Professional Documents
Culture Documents
forGEOs FindingMiddleGround
JenniferKuzma
GoodnightNCGSKFoundationDistinguishedProfessor
SchoolofPublicandInternationalAffairs
CoDirectorGeneticEngineeringandSocietyCenter
NASILARRoundtable
December8,2015
Regulation,oversight,governance
Governance
Complexsetofnorms,values,
andprocesses,andinstitutions
Governance
Oversight
Oversight
Watchfulandresponsiblecare
undergovernance
regulation
Regulation
Regulation
Authoritativerulesdealingwith
detailsorprocedurehavingthe
forceoflaw
Kuzma,EnvironmentalLawReporter2006
CoordinatedFrameworkfortheRegulationofBiotechnology
Products(1986present)
Must be science based
No new risks, no new laws needed, product not process
Agency
Jurisdiction
Laws
US Dept. of
Agriculture (USDA)
Environmental Protection
Agency
(EPA)
Federal Insecticide,
Fungicide, and Rodenticide
Act (FIFRA)--1947; Toxic
Substances Control Act
(TSCA) 1976
Howdidthissystemkeepupwithtechnology?
ThePacingProblem
PhasesofCFRB
Evolution(1950s1986)
Establishmentofpacingthroughexecutivebranch
agencypolicymaking
Implementation(1986circa2002)
pacingthroughrules
Adaptation(2002circa2009)
pacingthroughguidance
Revolution(circa2009present)
pacingthroughpower(fundamentalpolitical
shift)
CycleofoversightforGEOs
ConflictandReaction
Whatnext!
???
Pacing
through
Power
(Revolution)
External
pressure
Pacing
through
Policy
PhasesoverTime
Pacing
through
Guidance
External
pressure
Nextgeneration
of
GEOsoversight
External
pressure
Pacing
through
Rules
ContestedSysteminUnitedStates
Paced,butproperlypaced?
Policyprocessesarecontestedinkeyways:
Buyingofnatural,local,organicfoods
NGOlegalsuitsconcerningGMcrops
Recentlabelingpropositionsonstateballotsandstatebills
Transgenicsalmonapprovalandcontroversy
Delaysintechnologydeployment
LONG(overdecade)approvalforGMsalmon(1st animalderivedfood)
PreviousdownturninVARIETYofGMplantssubmittedforregulatoryapproval
UNTIL.geneediting!
CompaniesarestartingtouseGMmethodsthatstretchdefinitionofgeneticengineering
orrDNA
ActiveRegulatoryAvoidance
Promotinginnovationaroundregulation
Argumentsnottoregulatebasedonprocess
USDAdecidingmanyGMcropsoutsideofregulatoryscope
IntegratedOversightAssessment
NSFgrant20072011
How do the
attributes evolve
over time ?
ComplexSystemofGEOsGovernance:
IntertwinedNormative,Empirical,andInstitutional
Criteria
Data
requirements
A9
Public
Confidence
O24
Public Input
D4
Incentives
A14
Public Input
A19
9
p<0.05,p<0.002
GMOversight:Properpacing?
(Kuzma etalJLME2009)
Littletransparency
Highflexibility
Clearsubjectmatter(although
changing)
Lowlevelofinformedconsent
Weaklegalgroundingallowingfor
multipleinterpretations
Fewopportunitiesforpublic
input
Complexinstitutionalstructure
Lowcapacity
Earlywork
ongenomeediting(Tagmo)
NSFDBSAward0923827
(20092013)
PreciseEngineeringofPlantGenomesusing
ZincFingerNucleases&Societalimplications
Voytas UofMNPI
Drena Dobbs,ISUcoPI
JenniferKuzma,UofMN(NCSU),coPI
KenWang,Harvard,coPI
MappingoftheScientific
LandscapeofGeneEditing
Interpretation&Analysisof
OversightSystem
ExpertVisionsofGovernance
DocumentAnalysis
Bibliometrics
Interviews&Surveys(contentanalysis)
Workshop
Sept.2011
Keyfindings(20102011):
Varietyofnewplantgeneticengineeringtechniques
Manymayfalloutsideexistingregulatorytriggers
UncertainhowoversightsystemswilladdressTagMo
Challengedefinitionofgeneticengineeringandplantpest
Concentrated
Focusingonbiomedicalproblems
FewpartnershipswithLDCs
DifferentfociinDCsandLDCs
LittleCollaborationamongU.S.funders
RelatedtoHistoryofproblemsofagbiotech
Littlesafetyresearchcomparedtodevelopment
funding
Riskofrepeatingsocio=politicalcontextofconflict
andcontention
Experttechnologyunderstandingsfordonotmapneatlyonto
governancepolicypreferences
SubjectMatterStakeholderExperts
Concernsaboutgeneediting
Attitudesaboutoversight
KeyNarratives
Geneeditingisan
IncrementalTechnology
GeneEditingisa
RevolutionaryTechnology
Maybeitdoesntchangetechnology
concernsdramatically
ItdoesntFORCEagovernancechange,
butgivesusOPPORTUNITYtoreexamine
andchangegovernance.
Diversityofchangessuggestedfrommore
relaxedtomorerigorous
Pragmatist/Opportunist
Geneeditingisadramatically
differenttechnologythatforcesa
changeingovernance:How?
Relaxes
needfor
oversight
HypertechHypoReg
Processbasedargument
Intensifies
needfor
oversight
SystemsView
Twogeneeditingresearchers
Pointsofagreementquantitative
survey
Majority ofthesubjectmatterexperts(SMEs)agreethatmistakes
ingovernanceweremadewith1st generationGMOs
Majoritywouldprefersomelevelofpremarketreviewby
government
Majority acknowledgethatmorestakeholdersandcitizensneedto
beinformed/engaged
WhatarewedoinginU.S.?
U.S.StakeholderApproaches
Government
DecidenottocaptureseveralGM
plants,includinggenomeedited
plants,atall(USDA)underplant
pestregulations
Makingdecisionslargelyn
private,lackofadvisoryor
stakeholdercommittees
UntilrecentlyCFRBmeetings.
U.S.workingoutsideof
internationalprocessesinsome
cases(CBD,etc.)
Developers:
Innovatingaroundregulations
Appealingtosoundscience
AppealingtoProductnotprocessas
whygeneeditingshouldntbe
regulated
Codeforlimitingoversight
considerationstodirecthuman
healthandenvironmentalharms
NGOs
Continuetofightdecisionsin
federalcourt
Continuetosupportlabeling
initiatives
Harmonization?
InternationalPolicyProcessApproaches
U.S.
LetItGobehindcloseddoors
ifnotplantpestorpesticide
Japan
thinkandpublish,internationaltreaty(Cartegenamodernbiotech)
SDN1,2,and3distinctions
EU
EFSAdeliberativeexpertgroup
SDN1,2,and3distinctions
NewZealand
Letitgo
SDN1(2?)exemptioncontestedinlawsuits
Trade?PublicPerception?HealthandEnvironmentalSafety?
Respectingvaluesofothercountries?
1)DifferentScientificConceptionsofRisk(Renn,1992,etal)
Differenttypesofharmsthatneedtobeconsideredinriskanalysis
Theyarescientific
Harmsanddamagesthatcanoccurwithexposure
1st orderphysicalhealthandenvironmental
2nd orderphysicalhealthandenvironmental
Socialstructureharm
Ethicalaffronts(withoutchoice,voice,orconsent)
Psychologicalwellbeing
Financialimpacts(direct)
Economicimpacts(indirect)
Culturaldisruption
Onlyawiderangeofperspectivesandvoicescanassessthese
2)ValuesintheRA
Endpointschosen
InterpretingRiskRelevantData
Temporalandgeographicaltimescale
Choiceofbaseline(pristinenature?,tenyearsago?,conventional
breeding?,pastbiocontrol agents?)
Decisionoptionsandscenarios(arenontechnologicalormore
naturaloptionsfullyconsidered)
Ecologicaleconomics(arenonuseandexistentialvaluesbeing
incorporated)
Sciencealonecannotspursocialaction
Itcannottelluswhattodo
Placesforvalues
Interpretationofdata
Standardsforsafety
Choiceofendpoints
3)RiskManagementisalwaysvalueladen
(soisdrawingregulatoryboundaries)
Thereisalwaysriskandalwaysuncertainty
Precautionisnotantiscience,itsabeliefaboutriskgovernance
Antiprecautionistoo.
Productversusprocess,binaryframingnothelpful
Regulateallornone,asRAcomesintotheproductreview,sohowcanyouknowtherisk
beforehandtocapturetheproductsinapurelyobjectiveway?
Hugedebatesstemfromdifferencesinworldviewaboutroleofgovernment,
regulation,andlevelofprecautionthatiswarranted.
Progressoftechnologyisoftenpittedagainstgovernmentregulation.
Governmentregulationseenasprohibitingtechnologicaldevelopment
TechnologicalRisk
Alwaysrisk,neverzero
Aswithanytechnology,therearetradeoffs
Desirabilityshoulddependon
carefulrisk/benefitanalysis
lifecycleanalysis
socioeconomicimpactsanalysis(+/)
jobslost/jobsgained
systemsanalysis
culturalharms/benefits
distributionofharmsandbenefits
comparisonofabovetoothertechnologicalorsocio
culturaloptions
GeneEditingandDrivesandEthicalDimensions
Issues
Waysofthinkingabout
ethics
Utilitarian
BioethicsPrinciples
Rightsbased
Procedural/Structural
Ethicsofcare
DeepEcology
Etc.
Power
Voice
Autonomy
Informed
Consent
Equityissues
Integrity
Donoharm
principle
Utilitarianism
(Costsand
Benefits)
Conceptions
anddesires
fornature
Rightsofnon
human
species
Inter
generational
equity
GeneDrivesSpreadThemselves
Esvelt etal.2014
https://www.youtube.com/watch?v=Cy69C6vnFCQ\
DrafttypologygenedrivesforanalyzingIntergenerationalEquity
Kuzma andRawlsinreview2015
Whatabouttheanimals!?
DoAnimalsengineeredwithgenedriveshaverights?
ToIntegrityofbeingintheirnaturalorunengineered state?
Toexistinthefaceofkillingsystemsandgenedrives?(killthemselves
essentially)
Atindividuallevel
Atpopulationlevel
Atspecieslevel
Wouldgenedrivesprovideleastamountofsuffering?
(asopposedtoratpoisononislandsforexample)
Geneeditingharmfulofftargetmutations(CRISPR0.1%toover60%,
Joung etal)greaterorlessthangeneticengineering?Conventional
breeding?
4)Peoplearenotirrational
Theycangetit
Amazedbypeoplesabilitytogetthe
scienceandaskimportantquestions
Ourfocusgroupstudies
Myandothersparticipationinmultiplepublic
engagementevents
Theybasetheirviewsonavarietyoffactors
JUSTLIKEWE(asexperts)DO
PsychometrictheoryofRiskPerception(Slovic 1987)
Featuresoftechnologymatter
Unknown
Uncontrollable
Reasonswhypeopledonotviewriskofdrivingacarthesameasriskofairtravel
(orGEOs)eventhoughtfatalitiesperyearperpersonaremuch,muchgreater
Publicperceptionofemergingtechnologies:AltruismandSkepticism
(Brown,Fatehi,Kuzma JNR2015)
U.S.Consumerprioritiesinlabeling
(Brown&Kuzma inprep)
PublicperceptionSummary
ConsistentinliteratureofWillingnesstoPayfornonGM
Consistentdesireforlabeling
Acceptancedependsonproduct
Differentculturalconsumergroups
Complexsetofperceptionfactorsincludingtrust,culturalworldview,
demographics,riskandbenefit.
Movefrompuresciencebasedto
scienceinformed,valueattentive,
publicrespectfuloversight
Itsnotallaboutmessagingorunderstanding
publicattitudes
Itsaboutlistening,dialogue,andmutual
socialandbidirectionallearning
Analyticaldeliberativeprocesses(NRC1996)
Problem
Whatpublicperceptionstudies
andengagement
tellusaboutoversight
(whatthepubliccaresabout)
Transparency
Mandatorysystems
OpportunitiesforInput
Knowledge
Choice
Howemerging
technology
oversightsystems
(nonmedicalproducts)
develop
andoperate
LittleTransparency(CBI)
Voluntarylabeling
Fewopportunitiesforinput
(FedReg,and
PublicMeetings)
WillgeneeditingandgenedrivesinGEOsdeployedin
naturepromptachangeingovernance?
Willthepolicywindowinthemultiplestreamscrack?Ithas.
GreaterrecognitionofproblemofGEOsgovernanceduetogenedrives?
(problemstream)
Plentyofpolicyoptionsproposed
(policystream)
ButContentioninthepoliticsstream
NeedforstrongPolicyEntrepreneurs tonegotiatetheintegrationofthe
threestreams,andlikelyaFocusingEvent
PolicyStreams(Kingdon)
Paradigmsforbettergovernancearenottheproblem
Need
Valuesareimplicitinalltypesof
assessment
Scienceisuncertain
Neverenoughforsound
sciencetomakedecisions
IndustryandGovt.Scientistsare
nottheonlyoneswhoshould
haveavoice
Challenges
TechnologicalElitism
ScienceBasedsysteminfaceof
uncertainty/ambiguityleadsto
biasedinterpretationsofevidence
onallsides.
Stickingtothesciencemarginalizes
otherworldviews,localand
specializedknowledge
Createsdistrust,skepticism
ATheoreticalMiddleGround
Forward
OnlyprocessmattersandwedontlikeGMprocess
CONS:Precludepotentiallysaferandcheapertechnologydevelopment
Onlyproductsmatterandimpacts
CON:Notenoughriskscience,hypocrisy,lackoftrust
PostnormalscienceinDecisionmaking
Opendialogue,extendedpeercommunities
Researchasobjectofcriticalscrutiny
StructureforStakeholderInvolvement
IRGC2006
ReachingouttoNGOsfromdevelopers
ResponsibleResearch&Innovation
Owen&VonSchomberg (2013).
Icategorise herefourtypesofirresponsibleinnovation:Technologypush,
Neglectance offundamentalethicalprinciples,PolicyPull,andLackof
precautionarymeasuresandtechnologyforesight.
ResponsibleResearchandInnovationisatransparent,interactiveprocess
bywhichsocietalactorsandinnovatorsbecomemutuallyresponsivetoeach
otherwithaviewtothe(ethical)acceptability,sustainabilityandsocietal
desirabilityoftheinnovationprocessanditsmarketableproducts(inorder
toallowaproperembeddingofscientificandtechnologicaladvancesinour
society).
Dynamic Oversight:
An example practical way forward
Spectrum of Oversight
Softer
Approaches
Voluntary datasharing
Codes of conduct
Voluntary
consultation with
agency review
Guidelines
Coordinating
Entity or
Process*
Agency
Implementation
Public
Engagement
and Input
Harder
Approaches
Ban, moratorium
Standards
Stringent premarket testing
Enforceable fines
Principles
Anticipatesconvergence
Inclusive
Publicempowerment
Learningamonggroups
Respectful
Multipleiterations
Preparednessatallstages
(includingpostmarket)
Transparent
Adequateresources
Continuous
Evolving
Informationgenerating
Information andvaluebased
PolicyDelphiforAnticipatoryGovernanceofSB
SocietalRiskEvaluationScheme(CummingsandKuzma inreview)
Frames
PolicySciences
FutureStudies
UpstreamTechnologyAssessment
Casesofmediumtolongertermdevelopment
Mentalmodels(mapping)ofdiverseSMEs
RiskAnalysis,andGovernancequestions
PolicyDelphiprocessin4rounds
Interviews
Survey
Workshop
Survey
48
(ResponsibleInnovation)Recommendations
DeploySRESinAnticipatoryGovernance
atearlystagesofproductdevelopment
(beforeinvestment)
SRESasscreeningtoolatR&D
stage
Asproductdeveloping,gathermore
informationanddatainhighSRES
areasdialogueorinterviewsforspecific
researchneeds
Dialogueformore
specificneeds
Theseactivitiesasfoundationfor
resourceallocationandfundingfor
informationtoinformdecisionmaking
Resources
ForData&
Analysis
49
Acknowledgments