Evaluating Progress for the Implementation of European Union Nanotechnology Strategies for Safe Design and Responsible Innovation of Nanomaterials by MAURICE EDWARD ANTHONY BRENNAN A thesis submitted to the University of Birmingham for the degree of DOCTOR OF PHILOSOPHY School of Geography, Earth and Environmental Sciences University of Birmingham April 2019 University of Birmingham Research Archive e-theses repository This unpublished thesis/dissertation is copyright of the author and/or third parties. The intellectual property rights of the author or third parties in respect of this work are as defined by The Copyright Designs and Patents Act 1988 or as modified by any successor legislation. Any use made of information contained in this thesis/dissertation must be in accordance with that legislation and must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the permission of the copyright holder. Abstract This study examines the twin themes of risk governance and anticipatory governance to establish whether European Union (EU) risk governance instruments and others such as Responsible Research and Innovation( RRI ) are delivering on their promises for the safe and responsible development of nanomaterials(NM). This is an empirical study that conducts semi-structured interviews with cross-sectoral experts working within nanotechnologies to examine these issues. The main findings identify critical flaws in the principal chemical safety regulations(REACH) due to the lack of specificity for NM safety testing, and the scientifically contested EU definition for NM. Both of which undermine legal authority for enforcing regulatory compliance. Secondly, critical scientific gaps are evident that prevent comprehensive nano-risk analysis of the Environmental, Health and Safety (EHS) implications of NM production. Thirdly, there are indications that the nano industry is seeking to avoid engaging with either product regulation (REACH) or the social-ethical appraisal of NM production. Finally, compounding these deficiencies, the EU does not provide a bespoke overarching EU risk governance framework to scrutinise either the EHS effects or the wider social implications of current and future nano-innovation pathways. In this study, I proposes a novel solution for such a framework centred on a ‘Safety by Social Design’ approach. Its purpose is to facilitate responsible innovation by the societal alignment of nano innovation within an adaptive and integrative risk governance framework. This will serve the purpose of progressing the EU towards a more anticipatory governance approach for nano innovation. Key Words: Nanomaterials, Risk Governance, Anticipatory Governance, Responsible Research and Innovation, Safety by Social Design i Dedication I dedicate this thesis to my family. To my wonderful wife Lyn who has been so supportive and uncomplaining of the long hours I have committed to this research. To my children Amanda and James, and their beloved baby sister Charlotte whose loving memory will always be with us . ii Acknowledgements I owe a great deal to my supervisor, Dr Julian Clark , who has been exemplary in his support for this research. His patience, advice, good humour and all-round academic ability have all been critical in steering me through the dense maze that is a PhD thesis. I cannot thank him enough. I must also say big thank you’s to Professor Eva Valsami-Jones and Professor Iseult Lynch for their continuing expert academic advice on the fast-changing world of nanomaterials. Their personal invitations for me to attend many restricted high level scientific and regulatory events have helped me enormously in my understanding of risk governance at the frontiers of science. Their personal warmth and generosity does them great credit. Finally, but by no means least, is my charming friend Indrani Mahapatra who has been a rock throughout this process, as I followed her footsteps in researching risk governance of nanomaterials. She has been a fount of information, a guide on many critical aspects for this research, and picked me up in the moments when I was down. No one has been a better friend and mentor to me during this time. iii Table of Contents Abstract ................................................................................................................. i Dedication ............................................................................................................ ii Acknowledgements.............................................................................................. iii Table of Contents ................................................................................................. iv List of Tables ....................................................................................................... vii List of Figures ..................................................................................................... viii Abbreviations ...................................................................................................... ix Chapter 1: Introduction.................................................................................... 1 Introduction ............................................................................................................... 1 Background ................................................................................................................ 1 Nanomaterials : Why are they different? .................................................................. 4 Potential Risks to Human and Environmental Health ............................................... 6 EU Strategy for the Risk Governance of Nanomaterials ........................................... 8 Research Context ..................................................................................................... 14 Research Purpose .................................................................................................... 15 Research Objectives ................................................................................................. 15 Organisation and the Structure of this study .......................................................... 16 Chapter 2: Current EU public policy on nanotechnologies, existing scientific and future debates ................................................................................................ 19 Introduction ............................................................................................................. 19 What are the risks from nanomaterials? ................................................................. 21 EU Risk Governance policy for nanomaterials......................................................... 23 2.3.1 The Current EC Policy Position .................................................................................................. 23 2.3.2 EU Nanoparticle definition- Why is it still contentious? ........................................................... 25 2.3.3 REACH and Nanomaterials – The critical issues ....................................................................... 27 2.3.4 The Precautionary Principle and its role in nano-safety. .......................................................... 30 Evaluating the current and future status of regulatory sciences for nano-safety .. 34 2.4.1 The importance of the intrinsic and extrinsic physico-chemical characteristics for nanoparticles. .................................................................................................................................... 34 2.4.2 New paradigms for nanomaterial risk analysis ........................................................................ 35 2.4.3 Safety by Design to facilitate upstream design modification to nanoparticles. ...................... 40 Conclusions .............................................................................................................. 42 Chapter 3: Literature Review ......................................................................... 44 Introduction ............................................................................................................. 44 Risk Governance ...................................................................................................... 45 3.2.1 Risk Governance and the ‘Taxonomy of Regulation’ ................................................................ 47 3.2.2 An analytical-deliberative approach to risk governance for nanomaterials ............................ 50 3.2.3 Adaptive and integrative risk governance for nanotechnologies............................................. 52 iv 3.2.4 Safety by Design – risk governance to oversee ‘safe’ nano-innovation? ................................. 55 Anticipatory Governance of Nanomaterials ............................................................ 57 3.3.1 The Precautionary Principle and Anticipation .......................................................................... 59 3.3.2 The role of Responsible Research and Innovation in Anticipatory Governance ....................... 60 3.3.3 Midstream modulation – the upstream management of risk .................................................. 63 Conclusions .............................................................................................................. 64 Chapter 4: Methodology ................................................................................ 68 Introduction ............................................................................................................