A Responsible Research and Innovation

Scheme for Nanotechnology ?Panel on Responsible development, economic development and regulation in

nanotechnologiesContribution of Dr. Françoise ROURE

French High Coucil for Economy, Industry, Energy and Technologies

CONSEIL GENERAL DE L’ECONOMIEDE L’INDUSTRIE, DE L’ENERGIE ET DES 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

Roure_Montreal_2012

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 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

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

Roure_Montreal_2012

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. ►►► Transatlantic Economic Forum Agenda

Roure_Montreal_2012

Roure_Montreal_2012 6

6 Taxonomy as a prerequisite for efficient regulations

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

Source : http://www.icsu.org/events/ICSU%20Events/workshop-on-the-description-of-nanomaterials

ROBUST DESIGNKNEW

KNOWLEDGE

Roure_Montreal_2012 7

Nano-metrology as another pre-requisite for effective regulation

and B2B relationships improvement: Challenges

8

Why preparing for better regulations of nanotechnology-induced changes?

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

Roure_Montreal_2012

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 ?

Roure_Montreal_2012

Roure_Montreal_2012 11

SpiderNet representation of a Nanocode Meter ( EU NanoCode Project 2011)

12

Responsible Innovation for economic development?

Roure_Montreal_2012

13

Managing the gap between Risk and Risk Perception ?

Roure_Montreal_2012

14

What do we mean by Responsible Research and Innovation? (RRI Concept)

Roure_Montreal_2012

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 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

Roure_Montreal_2012 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

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

Roure_Montreal_2012

19

FramingNano reference for a sustaibable, reflexive governance of nanotechnology (EU)

Roure_Montreal_2012

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

Roure_Montreal_2012

A Responsible Research and Innovation

Scheme for Nanotechnology ?Thank You for your Attention

Contribution of Dr. Françoise ROUREFrench High Coucil for Economy, Industry, Energy and Technologies

francoise.roure@finances.gouv.fr

CONSEIL GENERAL DE L’ECONOMIEDE L’INDUSTRIE, DE L’ENERGIE ET DES TECHNOLOGIES