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Regulating technological risk:
 the case of genetically-modified
               crops in India
                     Ian Scoones
     STEPS Centre, Institute of Development Studies,
                University of Sussex, UK
From Bt cotton to Bt brinjal
Three phases
1. Regulatory approval: science and protest
   (1995-2002)
2. Regulatory impasse (2002-2009): informal,
   then formal release
3. Regulatory precaution (2009- ):
   public consultations, political
   intervention and a moratorium
Technical risk: experts rule?
•   A regulatory framework - RCGM and GEAC
•   Imports, and technical discussions
•   Protest and direct action
•   2002 decision: release
•   Attempts by the centre to
    regulate, but resistance
    from states and farmers
A regulatory impasse
• Experts, inquiries, new regulatory structures
  proposed
• Business pressure to reduce regulatory ‘red
  tape’ – pharma vs agriculture
• Disputes within scientific establishment and
  regulatory body (GEAC) Increase in registered
• Concerns about Bt resistance (CICR, Nagpur
  report)
• Bt cotton varieties and massive expansion of
  cropped area.
The Bt brinjal episode
• Significant public mobilisation: a symbolic
  food crop
• Technical vs political response
• A recognition of uncertainty/ignorance and
  the need for dialogue about contrasting
  framings to build broader public trust as part
  of regulation
• Towards a co-evolutionary approach to the
  regulation of risk (and uncertainty)
Key developments….
• A recognition of uncertainty/
  ignorance and the need for a
  precautionary approach
• The importance of dialogue about contrasting
  framings to build broader public trust as part
  of regulation
• Towards a co-evolutionary approach to the
  regulation of technological risk – in the
  context of scientific uncertainty and public
  contention
Risk and regulation: a simple framework

                            knowledge about outcomes
                 unproblematic                         problematic

 unproblematic




knowledge
about
likelihoods




   problematic
‘Closing down’ around a narrow
risk framing
                               knowledge about outcomes
                 unproblematic                            problematic

 unproblematic   RISK
                 Biosafety – environmental &
                 health risks are predictable

knowledge
about
likelihoods




   problematic
‘Closing down’

                               knowledge about outcomes
                 unproblematic                            problematic

 unproblematic   RISK
                 Biosafety – environmental &
                 health risks are predictable

knowledge
about
likelihoods

                 Unfamiliar toxic effects,
                 complex synergies, unknown
                 pest emergence/resistance
                 ecology

   problematic   UNCERTAINTY
‘Closing down’

                                 knowledge about outcomes
                 unproblematic                                    problematic

 unproblematic   RISK                                              AMBIGUITY
                 Biosafety – environmental    Different interests and priorities
                 &health risks                      divergent notions of harm
                 are predictable                          trust, fairness, ethics
knowledge
about
likelihoods

                 Unfamiliar toxic effects,
                 complex synergies, unknown
                 pest emergence/resistance
                 ecology

   problematic   UNCERTAINTY
‘Closing down’

                                 knowledge about outcomes
                 unproblematic                                  problematic

 unproblematic   RISK                                           AMBIGUITY
                 Biosafety – environmental     different interests / priorities
                 &health risks                   divergent notions of harm
                 are predictable                       trust, fairness, ethics
knowledge
about
likelihoods

                 Unfamiliar toxic effects,     Unknowns, surprise, novelty
                 complex synergies, unknown
                                              of envtal and health impacts
                 pest emergence/resistance
                 ecology

   problematic   UNCERTAINTY                                    IGNORANCE
Three phases

                             knowledge about outcomes
                 unproblematic                            problematic

 unproblematic
                      Technical
                      approval
                        1995-
                        2002
knowledge                             Dialogue,
about                                  debate,
likelihoods                              and
                                     precaution
                                        2009 -
                                                        Regulatory
                                                         impasse
                                                         2002-09
   problematic
‘Closing down’
powerful pressures to justify a narrow risk framing

                                 knowledge about outcomes
                   unproblematic                                       problematic

 unproblematic     RISK                   expert decisions             AMBIGUITY
                                          aggregative analysis
                                          political closure


knowledge                                                        public deliberation
about             risk based regulation                          `
                                                                 political debate
likelihoods       reductive modeling
                                                                 agenda-setting
                  legal frameworks
                                                                 horizon scanning
                  insurance
                                                                 multiple expertises
                                          harm definitions
                                          indicators / metrics
                                          regulatory remits
                                          Liability law
   problematic     UNCERTAINTY                                        IGNORANCE
‘Opening up’ regulation

                               knowledge about outcomes
                 unproblematic                                 problematic

 unproblematic   RISK                                          AMBIGUITY
                 Narrow , expert-led             participatory deliberation
                 biosafety-focused,                     scenario workshops
                 technical risk                       stakeholder dialogues
                 regulation                  interactive options modelling
knowledge
                                              social, political and technical
about                                                             dimensions
likelihoods
                                                                precaution
                 uncertainty heuristics            continuous monitoring
                 sensitivity testing               adaptive management
                 tracking                            institutional learning
                                             high reliability management
   problematic   UNCERTAINTY                                  IGNORANCE
Reimagining regulation
• Accept uncertainty and ignorance, avoid closing
  down towards narrow versions of risk regulation
• Debating ambiguities – different perspectives,
  opinions and evidence – should be encouraged
• Multiple expertises are important. Science on
  tap, not on top.
• Regulation is both technical and political –
  requires a mature, transparent co-evolutionary
  approach. Not the dominance of one or the
  other.

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Regulating technological risk: the case of genetically modified crops in India

  • 1. Regulating technological risk: the case of genetically-modified crops in India Ian Scoones STEPS Centre, Institute of Development Studies, University of Sussex, UK
  • 2. From Bt cotton to Bt brinjal Three phases 1. Regulatory approval: science and protest (1995-2002) 2. Regulatory impasse (2002-2009): informal, then formal release 3. Regulatory precaution (2009- ): public consultations, political intervention and a moratorium
  • 3. Technical risk: experts rule? • A regulatory framework - RCGM and GEAC • Imports, and technical discussions • Protest and direct action • 2002 decision: release • Attempts by the centre to regulate, but resistance from states and farmers
  • 4. A regulatory impasse • Experts, inquiries, new regulatory structures proposed • Business pressure to reduce regulatory ‘red tape’ – pharma vs agriculture • Disputes within scientific establishment and regulatory body (GEAC) Increase in registered • Concerns about Bt resistance (CICR, Nagpur report) • Bt cotton varieties and massive expansion of cropped area.
  • 5.
  • 6. The Bt brinjal episode • Significant public mobilisation: a symbolic food crop • Technical vs political response • A recognition of uncertainty/ignorance and the need for dialogue about contrasting framings to build broader public trust as part of regulation • Towards a co-evolutionary approach to the regulation of risk (and uncertainty)
  • 7.
  • 8. Key developments…. • A recognition of uncertainty/ ignorance and the need for a precautionary approach • The importance of dialogue about contrasting framings to build broader public trust as part of regulation • Towards a co-evolutionary approach to the regulation of technological risk – in the context of scientific uncertainty and public contention
  • 9. Risk and regulation: a simple framework knowledge about outcomes unproblematic problematic unproblematic knowledge about likelihoods problematic
  • 10. ‘Closing down’ around a narrow risk framing knowledge about outcomes unproblematic problematic unproblematic RISK Biosafety – environmental & health risks are predictable knowledge about likelihoods problematic
  • 11. ‘Closing down’ knowledge about outcomes unproblematic problematic unproblematic RISK Biosafety – environmental & health risks are predictable knowledge about likelihoods Unfamiliar toxic effects, complex synergies, unknown pest emergence/resistance ecology problematic UNCERTAINTY
  • 12. ‘Closing down’ knowledge about outcomes unproblematic problematic unproblematic RISK AMBIGUITY Biosafety – environmental Different interests and priorities &health risks divergent notions of harm are predictable trust, fairness, ethics knowledge about likelihoods Unfamiliar toxic effects, complex synergies, unknown pest emergence/resistance ecology problematic UNCERTAINTY
  • 13. ‘Closing down’ knowledge about outcomes unproblematic problematic unproblematic RISK AMBIGUITY Biosafety – environmental different interests / priorities &health risks divergent notions of harm are predictable trust, fairness, ethics knowledge about likelihoods Unfamiliar toxic effects, Unknowns, surprise, novelty complex synergies, unknown of envtal and health impacts pest emergence/resistance ecology problematic UNCERTAINTY IGNORANCE
  • 14. Three phases knowledge about outcomes unproblematic problematic unproblematic Technical approval 1995- 2002 knowledge Dialogue, about debate, likelihoods and precaution 2009 - Regulatory impasse 2002-09 problematic
  • 15. ‘Closing down’ powerful pressures to justify a narrow risk framing knowledge about outcomes unproblematic problematic unproblematic RISK expert decisions AMBIGUITY aggregative analysis political closure knowledge public deliberation about risk based regulation ` political debate likelihoods reductive modeling agenda-setting legal frameworks horizon scanning insurance multiple expertises harm definitions indicators / metrics regulatory remits Liability law problematic UNCERTAINTY IGNORANCE
  • 16. ‘Opening up’ regulation knowledge about outcomes unproblematic problematic unproblematic RISK AMBIGUITY Narrow , expert-led participatory deliberation biosafety-focused, scenario workshops technical risk stakeholder dialogues regulation interactive options modelling knowledge social, political and technical about dimensions likelihoods precaution uncertainty heuristics continuous monitoring sensitivity testing adaptive management tracking institutional learning high reliability management problematic UNCERTAINTY IGNORANCE
  • 17. Reimagining regulation • Accept uncertainty and ignorance, avoid closing down towards narrow versions of risk regulation • Debating ambiguities – different perspectives, opinions and evidence – should be encouraged • Multiple expertises are important. Science on tap, not on top. • Regulation is both technical and political – requires a mature, transparent co-evolutionary approach. Not the dominance of one or the other.