheLBRGMpotatosafeforhumanhealthandtheenvironmentovertime?It is possible to develop cisgenic LBR GM potato, and these GM plants may be more safe thantransgenicpotatoes.TheGMOpaneloftheEuropeanFoodandSafetyAuthority(EFSA)concludedin2012thattherisksassociatedwithcisgenicandtraditionallybredplantsarethesame,whiletransgenicplantsmayresultinnovelrisks(EFSA2012).Thisconclusionwasgene-based,meaningthatbecausethegenesareknowntobesafe,thecisgenicapproachwasalsoconsideredsafe.Otherresearchers,do,however,emphasizethateveniftheinsertedgeneisknown,thisdoesnot mean that uncertaintiesassociated with the transformationprocess are known. Hence, incontrast to the conclusion of theEFSA, it is argued that, in terms offood and environmental safety,cisgenic cannot be regarded asequivalenttoconventionalbreeding,nor that the safety of the productsresultingfromtraditionallybreedingandcisgenictechnologiesaresimilar,basedontheunknownbehaviorandeffectsofthegenesinthetransformationprocessandtheirfunctioningwithinthemechanismsofthehostplant(e.g.randomintegrationofgenesinthehostgenome)(SchubertandWilliams2006,Wilsonand Latham 2007, Austrian Agency for Health and Food Safety 2012). It is also documented thatchromosomalpositioncanplayanimportantroleintheexpressionoftheRgene(Krameretal.2009).Thisexemplifiessomeofthedifficultiesofpredictingthefunctionofageneticconstructwhenmovedintoanewhost,evenwhenthehostisacloselyrelatedspecies.Asalreadydiscussed,itisexpectedthatcultivatingLBRGMpotatowillreducetheneedforfungicidestocontrollateblight.Thismeansthatconsumersandproducersmaybelessexposedtofungicides,whichisalsoimportanttotakeintoconsiderationwhenassessingthesafetyofthistypeofGMpotato.

Knowledgegapsandresearchneeds:ToevaluatethesafetyofcisgenicGMpotatoonhumanhealthitisimportanttocarryoutresearchon:

• Theproteinbeingproducedbythecisgene,aswellascheckingforitsallergenicpotentialoranyunexpectedalterationsinproteinstructureandquantity

• Metabolicdisturbancescausedbytheintroductionofthenoveltraitorbytheexpressionofcisgene.Thiscanbeachievedbyuntargetedmolecularapproachessuchasmulti-omicsanalyses

Photo:©demachy/adobestock.com

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DoestheprofitabilityoffarmerswhocultivateLBRGMpotatoimproveovertime?WhetherfarmersbenefiteconomicallyfromcultivatingLBRGMpotatodependsonhowitinfluencestheuseofinputfactors(e.g.seedpotato,herbicides,fertilizers,fuel,labor,capitaletc.)perproductionunit.Norwegianpotatoproducersspendmostmoneyonbuyingseedpotato(approximately40%ofthetotalvariablecosts),whilefungicidesonlyaccountsfor6%ofthetotalcosts.Otherimportantcostarefertilizers(28%),herbicides(3%),syntheticchemicalstokillhaulm(5%),andtransportofthepotatocrop(18%)(Pettersenetal.2014).CultivatingLBRGMpotatoisexpectedtoreducethemoneyandtimefarmersspendonsprayingwithsyntheticfungicidestocontrollateblight.ItisestimatedthatNorwegianpotatoproducersspend48,5millionNOKonbuyingandapplyingfungicidestocontrol lateblighteveryear(Sæthreetal.2006).FieldtrialswithLBRGMpotatoindicatean80%reductionintheneedforfungicidestocontrollateblight(Haverkortetal.2016),whichmeansthatcloseto40millionNOK,canpotentiallybesavedwhencultivatingLBRGMpotatoinNorway.Moreover,additionalcostsassociatedwiththelaborandenergyrequiredtoapplyfungicidesmayalsobereduced.Approximately25%ofthepotatoesplantedeveryyearinNorwayarecurrentlycertifiedseedpotatoes,the remaining 75% are seed potatoes that farmers reuse from their own harvest (personalcommunicationMuathAlsheik10.10.2016).Still,buyingseedpotatoesrepresentthemostimportantcostforNorwegianpotatoproducers.TheextenttowhichfarmerswillprofitfromcultivatingLBRGMpotato will therefore also depend on the price of seed potatoes, farmer opportunity to use GM

potatoes from their own crop as seedpotatoes, and how frequently farmersmustbuynewseedpotatoes.MeasurementstoensuresegregationofGMand non-GM potato production lines, andavoid unintentional spread of GM potatomust be in place if GM potatoes are to becultivated in Norway. Therefore, farmerscultivating LBR GM potato will most likelyhavesomeadditionalcoststocomplywithco-existence, segregation and labellingrequirements.

Knowledgegapsandresearchneeds:Toassesswhether farmersbenefiteconomically fromcultivatingGMLBRpotato, it is importanttoconductresearchtoestimate:

• How farmerswill be impacted economically from the expected reduction in fungicide usewhen cultivating GM LBR potato, taking also into account the cost of seed potato andopportunitytoreusepotatoesasseedpotato

• Coststocomplywithrequirementsforco-existenceandsegregationbetweenGM-potatoandnon-GMpotatointheproductionchain

Photo:©RuudMorijn/adobestock.com

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DoesthecultivationofLBRGMpotatoaffectopportunitiesforco-existencebetweenGM,conventionalandorganicpotatoproduction,andthediversityofcommercialpotatovarietiesavailabletofarmers?Thepotatoplant’sbiologicalcharacteristics(i.e.vegetativepropagation,limitedseedproductionandnowildrelativesinNorway)reducethepotentialforaccidentalspreadofGMpotatotoneighboringfarmlandandinthesurroundingenvironmentinNorway.RisksofunintentionalspreadofGMpotatois thereforemainly related to handling of GM seed potatoes andGMpotatoes during cultivation,storage,processingandtransport(Finne2005).

Regulationstoassureco-existencebetweenGM,conventionalandorganicpotatoproductionarenotyet in place in Norway, but the Norwegian Scientific Committee for Food Safety has providedrecommendationsforco-existencemanagementstrategies(NorwegianScientificComitteeforFoodSafety2006).ThisreportconcludesthatitisveryunlikelythatcultivationofGMpotatoinNorwaywillresult inunintentionalpresenceofGMpotato inorganicandconventionalpotatobatchesaboveathresholdof0,9%.Suggestedstrategiestoensureco-existenceincludes;(i)anisolationdistanceof20mbetweenfieldswithGMpotatoandnon-GMpotato,(ii)carefulcleaningofmachineryforpotatoseeding,harvest,transportandstorageifthisistobeusedfordifferentproductionforms,(iii)carefulmonitoringofGMpotatofieldstoremoveGMpotatotubersandvolunteerpotatoplantsafterharvest,and(iv)specific requirements forcultivation intervals ifnon-GMpotato is tobecultivated in fieldswhereGMpotatoeshavegrown(NorwegianScientificComitteeforFoodSafety2006).OneissuethatcouldberelevanttoconsiderinrelationtopotentialunintentionalspreadofGMpotato,isthecommonpracticeofcultivatingpotatoesinprivategardensinNorway,wheremanyhouseholdsreuseandshareseedpotatoes.SuchpracticesmayinterferewithintellectualpropertyprotectionofGMpotatoandposechallengesforco-existencemanagement.70differentpotatovarietiesareapprovedforcultivationinNorway(Plantesortsnemnda2016).Amongthese,approximately40varietiesaregrowntosomedegree,whichincludes12varietiesthataremostcommonly cultivated in Norway.Most of these varieties are quitesusceptible to late blight(Møllerhagen 2015). Factors thatmayinfluencewhethercultivationof LBR GM potato will influencethediversityofcommercialpotatovarieties available to farmersinclude: the intended use of theGM potato (direct consumption/processing), whether the GMpotato is suitable for theagronomic conditions specific toNorway,and if it satisfies specificconsumerpreferences.

Photo:©panoramarx/adobestock.com

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Knowledgegapsandresearchneeds:To evaluate how cultivation of GM LBR potato may influence the diversity of commercial potatovarietiesthatareavailabletoNorwegianfarmersandconsumersitisimportantto:

• ConductfieldtrialstotestwhethertheLBRGMpotatoissuitablefortheagronomicconditionsspecifictoNorway

• Conduct an expert workshop to develop guidelines for co-existence between GM,conventional and organic potato production and segregation in the production chain (i.e.storage,transportationandprocessingline)

4. Importantconsiderationsforanassessmentofethicaljustifiability

DoescultivationofLBRGMpotatoaffectfarmers’,manufacturers’andconsumers’freedomtochoosedifferentpotatovarietiescultivatedunderdifferentproductionsystems?Democraticrights,suchasthefreedomtochoosewhatyouwanttogrowasafarmerandeatasaconsumerisimportantinoursociety.ThemandatorylabellingofGMfoodinNorwayisoneexampleof recognition of this right. To what extent cultivation of LBR GM potato will influence farmers’,manufacturers’ and consumers’ freedom to choosewhich potato theywant to grow and eat,willdependonawiderangeof factorsthataredifficult topredictpriortocommercial release.SeveralquestionswereraisedwhenNorwegianstakeholdersdiscussedthisissue(Gillundetal.2015),suchas(i)mayLBRGMpotatodominate futurepotatomarketsand thereby reduce thediversityof otherpotatovarietiesavailabletofarmersandconsumers?(ii)canpotatoproducersreuseGMpotatofromtheirownharvestasseedpotato?(iii)couldcultivatingLBRcisgenicGMpotatothatexpressseveralRgenes increase the selection pressure within the pathogen population and possibly speed up thedevelopmentofmulti-resistantP.infestansstrains?Ifso,willfuturepotatoproducersbefacedwithamore aggressive pathogen? How will a potential approval of LBR cisgenic GM potato in NorwayinfluencepotatoproducerswhochoosenottocultivateGMpotato?Will itbedifficultforafarmerwhohasstartedtogrowLBRGMpotatotoreturntoconventionalororganicpotatoproductioninthefuture?Importantly,apotatofarmerisallowedtosaveapartofitspotatoharvesttoreusethenextyearasseedpotato,underthePlantBreedersRights(PBR)thatsecuresbreedersownershipandcontroloverpotatovarietiescurrentlycultivatedinNorway.ThisopportunitytoreuseseedpotatoisimportantfortheNorwegianpotatoindustry,asfarmerstakearound70-75%oftheirseedpotatoesfromtheirowncrop.LBRGMpotatoispatentedwhichimpliesthatthefarmersmustobtainalicensefromthepatentholdertocultivateandimpliesthatfarmersaretypicallynotallowedtoreuseseeds.Knowledgegapsandresearchneeds:ToevaluatehowcultivationofLBRGMpotatomayaffectfarmers’,manufacturers’andconsumers’freedom to choose different potato varieties cultivated under different productions systems it isimportanttoconductresearchon:

• Howtheintroductionofpatentedseedpotatomayaffectfarmers’rightsandcontrolovertheircrop?

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• Potential changes in the Norwegian potato market posed by the introduction of LBR GMpotato

• How cultivation of LBR GM potato influences the P. infestans population in the receivingsystem, and possibility to practice other potato production forms and late blight controlstrategiestodayandinthefuture

IstheLBRGMpotatoavailableforfurtherbreedingandresearch?Theanswer to thisquestionwill dependonhow thebreeder’sownershipof an LBRGMpotato isprotected.GMOsareoftenpatented,whichmeansthatotherpersonsmusthavealicensefromthepatentholdertodoresearchortacarryoutfurtherbreedingonthematerial.SomepatentspreventanyoneotherthantheseedcompanyfromconductingresearchorfurtherbreedingonGMcrops.TheownershipofconventionallybredplantvarietiesarecurrentlyprotectedunderPlantBreederRights(PBR),whichgivesthebreederanexclusivecontroloverthebreedingofaparticularvariety.However,in contrast topatents,PBR implies ‘breeder’sexemption’ thatallowsbreeders touseeachother’svarieties in breeding programs without necessarily obtaining a license or agreeing on financialcompensation.All theR genes introduced into LBRGMpotato varieties that are currentlyunderdevelopmentbyEuropean research institutes are patented. Interestingly however, theR genes isolatedwithin theDurphprojectispatentedbytheWageningenUniversityundera“humanitarianuselicensing”.Thisimpliesthatpoorcountriesmay,undercertainconditions,getavailableRgenesthatcanbeintroducedbygeneticengineeringintolocalpotatocultivars.Informationabouttherequirementsspecifiedinthelicense is important in order to evaluate how poor countries and farmers may benefit from thetechnology.Knowledgegapsandresearchneeds:ToconsidertheavailabilityoftheLBRGMpotatoforfurtherbreedingandresearchitisimportanttoknow:

• TherequirementsgivenbythepatentholderonfurtherbreedingandresearchontheLBRGMpotatovariety,andhowtheserequirementsdifferfrombreedersrightsonconventionallybredpotatocultivarscurrentlycultivatedinNorway

5. Conclusionsandrecommendationsforfurtherresearch

This Biosafety Report presents ten assessment questions that are consider particularly relevant toevaluateethical, socialandsustainability implicationsofcultivatingLBRGMpotato inaNorwegianagriculturalcontext.Thereportdoesnotprovideafullassessmentofthesequestionsanddonotmakeanyconclusionsabouttheethicaljustifiability,socialutilityorsustainabilityofthepotentialcultivationofLBRGMpotatoinNorway.Rather,itsummarizessomeoftheinformationthatisavailabletoassessthesequestionsandpointstofurtherresearchneeds.Thetenassessmentquestionsdiscussedinthisreportandresearchneedsidentifiedarepresentedinthetable.

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Assessmentquestion Recommendedareasforfurtherresearch:DoestheLBRGMpotatocontributetosolveanimportantproblemfor

Norwegianpotatoproducers?

Updatedstatisticaldataon:• Theprevalenceofthelateblightdiseaseindifferentpotatoproducing

regionsinNorway• Economiclossescausedbythedisease• Otherimportantcostsandlossesassociatedwithpotatoproduction

IsthereademandfortheLBRGMpotatoinNorway?

• Consumersurveys(includingpopulationandamonginterestedparties)on:• AttitudestoLBRGMpotato• AttitudestocisgenicLBRpotato

Whatarethealternative

approachestobreedforLBRpotatovarieties?

Researchthatidentifies:• CurrentbreedingeffortsandapproachesforLBRpotatoes,particularlyin

NorwayandEurope• TheprioritygiventoLBRinpotatobreedingprograms,particularlyinNorway

andEurope• OtherpotatobreedingapproachesforLBR

IstheGMpotatoplant’sLBRdurableovertime?

Basicresearchon:• ThemolecularmechanismsunderlyingtheobservedLBR• ThemechanismsandevolutionofvirulencedevelopmentintheP.infestans

populationConductanexpertworkshopto:• EvaluateriskforvirulencedevelopmentintheNordicP.infestans

populationsandsuggestaresistancemanagementprogramDoestheLBRGMpotatoreduce

theneedforfungicidestocontrolLBovertime?

Fieldtrialstoexamine:• FungiciderequirementsforcultivatingLBRGMpotatounderdifferent

climaticconditionsandduringallphasesofthegrowingseason• Tissue-specificexpressionofRgenesandtowhatextenttheyconferLBRin

differentpartsofthepotatoplant• Howsecondarypestsrespondstoreducedsprayingagainstorless

prevalenceofP.infestansIstheLBRGMpotatosafefor

humanhealthandtheenvironmentovertime?

Researchon:• Theproteinbeingproducedbythecisgene,aswellascheckingforits

allergenicpotentialoranyunexpectedalterationsinproteinstructureandquantity

• Metabolicdisturbancescausedbytheintroductionofthenoveltraitorbytheexpressionofcisgene.Thiscanbeachievedbyuntargetedmolecularapproachessuchasmulti-omicsanalyses

DoestheprofitabilityoffarmerswhocultivatetheLBRGMpotato

improveovertime?

Researchtoestimate:• Howfarmerswillbeimpactedeconomicallyfromtheexpectedreductionin

fungicideuse,takingalsointoaccountthecostofGMseedpotatoandopportunitytoreusepotatoes

• Costtocomplywithrequirementsforco-existenceandsegregationbetweenGM-potatoandnon-GMpotatointheproductionchain

DoestheLBRGMpotatoaffectopportunitiesforco-existence,andthediversityofcommercialpotato

varietiesavailabletofarmers?

Expertworkshopto:• Developguidelinesforco-existencebetweenGM,conventionalandorganic

potatoproductionandsegregationintheproductionchainFieldtrialsto:• TestwhethertheLBRGMpotatoissuitablefortheagronomicconditions

specifictoNorwayDoestheLBRGMpotatoaffectfarmers’,manufacturers’andconsumers’freedomtochoose

differentpotatovarietiescultivatedunderdifferentproduction

systems?

Researchon:• Howtheintroductionofpatentedseedpotatomayaffectfarmers’rightsand

controlovertheircrop?• PotentialchangesintheNorwegianpotatomarketposedbytheintroduction

ofLBRGMpotato• HowcultivationofLBRGMpotatoinfluencestheP.infestanspopulationin

thereceivingsystem,andpossibilitytopracticeotherpotatoproductionformsandlateblightcontrolstrategiestodayandinthefuture

IstheLBRGMpotatoavailableforfurtherbreedingandresearch?

Informationabout:• Therequirementsgivenbythepatentholderonfurtherbreedingand

researchontheLBRGMpotatovariety,andhowtheserequirementsdifferfrombreedersrightsoverconventionallybredpotatocultivarscurrentlycultivatedinNorway

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