Risk Management and Safe Innovation For Nanotechnologies

Transcription

1 Risk Management Strategy for nanotechnologies: How research results could be used by decision-makers? HORIZON 2020 EUROPEAN UNION FUNDING FOR RESEARCH & INNOVATION

2 Table of Content Introduction Risk management frameworks for nanotechnologies Towards the creation of a European Centre for Risk Management and Safe Innovation for Nanotechnologies and Nanomaterials Take home messages Emeric Fréjafon Olivier Salvi Benoît Hazebrouck

3 1. Introduction 3

4 Rationale & content Rationale: Risk management is about managing risks and uncertainties in a given context Risk assessment vs. risk management Risk governance and emerging risk management Society Public Authorities Experts Content: 1. Overview of relevant risk management schemes for nanomaterials 2. The Emerging Risk Management Framework (ERMF) of integ-risk project applied to nanomaterials 3. Contribution of EU expertise to risk management of nanomaterials Industry 4

5 2. Risk management frameworks for nanotechnologies 5

6 ISO Guide 73: 2009 Definition Risk: effect of uncertainty on objectives Risk management: coordinated activities to direct and control an organization with regard to risk Risk management policy: statement of the overall intentions and direction of an organization related to risk management 6

7 ISO 31000:2009 Risk Management Source: 7

8 International Risk Governance Framework Source: 8

9 integ-risk: The common (EU) response Emerging risks from Emerging risks from Known Technologies New Technologies Early Recognition, Monitoring and Integrated Management of Emerging, New Technology related Risks RISKS EMERGING RISKS EU RESPONSE TECHNOLOGIES and INTEGRATED SOLUTION (integrating all interested parties) Improved safety and enhanced global competitiveness of the EU industry 9

10 Some figures 60 Partners 27 Third parties 431 Persons 5 SPs (Subprojects) 42 WPs (Workpackages) 4,5 Years / ca. 13,5 Mil. EUR funding (total budget, ca Mil EUR) 224 Tasks 222 Deliverables integ-risk has been coordinated by the European Virtual Institute for integrated Risk Management (EU-VRi) 10

11 The Big 7 from integ-risk The Big 7 are Big 7 1. integ-risk Catalogue of Emerging Risks 2. integ-risk Framework for Emerging Risk Management 3. integ-risk Library of Methods, Handbooks and Guidelines 4. integ-risk Library of Emerging Risks Key Indicators 5. integ-risk CWA (CEN Workshop Agreement) 6. European Master and Certification in the area of Risk Engineering and Management, and, 7. integ-risk Risk Radar & 1StopShop the web-based system-of-systems for early detection, recognition, monitoring and management of emerging risks 11

12 DIN CWA 16649: DIN CWA 16649: Managing emerging technology-related risks was published in October

13 EU-OSHA Definition of Emerging Risks The risk is new and emerging if: a) the risk did not previously exist and is caused by new processes, new technologies, new types of workplace, or social or organisational change; or, b) a long-standing issue is newly considered as a risk due to a change in social or public perceptions; or, c) new scientific knowledge allows a long-standing issue to be identified as a risk The risk is increasing if: a) the number of hazards leading to the risk is growing, or b) the exposure to the hazard leading to the risk is increasing (exposure level and/or the number of people exposed); or c) the effect of the hazard on workers' health is getting worse (seriousness of health effects and/or the number of people affected). 13

14 Extending the definition by elements from IRGC* focusing on the systemic nature of emerging risks the link of emerging risks to HILP events (high impact low probabilities) the multidisciplinary character by the concept of the risks emergence and its maturation Likelihood Emergence of a risk Risk A: Still emerging, possibly leading to disaster Risk B: Mature, regularly monitored, well under control Current risks Impact (positive or negative) Emerging risks Risk emergence (threat or opportunity) weak signals occurrences Risk C: Put on watch-list or backlist Government decisions, internal regulation time *International Risk Governance Council 14

15 Normative References BS 31100:2011, Risk management - Code of practice and guidance for the implementation of BS ISO EN ISO 14001:2004, Environmental management systems - Requirements with guidance for use EN ISO 14044:2006, Environmental management - Life cycle assessment - Requirements and guidelines EN ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories ISO/IEC Guide 51:1999, Safety aspects Guidelines for their inclusion in standards ISO Guide 72:2001, Guidelines for the justification and development of management system standards ISO Guide 73:2009, Risk management - Vocabulary ISO 26000:2010, Guidance on social responsibility ISO/IEC 27000:2009, Information technology - Security techniques - Information security management systems - Overview and vocabulary ISO 31000:2009, Risk management - Principles and guidelines ISO/IEC 31010:2009, Risk management - Risk assessment techniques UNI 11230:2007, Risk Management - Vocabulary 15

16 Basic ERMF procedure Activity Emerging Risks Unknown Known 9. Communication and consultation 10. Monitoring, review & continuous improvement 1. Early warnings - notions 8. Management & decision (treatment) 2. Context & concerns 7. Evaluation of tolerability & acceptability 3. Identification of risk scenarios 6. Characterization 4. Pre-assessment 5. Analysis (appraisal/assessment) 16

17 towards a collaborative management Connect experts for early detection Listen to the stakeholders Research results for data and inform risk management strategies Coordinated research investment Good practice guides Standards Regulations 17

18 10 Steps to manage emerging risks & a set of tools I - Horizon Screening/Scanning: 1. Early warnings notions II - Pre-Assessment: 2. Context and concern 3. Identification of risk scenarios 4. Pre-assessment III - Appraisal/Assessment: 5. Analysis 6. Characterization 7. Evaluation of tolerability and acceptability 8. Management and decision (treatment) IV - Continuous Activities: 9. Communication and consultation 10. Monitoring, review and continuous improvement integ-risk 1StopShop and the European Emerging Risk Radar (E2R2) provides innovative solutions especially for steps

19 Wrap-up Emerging risk management is an essential topic for sustainable innovative business integ-risk project has developed a structured framework for emerging risk management consolidating ISO 31000, IRGC and EU-OSHA contributions The framework is available as a standard document: DIN CWA 16649: , it helps to structure the risk management procedure integ-risk tools are useful in particular for the maturation process and characterize the emergence 19

20 (Main) contributors / developers of the CWA EU-VRi - European Virtual Institute for Integrated Risk Management EEIG EDF Électricité de France S.A. GDF Suez GIE AXA INERIS - Institut National de l'environnement Industriel et des Risques KMM-VIN European Virtual Institute on Knowledge-based Multifunctional Materials AISBL MERL - Materials Engineering Research Laboratory Limited R-Tech - Steinbeis Advanced Risk Technologies GmbH Stiftelsen Sintef Swiss Re - Swiss Reinsurance Company Ltd Tecnalia - Fundacion Tecnalia Research & Innovation TNO Research Group Q&S University of Stuttgart SECRETARIAT: DIN 20

21 3. Towards the creation of a European Centre for Risk Management and Safe Innovation for Nanomaterials and Nanotechnologies 21

22 Context and objectives Safe innovation & sustainable production need to: - Understand risks and benefits (diagnostic, assessment) - Identify and implement risk reduction strategies (manage) - Communicate on residual risks (acceptance) The knowledge production to inform risk-based decisions is very intense (hazard characterization, risk diagnostic, assessment) But the mechanisms to efficiently use it for risk management (reduction strategies) have difficulties to become effective. We need to: Bridge the gap between research and application (public, private) Bridge the gap between knowledge on risks and risk management Promote integrated expertise in a Stair approach, Balance between Science and Appliance 22

23 Context and objectives Concept is then based on : - Transferring knowledge into operational tools - Connecting Science, regulators, industry, society - Offering public & private Expertise & Services - Integrating knowledge and services of EU actors In order to : Gather the available expertise Make available reference information, best practices and SOPs Transfer research results & Combine multidisciplinary expertise into operational tools and services Develop EU-wide education, training, and certification Monitor new and emerging risks Provide feedback on research needs to upgrade expertise Make available access to infrastructure for other organizations./. 23

24 Clustering Technological platforms dedicated to all elements involved in RM In order to : Make available access to infrastructures for other organizations (temporally, permanently) Share methods, tools and lab expertise For cost efficiencies, complementarities Knowledge transfer, training Contribute to validate tools and SOPs Evaluate performances, facilitate inter-comparison 24

25 Activities (1/4) Gather the available expertise in the Member States, their respective infrastructures, SOPs and good practice stream knowledge Combine multidisciplinary expertise for the integrated (global) risk management reduce uncertainties in the decision To support towards industry, industry consortia, federations ; To support towards the European Commission To support towards Member States To support towards Expertise en Research community 1. Global or individual, elemental or integrated expertise to support risk management and safe innovation in compliance with regulations and standards 2. Benchmark of expertise, meaning the Sum of each institute expertise in RM 3. Concerted expertise meaning the analysis of all expertise for decision maker 25

26 Activities(2/4) Make available reference information disseminate the knowledge gained Create and manage a web portal with on-line access to relevant docs. Integrate scientific knowledge into safety data sheets; Inform on state of the art in all components involved in RM Produce guidance on Best Available Technologies in RM Transfer research into operational tools and services Promote Standardization, Certification and Smart Regulation Contribute to develop Smart regulations on risk management contributing and using results from Projects (Nanoreg, prosafe, nanoreg2, Qnano..), programs (partnership), initiatives (EU-US NSC) and working groups (RAC, SEAC ), Contribute to international groups such as OECD and ISO. Survey for standardization candidates of tools involved in RM, organize standardization seminars, define a plan of actions up to NWIP Provide operational advice to research agencies for increasing the rate of standardization of research results in their calls 26

27 Activities (3/4) Make available access to infrastructure for other organizations Temporary (understand, be trained) or permanent (sharing resources). Help the institute to access to the state of the art in technological platforms dedicated to RM and safe innovation of NN Transfer the knowledge (train on how to design and use the platform) Share the access to the technological platform (temporary until their own, permanently for cost sharing ) : access to the data, access to the technological platform (the tool and the staff), access to the tool Develop education and training programs adapted to the diversity of the stakeholders. Propose a variety of training courses from the various locations in EU and in various languages, jointly agree on the curriculum and content of the courses Elaborate a certification schemes for the qualification of workers involved Elaborate, with member states interested, periodic meetings with specific stakeholders (ngos, public authorities ) in order to inform on the level knowledge in RM and uncertainties associated 27

28 Activities (4/4) Monitor new and emerging risks related to nanotechnologies (Radar) To support the early detection of emerging issues To support the maturation of the emerging risks (information of the risks, consequences and impact, occurrence, uncertainties ) To support decision making using the process presented in the CWA DIN CWA 16649: (Managing emerging technology-related risks) Provide feedback on research needs (upgrade knowledge) Contribute to define the research and technological gaps to support risk management of nanotechnologies Make a survey of the production of research results and compare to the needs expressed by the stakeholders for risk management Support thematic working groups to share research ideas and research results 28

29 Structure A Core group of experts Having member state representative At both private and public positioning Gathering knowledge gained from research and all stakeholders Industries, organisations Technological Centres Society, NGOs Policy makers Clustering Technological platforms, tools, expertise dedicated to elements involved in RM For risk management & safe innovation in MNMs

30 Organisation Core group Built at European level INERIS TNO - BAM - FIOH TECNALIA - NRCWE SP HSE/HSL - still under construction Partners: Public authorities, Civil society, Academics and university, Technological & innovation centres, Expert institutes, Industry, standardization bodies, ETPs Contributors: Expert institutes, Scientific centers, Agencies, Centers outside Europe

31 Organisation In relation with existing Centres Dedicated to innovation (eg. Nanomedicin, NanoTech foundation) Dedicated to Hazard or risk assessment (eg. Toxicology, ) Delivering expertise outside Europe (eg. US, China, South America) With the support of specific expertise On Hazard Characterization On Risk Assessment On knowledge transfer/ dissemination/ exploitation

32 Schedule for development and operation Schedule: End 2015: Concept for EU-proposal : Creation Demonstration > 2018: Sustainable operation appropriate business model Business model based on : 1. Public funding for specific public missions (Member States, Europe ) 2. Private funding for specific services (industry, companies.)

33 Take home messages 33

34 Take home messages Risk management of new technologies requires the implementation of a structured framework that makes the best use of the scientific production for decision makers from industry and public authorities Society CWA 16649:2013 Managing emerging technology-related risks provides the adequate framework for the management of risk related to nanomaterials and supporting tools are available Standardization plays a key role to enable use and implementation of research results Public Authorities Experts Platforms such as nanostair for nanotechnologies contributes to bridge the gap between research and risk management Industry 34

35 Take home messages A platform to support collaborative risk management is needed Public Authorities Experts Society Industry Objective: To share the results from research among industry, public authorities and the society to build risk management strategies combining Regulations (defining the minimum requirements for safety) Standards and codes of good conduct Continuous improvement based on new knowledge gained through research 35

36 Take home messages An emerging initiative : toward a European Centre for Risk Management and Safe Innovation in MNMs Aiming to : Gather the available expertise Make available reference information Transfer research results & Combine multidisciplinary expertise into operational tools and services Develop EU-wide education, training, and certification Monitor new and emerging risks Provide feedback on research needs to upgrade expertise Make available access to infrastructure for other organizations 36

37 Acknowledgement The presentation is based on research performed in projects that have received co-funding from the European Commission under the Seventh Framework Programme (integ-risk GA: CP-IP ) (NanoMile GA: NMP4-LA ) (nanostair GA: NMP4-SA ) (SCAFFOLD GA: NMP4-SL ) 37