Working Paper No. 2016/6 | May 2016

International Regulation of Emerging Technologies: Global Ideologies and Local Headaches

Dannie Jost World Trade Institute dannie.jost@wti.org

This paper begins to address the international regulation of emerging technologies taking an approach that includes the co-production of technologies and the nature of wicked problems. Both the development of technologies over time, the role of science in regulation, and results from case studies in the regulation of biotechnologies are discusses. Biotechnology, nanotechnology and synthetic biology receive the most attention.

Research for this paper was funded by the Swiss National Science Foundation under a grant to the National Centre of Competence in Research on Trade Regulation, based at the World Trade Institute of the University of Bern, Switzerland. This is an early draft of the working paper. All comments and criticism is welcome.

NCCR TRADE WORKING PAPERS are preliminary documents posted on the NCCR Trade Regulation website (<www.nccr-trade.org>)and widely circulated to stimulate discussion and critical comment. These papers have not been formally edited. Citations should refer to an “NCCR Trade Working Paper”, with appropriate reference made to the author(s).

TableofContentsInAnthropoceneorinChuthulucene.................................................................................3

Technologies.....................................................................................................................4

Co-production...................................................................................................................5

ScienceattheServiceofTechnologies...............................................................................7

BiotechnologyrevisitedintheChuthulucene.....................................................................7TheGlobalIdeologies.................................................................................................................8TheLocalHeadaches..................................................................................................................9

RegulationandGovernanceDreamscapes.......................................................................12

InAnthropoceneorinChuthulucene

ThisessayconsidersinternationalregulationofemergingtechnologiesatdawnoftheChutullucene1andstartstheenterpriseofreengineeringregulatoryandgovernanceconceptstotakeintoaccountconceptsofknowledgeco-production2andwickedcomplexity.3IfwearetotaketheadviceofDonnaHaraway,“wemustaddressintense,systemicurgencies.“4Isclimatechangeoneofthesesystemicurgencies?Whatrolehastechnology,moreappropriately,whatrolewilltechnologiesplayandwhathasourunderstandingofpasttechnologiesandtheirregulationplayedinourabilitytoproduceregulation,internationalorotherwise,thatisappropriate?Oneworkingprincipleisthatappropriatenessofregulationandgovernanceisindicatedbytheabilitytobringoutdesiredoutcomes,thatiseffectiveness.Thisinturnimpliesthatregulationandgovernancemustbeinformedbycorrespondingvaluesasorganisingprinciples.

Oneofthemanyclaimsbeingmadeinacademicandnon-academicnarratives,itisthatsyntheticbiology,atleastintheformofiGEM(internationalgeneticallyengineeredmachines),5isthatoneenablerintheso-calledthirdindustrialrevolution.6Howeverthisthirdindustrialrevolutionisasclutteredwithclaimstoitsenablersasitistoitsveryhappening.Someproposethatweareseeingwiththeemergenceofartificialintelligenceandtheconvergenceofphysical,mechanical,digital,chemicalandbiologicaltechnologies,isthefourthindustrialrevolution.7It’snotcomplicated,itiscomplexandmuddled.

1DonnaHaraway,‘Anthropocene,Capitalocene,Plantationocene,Chthulucene:MakingKin’,EnvironmentalHumanities6(2015):159–65.Notethevariousproposednamesforthepresentepocharesubjectsofconsiderabledebate,andinitselfpointtothecomplexnatureofthepluratiyinwhichwelive.2SheilaJasanoffandSang-HyunKim,eds.,DreamscapesofModernity:SociotechnicalImaginariesandtheFabricationofPower(UniversityofChicagoPress,2015),3,6–7,14,22,326,332.3Foranintroductiontothenatureof‘wickedcomplexity’asopposedto‘staticcomplexity’see:BradenR.AllenbyandDanielSarewitz,TheTechno-HumanCondition(Cambridge,Mass.:TheMITPress,2013),109.4Haraway,‘Anthropocene,Capitalocene,Plantationocene,Chthulucene:MakingKin’.5ManuelPorcarandJuliPeretó,SyntheticBiology:FromiGEMtotheArtificialCell(Springer,2014);ChristinaDSmolke,‘BuildingoutsideoftheBox:iGEMandtheBioBricksFoundation’,NatBiotech27,no.12(December2009):1099–1102;RudolphMitchell,YehuditJudyDori,andNatalieH.Kuldell,‘ExperientialEngineeringThroughiGEM-AnUndergraduateSummerCompetitioninSyntheticBiology’,JournalofScienceEducationandTechnology20(2011):156–60.6GeorgeM.ChurchandEdRegis,Regenesis:HowSyntheticBiologyWillReinventNatureandOurselves(BasicBooks,2012),179.7KlausSchwab,TheFourthIndustrialRevolution(WorldEconomicForum,2016);M.WaidnerandM.Kasper,‘SecurityinIndustrie4.0-ChallengesandSolutionsfortheFourthIndustrialRevolution’,Dresden,inDesign,AutomationTestinEuropeConferenceExhibition(Dresden:IEEE,2016),1303–8;AndrewD.Maynard,‘Navigating

Thispaperbeginstoaddresstheroleandprospectsofinternationalregulationofemergingtechnologiesgivenbythecontextsprovidedbyaglobaleconomy,theaspirationsofsustainabledevelopment,andthedesiretorespecthumanrightsasorganisingprinciples.Todothisthecomplexrelationshipbetweentheworldsofscienceandtechnologyandthatoflawneedtoberevisitedwiththehopeofrecognizingpastfailuresandpotentialvenuesforaction.Aftersettingthetechnologies-contextandintroducingtheconceptofco-production,thecaseofbiotechnologyistakenupanddiscussedinlightofitsnewestdevelopmentsinsyntheticbiology.Abriefperusalthroughwhatinternationalregulationoftechnologiesingeneral,andWTOlawinparticularofferindealingwiththeadvancingedgeoftechnologyfindsthesystemwanting.Whiletherearemanyproposalsforglobalgovernanceoftechnologies,noneseemtolendthemselvestotheaspirationsofsustainabledevelopmentandanincreasingexpectationthatwhateverhappensintechnologyoreconomicsbeinclusive.

Technologies

Technologyisnotonediscipline;itisneithermonolithicnorhomogeneous.Apluralityoftechnologiesrangingfromthemoleculartotheplanetaryhaveevolvedovertimeandareemergingacrossallscientificandtechnicaldisciplines.Aboveall,technologyisnormative,notapanacea.8Onecanalsosaythattechnologiesareartefactual,andlocatedintimeandspace.Tocontextualizeinternationaleconomiclawandhowittreatstheregulationoftechnologyintimeandspacecallsforanunderstandingoftheinterfacesbetweenlawandtechnologywithinouractuality.Whetherwewanttoconsiderouractualityasmodernpost-modern,oraccelerationistmayaffecttheassumptionstobemadeabouttechnology’sroleinsocietywhichinturnyielddifferentresultsastotheregulatoryoptionsavailableforconsideration.Inthisessayweusetheideaofmodernity,andleaveapost-modernistapproachforalateroccasion.Alreadythebridgingofmodernity–andtechnologyisataskthatleavemostlookingforeasierterraintoexplore.

Thenatureofouractualityismarkedbypolitical,legal,moral,technological,andscientificdiscoursesaroundglobalclimatechange,humanrightsanddignity(terrorismandwar,migration,globalisation),plussustainability,allwithanunprecedentedaccelerationofdevelopmentsthatstrainandstressnotionsoflegitimacy,legalconcepts,establishedregulatoryagenciesandmankind’sownunderstandingofitself.

First,theevolutionofourunderstandingoftechnologydirectsustocometogripswithwhattechnologyisandtotrytounderstanditwithintheglobalisationcontext.Broadlyspeakingtechnologyistheapplicationofscientificknowledgeforpracticalpurposes,especiallyintheFourthIndustrialRevolution’,NatureNanotechnology10,no.12(December2015):1005–6.8HansRadder,‘WhyTechnologiesAreInherentlyNormative’,inPhilosophyofTechnologyandEngineeringSciences,ed.AnthonieMeijers,HandbookofthePhilosophyofScience(Amsterdam:North-Holland,2009),887–921,http://www.sciencedirect.com/science/article/pii/B9780444516671500379.

industry.Suchadefinition,eveniftakenfromthedictionary,iscolouredbyinstrumentalrationality.Forregulatorypurposestechnologyhasbeentreatedasanexogenousobjectthatcanbecontrolledinapredefinedwayandthatistoopedestrianforproperconsiderationbythehighpriestsofthesocialsciences.Thisantiquatedideaassumesthat(ubiquitous)control(oftechnology)ispossible.Italsooverlooksunintendedconsequences(surprises)andemergentphenomena.

Asystemicapproachtotechnologyregulationthataddressesitsupdatedcontemporaryubiquity,diversityanduncertaintiesappearsunexplored.Technologyregulationcanbeappliedinmanydifferentsocialcontexts–production,consumption,use,disposal,etc.–thatgenerateplentyoflegalquestionsandrequireamultitudeofcarefullydifferentiatedconsiderationswithrespecttothelife-cycleofthespecifictechnology,andtheproduction-chainofthatindustry.Technology’snormativityhasoftenbeenignoredandarangeofattitudesandvalueshavebeenattributedtoitdependingonwhateverideologyortheorypermeatedthethinkingofscholarsandregulators.Infact,pervasivenessandsuccessofmoderntechnologymeansthattechnologicaldecisionsincreasinglyaffectsociallife.Thatis,duetothispervasiveness,intensity,andinterwovencharacterofthefibresofsocietyandtechnology,“onecandrawdiametricallyopposedconclusions:eitherpoliticsbecomesanotherbranchoftechnology,ortechnologyisrecognizedaspolitical”.9

Co-productionWecangenerallyagreethatanapparentaccelerationintechnologicaldevelopmentcreateschallengestoexistingpracticesandnormativeunderstandingthatareyettobeidentifiedbeitinquality,quantityorscope.Thatis,uncertaintyiswhatweneedtocopewithinaworldmarkedbyincreasinglywickedproblems.Twodifferenthistoricisedsurveysoftechnologysystemscanserveasguidingpoststowardstryingtogainperspective.Thefirstonedatesfrom1946,andthesecondfrom2013.LewisMumford’s1946classification10isseparatedintimebyhalf-centuryfromthatofAllenbyandSarewitz11andwhilesinninginthedirectionofreductionism,theycanlaterbeanalysedthroughtheprismofcriticaltheorysuchasthatofferedbyFeenberg.12

Mumforddistinguishesthreesuccessivemaintechnologyphases:eotechnic,paleotechnic,andneotechniceachmarkedbyasetofdistinctinventions.Theeotechnicorearlyphaseoftechnicsstretchesroughlyfrom1000to1750when“inventionandexperimentaladaptation

9AndrewFeenberg,QuestioningTechnology(Routledge,2012),2.10LewisMumford,TechnicsandCivilization(London:GeorgRoutledge&Sons,Ltd.,1946).11AllenbyandSarewitz,TheTechno-HumanCondition.12Feenberg,QuestioningTechnology;AndrewFeenberg,BetweenReasonandExperience:EssaysinTechnologyandModernity(MITPress,2010);TylerJ.Veak,DemocratizingTechnology:AndrewFeenberg’sCriticalTheoryofTechnology(SUNYPress,2006);AndrewFeenberg,TransformingTechnology :ACriticalTheoryRevisited:ACriticalTheoryRevisited(OxfordUniversityPress,USA,2002).

wentonataslowlyacceleratingpace”andnewsourcesofenergyweredeveloped.13Onceequippedwithmechanicalclocks,telescopes,cheappaper,printingpresses,magneticcompassesfromtheeotechnicthenextphase–thepaleotechnic–sawtheinventionofthesteamengineandthebeginningofthedestructionoftheenvironment,andthedegradationoftheworkerallinfavourinthedoctrineofprogressinwhatweareaccustomedtocallthefirstindustrialrevolutionfromca.1760to1820,whichisalsooftenreferredtoasthefirstindustrialrevolution.Theneotechnicphase,theoneduringwhichMumfordwrotehisobservations,isinhiswords“adefinitephysicalandsocialcomplex”thatbeganin1832withthe“perfectionofthewater-turbinebyFourneyron14andismarkedbytheconquestofnewformsofenergy,namelyelectricity.15Mumford’sdistinctionsareusefulastheyillustratethecumulativenatureoftechnology,anditsinextricabilityfromthesocialconditionofmanfromalinearhistoricalperspectivethatalsodemonstratestheso-calledaccelerationofthepaceofinvention.Onceelectricityandthesteamengineenteroursociotechnicalworld,technologiesmultiplyineverypossibledirectionintoeveryaspectofhumanactivity.

TheapproachdevelopedbyAllenbyandSarewitzdistinguishthreelevelsoftechnologydesignatedI,II,andIII.Thistaxonomypermitsaclearerstructuralunderstandingofthedifferencesbetweentoastersandnuclearweaponsperspective.16AtlevelI,technology’sintentionandeffectareathand.Forexample,toastersreliablyandsafelydelivertoastedbreadorairplanescarrypassengersfrompointAtopointB.AtlevelIoftechnology,systemiccomplexityisforgotten.LevelII,intheAllenby-Sarewitzmodelweencounterthesystemiccomplexityaroundairtravel(ortheproductionoftoastersorautomobiles).Thatis,tostaywithAllenby-Sarewitzmodel,atlevelIIwehavetheairtransportationsystemembodiedwith“theirrationality,dysfunctionandinsanepricesystem,theabsurdinefficiencyofitsboardingandsecurityprocesses,thecontinualdelays,and…”.17LookingattechnologyasawholeinlevelII,wesoondiscernthefirstcontoursofasystemandtheemergenceofthelock-inphenomenaconcurrentlywithalevelIIambivalenceandambiguitythatisaccompaniedbyareliablelevelItechnology.TheAllenby-SarewitzlevelIIIpatterninthistechnologytaxonomyisperhapseasiertorecognizeinhighlynetworkedtransportationsystems(still,wecanalsoseeinenergyproductionsystems,telecommunications,agriculture,textiles)suchasthoseoftransportationeitherbyairorland.AtlevelIIIweobservetheco-evolutionof“significantchangesinenvironmentalandresourcesystems;mass-marketconsumercapitalism;individualcredit;behaviouralandaestheticsubculturesandstereotypes;withoilspills;withopportunitiesfor,andasenseof,extraordinaryhumanfreedom,especiallyforwomen…“.18Mumford,AllenbyandSarewitz,inspiteoftheseventyyearsbetweentheirobservationsbothpointtotheunequivocalco-productionoftechnologyorthe“constantintertwiningofthe13Mumford,TechnicsandCivilization,111–23.14DietrichEckardt,GasTurbinePowerhouse:TheDevelopmentofthePowerGenerationGasTurbineatBBC-ABB-Alstom(WalterdeGruyterGmbH&CoKG,2014),49.BenoitFourneyron(1802-1867)wasaFrenchengineereducatedattheÉcoleNationaledesMinesdeSaint-Etiénne.15Mumford,TechnicsandCivilization,212ff.16AllenbyandSarewitz,TheTechno-HumanCondition,36.17Ibid.,37.18Ibid.,39.

cognitive,thematerial,thesocialandthenormative”.19Co-productionofnaturalandsocialordersmeansthatthewaysinwhichwerepresenttheworldareinseparablefromthewaysthatwechoosetoliveinit.20Thatis,explanatorypowerisgainedbythinkingofnaturalandsocialorderstogetherwherebothnatureandsocietyareinseparable.21

ScienceattheServiceofTechnologies

Thecommonunderstandingisthatwhenevaluatingatechnology’seffectivenessandsafetytheusualcourseofactionistomakerecoursetoscienceinassessingthetechnology’seffectivenessandsafety.Therearethentwotasksthatscienceoughttoaccomplish:factfindinganddecidingwhatissafeandeffective.Thefirsttaskistheonethattraditional–normalscience–isbestequippedtodowithinitsreductionistwalls.Thesecondtaskisuncomfortableforscientists–postnormalscience–involvestheacknowledgedadditionofvalues.22Howeveritisthatlasttaskthatattemptstoconnectthedotsofuncertaintybyappealingtovaluesthatcouldbearthemarkofaleastcommondenominator.Whattheresultsare,doesdependonthevaluesapplied.Itishowevernotclearthatitispossibletofindthatleastcommondenominatorforall.Or,toputinotherwords“theauthorityofscienceisnotafoundationforfactualenlightenmentbutanideologicalfoundationforauthoritarianpolicyprescriptionsthatmightotherwisebedifficulttoimplement”inworldofwickedproblems,“morelikelytodeliversurprisesthansolutions.”23

BiotechnologyrevisitedintheChuthulucene

Thetransitionfrombiotechnologytosyntheticbiologyhasbeenevolutionary,andinkeepingwiththegeneraldevelopmentallowedbyacademicandeconomicfreedoms.Stillwhiletherearemanycommonalities,therearealsomarkeddifferences.Themostradicaldifferencebeingthatofthepossibilitiesenabledbythediscoveryofagroupofgenesthatallowforverypreciseengineeringofgenomes.24

19SheilaJasanoff,‘TheIdiomofCo-Production’,inStatesofKnowledge :TheCo-ProductionofScienceandSocialOrder,ed.SheilaJasanoff,InternationalLibraryofSociology(London:Routledge,2004),1–12.20Ibid.21Ibid.22SilvioO.FuntowiczandJeromeR.Ravetz,‘ScienceforthePost-NormalAge’,Futures25,no.7(September1993):739–55;JerryRavetz,‘ThePost-NormalScienceofPrecaution’,Futures36,no.3(April2004):347–57.23AllenbyandSarewitz,TheTechno-HumanCondition,122.24SimonN.Waddingtonetal.,‘ABroadOverviewandReviewofCRISPR-CasTechnologyandStemCells’,CurrentStemCellReports2,no.1(11February2016):9–20;JacobS.Sherkow,‘CRISPR:PursuitofProfitPoisonsCollaboration’,Nature532,no.7598(13April2016):172–73;EricS.Lander,‘TheHeroesofCRISPR’,Cell164,no.1–2

TheGlobalIdeologies

Arecentreviewof99peer-reviewedjournalarticlespublishedsince2004onthesocialimpactsofgeneticallymodified(GM)cropsinagriculturecomestotheconclusionthatthemostcommonlystudiedimpact–economic–mainlyreportthattherearebenefitswhileothersocialimpactsthatarelessstudiedpresentamorecomplexpicture.25

Biotechnologyhasreceiveddetailedattentionininternationallaw,internationalrelations,andthescienceandtechnologystudiesliterature.26Brieflystated,differencesofopinionandvaluesbetweentheUnitedStatesandtheEuropeanUnionovertheregulationofgeneticallymodifiedorganismshaveresultedinalackofcooperationandstarkdifferencesinregulatorystandardsandframeworkswhiletherestoftheworldmuddlesthrough.27

Oneviewisthatthereisnoperceivedpubliccrisisinbiotechnologythatcreatedaspecificregulatorymomentashasbeenthecaseforotherregulatoryobjects.28Thatmaybeso,andthedifferencesmayarisefromamultitudeofsources,andtheymaybeendogenousor

(14January2016):18–28;DanielSarewitz,‘CRISPR:ScienceCan’tSolveIt’,Nature522,no.7557(23June2015):413–14;DavidCyranoski,‘CRISPRTweakMayHelpGene-EditedCropsBypassBiosafetyRegulation’,Nature,19October2015,http://www.nature.com/doifinder/10.1038/nature.2015.18590;JenniferA.DoudnaandEmmanuelleCharpentier,‘TheNewFrontierofGenomeEngineeringwithCRISPR-Cas9’,Science346,no.6213(28November2014):1258096.25KlaraFischeretal.,‘SocialImpactsofGMCropsinAgriculture:ASystematicLiteratureReview’,Sustainability7,no.7(2July2015):8598–8620.26ThomasBernauer,Genes,Trade,AndRegulation:TheSeedsOfConflictInFoodBiotechnology(PrincetonUniversityPress,2003);SusetteBiber-Klemmetal.,‘ChallengesofBiotechnologyinInternationalTradeRegulation’,inTheProspectsofInternationalTradeRegulation:FromFragmentationtoCoherence,ed.ThomasCottierandPanagiotisDelimatsis(Cambridge ;NewYork:CambridgeUniversityPress,2011),284–320;SheilaJasanoff,DesignsonNature:ScienceandDemocracyinEuropeandtheUnitedStates(Princeton,N.J:PrincetonUniversityPress,2005);MarkA.PollackandGregoryC.Shaffer,WhenCooperationFails:TheInternationalLawandPoliticsofGeneticallyModifiedFoods(OUPOxford,2009);DanielWügerandThomasCottier,eds.,GeneticEngineeringandtheWorldTradeSystem,WorldTradeForum(Cambridge ;NewYork:CambridgeUniversityPress,2008).27PollackandShaffer,WhenCooperationFails,1–32.28MichaelHowlettandDavidLaycock,eds.,RegulatingNextGenerationAgri-FoodBiotechnologies(Routledge,2013),49–72;MichaelHowlettandJoshuaNewman,‘After“theRegulatoryMoment”inComparativeRegulatoryStudies:ModelingtheEarlyStagesofRegulatoryLifeCycles’,JournalofComparativePolicyAnalysis:ResearchandPractice15,no.2(1April2013):107–21.

exogenous.29Theproblemisanoldone.Whatlooksgoodintheory,encountersproblemswhenputintopractice,andtherealitymaybemorecomplexthanitwashopedfor.

Academics,farmers,activists,multinationalcorporations,governmentofficialsallpromotetheirviewsontheadvantagesoftechnologyoritsregulation,howeverwhenitcomestoGMcrops“thescientificdataareofteninconclusiveorcontradictory”.30In2013arecordof175.2millionhectaresofbiotechcropsweregrownglobally.31Meanwhileabitofdusthasstartedtoaccumulateonsomeofearliertextsontheinternationalaspectsofgeneticallymodifiedorganisms(GMO),andonewondershowthesenarrativescomparewithlocalfarmer’srealities.

TheLocalHeadaches

Let’stakethecaseofGMcottonwhichconstitutesalargefractionofthetotalglobalproductionofallofGMcrops.TheestimateisthatintheUSmorethan90percentoftheplantedcottonis2014wasGM.32InArgentinatheestimateisthatitcoversabout80-90percentoftheareasownalbeitwithuncertifiedtransgenicseed.33Briefly,therearethreemaintypesofGMcottonvarietiesbasedontwodifferentgenetictraits:oneisresistanttotheherbicideglyphosate(alsoknownbyMonsanto’strademarkRoundup),anotherproducestoxinsthatkillcottonbollworm.ThetreetypesofGMcottononthemarketare:onethatisglyphosateresistant,onethatproducestheBttoxin,andathirdincorporatingbothtraits.OverfiftydifferentcommercialGMcottonseedshavebeenapproved.TheseedstradenamesanddetailsareavailableindatabasessuchasthosemaintainedbytheInternationalServicefortheAcquisitionofAgri-BiotechApplications34,GMOCompass.35TheInternationalCottonAdvisoryCommittee36providesstatisticsonworldcottonproduction,consumption,trade,andservesas

29MichaelHowlettandAndreaMignone,‘RegulatoryLifecyclesandComparativeBiotechnologyRegulation’,inRegulatingNextGenerationAgri-FoodBio-Technologies,ed.MichaelHowlettandDavidLaycock(Routledge,2013),64.30NatashaGilbert,‘CaseStudies:AHardLookatGMCrops’,Nature497,no.7447(1May2013):24–26.31CliveJames,‘GlobalStatusofCommercializedBiotech/GMCrops:2013-ISAAABrief46-2013:ExecutiveSummary’,InternationalServicefortheAcquisitionofAgri-BiotechApplications,2014,http://www.isaaa.org/resources/publications/briefs/46/executivesummary/.32http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption.aspx33Maria-EugeniaFazioetal.,‘LocalRealitiesforTransgenicCotton’,inRegulatingTechnology:InternationalHarmonizationandLocalRealities,ed.PatrickVanZwanenberg,AdrianEly,andAdrianSmith(London ;Washington,DC:Earthscan,2011),73–98.34http://www.isaaa.org/35http://www.gmo-compass.org/36https://www.icac.org/

aclearinghousefortechnicalinformationaboutcottonandcottontextiles;italsorepresentstheinternationalcottonindustrybeforeUNagenciesandotherinternationalorganizations.

Intheoryandinthelaboratory,butalsofromanideologicalpointofview,greatopportunitiesforbetterintegrationofconventionalbreedingandmolecularbiologytoimprovecultivarsandheraldanewageincottonimprovementseempromising.37Itisclaimedthat80%ofglobalcottonproductionin2012wasthatfromgeneticallymodifiedseeds38Therealityonthegroundtellsadifferentstory.

Intheglobalsouth,onestudyintheChacoprovinceinArgentinawhatwasfoundwasthatonlythe2percentoffarmerswithmorethan200hectaresoflandandproducing70percentofthecottonhadboththemeanstobuycertifiedtransgeneticseedandboththeknowledgeandscaletomaintainqualityofsuccessivemultiplicationsofsavedseed.39Toaddinsulttoinjury,the‘2percentfarmers’arealsoadeptatignoringcontractsthatwouldbindthemtotakerecommendedmeasurestomaintainthequalityofthenewseedandtodelaydevelopmentofpestresistancetotheBttoxinwhilethemajorityinthesameregionwhoobtainnon-certifiedseedsininformalmarketshaveneithertheginstodelinttheseedsnortheknowledgetoensurequalityormakethebestofwhatthey.40Thatis,themajorityoftheseArgentiniansmallcottonfarmersgetseedsofnotonlyvariable,butdoubtfulqualitywithtransgenicandnon-transgenictraits,andduetothelackofknowledgeormislabellingfarmersendupwithpooryieldsasmaybecaseifaherbicideresistanceisassumedwheninsteadthenon-certifiedseedispesticideresistant.Thatis,thesesmallcottonfarmersarebeyondthereachoftheregulatoryregime.Inthiscase,thelocalregulatoryagency–theInsitutoNacionaldeSemillas(INASE)–ispracticallyincapableofassertinganyoversightespeciallyininformalmarkets,butalsotherewherefarmersignorecontractualobligationsalthoughtheirtaskisthatofapplyingtheSeedLaw(LeydeSemillasYCreacionesFitogenéticasN°20.247).Theresultingsituationisonewhereregulationofthetechnologyfailsatseverallevelsbeyondtheinternationalmodalitiesthatmadeitpossiblefortheseedtoenterthemarket.Theinterestsofthosewhomthetechnologyoughttobenefitareleftunattendedbylocalandnationalgovernments.Therights,moralandethicalvaluesrecognizedbyinternationallawareorphaned.

Thissituationalsoraisesquestionofbiosafetyandbiodiversity.ThefactthatuncontrolledGMseedsreachtheinformalmarketswithoutbiosafetytestingandapproval,leavesopenthe

37GregConstableetal.,‘CottonBreedingforFiberQualityImprovement’,inIndustrialCrops,ed.VonMarkV.CruzandDavidA.Dierig,HandbookofPlantBreeding9(SpringerNewYork,2015),191–232,http://link.springer.com/chapter/10.1007/978-1-4939-1447-0_10.38Ibid.39Fazioetal.,‘LocalRealitiesforTransgenicCotton’.40Ibid.

questionof“regulatorycapacitytoanticipateanddiminishpotentialenvironmentalimpacts,ortoassureinternationalmarketsthatexportedproductsarewhattheypurporttobe”.41

IntheprovincesofHubeiandShandonginChinathesociotechnicaldynamicsaredifferentfromthoseintheChacoprovinginArgentina,andcorrespondinglytheregulatoryfailuresaredifferent.Usingnationallyrepresentativepaneldata,ArzaandvanZwanenberganalysedtheeconomicimpactofBtcottonadoptionanditssustainability,after15yearsofitscommercializationinChina.Consistentwithitsshort-termimpact,thestudytheyshowedthattheeconomicbenefitofBtcottondidnotdiminish,butremainedstableandcontinuousinChina.42TheirstudythatusesnationallyrepresentativedataandfocusesontheeconomicbenefitofBtcottonanditsdynamics.“Asshowninthispaper,thefirstgenerationofcottonvarietieswithasingleBtgenestillcaneffectivelycontrolthebollworm.EventhoughfarmersinsomecountrieshaveswitchedfromunpatentedandroyaltyfeecottonvarietieswithasingleBtgenetopatentedcottonvarietieswithstackedgenes,rigorousanalysisisneededtoanswerwhetherthisswitchiseconomicaloraresultcausedbymanyfactors.”43

Thepatternsdescribedfor“internationaltransfertoandadaptationofgeneticallymodified(GM)cottoninArgentina,andaskwhetherpoliticalbargainingbetweenthetechnologyowner,amultinationalenterprise(MNE),andhostcountryactorsmayhaveinfluencedupgrading”toGMcrops.Theseauthorssuggestthat“theMNEwasabletouseitsexclusivecapacitytoupgradeGMcottontechnologiesasanegotiationtooltopersuadehostactorstochangetherulesthataffecteditsmultiplelineofbusinessinthecountry.Thisimplieswiderpolicyscopetoencouragetechnologyupgrading;hostactorscouldnegotiateoverawiderrangeofaspectsofinteresttoMNEs.”44

Thattheremanymoreproblemstobeaddressedbeyondtheinterestsofmultinationalcorporationsoughttobeevident.Thatis,“despitethewidespreadadoptionofBtcropsandacontinuedincreaseintheareaonwhichtheyaregrown,therearestillanumberofunansweredquestionsassociatedwithlongertermagro-ecosysteminteractions,forinstancetheimpactofsecondarypests.”45

Meanwhilethesituationisnotoptimalintheglobalnortheithereveniftheproblemshaveadifferentcharacter.IntheUStheannualstatisticsfor1992to2009oncottonplantedindicatesthatwhilethepercentageofgeneticallymodifiedcottonhasincreasedtonearly90percent,theaverageannualtotalherbicideapplicationrateforcotton(massperarea)failstoshowa

41Ibid.,85.42ValeriaArzaandPatrickvanZwanenberg,‘ThePoliticsofTechnologicalUpgrading:InternationalTransfertoandAdaptationofGMCottoninArgentina’,WorldDevelopment59(July2014):521–34.43FangbinQiao,‘FifteenYearsofBtCottoninChina:TheEconomicImpactandItsDynamics’,WorldDevelopment70(June2015):177–85.44ArzaandvanZwanenberg,‘ThePoliticsofTechnologicalUpgrading’.45RuiCatarinoetal.,‘TheImpactofSecondaryPestsonBacillusThuringiensis(Bt)Crops’,PlantBiotechnologyJournal13,no.5(1June2015):601–12.

decreasealthoughitwouldhavebeenexpectedaccordingtotheoryandrationaleofintroducingtransgenetictraits.46

RegulationandGovernanceDreamscapes

Nanotechnologies,likeotherproceedingtechnologies,havegottenmuchattentionandatoolargebodyofliteraturehasbeengenerateddisplayingaspectrumofviews.Thereissomeagreementthattherearetwomaindangers.Oneisthata“blinkeredadherencetoscience-drivenandhierarchicaldecision-makingapproach”inregulationwillignorethevaluesofthecitizenswhoseektoinfluenceregulationbysomeparticipativeorotherlegitimizingmechanisms.47Anotheristhatperceptionscountertocurrentscientificunderstandingmayhaveanundueornon-justifiableinfluenceonregulatorydecisions.48Thatis,balanceisrequired,andsocial,regulatoryandgovernanceinnovationiscalledupontoassuretransparency,legitimacyandtrustintheregulatoryprocess.

“Wehavecometothepointinsyntheticbiologywheretherearemanylab-scaleorproof-of-conceptexamplesofchemicallycontrolledsystemsusefultosensesmallmolecules,treatdisease,andproducecommerciallyusefulcompounds.Thesesystemshavegreatpotential,butmoreattentionneedstobepaidtotheirstability,efficacy,andsafety.”49(linktocasestudieswhereappropriate)

Gervaisanalysisusesaclassificationoftechnologythatisinterestingasananalyticaltool,andreliesmainlyontheprecautionaryprincipleapplicationtoleavetheemergingtechnologyunregulatedandpleadsforanimbleregulatoryapproach(courts,regulatoryagencies)whenrisksemerge.50Thisproposedapproachignoresthenatureoftechnologyandco-production.(tobeexpanded)

46SeeTable3in:RichardHCoupeandPaulDCapel,‘TrendsinPesticideUseonSoybean,CornandCottonsincetheIntroductionofMajorGeneticallyModifiedCropsintheUnitedStates’,PestManagementScience,1August2015,n/a-n/a.47AndrewD.Maynard,DianaM.Bowman,andGraemeA.Hodge,‘Conclusions:Triggers,Gaps,RisksandTrust’,inInternationalHandbookonRegulatingNanotechnologies,ed.GraemeA.Hodge,DianaMBowman,andAndrewD.Maynard(Cheltenham,UK:Elgar,2010),573–86.48Ibid.49TylerJFordandPamelaASilver,‘SyntheticBiologyExpandsChemicalControlofMicroorganisms’,CurrentOpinioninChemicalBiology,Syntheticbiology•Syntheticbiomolecules,28(October2015):20–28.50DanielJ.Gervais,‘TheRegulationofInchoateTechnologies’,HoustonLawReview47,no.3(18November2010):665–705.

Harmonizationpresumesstableandwidelysharedgoals.Develop.“Howdoharmonizingregulationsimpactontheopportunitiesforpoorercommunitiesindevelopingcountriestoeffectivelyaccessnewtechnologies,assurethemselvesofbenefits,whilstguardingagainstrisks?Howdoharmonizingregulationsaffectthecapacityofpoorercommunities,localandnationalbusinesses,andnationalgovernmentstodeveloplocallyappropriateformsoftechnologyuse?Doregulationsenableenvironmentallysustainableandsociallyjusttechnologydevelopmentpathwaysappropriatetospecificsituationsordotheyhinderthem?”51

Lastbutnotleast,thereistheissueofwhatcanWTOdotodealwithemergingtechnologies.Theverdictisthatifananalysis(type)oftheEUGMregulationinlightoftheWTOtradedisputesisindeedlegal,butitcertainlyhasbeencostly.52Thenwhenlookedatindetail,whileWTOandinternationallawcannotreallyeasetheburdenofdealingwithwickedregulatoryandgovernanceproblems,astreamliningofitsfunctionscouldbehelpfulisreducingofoftheburdens.(tobedeveloped,TBTiswhatisontheline,itisaboutstandardsafterall).

51CompareEly,Winter,Maynard,andGervais(considerFeenberg)AdrianEly,PatrickVanZwanenberg,andAndrewStirling,‘BroadeningoutandOpeningupTechnologyAssessment:ApproachestoEnhanceInternationalDevelopment,Co-OrdinationandDemocratisation’,ResearchPolicy43,no.3(April2014):505–18;GerdWinter,‘InSearchforaLegalFrameworkforSyntheticBiology’,inSyntheticBiologyAnalysed,ed.MargretEngelhard,EthicsofScienceandTechnologyAssessment44(SpringerInternationalPublishing,2016),171–211,http://link.springer.com/chapter/10.1007/978-3-319-25145-5_7;GerdWinter,‘TheRegulationofSyntheticBiologybyEULaw:CurrentStateandProspects’,inSyntheticBiology,ed.BerndGieseetal.,RiskEngineering(SpringerInternationalPublishing,2015),213–34,http://link.springer.com/chapter/10.1007/978-3-319-02783-8_11;B.Erickson,R.Singh,andP.Winters,‘SyntheticBiology:RegulatingIndustryUsesofNewBiotechnologies’,Science333(1September2011):1254–56;ElenStokesandDianaM.Bowman,‘LookingBacktotheFutureofRegulatingNewTechnologies:TheCasesofNanotechnologiesandSyntheticBiology’,EuropeanJournalofRiskRegulation2012(2012):235;JenniferKuzmaandToddTanji,‘UnpackagingSyntheticBiology:IdentificationofOversightPolicyProblemsandOptions’,Regulation&amp;Governance4(1February2010):92–112;HenryMillerDrewKershen,‘WillOverregulationInEuropeStymieSyntheticBiology?-Forbes’,Forbes.com,n.d.;MithunBantwalRaoetal.,‘TechnologicalMediationandPower:Postphenomenology,CriticalTheory,andAutonomistMarxism’,Philosophy&Technology28,no.3(September2015):449–74;GregoryConkoetal.,‘ARisk-BasedApproachtotheRegulationofGeneticallyEngineeredOrganisms’,NatureBiotechnology34,no.5(May2016):493–503;AlexanderKelle,‘BeyondPatchworkPrecautionintheDual-UseGovernanceofSyntheticBiology’,ScienceandEngineeringEthics,26May2012.52MaartenJ.PuntandJustusWesseler,‘LegalButCostly:AnAnalysisoftheEUGMRegulationintheLightoftheWTOTradeDisputeBetweentheEUandtheUSA’,TheWorldEconomy39,no.1(1January2016):158–69.