Governance and Ethics of Nanotechnology

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1 Governance and Ethics of Nanotechnology Codes of conduct and risk governance models on nanotechnologies: An overview Dr. Antje Grobe University of Stuttgart Scientific Adviser IRGC Source: Evonik, Nano & Art Competition Disclaimer: The views expressed in this presentation are personal and may not necessarily reflect those of the IRGC Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 1

2 Overview 1. Background Of Voluntary Codes Of Conduct 1.1 High Expectations & Raising Concerns 1.2 The IRGC 4 Generation Model Of Nanotechnologies 2. Different Codes & Frameworks 2.1 The Responsible Care Code 2.2 The Responsible Nano Code 2.3 The Nano Risk Framework 2.4 The Code Of Conduct For Responsible Nanosciences and Nanotechnologies Research 3. Comparison And Assumptions 4. Conclusions Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 2

3 1. Background Of Voluntary Codes Of Conduct Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 3

4 1.1High Expectations & Raising Concerns High Expectations in Public Perception Medical Devices Environmental Technologies Sustainable Products Raising Concerns in Public Perception Occupational Health Environmental Safety Consumer Safety / Product Stewardship How to manage ambiguity and uncertainty? Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 4

5 1.3 The IRGC 4 Generation Model EXPECTATIONS CONCERNS 4. Generation Heterogeneous molecular Nanosystems 3. Generation Integrated Nanosystems 2. Generation Active Nanostructures 1. Generation Passive Nanostructures Frame 2 Frame 1 Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 5

6 1.3 The IRGC 4 Generation Model and the raising social and ethical questions EXPECTATIONS CONCERNS 4. Generation Heterogeneous molecular Nanosystems 3. Generation Integrated Nanosystems 2. Generation Active Nanostructures 1. Generation Passive Nanostructures Definition of life Human Enhancement Control / Reversibility Hazards & Exposure Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 6

7 2. Different Codes & Frameworks Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 7

8 2.1 The Responsible Care Code Voluntary industrial global Charta Target Group: Chemical Industry (ICCA) Status: Adopted in 53 member countries, developed and modified since the mid-80s Not explicitly on nanotechnologies but covering industries health, safety and environmental initiatives Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 8

9 2.2 The Responsible Nano Code Voluntary code as a result of a stakeholder dialogue workshop Target Group: Companies, retailers, commercial partnerships, research laboratories, universities, private or public funded bodies Status: In the re-drafting process Explicitly on Nanotechnologies to provide clarity on the strategic issues that organizations need to address Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 9

10 2.3 The Nano Risk Framework Voluntary Stakeholder Dialogue Project Target Group: Environmental Defense & Dupont; Blueprint for Global Players with an American Background Status: Adopted for several products Explicitly on the responsible research and use of nanomaterials providing general principles and concrete guidance / worksheets Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 10

11 2.3 The Nano Risk Framework Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 11

12 2.4 The code of conduct for responsible nanosciences and nanotechnologies research Voluntary Code of the EU Commission Target Groups: Member States, national and regional authorities, employers and research funding bodies, researchers, and any individual or civil society organisation involved or interested in N&N research Status: Adopted by the Commission on 07/02/2008, review & monitoring every two years General principles and guidelines on research, providing criteria for funding, auditing, monitoring, evaluation and encouraging dialogue Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 12

13 3. Comparison And Assumptions Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 13

14 Comparison (Grobe et al., IRGC 2008) Criteria to regard Responsible Care EU Code of Conduct Research Responsible NanoCode Nano Risk Framework Signed Commitment (on CEO-level) directly mentioned directly mentioned (national) directly mentioned directly mentioned Support Regulatory Frame directly mentioned directly mentioned directly mentioned directly mentioned Life-Cycle Approach directly mentioned directly mentioned directly mentioned directly mentioned Fundamental rights (ethical standards) directly mentioned Sustainability Indirectly mentioned directly mentioned Indirectly mentioned directly mentioned Precautionary principle directly mentioned directly mentioned Occupational health Indirectly mentioned Indirectly mentioned directly mentioned directly mentioned Reflection of Social and Ethical concerns Transparency /Access to Information directly mentioned directly mentioned directly mentioned Indirectly mentioned Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 14 directly mentioned directly mentioned (see indicators) directly mentioned Stakeholder Engagement directly mentioned directly mentioned directly mentioned directly mentioned

15 Criteria to regard Continuously Improvement /Best science standards directly mentioned directly mentioned Indirectly mentioned directly mentioned Innovation and Growth directly mentioned directly mentioned directly mentioned directly mentioned Accountability Indirectly mentioned directly mentioned directly mentioned Cooperation with Governments on regulation and standardization Responsible sales and marketing Comparison Part 2 (Grobe et al., IRGC 2008) Support to adopt the code along the value chain Guidelines for characterization, risk assessment, risk management, risk evaluation, documentation and communication Responsible Care directly mentioned directly mentioned directly mentioned directly mentioned Indirectly mentioned EU Code of Conduct Research Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 15 Responsible NanoCode directly mentioned Nano Risk Framework directly mentioned Indirectly mentioned directly mentioned directly mentioned directly mentioned Concern assessment Indirectly mentioned directly mentioned Indirectly mentioned indirectly mentioned Framing of the issue Indirectly mentioned directly mentioned Indirectly mentioned Indirectly mentioned

16 Assumptions Fundamental Rights & Ethical Standards Restrictions for non-therapeutic human enhancement Restrictions for exposure to humans and the environment before longterm safety is approved Precautionary Principle Adaption of special health, safety and environment measures Application of existing good practices of classification and labelling Risk assessment presented along with submission of a proposal for funding Availability Of Information For Lay People These criteria have to be adopted and to be monitored and need scientific, social and ethical predefinitions / frames Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 16

17 4. Conclusions Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 17

18 Conclusion 1 The EU Code of Conduct on Responsible N&N Research covers the future 4 generations of nanotechnologies 4. Generation Heterogeneous molecular Nanosystems Definition of life 3. Generation Integrated Nanosystems 2. Generation Active Nanostructures Human Enhancement Control / Reversibility 1. Generation Passive Nanostructures Hazards & Exposure Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 18

19 Conclusion 2 The EU Code of Conduct on Responsible N&N Research added the direction of research as a subject for societal and ethical reflection and dialogue Direction of Research EU Code of Conduct N&N Research Responsible Care Responsible Nano Code Nano Risk Framework Basic Research Research & Development Production Use & Retailing End of Life ~ 3-5 y Risk Assessment & Risk Evaluation Communication Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 19

20 Thank you! Risk Dialogue Foundation Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 20

21 IRGC 2008 Antje Grobe, Ortwin Renn, Alexander Jaeger DIALOGIK gemeinnuetzige GmbH, Stuttgart Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 21

22 Risk Governance Model (White Paper 2006) Management Sphere: Decision on & Implementation of Actions Assessment Sphere: Generation of Knowledge 3 Pre-Assessment Pre-Assessment: Problem Framing Early Warning Screening Determination of Scientific Conventions Risk Management Risk Management Implementation Option Realisation Monitoring & Control Feedback from Risk Mgmt. Practice Decision Making Option Identification & Generation Option Assessment Option Evaluation & Selection Communication Risk Appraisal Risk Appraisal: Risk Assessment Hazard Identification & Estimation Exposure & Vulnerability Assessment Risk Estimation Concern Assessment Risk Perceptions 1 Social Concerns Socio-Economic Impacts Tolerability & Acceptability Judgement Risk Evaluation Judging the Tolerability & Acceptability Need for Risk Reduction Measures Risk Characterisation Risk Profile Judgement of the Seriousness of Risk Conclusions & Risk Reduction Options Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 22

23 1.2 Public Perception In International Surveys (Grobe et al., IRGC 2008) Public Knowledge Base on Nanotechnologies in International Surveys Data in Percentage USA UK Germany USA 2005 A 40 USA 2005 B Canada USA USA Germany heard little or nothing heard some or a lot USA 2004 Cobb & Macoubrie; UK 2004 Royal Society; Germany 2004 komm.passion; USA 2005 A Einsiedel; USA 2005 B Macoubrie; Canada 2005 Einsiedel; USA 2006 Hart; USA 2007 Kahan et al.; Germany 2007 BfR Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 23

24 1.2 Public Perception In International Surveys (Grobe et al., IRGC 2008) Data in Percentage USA 2004 Expectations About Benefits And Risks Of Nanotechnologies UK Germany USA 2005 A USA 2005 B 51 Canada USA USA Germany 2007 expect more benefits neutral / ambivalent / not sure expect more risks 33 Overall positive Risk-Benefit-Ratio Expectation of risks climbed to ~ 30 %, independent of the knowledge More information corresponds to more differentiation The more information / familiarity is reached the more consumers are positive USA 2004 Cobb & Macoubrie; UK 2004 Royal Society; Germany 2004 komm.passion; USA 2005 A Einsiedel; USA 2005 B Macoubrie; Canada 2005 Einsiedel; USA 2006 Hart; USA 2007 Kahan et al.; Germany 2007 BfR Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 24

25 2.1 The Responsible Care Code Continuously improve the environmental, health and safety knowledge and performance of our technologies, processes and products over their life cycles so as to avoid harm to people and the environment. Use resources efficiently and minimise waste. Report openly on performance, achievements and shortcomings. Listen, engage and work with people to understand and address their concerns and expectations. Cooperate with governments and organisations in the development and implementation of effective regulations and standards, and to meet or go beyond them. And provide help and advice to foster the responsible management of chemicals by all those who manage and use them along the product chain. (ICCA 2007,p 2 and 4) Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 25

26 Principle One: Each Organisation should ensure that responsibility for guiding and managing its involvement with nanotechnologies resides with the Board or governing body Principle Two: Each Organisation should proactively engage with its stakeholders and be responsive to their views in its development or use of products using nanotechnologies Principle Three: Each Organisation should identify and minimise sources of risk for workers handling products using nanotechnologies, at all stages in the production process or in industrial use, to ensure high standards of occupational health and safety Principle Four: Each Organisation should carry out thorough risk assessments and minimise any potential public health, safety and environmental risks relating to its products using nanotechnologies Principle Five: Each Organisation should consider and respond to any social and ethical implications and impacts in the development or sale of products using nanotechnologies Principle Six: Each Organisation should adopt responsible practice in the sales and marketing of products using nanotechnologies Principle Seven: Each Organisation should engage with suppliers and/or business partners to encourage and stimulate their adoption of the Code and so assure its own ability to fulfil its Code commitments. (Responsible NanoCode 2007, p 7) Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 26

27 2.4 The code of conduct for responsible nanosciences and nanotechnologies research Meaning: N&N research activities should be comprehensible to the public. They should respect fundamental rights and be conducted in the interest of the well-being of individuals and society in their design, implementation, dissemination and use; Sustainability: N&N research activities should be safe, ethical and contribute to sustainable development. They should not harm or threaten people, animals, plants or the environment, at present or in the future; Precaution: N&N research activities should be conducted in accordance with the precautionary principle, anticipating potential environmental, health and safety impacts of N&N outcomes and taking due precautions, proportional to the level of protection, while encouraging progress for the benefit of society and the environment; Inclusiveness: governance of N&N research activities should be guided by the principles of openness to all stakeholders, transparency and respect for the legitimate right of access to information. It should allow participation in the decision-making processes of all stakeholders involved in or concerned by N&N research activities; Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 27

28 2.4 The code of conduct for responsible nanosciences and nanotechnologies research Excellence: N&N research activities should meet the best scientific standards, including integrity of research and good laboratory practices; Innovation: governance of N&N research activities should encourage maximum creativity, flexibility and planning ability for innovation and growth; Accountability: researchers and research organisations should remain accountable for the social, environmental and human health impacts of their work. (EU Commission, Cordis 2008) Governance and Ethics of Nanotechnology, Brussels 07 May 2008 Dr. Antje Grobe Nr. 28

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