EUROPEAN COMMISSION Community Health and Consumer Protection NANOTECHNOLOGIES: A PRELIMINARY RISK ANALYSIS ON THE BASIS OF A WORKSHOP ORGANIZED IN BRUSSELS ON 1–2 MARCH 2004 BY THE HEALTH AND CONSUMER PROTECTION DIRECTORATE GENERAL OF THE EUROPEAN COMMISSION Cover page illustration: The picture on the cover page shows nanoparticles of titanium silicide embedded in silicon (3200Å × 3200Å × 291Å). (Courtesy of Professor Mark E. Welland, Cambridge University.) LEGAL NOTICE: Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. The views expressed in this publication are the sole responsibility of the authors and do not necessarily reflect the views of the European Commission. The present report may be found under http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm. © European Communities, 2004 2 FOREWORD Nanotechnologies refer to “technologies of the tiny”. They span domains as diverse as computing, material science, medicine, energy production and storage, etc., bring together fields as varied as physics, chemistry, genetics, information and communication technologies, and cognitive sciences, and should become virtually ubiquitous before long. Nanotechnologies are with us already. Indeed, consumers are already being offered products manufactured with nanotechnologies including cosmetics, clothing, and sporting goods. But, while technology and market analysts alike expect the very small to become very big, nanotechnologies are still emerging. Like other new technologies before them, nanotechnologies may not only present potential benefits, but also potential risks. Today therefore constitutes an appropriate time to establish a dialog on nanotechnologies involving scientists, consumers, workers, industrialists, and other stakeholders. Today also represents an opportune moment to reflect on the implications of these “technologies of the tiny” for public health, health and safety at work, and the environment. Today presents us with a unique chance to set nanotechnologies on a responsible development trajectory, one that will benefit both human and environmental health and global competitiveness. The “Mapping out Nano Risks” workshop represents a modest first step—albeit an important one—towards analyzing the potential risks of nanotechnologies and what they may imply. Consequently, I should like to thank all the experts who took part in the workshop for contributing written statements prior to the workshop, for actively participating in the workshop, and for producing this timely report. This report is available under http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm. Risk Assessment Unit Public Health and Risk Assessment Directorate Health and Consumer Protection Directorate-General 3 4 TABLE OF CONTENTS FOREWORD............................................................................................................................ 3 LIST OF WORKSHOP PARTICIPANTS ............................................................................ 7 EXECUTIVE SUMMARY.................................................................................................... 11 INTRODUCTION.................................................................................................................. 13 PART 1: WORKSHOP OUTCOMES ................................................................................. 15 1. PRELIMINARY RISK ANALYSIS ...................................................................................... 17 1.1. Overview .............................................................................................................. 17 1.1.1 Hazard identification........................................................................................... 17 1.1.1.1 Clarifications ....................................................................................................... 18 1.1.1.2 Concerns.............................................................................................................. 18 1.1.1.2.1 Toxicology and ecotoxicology............................................................................ 18 1.1.1.2.2 Ethics ............................................................................................................... 19 1.1.1.2.3 Security ............................................................................................................... 20 1.1.1.3 Limits .................................................................................................................. 21 1.1.2 Policy options evoked during the meeting .......................................................... 22 1.1.3 Twelve recommendations from experts at the workshop.................................... 24 1.2. Options for future policies identified by the workshop secretariat ...................... 27 2. GENERAL STATEMENT ON NANOTECHNOLOGIES .......................................................... 33 3. CONCEPT NOTE ON A HAZARD TRIGGER ALGORITHM AS A POTENTIAL PRIORITIZATION TOOL FOR USE BY REGULATORS ................................................................................... 35 PART 2: DOCUMENTS PRODUCED AND CIRCULATED PRIOR TO 1 MARCH 2004..................................................................................................................... 37 1. COLLECTION OF SHORT CONTRIBUTIONS BY THE INVITED EXPERTS ............................. 39 Security Problems from Nanotechnology Jürgen Altmann ..................................................................... 39 Moving the nanoscience and technology (NST) debate forwards Short-term impacts, long-term uncertainty and the social constitution Alexander Arnall* and Douglass Parr** ....................................... 43 A need for integrated testing of products in Nanotechnology Paul J.A. Borm and Wolfgang Kreyling ... 47 Engineered anomaterials and risks: One perspective Vicki Colvin......................................................... 49 Mapping Out Nano Risks. Some considerations on possible toxicity W.H. de Jong .............................. 51 Complexity and Uncertainty A Prudential Approach To Nanotechnology Jean-Pierre Dupuy................ 71 Nano Ethics Primer Göran Hermerén, ................................................................................................... 95 Nanotechnology - From the insurers' perspective Annabelle R. Hett ................................................... 103 A briefing note on Nanoparticles C.Vyvyan Howard............................................................................ 105 Mapping Out Nano Risks Lutz Mädler.................................................................................................. 109 Social Imagination for Nanotechnology Alfred Nordmann .................................................................... 111 Emerging Concepts in Nanoparticle (NP) Toxicology G. Oberdörster,................................................. 115 “Mapping Out Nano Risks” M.A.Pierotti ............................................................................................... 117 Mapping out Nano Risks Jos Put ......................................................................................................... 119 Public Perception of Nanotechnology Ortwin Renn.............................................................................. 123 Risks and Ethical Challenges of Nanotechnology in Healthcare D.G. Rickerby................................... 127 5 Towards an appropriate corporate and public governance of Nano Risks : Promoting and strengthening a multilateral approach Françoise Roure............................................... 131 Nanotechnology and its implications M E Welland.............................................................................. 135 2. TERMS OF REFERENCE................................................................................................. 137 3. AGENDA ...................................................................................................................... 143 6 LIST OF WORKSHOP PARTICIPANTS THE EXPERT GROUP Dr Jürgen ALTMANN1 Institut für Exp. Physik III Ruhr-Universität Bochum Bochum,Germany and Experimentelle Physik III Universität Dortmund Mr Alexander Huw ARNALL Department of Geography University of Sheffield Sheffield, UK Prof. Paul J.A. BORM Centre of Expertise in Life Sciences (CEL) Heerlen and Department of Particle Toxicology/Institut für Umweltmedizinische Forschung (IUF) Department of Particle Research University of Düsseldorf Düsseldorf, Germany Dr Vicki COLVIN Director, Center for Biological and Environmental Nanotechnology (CBEN) Rice University Houston TX, USA Dr Wim H. DE JONG Laboratory for Toxicology, Pathology and Genetics National Institute for Public Health and the Environment Bilthoven, The Netherlands Dr Jean-Pierre DUPUY1, 2 Centre of Research in Applied Epistemology (CREA) École Polytechnique Paris, France Prof. Göran HERMERÉN President of the European Group on Ethics in Science and New Technologies Lund, Sweden Dr Annabelle R. HETT Swiss Re Zurich, Switzerland 1 Member of the High Level Expert Group (HLEG) on “the new wave of emerging technologies and the convergence of nano, bio, info and cogno-technologies” set up by the Research Directorate-General to analyse and suggest proposals on European actions in these areas. Results and report expected for October 2004. For any further information, please contact Michael Rogers or Elie Faroult . 2 Invited expert