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Framingnano Project: a Multistakeholder Dialogue Platform Framing the Responsible Development of Nanosciences & Nanotechnologies

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Framingnano Project: a Multistakeholder Dialogue Platform Framing the Responsible Development of Nanosciences & Nanotechnologies 1. FramingNano Report FramingNano Project: A multistakeholder dialogue platform framing the responsible development of Nanosciences & Nanotechnologies www.framingnano.eu MAPPING STUDY ON REGULATION AND GOVERNANCE OF NANOTECHNOLOGIES Released: January 2009 PROJECT CONSORTIUM 1 FramingNano Report MAPPING STUDY ON REGULATION AND GOVERNANCE OF NANOTECHNOLOGIES Published under the FramingNano project as deliverable D1.1 for Work Package 1. FramingNano is a support action (SA) funded under the Programme Capacities, in the area Science in Society, within the 7° Framework Program (FP7). (SiS-2007-1.2.3.2-CT, Project N. 217724) Report prepared by: AIRI/Nanotec IT, The Innovation Society Authors: Elvio Mantovani, Andrea Porcari, AIRI/Nanotec IT Christoph Meili, Markus Widmer, The Innovation Society The other partners of the Consortium have also contributed to the preparation of the report. PROJECT CONSORTIUM AIRI/Nanotec IT, Italy www.nanotec.it The Innovation Society, Switzerland www.innovationsociety.ch The Institute of Nanotechnology, UK www.nano.org.uk National Institute for Public Health & the Environment, The Netherlands www.rivm.nl Fondation EurActiv,Belgium www.euractiv.com Technology Centre, Czech Republic www.tc.cz The report is the result of a desk analysis of information from publicly available documents. Contents and conclusions are based on this information and are under the responsibility of the authors. www.framingnano.eu 2 FramingNano Report Table of Contents EXECUTIVE SUMMARY…………………………………………………………………………………………………………………………..3 1. Foreword ..................................................................................................... 9 1.1. The FramingNano Project ............................................................................ 10 1.2. Purpose of the report ................................................................................. 12 1.3. Structure and methodology .......................................................................... 13 2. INTRODUCTION ............................................................................................. 15 2.1. The Nature of Nanotechnologies .................................................................... 15 2.2. Nanotechnology Applications ........................................................................ 16 2.3. The Role of Policy and Regulation .................................................................. 22 3. THE DEBATE ABOUT RISKS AND CONCERNS RELATED TO NANOTECHNOLOGIES .............. 23 3.1. Health & Safety Effects on Humans and the Enviroment ....................................... 24 3.2. Environmental Effects ................................................................................ 30 3.3. Ethical, Legal and Societal Issues (ELSI) ........................................................... 34 3.4. Research Needs ........................................................................................ 44 4. NANOTECHNOLOGIES REGULATORY APPROACHES .................................................. 48 4.1. Shortcoming of Nanotechnology Governance ..................................................... 48 4.2. Existing Regulatory Frameworks Including Nanomaterials ...................................... 51 4.3. Standardisation ........................................................................................ 76 4.4. Voluntary Measures ................................................................................... 85 4.5. Stakeholders Initiatives and Positions.............................................................. 94 5. CONCLUSIONS ............................................................................................ 105 6. References ................................................................................................ 107 7. Annexes ................................................................................................... 116 7.1. Proposed and Existing Strategies and Action Plans ............................................ 116 7.2. Ongoing Research Projects ........................................................................ 124 7.3. Standards organisations and nanotechnology ................................................... 131 7.4. Detailed Table of Contents ........................................................................ 133 A detailed Table of Contents is available in section 7.4 (pg 133) www.framingnano.eu 3 FramingNano Report Executive Summary Nanotechnologies are expected to be one of the main drivers of the technological evolution of the early part of the XXI Century. Due to the unique properties and behaviour of matter at the nanoscale and its enabling characteristics, nanotechnologies have the potential to profoundly transform all the most important industrial sectors and everyday life. All over the world, both developed and emerging countries are devoting increasing resources to promote nanoscience and nanotechnologies in an effort aimed at gaining a leading position in the field and reaping the benefits promised. However, the belief is also becoming widely shared that the hopes pinned on this emerging technology will fully materialise only if its development will take place responsibly. The level of attention directed towards the health, safety and environmental (EHS) effects and ethical, legal and social issues (ELSI) deriving from nanotechnology and its applications has increased considerably in recent years. Addressing these issues properly and responsibly will be of paramount importance for the success of nanotechnology. Most of the countries with an interest in nanotechnology and supranational organisations are placing high on the agenda their attention on how to manage the development of this technology. Governments, regulatory and standards-setting agencies/bodies have started to develop expertise and technical background to cope with the related regulatory issues. The European Commission has condensed its position to promote the safe growth of nanotechnology into an Action Plan and, in the past years together with regulatory authorities and scientific committees, has started specific initiatives and published various in-depth analyses on this matter. The request to review current EU regulatory legislation to take into consideration nanotechnology is one of the instruments considered and the initiative to extend the application of REACH to nanomaterials is an example of this action. In February 2008, the EC published a Code of Conduct (CoC) for responsible research in nanosciences and nanotechnologies. The principles that guide the CoC are: • Meaning: research activities should be understandable by the public; • Sustainability: research activities should be safe, ethical and contribute to a sustainable development; • Precaution: research activities should be conducted in accordance with the precautionary principle; • Inclusiveness: governance of research activities should be guided by the principle of openness, transparency and respect to all stakeholders; • Excellence: research activities should meet the best scientific standards; • Innovation: research activities should encourage maximum creativity and flexibility: • Accountability: researchers and research organisations should remain accountable for the social, environmental and human health impact of their research. www.framingnano.eu 4 FramingNano Report The CoC represents a flexible and high level instrument, applicable to existing and future applications of nanotechnologies, and providing all stakeholders with principles and guidelines for a responsible and open approach to nanoscience and nanotechnology research. All European Countries have been urged by the EC to adopt the Code for their activities in nanotechnology but, being voluntary, its effectiveness will of course depend on the level of application and on the instruments, mainly scientific, to comply with its guidelines. France, Germany, Switzerland, The Netherlands, UK and some Scandinavian Countries are, in Europe, the most active in addressing the various issues related to nanoregulation. In these countries, the commitment to understand the health and environmental implications of nanotechnology is quite strong and their governments are currently supporting a number of research activities to this end. As a result of these initiatives, guidance documents on risk assessment and risk management of nanotechnology as well as on the implementation of current legislation (mainly based on REACH) have been published. In the USA, EHS issues are now among the priorities of the National Nanotechnology Initiative (NNI) and the funding for research in this field has been stepped up considerably in the last two years. The EPA and FDA have set up specific task forces on nanotechnology, and have published reviews of their legislation in relation to nanotechnology. Most of the discussion so far has been on the applicability to nanomaterials of the EPA TSCA statute (analogous to REACH) and on FDA statutes, in particular in relation to cosmetics, food and food additives, and drugs. The Consumer Product Safety Commission (CPSC - under whose jurisdiction fall most consumer products using nanotechnology), has not so far published relevant documents on nanotechnology regulation. Australia and Canada are also rather active on nanoregulation. Both have important programmes on EHS research and have published in-depth reviews of their regulations to assess eventual limits when dealing with nanotechnology. Even though no specific laws have been set up, the
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