Value andRiskBasedGovernance

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)

Plant pests, plants,

veterinary biologics

Federal Plant Pest Act

(PPA)1957, 2000

Food and Drug

Administration
(FDA)

Food, feed, food additives,

vet. drugs, human drugs,
medical devices

Federal Food, Drug and

Cosmetic Act (FFDCA)-1958

Environmental Protection
Agency
(EPA)

Microbial and plant

pesticides; novel microbes

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 was the

oversight model
developed ?
What are its
outcomes ?

What are its

attributes ?

How do the
attributes evolve
over time ?

Kuzma,, Paradise, et al Risk Analysis(2008)

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

More controversy, delay, rejection?

Too much uncertainty for developers of new GM products?

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)

Thompson2007;Kuzma andBesley 2008

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

Funtowicz andRavetz (2006)

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

Ramachandran, et al. 2011

* with citizen, governmental, academic, industry, tribal, and NGO representation

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