Conférence du Consortium industriel canadien en nanotechnologie (CICN)

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
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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 enad
converging 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
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4. Questionning any Regulation Efficiency
when a legal link between a fact and a cause
cannot be clearly established
1. 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
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5. Questionning any regulation efficiency
when 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.
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6. Taxonomy as a prerequisite for efficient
regulations
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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
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7. Nano-metrology as another pre-requisite
for effective regulation
and B2B relationships improvement:
Challenges
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8. Why preparing for better regulations of
nanotechnology-induced changes?
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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
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10. How preparing for better regulations
of 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 ?
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11. SpiderNet representation of a Nanocode
Meter ( EU NanoCode Project 2011)
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12. Responsible Innovation for economic development?
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13. Managing the gap between Risk and Risk Perception ?
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14. What do we mean by Responsible Research and
Innovation? (RRI Concept)
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15. Towards a EU « RRI » Scheme
inspired 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.
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16. Examples of contested innovation in the EU
Contested 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
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17. Examples of successful Innovations
Highly innovative products providing solutions for
societal, 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
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18. « RRI concept » : Following the National
Public 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
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19. FramingNano reference for a sustaibable,
reflexive governance of nanotechnology (EU)
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20. Co-evolution of Science and society can be
obtained by a « Reflexive governance »
approach inspired by a “RRI” concept
(Arie RIP, NL)
Reflexive ethics, prerequisite for a reflexive governance
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21. CONSEIL GENERAL DE L’ECONOMIE
DE L’INDUSTRIE, DE L’ENERGIE ET DES TECHNOLOGIES
A 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