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).
TableofContents
InAnthropoceneorinChuthulucene.................................................................................3
Technologies.....................................................................................................................4
Co-production...................................................................................................................5
ScienceattheServiceofTechnologies...............................................................................7
BiotechnologyrevisitedintheChuthulucene.....................................................................7
TheGlobalIdeologies.................................................................................................................8
TheLocalHeadaches..................................................................................................................9
RegulationandGovernanceDreamscapes.......................................................................12
InAnthropoceneorinChuthulucene
Thisessayconsidersinternationalregulationofemergingtechnologiesatdawnofthe
Chutullucene1andstartstheenterpriseofreengineeringregulatoryandgovernanceconcepts
totakeintoaccountconceptsofknowledgeco-production2andwickedcomplexity.3Ifweare
totaketheadviceofDonnaHaraway,“wemustaddressintense,systemicurgencies.“4Is
climatechangeoneofthesesystemicurgencies?Whatrolehastechnology,more
appropriately,whatrolewilltechnologiesplayandwhathasourunderstandingofpast
technologiesandtheirregulationplayedinourabilitytoproduceregulation,internationalor
otherwise,thatisappropriate?Oneworkingprincipleisthatappropriatenessofregulationand
governanceisindicatedbytheabilitytobringoutdesiredoutcomes,thatiseffectiveness.This
inturnimpliesthatregulationandgovernancemustbeinformedbycorrespondingvaluesas
organisingprinciples.
Oneofthemanyclaimsbeingmadeinacademicandnon-academicnarratives,itisthat
syntheticbiology,atleastintheformofiGEM(internationalgeneticallyengineered
machines),5isthatoneenablerintheso-calledthirdindustrialrevolution.6Howeverthisthird
industrialrevolutionisasclutteredwithclaimstoitsenablersasitistoitsveryhappening.
Someproposethatweareseeingwiththeemergenceofartificialintelligenceandthe
convergenceofphysical,mechanical,digital,chemicalandbiologicaltechnologies,isthefourth
industrialrevolution.7It’snotcomplicated,itiscomplexandmuddled.
1
DonnaHaraway,‘Anthropocene,Capitalocene,Plantationocene,Chthulucene:
MakingKin’,EnvironmentalHumanities6(2015):159–65.Notethevariousproposed
namesforthepresentepocharesubjectsofconsiderabledebate,andinitselfpointto
thecomplexnatureofthepluratiyinwhichwelive.
2
SheilaJasanoffandSang-HyunKim,eds.,DreamscapesofModernity:Sociotechnical
ImaginariesandtheFabricationofPower(UniversityofChicagoPress,2015),3,6–7,
14,22,326,332.
3
Foranintroductiontothenatureof‘wickedcomplexity’asopposedto‘static
complexity’see:BradenR.AllenbyandDanielSarewitz,TheTechno-HumanCondition
(Cambridge,Mass.:TheMITPress,2013),109.
4
Haraway,‘Anthropocene,Capitalocene,Plantationocene,Chthulucene:MakingKin’.
5
ManuelPorcarandJuliPeretó,SyntheticBiology:FromiGEMtotheArtificialCell
(Springer,2014);ChristinaDSmolke,‘BuildingoutsideoftheBox:iGEMandthe
BioBricksFoundation’,NatBiotech27,no.12(December2009):1099–1102;Rudolph
Mitchell,YehuditJudyDori,andNatalieH.Kuldell,‘ExperientialEngineeringThrough
iGEM-AnUndergraduateSummerCompetitioninSyntheticBiology’,JournalofScience
EducationandTechnology20(2011):156–60.
6
GeorgeM.ChurchandEdRegis,Regenesis:HowSyntheticBiologyWillReinvent
NatureandOurselves(BasicBooks,2012),179.
7
KlausSchwab,TheFourthIndustrialRevolution(WorldEconomicForum,2016);M.
WaidnerandM.Kasper,‘SecurityinIndustrie4.0-ChallengesandSolutionsforthe
FourthIndustrialRevolution’,Dresden,inDesign,AutomationTestinEurope
ConferenceExhibition(Dresden:IEEE,2016),1303–8;AndrewD.Maynard,‘Navigating
Thispaperbeginstoaddresstheroleandprospectsofinternationalregulationofemerging
technologiesgivenbythecontextsprovidedbyaglobaleconomy,theaspirationsof
sustainabledevelopment,andthedesiretorespecthumanrightsasorganisingprinciples.To
dothisthecomplexrelationshipbetweentheworldsofscienceandtechnologyandthatoflaw
needtoberevisitedwiththehopeofrecognizingpastfailuresandpotentialvenuesforaction.
Aftersettingthetechnologies-contextandintroducingtheconceptofco-production,thecase
ofbiotechnologyistakenupanddiscussedinlightofitsnewestdevelopmentsinsynthetic
biology.Abriefperusalthroughwhatinternationalregulationoftechnologiesingeneral,and
WTOlawinparticularofferindealingwiththeadvancingedgeoftechnologyfindsthesystem
wanting.Whiletherearemanyproposalsforglobalgovernanceoftechnologies,noneseemto
lendthemselvestotheaspirationsofsustainabledevelopmentandanincreasingexpectation
thatwhateverhappensintechnologyoreconomicsbeinclusive.
Technologies
Technologyisnotonediscipline;itisneithermonolithicnorhomogeneous.Apluralityof
technologiesrangingfromthemoleculartotheplanetaryhaveevolvedovertimeandare
emergingacrossallscientificandtechnicaldisciplines.Aboveall,technologyisnormative,not
apanacea.8Onecanalsosaythattechnologiesareartefactual,andlocatedintimeandspace.
Tocontextualizeinternationaleconomiclawandhowittreatstheregulationoftechnologyin
timeandspacecallsforanunderstandingoftheinterfacesbetweenlawandtechnologywithin
ouractuality.Whetherwewanttoconsiderouractualityasmodernpost-modern,or
accelerationistmayaffecttheassumptionstobemadeabouttechnology’sroleinsociety
whichinturnyielddifferentresultsastotheregulatoryoptionsavailableforconsideration.In
thisessayweusetheideaofmodernity,andleaveapost-modernistapproachforalater
occasion.Alreadythebridgingofmodernity–andtechnologyisataskthatleavemostlooking
foreasierterraintoexplore.
Thenatureofouractualityismarkedbypolitical,legal,moral,technological,andscientific
discoursesaroundglobalclimatechange,humanrightsanddignity(terrorismandwar,
migration,globalisation),plussustainability,allwithanunprecedentedaccelerationof
developmentsthatstrainandstressnotionsoflegitimacy,legalconcepts,established
regulatoryagenciesandmankind’sownunderstandingofitself.
First,theevolutionofourunderstandingoftechnologydirectsustocometogripswithwhat
technologyisandtotrytounderstanditwithintheglobalisationcontext.Broadlyspeaking
technologyistheapplicationofscientificknowledgeforpracticalpurposes,especiallyin
theFourthIndustrialRevolution’,NatureNanotechnology10,no.12(December2015):
1005–6.
8
HansRadder,‘WhyTechnologiesAreInherentlyNormative’,inPhilosophyof
TechnologyandEngineeringSciences,ed.AnthonieMeijers,Handbookofthe
PhilosophyofScience(Amsterdam:North-Holland,2009),887–921,
http://www.sciencedirect.com/science/article/pii/B9780444516671500379.
industry.Suchadefinition,eveniftakenfromthedictionary,iscolouredbyinstrumental
rationality.Forregulatorypurposestechnologyhasbeentreatedasanexogenousobjectthat
canbecontrolledinapredefinedwayandthatistoopedestrianforproperconsiderationby
thehighpriestsofthesocialsciences.Thisantiquatedideaassumesthat(ubiquitous)control
(oftechnology)ispossible.Italsooverlooksunintendedconsequences(surprises)and
emergentphenomena.
Asystemicapproachtotechnologyregulationthataddressesitsupdatedcontemporary
ubiquity,diversityanduncertaintiesappearsunexplored.Technologyregulationcanbeapplied
inmanydifferentsocialcontexts–production,consumption,use,disposal,etc.–thatgenerate
plentyoflegalquestionsandrequireamultitudeofcarefullydifferentiatedconsiderations
withrespecttothelife-cycleofthespecifictechnology,andtheproduction-chainofthat
industry.Technology’snormativityhasoftenbeenignoredandarangeofattitudesandvalues
havebeenattributedtoitdependingonwhateverideologyortheorypermeatedthethinking
ofscholarsandregulators.Infact,pervasivenessandsuccessofmoderntechnologymeans
thattechnologicaldecisionsincreasinglyaffectsociallife.Thatis,duetothispervasiveness,
intensity,andinterwovencharacterofthefibresofsocietyandtechnology,“onecandraw
diametricallyopposedconclusions:eitherpoliticsbecomesanotherbranchoftechnology,or
technologyisrecognizedaspolitical”.9
Co-production
Wecangenerallyagreethatanapparentaccelerationintechnologicaldevelopmentcreates
challengestoexistingpracticesandnormativeunderstandingthatareyettobeidentifiedbeit
inquality,quantityorscope.Thatis,uncertaintyiswhatweneedtocopewithinaworld
markedbyincreasinglywickedproblems.Twodifferenthistoricisedsurveysoftechnology
systemscanserveasguidingpoststowardstryingtogainperspective.Thefirstonedatesfrom
1946,andthesecondfrom2013.LewisMumford’s1946classification10isseparatedintimeby
half-centuryfromthatofAllenbyandSarewitz11andwhilesinninginthedirectionof
reductionism,theycanlaterbeanalysedthroughtheprismofcriticaltheorysuchasthat
offeredbyFeenberg.12
Mumforddistinguishesthreesuccessivemaintechnologyphases:eotechnic,paleotechnic,and
neotechniceachmarkedbyasetofdistinctinventions.Theeotechnicorearlyphaseof
technicsstretchesroughlyfrom1000to1750when“inventionandexperimentaladaptation
9
AndrewFeenberg,QuestioningTechnology(Routledge,2012),2.
LewisMumford,TechnicsandCivilization(London:GeorgRoutledge&Sons,Ltd.,
1946).
11
AllenbyandSarewitz,TheTechno-HumanCondition.
12
Feenberg,QuestioningTechnology;AndrewFeenberg,BetweenReasonand
Experience:EssaysinTechnologyandModernity(MITPress,2010);TylerJ.Veak,
DemocratizingTechnology:AndrewFeenberg’sCriticalTheoryofTechnology(SUNY
Press,2006);AndrewFeenberg,TransformingTechnology :ACriticalTheoryRevisited:
ACriticalTheoryRevisited(OxfordUniversityPress,USA,2002).
10
wentonataslowlyacceleratingpace”andnewsourcesofenergyweredeveloped.13Once
equippedwithmechanicalclocks,telescopes,cheappaper,printingpresses,magnetic
compassesfromtheeotechnicthenextphase–thepaleotechnic–sawtheinventionofthe
steamengineandthebeginningofthedestructionoftheenvironment,andthedegradationof
theworkerallinfavourinthedoctrineofprogressinwhatweareaccustomedtocallthefirst
industrialrevolutionfromca.1760to1820,whichisalsooftenreferredtoasthefirst
industrialrevolution.Theneotechnicphase,theoneduringwhichMumfordwrotehis
observations,isinhiswords“adefinitephysicalandsocialcomplex”thatbeganin1832with
the“perfectionofthewater-turbinebyFourneyron14andismarkedbytheconquestofnew
formsofenergy,namelyelectricity.15Mumford’sdistinctionsareusefulastheyillustratethe
cumulativenatureoftechnology,anditsinextricabilityfromthesocialconditionofmanfroma
linearhistoricalperspectivethatalsodemonstratestheso-calledaccelerationofthepaceof
invention.Onceelectricityandthesteamengineenteroursociotechnicalworld,technologies
multiplyineverypossibledirectionintoeveryaspectofhumanactivity.
TheapproachdevelopedbyAllenbyandSarewitzdistinguishthreelevelsoftechnology
designatedI,II,andIII.Thistaxonomypermitsaclearerstructuralunderstandingofthe
differencesbetweentoastersandnuclearweaponsperspective.16AtlevelI,technology’s
intentionandeffectareathand.Forexample,toastersreliablyandsafelydelivertoasted
breadorairplanescarrypassengersfrompointAtopointB.AtlevelIoftechnology,systemic
complexityisforgotten.LevelII,intheAllenby-Sarewitzmodelweencounterthesystemic
complexityaroundairtravel(ortheproductionoftoastersorautomobiles).Thatis,tostay
withAllenby-Sarewitzmodel,atlevelIIwehavetheairtransportationsystemembodiedwith
“theirrationality,dysfunctionandinsanepricesystem,theabsurdinefficiencyofitsboarding
andsecurityprocesses,thecontinualdelays,and…”.17Lookingattechnologyasawholein
levelII,wesoondiscernthefirstcontoursofasystemandtheemergenceofthelock-in
phenomenaconcurrentlywithalevelIIambivalenceandambiguitythatisaccompaniedbya
reliablelevelItechnology.TheAllenby-SarewitzlevelIIIpatterninthistechnologytaxonomyis
perhapseasiertorecognizeinhighlynetworkedtransportationsystems(still,wecanalsosee
inenergyproductionsystems,telecommunications,agriculture,textiles)suchasthoseof
transportationeitherbyairorland.AtlevelIIIweobservetheco-evolutionof“significant
changesinenvironmentalandresourcesystems;mass-marketconsumercapitalism;individual
credit;behaviouralandaestheticsubculturesandstereotypes;withoilspills;with
opportunitiesfor,andasenseof,extraordinaryhumanfreedom,especiallyforwomen…“.18
Mumford,AllenbyandSarewitz,inspiteoftheseventyyearsbetweentheirobservationsboth
pointtotheunequivocalco-productionoftechnologyorthe“constantintertwiningofthe
13
Mumford,TechnicsandCivilization,111–23.
DietrichEckardt,GasTurbinePowerhouse:TheDevelopmentofthePower
GenerationGasTurbineatBBC-ABB-Alstom(WalterdeGruyterGmbH&CoKG,
2014),49.BenoitFourneyron(1802-1867)wasaFrenchengineereducatedatthe
ÉcoleNationaledesMinesdeSaint-Etiénne.
15
Mumford,TechnicsandCivilization,212ff.
16
AllenbyandSarewitz,TheTechno-HumanCondition,36.
17
Ibid.,37.
18
Ibid.,39.
14
cognitive,thematerial,thesocialandthenormative”.19Co-productionofnaturalandsocial
ordersmeansthatthewaysinwhichwerepresenttheworldareinseparablefromtheways
thatwechoosetoliveinit.20Thatis,explanatorypowerisgainedbythinkingofnaturaland
socialorderstogetherwherebothnatureandsocietyareinseparable.21
ScienceattheServiceofTechnologies
Thecommonunderstandingisthatwhenevaluatingatechnology’seffectivenessandsafety
theusualcourseofactionistomakerecoursetoscienceinassessingthetechnology’s
effectivenessandsafety.Therearethentwotasksthatscienceoughttoaccomplish:fact
findinganddecidingwhatissafeandeffective.Thefirsttaskistheonethattraditional–
normalscience–isbestequippedtodowithinitsreductionistwalls.Thesecondtaskis
uncomfortableforscientists–postnormalscience–involvestheacknowledgedadditionof
values.22Howeveritisthatlasttaskthatattemptstoconnectthedotsofuncertaintyby
appealingtovaluesthatcouldbearthemarkofaleastcommondenominator.Whatthe
resultsare,doesdependonthevaluesapplied.Itishowevernotclearthatitispossibletofind
thatleastcommondenominatorforall.Or,toputinotherwords“theauthorityofscienceis
notafoundationforfactualenlightenmentbutanideologicalfoundationforauthoritarian
policyprescriptionsthatmightotherwisebedifficulttoimplement”inworldofwicked
problems,“morelikelytodeliversurprisesthansolutions.”23
BiotechnologyrevisitedintheChuthulucene
Thetransitionfrombiotechnologytosyntheticbiologyhasbeenevolutionary,andinkeeping
withthegeneraldevelopmentallowedbyacademicandeconomicfreedoms.Stillwhilethere
aremanycommonalities,therearealsomarkeddifferences.Themostradicaldifferencebeing
thatofthepossibilitiesenabledbythediscoveryofagroupofgenesthatallowforveryprecise
engineeringofgenomes.24
19
SheilaJasanoff,‘TheIdiomofCo-Production’,inStatesofKnowledge :TheCoProductionofScienceandSocialOrder,ed.SheilaJasanoff,InternationalLibraryof
Sociology(London:Routledge,2004),1–12.
20
Ibid.
21
Ibid.
22
SilvioO.FuntowiczandJeromeR.Ravetz,‘ScienceforthePost-NormalAge’,Futures
25,no.7(September1993):739–55;JerryRavetz,‘ThePost-NormalScienceof
Precaution’,Futures36,no.3(April2004):347–57.
23
AllenbyandSarewitz,TheTechno-HumanCondition,122.
24
SimonN.Waddingtonetal.,‘ABroadOverviewandReviewofCRISPR-Cas
TechnologyandStemCells’,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-reviewedjournalarticlespublishedsince2004onthesocialimpacts
ofgeneticallymodified(GM)cropsinagriculturecomestotheconclusionthatthemost
commonlystudiedimpact–economic–mainlyreportthattherearebenefitswhileother
socialimpactsthatarelessstudiedpresentamorecomplexpicture.25
Biotechnologyhasreceiveddetailedattentionininternationallaw,internationalrelations,and
thescienceandtechnologystudiesliterature.26Brieflystated,differencesofopinionand
valuesbetweentheUnitedStatesandtheEuropeanUnionovertheregulationofgenetically
modifiedorganismshaveresultedinalackofcooperationandstarkdifferencesinregulatory
standardsandframeworkswhiletherestoftheworldmuddlesthrough.27
Oneviewisthatthereisnoperceivedpubliccrisisinbiotechnologythatcreatedaspecific
regulatorymomentashasbeenthecaseforotherregulatoryobjects.28Thatmaybeso,and
thedifferencesmayarisefromamultitudeofsources,andtheymaybeendogenousor
(14January2016):18–28;DanielSarewitz,‘CRISPR:ScienceCan’tSolveIt’,Nature522,
no.7557(23June2015):413–14;DavidCyranoski,‘CRISPRTweakMayHelpGeneEditedCropsBypassBiosafetyRegulation’,Nature,19October2015,
http://www.nature.com/doifinder/10.1038/nature.2015.18590;JenniferA.Doudna
andEmmanuelleCharpentier,‘TheNewFrontierofGenomeEngineeringwithCRISPRCas9’,Science346,no.6213(28November2014):1258096.
25
KlaraFischeretal.,‘SocialImpactsofGMCropsinAgriculture:ASystematic
LiteratureReview’,Sustainability7,no.7(2July2015):8598–8620.
26
ThomasBernauer,Genes,Trade,AndRegulation:TheSeedsOfConflictInFood
Biotechnology(PrincetonUniversityPress,2003);SusetteBiber-Klemmetal.,
‘ChallengesofBiotechnologyinInternationalTradeRegulation’,inTheProspectsof
InternationalTradeRegulation:FromFragmentationtoCoherence,ed.ThomasCottier
andPanagiotisDelimatsis(Cambridge ;NewYork:CambridgeUniversityPress,2011),
284–320;SheilaJasanoff,DesignsonNature:ScienceandDemocracyinEuropeandthe
UnitedStates(Princeton,N.J:PrincetonUniversityPress,2005);MarkA.Pollackand
GregoryC.Shaffer,WhenCooperationFails:TheInternationalLawandPoliticsof
GeneticallyModifiedFoods(OUPOxford,2009);DanielWügerandThomasCottier,
eds.,GeneticEngineeringandtheWorldTradeSystem,WorldTradeForum
(Cambridge ;NewYork:CambridgeUniversityPress,2008).
27
PollackandShaffer,WhenCooperationFails,1–32.
28
MichaelHowlettandDavidLaycock,eds.,RegulatingNextGenerationAgri-Food
Biotechnologies(Routledge,2013),49–72;MichaelHowlettandJoshuaNewman,
‘After“theRegulatoryMoment”inComparativeRegulatoryStudies:Modelingthe
EarlyStagesofRegulatoryLifeCycles’,JournalofComparativePolicyAnalysis:Research
andPractice15,no.2(1April2013):107–21.
exogenous.29Theproblemisanoldone.Whatlooksgoodintheory,encountersproblems
whenputintopractice,andtherealitymaybemorecomplexthanitwashopedfor.
Academics,farmers,activists,multinationalcorporations,governmentofficialsallpromote
theirviewsontheadvantagesoftechnologyoritsregulation,howeverwhenitcomestoGM
crops“thescientificdataareofteninconclusiveorcontradictory”.30In2013arecordof175.2
millionhectaresofbiotechcropsweregrownglobally.31Meanwhileabitofdusthasstartedto
accumulateonsomeofearliertextsontheinternationalaspectsofgeneticallymodified
organisms(GMO),andonewondershowthesenarrativescomparewithlocalfarmer’s
realities.
TheLocalHeadaches
Let’stakethecaseofGMcottonwhichconstitutesalargefractionofthetotalglobal
productionofallofGMcrops.TheestimateisthatintheUSmorethan90percentofthe
plantedcottonis2014wasGM.32InArgentinatheestimateisthatitcoversabout80-90per
centoftheareasownalbeitwithuncertifiedtransgenicseed.33Briefly,therearethreemain
typesofGMcottonvarietiesbasedontwodifferentgenetictraits:oneisresistanttothe
herbicideglyphosate(alsoknownbyMonsanto’strademarkRoundup),anotherproduces
toxinsthatkillcottonbollworm.ThetreetypesofGMcottononthemarketare:onethatis
glyphosateresistant,onethatproducestheBttoxin,andathirdincorporatingbothtraits.Over
fiftydifferentcommercialGMcottonseedshavebeenapproved.Theseedstradenamesand
detailsareavailableindatabasessuchasthosemaintainedbytheInternationalServiceforthe
AcquisitionofAgri-BiotechApplications34,GMOCompass.35TheInternationalCottonAdvisory
Committee36providesstatisticsonworldcottonproduction,consumption,trade,andservesas
29
MichaelHowlettandAndreaMignone,‘RegulatoryLifecyclesandComparative
BiotechnologyRegulation’,inRegulatingNextGenerationAgri-FoodBio-Technologies,
ed.MichaelHowlettandDavidLaycock(Routledge,2013),64.
30
NatashaGilbert,‘CaseStudies:AHardLookatGMCrops’,Nature497,no.7447(1
May2013):24–26.
31
CliveJames,‘GlobalStatusofCommercializedBiotech/GMCrops:2013-ISAAABrief
46-2013:ExecutiveSummary’,InternationalServicefortheAcquisitionofAgri-Biotech
Applications,2014,
http://www.isaaa.org/resources/publications/briefs/46/executivesummary/.
32
http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-cropsin-the-us/recent-trends-in-ge-adoption.aspx
33
Maria-EugeniaFazioetal.,‘LocalRealitiesforTransgenicCotton’,inRegulating
Technology:InternationalHarmonizationandLocalRealities,ed.PatrickVan
Zwanenberg,AdrianEly,andAdrianSmith(London ;Washington,DC:Earthscan,
2011),73–98.
34
http://www.isaaa.org/
35
http://www.gmo-compass.org/
36
https://www.icac.org/
aclearinghousefortechnicalinformationaboutcottonandcottontextiles;italsorepresents
theinternationalcottonindustrybeforeUNagenciesandotherinternationalorganizations.
Intheoryandinthelaboratory,butalsofromanideologicalpointofview,greatopportunities
forbetterintegrationofconventionalbreedingandmolecularbiologytoimprovecultivarsand
heraldanewageincottonimprovementseempromising.37Itisclaimedthat80%ofglobal
cottonproductionin2012wasthatfromgeneticallymodifiedseeds38Therealityonthe
groundtellsadifferentstory.
Intheglobalsouth,onestudyintheChacoprovinceinArgentinawhatwasfoundwasthat
onlythe2percentoffarmerswithmorethan200hectaresoflandandproducing70percent
ofthecottonhadboththemeanstobuycertifiedtransgeneticseedandboththeknowledge
andscaletomaintainqualityofsuccessivemultiplicationsofsavedseed.39Toaddinsultto
injury,the‘2percentfarmers’arealsoadeptatignoringcontractsthatwouldbindthemto
takerecommendedmeasurestomaintainthequalityofthenewseedandtodelay
developmentofpestresistancetotheBttoxinwhilethemajorityinthesameregionwho
obtainnon-certifiedseedsininformalmarketshaveneithertheginstodelinttheseedsnorthe
knowledgetoensurequalityormakethebestofwhatthey.40Thatis,themajorityofthese
Argentiniansmallcottonfarmersgetseedsofnotonlyvariable,butdoubtfulqualitywith
transgenicandnon-transgenictraits,andduetothelackofknowledgeormislabellingfarmers
endupwithpooryieldsasmaybecaseifaherbicideresistanceisassumedwheninsteadthe
non-certifiedseedispesticideresistant.Thatis,thesesmallcottonfarmersarebeyondthe
reachoftheregulatoryregime.Inthiscase,thelocalregulatoryagency–theInsitutoNacional
deSemillas(INASE)–ispracticallyincapableofassertinganyoversightespeciallyininformal
markets,butalsotherewherefarmersignorecontractualobligationsalthoughtheirtaskis
thatofapplyingtheSeedLaw(LeydeSemillasYCreacionesFitogenéticasN°20.247).The
resultingsituationisonewhereregulationofthetechnologyfailsatseverallevelsbeyondthe
internationalmodalitiesthatmadeitpossiblefortheseedtoenterthemarket.Theinterests
ofthosewhomthetechnologyoughttobenefitareleftunattendedbylocalandnational
governments.Therights,moralandethicalvaluesrecognizedbyinternationallaware
orphaned.
Thissituationalsoraisesquestionofbiosafetyandbiodiversity.ThefactthatuncontrolledGM
seedsreachtheinformalmarketswithoutbiosafetytestingandapproval,leavesopenthe
37
GregConstableetal.,‘CottonBreedingforFiberQualityImprovement’,inIndustrial
Crops,ed.VonMarkV.CruzandDavidA.Dierig,HandbookofPlantBreeding9
(SpringerNewYork,2015),191–232,http://link.springer.com/chapter/10.1007/978-14939-1447-0_10.
38
Ibid.
39
Fazioetal.,‘LocalRealitiesforTransgenicCotton’.
40
Ibid.
questionof“regulatorycapacitytoanticipateanddiminishpotentialenvironmentalimpacts,
ortoassureinternationalmarketsthatexportedproductsarewhattheypurporttobe”.41
IntheprovincesofHubeiandShandonginChinathesociotechnicaldynamicsaredifferent
fromthoseintheChacoprovinginArgentina,andcorrespondinglytheregulatoryfailuresare
different.Usingnationallyrepresentativepaneldata,ArzaandvanZwanenberganalysedthe
economicimpactofBtcottonadoptionanditssustainability,after15yearsofits
commercializationinChina.Consistentwithitsshort-termimpact,thestudytheyshowedthat
theeconomicbenefitofBtcottondidnotdiminish,butremainedstableandcontinuousin
China.42Theirstudythatusesnationallyrepresentativedataandfocusesontheeconomic
benefitofBtcottonanditsdynamics.“Asshowninthispaper,thefirstgenerationofcotton
varietieswithasingleBtgenestillcaneffectivelycontrolthebollworm.Eventhoughfarmersin
somecountrieshaveswitchedfromunpatentedandroyaltyfeecottonvarietieswithasingle
Btgenetopatentedcottonvarietieswithstackedgenes,rigorousanalysisisneededtoanswer
whetherthisswitchiseconomicaloraresultcausedbymanyfactors.”43
Thepatternsdescribedfor“internationaltransfertoandadaptationofgeneticallymodified
(GM)cottoninArgentina,andaskwhetherpoliticalbargainingbetweenthetechnologyowner,
amultinationalenterprise(MNE),andhostcountryactorsmayhaveinfluencedupgrading”to
GMcrops.Theseauthorssuggestthat“theMNEwasabletouseitsexclusivecapacityto
upgradeGMcottontechnologiesasanegotiationtooltopersuadehostactorstochangethe
rulesthataffecteditsmultiplelineofbusinessinthecountry.Thisimplieswiderpolicyscope
toencouragetechnologyupgrading;hostactorscouldnegotiateoverawiderrangeofaspects
ofinteresttoMNEs.”44
Thattheremanymoreproblemstobeaddressedbeyondtheinterestsofmultinational
corporationsoughttobeevident.Thatis,“despitethewidespreadadoptionofBtcropsanda
continuedincreaseintheareaonwhichtheyaregrown,therearestillanumberof
unansweredquestionsassociatedwithlongertermagro-ecosysteminteractions,forinstance
theimpactofsecondarypests.”45
Meanwhilethesituationisnotoptimalintheglobalnortheithereveniftheproblemshavea
differentcharacter.IntheUStheannualstatisticsfor1992to2009oncottonplantedindicates
thatwhilethepercentageofgeneticallymodifiedcottonhasincreasedtonearly90percent,
theaverageannualtotalherbicideapplicationrateforcotton(massperarea)failstoshowa
41
Ibid.,85.
ValeriaArzaandPatrickvanZwanenberg,‘ThePoliticsofTechnologicalUpgrading:
InternationalTransfertoandAdaptationofGMCottoninArgentina’,World
Development59(July2014):521–34.
43
FangbinQiao,‘FifteenYearsofBtCottoninChina:TheEconomicImpactandIts
Dynamics’,WorldDevelopment70(June2015):177–85.
44
ArzaandvanZwanenberg,‘ThePoliticsofTechnologicalUpgrading’.
45
RuiCatarinoetal.,‘TheImpactofSecondaryPestsonBacillusThuringiensis(Bt)
Crops’,PlantBiotechnologyJournal13,no.5(1June2015):601–12.
42
decreasealthoughitwouldhavebeenexpectedaccordingtotheoryandrationaleof
introducingtransgenetictraits.46
RegulationandGovernanceDreamscapes
Nanotechnologies,likeotherproceedingtechnologies,havegottenmuchattentionandatoo
largebodyofliteraturehasbeengenerateddisplayingaspectrumofviews.Thereissome
agreementthattherearetwomaindangers.Oneisthata“blinkeredadherencetosciencedrivenandhierarchicaldecision-makingapproach”inregulationwillignorethevaluesofthe
citizenswhoseektoinfluenceregulationbysomeparticipativeorotherlegitimizing
mechanisms.47Anotheristhatperceptionscountertocurrentscientificunderstandingmay
haveanundueornon-justifiableinfluenceonregulatorydecisions.48Thatis,balanceis
required,andsocial,regulatoryandgovernanceinnovationiscalledupontoassure
transparency,legitimacyandtrustintheregulatoryprocess.
“Wehavecometothepointinsyntheticbiologywheretherearemanylab-scaleorproof-ofconceptexamplesofchemicallycontrolledsystemsusefultosensesmallmolecules,treat
disease,andproducecommerciallyusefulcompounds.Thesesystemshavegreatpotential,but
moreattentionneedstobepaidtotheirstability,efficacy,andsafety.”49(linktocasestudies
whereappropriate)
Gervaisanalysisusesaclassificationoftechnologythatisinterestingasananalyticaltool,and
reliesmainlyontheprecautionaryprincipleapplicationtoleavetheemergingtechnology
unregulatedandpleadsforanimbleregulatoryapproach(courts,regulatoryagencies)when
risksemerge.50Thisproposedapproachignoresthenatureoftechnologyandco-production.
(tobeexpanded)
46
SeeTable3in:RichardHCoupeandPaulDCapel,‘TrendsinPesticideUseon
Soybean,CornandCottonsincetheIntroductionofMajorGeneticallyModifiedCrops
intheUnitedStates’,PestManagementScience,1August2015,n/a-n/a.
47
AndrewD.Maynard,DianaM.Bowman,andGraemeA.Hodge,‘Conclusions:
Triggers,Gaps,RisksandTrust’,inInternationalHandbookonRegulating
Nanotechnologies,ed.GraemeA.Hodge,DianaMBowman,andAndrewD.Maynard
(Cheltenham,UK:Elgar,2010),573–86.
48
Ibid.
49
TylerJFordandPamelaASilver,‘SyntheticBiologyExpandsChemicalControlof
Microorganisms’,CurrentOpinioninChemicalBiology,Syntheticbiology•Synthetic
biomolecules,28(October2015):20–28.
50
DanielJ.Gervais,‘TheRegulationofInchoateTechnologies’,HoustonLawReview47,
no.3(18November2010):665–705.
Harmonizationpresumesstableandwidelysharedgoals.Develop.“Howdoharmonizing
regulationsimpactontheopportunitiesforpoorercommunitiesindevelopingcountriesto
effectivelyaccessnewtechnologies,assurethemselvesofbenefits,whilstguardingagainst
risks?Howdoharmonizingregulationsaffectthecapacityofpoorercommunities,localand
nationalbusinesses,andnationalgovernmentstodeveloplocallyappropriateformsof
technologyuse?Doregulationsenableenvironmentallysustainableandsociallyjust
technologydevelopmentpathwaysappropriatetospecificsituationsordotheyhinder
them?”51
Lastbutnotleast,thereistheissueofwhatcanWTOdotodealwithemergingtechnologies.
Theverdictisthatifananalysis(type)oftheEUGMregulationinlightoftheWTOtrade
disputesisindeedlegal,butitcertainlyhasbeencostly.52Thenwhenlookedatindetail,while
WTOandinternationallawcannotreallyeasetheburdenofdealingwithwickedregulatory
andgovernanceproblems,astreamliningofitsfunctionscouldbehelpfulisreducingofofthe
burdens.(tobedeveloped,TBTiswhatisontheline,itisaboutstandardsafterall).
51
CompareEly,Winter,Maynard,andGervais(considerFeenberg)AdrianEly,Patrick
VanZwanenberg,andAndrewStirling,‘BroadeningoutandOpeningupTechnology
Assessment:ApproachestoEnhanceInternationalDevelopment,Co-Ordinationand
Democratisation’,ResearchPolicy43,no.3(April2014):505–18;GerdWinter,‘In
SearchforaLegalFrameworkforSyntheticBiology’,inSyntheticBiologyAnalysed,ed.
MargretEngelhard,EthicsofScienceandTechnologyAssessment44(Springer
InternationalPublishing,2016),171–211,
http://link.springer.com/chapter/10.1007/978-3-319-25145-5_7;GerdWinter,‘The
RegulationofSyntheticBiologybyEULaw:CurrentStateandProspects’,inSynthetic
Biology,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:RegulatingIndustryUsesofNew
Biotechnologies’,Science333(1September2011):1254–56;ElenStokesandDianaM.
Bowman,‘LookingBacktotheFutureofRegulatingNewTechnologies:TheCasesof
NanotechnologiesandSyntheticBiology’,EuropeanJournalofRiskRegulation2012
(2012):235;JenniferKuzmaandToddTanji,‘UnpackagingSyntheticBiology:
IdentificationofOversightPolicyProblemsandOptions’,Regulation&amp;
Governance4(1February2010):92–112;HenryMillerDrewKershen,‘Will
OverregulationInEuropeStymieSyntheticBiology?-Forbes’,Forbes.com,n.d.;Mithun
BantwalRaoetal.,‘TechnologicalMediationandPower:Postphenomenology,Critical
Theory,andAutonomistMarxism’,Philosophy&Technology28,no.3(September
2015):449–74;GregoryConkoetal.,‘ARisk-BasedApproachtotheRegulationof
GeneticallyEngineeredOrganisms’,NatureBiotechnology34,no.5(May2016):493–
503;AlexanderKelle,‘BeyondPatchworkPrecautionintheDual-UseGovernanceof
SyntheticBiology’,ScienceandEngineeringEthics,26May2012.
52
MaartenJ.PuntandJustusWesseler,‘LegalButCostly:AnAnalysisoftheEUGM
RegulationintheLightoftheWTOTradeDisputeBetweentheEUandtheUSA’,The
WorldEconomy39,no.1(1January2016):158–69.