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Françoise Roure_A possible research and innovation scheme for Nanotechnology?
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Françoise Roure_A possible research and innovation scheme for Nanotechnology?

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Conférence du Consortium industriel canadien en nanotechnologie (CICN)

Conférence du Consortium industriel canadien en nanotechnologie (CICN)

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  • 1. CONSEIL GENERAL DE L’ECONOMIE DE L’INDUSTRIE, DE L’ENERGIE ET DES TECHNOLOGIES A Responsible Research and Innovation Scheme for Nanotechnology ?Panel on Responsible development, economic development and regulation in nanotechnologies Contribution of Dr. Françoise ROURE French High Coucil for Economy, Industry, Energy and Technologies
  • 2. What have we learned from 10 years of Nanotechnology Regulation in the EU Early Involvement of the European Parliament European Commission answer  SCENHIR expertise and recommendations on adequate definitions  Joint Research Center roadmap including EHS databases  CEN and ISO under Vienna Agreement  Chemical Safety, REACH legal framework and second evalation of legally binding directive  Specific IUCLID track for urgent reaction on dangerous products reaching the market  The case of Cosmetics and « non soluble« nanoparticles in the scope definition  Codes of conduct 2 Roure_Montreal_2012
  • 3. What have we learned from 10 years of Nanotechnology Regulation in the EU? Adaptation of the French legal Framework Official report on Ethics and industriel foresight on nano enadconverging technologies ( DUPUY-ROURE) 2007 Grenelle de l’environnement, Commitment n° 159 2009 Grenelle Law art. 42 • NATIONAL Public Debate • Mandatory Reporting Scheme • Information on risks and protection measures • Methodology for assessing risks and benefits 2009-2010 National Public Debat on Governance issues for nanosciences and nanotechnologies 17 February 2012 : Two Ministerial Orders creating a mandadatory annual declaration of nanoparticulate substances and listing the organisms in charge 6 August 2012, Traceability ensured by an « Arrêté », describing the conditions of declaration created by the Ministerial Order Roure_Montreal_2012 3
  • 4. Questionning any Regulation Efficiency when a legal link between a fact and a cause cannot be clearly established1. What are we talking about ? Semantics Matters and have an Impact  Definitions: national, regional, other?  Standardized definitions ? For which purpose ? Industrial? Legal ? Other?  What about the difference of traceability on soluble/non soluble nanoparticles/nanomatérials?  Towards a unique method of DESCRIPTION of nano- objects and systems at the nanoscale, including nanomaterials MESSAGE : without traceability, no legal security, no anticipation, no compensation, NO TRUST, NO MARKET 4 Roure_Montreal_2012
  • 5. Questionning any regulation efficiencywhen a legal link between a fact and a cause cannot be clearly established 2) The role of ICSU-CODATA  Pespectives of a joint VAMAS-CODATA initiative : White Paper in preparation 2012-2013  Towards an international, widely supported, « nanomaterials description initiative » involving scientists, ICSU/International Unions, Industrials, …  CODATA decision follows an international, inter- disciplinary Workshop organized in Paris, Feb. 2012, with the participation of OECD. (J. Rumble, F. Roure) MESSAGE : without an agreed description, naming, defining, traçing and mandatory reporting will bring Regulatory divergence where actors need unified, harmonized regulations. Roure_Montreal_2012 Transatlantic 5
  • 6. Taxonomy as a prerequisite for efficient regulations 6 An integrated “Logic” Cascade : - Ontology - Taxonomy - Terminology - Definition - Description (Uniqueness/Equivalence) - - Representation (3D…4D…)Stakes : the capacity of teach, design, research, innovate, regulate, protect (IP), produce, evaluate, cooperate, even compete…on a level playing field.Solution : Universal description of matter and properties at the nanoscale, towards an open, well-curated, Meta-Database ICSU/CODATA- VAMAS Project. Paris Workshop 23-24 Feb. 2012 on the Description of nanomaterial http://www.icsu.org/events/ICSU%20Events/workshop-Source : on-the-description-of-nanomaterials Roure_Montreal_2012 6
  • 7. Nano-metrology as another pre-requisite for effective regulation and B2B relationships improvement: Challenges Roure_Montreal_2012 7
  • 8. Why preparing for better regulations of nanotechnology-induced changes? 8 Roure_Montreal_2012
  • 9. How preparing for better regulations of nanotechnology-induced changes? SOFT LAW : some examples 1. International standards  Nanolabeling : ISO TC 229 : focused on consumers information first • Even if B to B information stays crucial as responsibility matters.  « NanoR » TS « Nanoresponsibility » , CEN TC 352 WG 2 PG2  Nano-medicine, Nanomanufacturing Terminology, ISO TC 229  Consumers and Societal Dimension ISO TC 229 Survey, 2012  Perspectives of an ISO new TC « Biotechnology » including bio- sourced, nanoscale objects  Joint IEC 113 / ISO TC 229 WG on Terminology for nanoelectronics… MESSAGE : A standard is a voluntary adoption of a non mandatory norm, it may be used in regulations . It can be considered as a means to lowering costs, accelerating time to market, and avoiding EHS dumpings. It paves the way to non divergent regulations for global players, globalized markets 9 Roure_Montreal_2012
  • 10. How preparing for better regulationsof nanotechnology-induced changes?SOFT LAW Codes of Conduct for Responsible Research  Defined and impleented by the Industry ; limited succes (cf. UK evaluation)  Adopted for Researchers in Nanosciences by the European Commission  Not widely used  Not widely understood by researchers  No relevant frame in Scientific Public Institutions  Evaluated in 2011  How better meeting this critical need in the future ? 10 Roure_Montreal_2012
  • 11. SpiderNet representation of a Nanocode Meter ( EU NanoCode Project 2011) Roure_Montreal_2012 11
  • 12. Responsible Innovation for economic development? 12 Roure_Montreal_2012
  • 13. Managing the gap between Risk and Risk Perception ? 13 Roure_Montreal_2012
  • 14. What do we mean by Responsible Research and Innovation? (RRI Concept) 14 Roure_Montreal_2012
  • 15. Towards a EU « RRI » Schemeinspired by Nano / Emerging Technologies « RRI » concept comes after the EU « Science in Society » 6th Framework Program for 2007-2012 « RRI » concept is to promote a generic ethical frame to the 8th FP fpr Research, Development and Innovation, 2013-2020 ( around 80 billion € ) A group of Experts was asked in 2012 to preparing this generic framework  With different options, from status quo to a legally binding/reporting scheme  Adressing Ethical, Legal and Societal concerns as regards high risk, high complexity, high uncertainty research , innovation and development  With a constant compliance to European Values and Goals  Compliance scheme able to pave the way to new, adequate forms of Governance in the field of new, nano-enabled technologies. Roure_Montreal_2012 15
  • 16. Examples of contested innovation in the EUContested by societal actors…why? because of ethical concerns; Because of their failure to meet societal needs;EXAMPLES:  Nanotechnologies, at least until a success story meets expectations ( nanomedicine, cancer treatment…)  GMOs  E-mobility and traceability  Stem Cell Research  Online Social Networks  Biotech /Syn Bio  Dual-use Robotics  Nuclear Technologies  Some technologies for military or security purpose Roure_Montreal_2012 16
  • 17. Examples of successful InnovationsHighly innovative products providing solutions forsocietal, environmental and economic challenges.EXAMPLES:  Resource efficiency with bio-based, non extractive products  e-Health, like medical imaging  Privacy by Design, Privacy-enabling Technologies: new generation of software and ICT services compliant with Privacy while offering the desired functionnality Roure_Montreal_2012 17
  • 18. « RRI concept » : Following the NationalPublic Debate on nanotechnology in France A list of actions binding the Government to ensure appropriate follow up of the Debate Mandatory creation of an ethical committee in Research Laboratories focusing on Nanosciences and Nanotechnologies as a direct result of the national public debate on the nanotechnology governance issues Decision to involve stakeholders who would wish so to a dialogue, in particular when new production sites are at stake; towards a responsible development of nanotechnology applications Waste management of final waste including synthetic nanoparticles Public Laboratories in charge of Life Cycle Assessment of synthetic nanomaterials Public funding subject to TOX/ ECOTOX research Societal Sciences and humanities involved as regards nanotechnology- induced changes 18 Roure_Montreal_2012
  • 19. FramingNano reference for a sustaibable,reflexive governance of nanotechnology (EU) 19 Roure_Montreal_2012
  • 20. Co-evolution of Science and society can beobtained by a « Reflexive governance »approach inspired by a “RRI” concept(Arie RIP, NL) Reflexive ethics, prerequisite for a reflexive governance Roure_Montreal_2012
  • 21. CONSEIL GENERAL DE L’ECONOMIE DE L’INDUSTRIE, DE L’ENERGIE ET DES TECHNOLOGIESA Responsible Research and Innovation Scheme for Nanotechnology ? Thank You for your Attention Contribution of Dr. Françoise ROURE French High Coucil for Economy, Industry, Energy and Technologies francoise.roure@finances.gouv.fr