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KIT – University of the State of Baden-Wuerttemberg and National Research Center of the Helmholtz Association INSTITUTE FOR TECHNOLOGY ASSESSMENT AND SYSTEMS.

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Presentation on theme: "KIT – University of the State of Baden-Wuerttemberg and National Research Center of the Helmholtz Association INSTITUTE FOR TECHNOLOGY ASSESSMENT AND SYSTEMS."— Presentation transcript:

1 KIT – University of the State of Baden-Wuerttemberg and National Research Center of the Helmholtz Association INSTITUTE FOR TECHNOLOGY ASSESSMENT AND SYSTEMS ANALYSIS (ITAS) Torsten Fleischer Risk Governance and Communication A Perspective from the NanoSafety Project Team

2 2 Widening the Perspective EHS risks of nanomaterials show three fundamental characteristics: Complexity: Cause-effect (causal) relationships (e.g. application -> health impacts) are difficult to be identified and almost impossible to be quantified, since many co-factors may have an influence Uncertainty: Scientific risk assessment approaches its limits (characterization of noxa and hazards, measurement problems, variation of reactions on expositions, indeterminacy and lack of knowledge) Ambiguity (interpretative and normative): Consequences of EHS risks can be judged differently by different persons and groups, regardless of its factual probability of occurrence „Risk“: not only a scientific, engineering or economic concept, but also a perceptive and communicative phenomenon Therefore an integrative concept for the societal handling of (technical) risk is needed that takes all actors and all regulatory systems into account | Torsten Fleischer | ITAS |

3 3 Risk Governance includes the totality of actors, rules, conventions, processes, and mechanisms concerned with how relevant risk information is collected, analyzed and communicated and how management decisions are taken, is of particular importance in, but not restricted to, situations where there is no single authority to take a binding risk management decision but where instead the nature of the risk requires the collaboration and co- ordination between a range of different stakeholders, includes a multi-faceted, multi-actor risk process that encompasses the combined risk-relevant decisions and actions of both governmental and private actors, considers contextual factors such as institutional arrangements* and political culture, including different perceptions of risk. * Institutional arrangements are, e.g., the regulatory and legal framework that determines the relationship, roles and responsibilities of the actors and co-ordination mechanisms such as markets, incentives or self-imposed norms. (paraphrasing Renn 2008) | Torsten Fleischer | ITAS |

4 4 IRGC Risk Governance Framework Source: IRGC White Paper 2005 | Torsten Fleischer | ITAS |

5 5 Concern Assessment “is a social science activity aimed at providing sound insights and a comprehensive diagnosis of concerns, expectations and perceptions that individuals, groups or different cultures may link to a hazard.” (Renn/Walker 2008) Understanding these different concerns, expectations and perceptions is an important factor in understanding how individuals and groups perceive and assess risks, what actions (or non-actions) are perceived as being risky for what reasons, how the different actors in risk management and risk communication are expected to take action. Social sciences can contribute to these investigations, applying a broad set of methods | Torsten Fleischer | ITAS | standardized surveys (telephone, questionnaire, web-based, …) guided or narrative interviews deliberative formats (focus groups, citizens‘ conferences, …) content analyses (media; scientific, political or popular texts, …)

6 6 Data Source: Special Eurobarometer 341 / Wave 73.1: Biotechnology. Fieldwork Jan/Feb 2010 Citizens‘ Perspective: Eurobarometer 2010 St: Nanotechnology is safe for your and your family‘s health. agree disagree don‘t know EFTA | Torsten Fleischer | ITAS |

7 7 Citizens‘ Focus Groups – Recurring Themes Balanced perspective: Positive attitude in general - scepticism in detail Chances: medicine, energy, environment, relief from household routines Risks / poor acceptance: food, untested products on the market, ‘thoughtless commercialization’, (military applications) MPN are rarely distinguished from nanotechnology Oversight: vigilant and acting government, research (and marketing) under governmental supervision, ‘under control’ Wish for more transparency of governmental and industrial activities felt able to deal with scientific uncertainties when adequately informed Overall, didn’t feel well informed – Wish for improvement Positioning oriented on a consumer perspective Product information, mandatory labelling, ‘nano seal’, independent product tests, ‘declaration of harmlessness’ by government Binding force of regulatory instruments – doubts in voluntary measures | Torsten Fleischer | ITAS |

8 8 The Role of (Risk) Communication | Torsten Fleischer | ITAS | Risk communication has prima facie two different understandings: as instrumental or dialogical communication. In the process of anticipatory governance of potential EHS risks of MPN, dialogical risk communication plays the dominant role. It should put people that are concerned in a position to redeem their claim to be ‘capable of informed risk appraisal’ by making them appropriate offers of information, dialogue and participation. Parliament can actively contribute to the implementation of risk communication measures: by encouraging voluntary activities of communication among stakeholders and between authorities, stakeholders and the general public by making various risk communication measures mandatory in relevant legislative acts by supporting the provision of credible information on nanoproducts that will contribute to consumers’ trust and enable informed choice by supporting the development of (new) concepts for such information provision that address the concerns of all stakeholders involved (e.g. trust vs. confidentiality)

9 9 Definition of nanomaterials / nanoparticles Risk Management: Regulatory Debates Regulatory role of harmonized definition Elements of a definition: Size range covered, functionalities, … Nanomaterials in REACh (European Regulation of Chemicals) “Old” or “new” substance Separate dossiers for nanomaterials Reduced quantitative thresholds for registration / evaluation Regulatory instruments Labelling (of consumer products) Register for nanoproducts Tools for preliminary risk assessment Role and Operationalization of the Precautionary Principle Nanomaterials in sectoral law | Torsten Fleischer | ITAS |

10 10 Legal definitions in technology regulation Legal definitions of technical artefacts in technology regulation have to describe the object of regulation sufficiently precise to be clear to all parties affected by the regulation, have to consider practices of production and application of the artefacts, have to be enforceable by the responsible authorities, are usually science-based but not necessarily identical to scientific definition(s) of the same term, will be shaped by – and in return are shaping – both the artefacts that they intend to describe as well as the contexts in which they are used, thus incorporate not only scientific and technological knowledge (and its respective uncertainties), but also include the results of policy choices and political decisions. | Torsten Fleischer | ITAS |

11 11 Numerous proposals for a definition by international organizations, industry associations, expert committees, … - numerous differences Various institutions called for a harmonized definition of NM Discussion about the defining features and the respective threshold values; size, PSD, VSSA, aggregates/agglomerates, properties, … Definitions vary according to purpose: scientific / regulatory Regulatory definitions vary by regulatory goals and contexts Debate about regulatory definitions includes (implicit) regulatory impact assessment – includes normative aspects, values, economic interests Debate about regulatory definition(s) is a political one and has to be decided by politics, informed by science European Commission, after public consultation in Fall 2010, published its recommendation on 18 October 2011 A Harmonized Definition for Nanomaterials? | Torsten Fleischer | ITAS |

12 12 Two Different Regulatory Paradigms ReactivePrecautionary Major playersMost industries, „innovation“ ministries, (research administration) CSO, some TPEA, „protection“ ministries Intervention justified when scientific evidence of hazard / harm Intervention already justified when reasonable abstract concern Current regulatory framework for NM/NT Mainly sufficient, only minor adaptions necessary Insufficient for nano specific challenges, substantial changes needed Definition of NMSize between 1 – 100 nm, higher upper limit when harm, additional consideration of PSD and VSSA Size + certain properties as heuristics, upper limit 300 nm, reduction possible in specific regulatory contexts REAChSufficient after minor adaption, nanoforms part of substance dossier NM as new substances, own dossiers, reduced quantity thresholds, additional information requirements LabellingIn l.o.i., where required, o.k., no general nano label, may be perceived as warning and confuse customers Mandatory labelling for all products releasing MPN or use them to enable specific properties Product registerUse of existing registers for products or substances, no general public register Semi public register and notification requirements for nano products, some content available to consumers | Torsten Fleischer | ITAS |

13 13 A Preliminary Risk Assessment Heuristic Probably hazardous – concern level high Criteria: Exposure occurs; materials have high mobility, reactivity, persistence or toxicity Action: concept for measures to minimize exposure and/or to avoid certain applications Possibly hazardous – concern level medium Criteria: Exposure cannot be ruled out; materials have unknown agglomeration or deagglomeration behaviour; too little is known about materials' solubility and biodegradability; the possibilities for release of nanoparticles from matrices have not yet been explored Action: concept for measures to reduce exposure of humans and the environment Probably not hazardous – concern level low Criteria: Exposure can largely be ruled out; materials are soluble or biodegradable; materials are bound in matrices; materials form stable aggregates or agglomerates Action: No measures in addition to those for "good work safety practice" (or "hygiene practice") are required Source: German NanoCommission II, February 2011 | Torsten Fleischer | ITAS |

14 14 Continue supporting research into EHS aspects of nanomaterials Intensify work on ‘orphan’ hazards (routes, endpoints, …) Consider to make the publication of nanotoxicological “no effect”-data data mandatory (especially when gained within publicly funded projects) (Re-)Focus toxicological research on providing orientation and knowledge for regulatory actions Support the development of measurement technologies that allow for characterization, control and enforcement discuss the future role of (‘the’) harmonized regulatory / legal definition for nanomaterials / MPN Work towards an mutually agreed regulatory paradigm for nanomaterials Develop options for public information on MNP risks and product labelling Support the development of a suitable risk characterization heuristic for manufactured (particulate) nanomaterials Investigate the need for a new regulatory framework for nanomaterials Options for Risk Governance Actions | Torsten Fleischer | ITAS |

15 15 Thank you very much for your attention Michael Decker Armin Grunwald Christiane Hauser Peter Hocke Jutta Jahnel Michael Reuss Stefanie Seitz | Torsten Fleischer | ITAS |

16 16 Backup Slides | Torsten Fleischer | ITAS |

17 17 EU Recommendation on Definition for NM 1. Member States, the Union agencies and economic operators are invited to use the following definition of the term "nanomaterial" in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies. 2. "Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. 3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials. 4. For the purposes of point (2), "particle", "agglomerate" and "aggregate" are defined as follows: (a) "Particle" means a minute piece of matter with defined physical boundaries; (b) "Agglomerate" means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; (c) "Aggregate" means a particle comprising of strongly bound or fused particles. 5. Where technically feasible and requested in specific legislation, compliance with the definition in point (2) may be determined on the basis of the specific surface area by volume. A material should be considered as falling under the definition in point (2) where the specific surface area by volume of the material is greater than 60 m 2 /cm 3. However, a material which, based on its number size distribution, is a nanomaterial should be considered as complying with the definition in point (2) even if the material has a specific surface area lower than 60 m 2 /cm By December 2014, the definition set out in points (1) to (5) will be reviewed in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased. Source: Commission Recommendation 2011/696/EU on the definition of the term “nanomaterial” as adopted on 18th October 2011 | Torsten Fleischer | ITAS |

18 18 Recommendation on Definition (4) The definition (…) should be used as a reference for determining whether a material should be considered as a "nanomaterial" for legislative and policy purposes in the Union. The definition (…) in Union legislation should be based solely on the size of the constituent particles of a material, without regard to hazard or risk. (…) (5) The definition of the term "nanomaterial" should be based on available scientific knowledge. (11) There is no unequivocal scientific basis to suggest a specific value for the size distribution below which materials containing particles in the size range 1 nm – 100 nm are not expected to exhibit properties specific to nanomaterials. The scientific advice was to use a statistical approach based on standard deviation with a threshold value of 0.15%. Given the widespread occurrence of materials that would be covered by such a threshold and the need to tailor the scope of the definition for use in a regulatory context, the threshold should be higher. A nanomaterial as defined in this recommendation should consist for 50 % or more of particles having a size between 1 nm – 100 nm. In accordance with the SCENIHR's advice, even a small number of particles in the range between 1 nm – 100 nm may in certain cases justify a targeted assessment. However, it would be misleading to categorise such materials as nanomaterials. Nevertheless there may be specific legislative cases where concerns for the environment, health, safety or competitiveness warrant the application of a threshold below 50 %. (16) The definition (…) should not prejudge nor reflect the scope of application of any piece of Union legislation or of any provisions potentially establishing additional requirements for those materials, including those relating to risk management. It may in some cases be necessary to exclude certain materials from the scope of application of specific legislation or legislative provisions even if they fall within the definition. It may likewise be necessary to include additional materials, such as some materials with a size smaller than 1 nm or greater than 100 nm in the scope of application of specific legislation or legislative provisions suited for a nanomaterial. (17) (…) the definition (…) should not prejudice the use of the term "nano" when defining certain pharmaceuticals and medical devices. Source: Commission Recommendation 2011/696/EU on the definition of the term “nanomaterial” as adopted on 18th October 2011 | Torsten Fleischer | ITAS |

19 19 Further Observations Diverse regulatory debate on multiple levels: state governments, national government(s), European Union, parliaments Options for action limited for state/national governments since for many sectors legislative competence lies with European institutions Most legislative plans shaped by clash of two different regulatory paradigms -> not only within parliaments, but also within administrations Positions cannot easily be ascribed to classic political camps A number decisions blocked so far - within and between institutions Role of European Regulation (and its institutions) for national discourses: driver as well as protective shield Missing concepts for adaptive (dynamic) regulation. Regulation should be able to react to changes in knowledge or threats in due time Fading trust in self-regulation and „soft law“ | Torsten Fleischer | ITAS |

20 20 Nanomaterials in REACh REACh: European regulation on production and use of chemical substances, after 8 years of discussion in force since 2007(?) “Registration, Evaluation, Authorization and Restriction of Chemicals” Separate procedures for phase-in (“old”) and new substances For phase-in substances, registration procedures (including toxicological test program) differ by tonnage per year. Regulatory review in 2012 Phase-in substance: REACh covers, in principle, also nanomaterials of the same substance. But modifications for NM necessary? Discussions: Toxicological data for materials in nanoform as part of the registration dossier of the “mother substance” Nanomaterials to be registered as new substance regardless of their chemical composition Reduction of tonnage thresholds for nanomaterials, additional test parameters | Torsten Fleischer | ITAS |

21 21 The MNP Risk Negotiation Landscape citizens environmental CSO consumer CSO Third-party econ. actors (chemical) industry RTD management (bench) scientists trade unions Scientific committees regulatory agencies ministries for RTD ministries for econom. affairs ministries for environment ministries for worker protect. ministries for consumer prot. parliaments general public industry science politics Stakeholder fora as arenas for negotiation | Torsten Fleischer | ITAS |

22 22 Particulate nanomaterials (PN) is an umbrella term for nanoobjects with two or three dimensions on the nanoscale (particles, fibres, rods, …) PN is one type of engineered nanomaterials that is already used in a number of applications There are indications that some PN may pose a thread to human health and the environment PN can occur in nature (ash, erosion, salt, …), can be incidentally produced (fumes, diesel, … ) or intentionally manufactured (MPN) Various factors may(!) affect MPN properties: size, shape, surface area, crystal structure, chemical composition, charge, aggregation properties, presence of surface coatings, particle number, methods of synthesis, and many more These factors may also influence human and eco-toxicity Some MPN are subject of public and regulatory concerns Manufactured Particulate Nanomaterials (MPN) | Torsten Fleischer | ITAS |

23 23 Polymeric Nanoparticles (Source: University of California - Santa Barbara) Representations of Nanotubes (Source: nanotechnologies.qc.ca) TiO 2 Nanoparticles (P25) (Source: UNSW Sydney) Clay Nanosheets (Source: University of Tokyo) TiO 2 Nanotubes (Source: Yale University) Silver Nanoparticles (Source: ACS) ZnO Nanorods (Source: University of Cambridge) Variety of Particulate Nanomaterials | Torsten Fleischer | ITAS |

24 24 Large variety of MPN used or under development, only few studied High research dynamics: Increased funding of toxicological studies, efforts to review and integrate distributed research results (meta studies), but in many cases results still inconclusive Hazard data can be reproduced only partially, transferability under debate Most studies via inhalation route, poor data on skin and gut absorption Substantial lack of measured and modeled exposure data of MPN, for humans and for the environment Available methodology is inadequate to measure MPN routinely in various media (esp. in liquids, biological media, technical matrices) Results of ‚no effects‘-experiments are usually not published Published interpretations of experimental results, especially those regarding potential impacts on human health and on the environment, are still insufficient, contradictory and controversial. Regulators, citizens, society at large expect answers Recent Toxicological Research Situation | Torsten Fleischer | ITAS |


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