Stakeholder Engagement and Communication Strategy

Transcription

1 Stakeholder Engagement and Communication Strategy G- TwYST GMP Two Year Safety Testing Sept 2014 Armin Spök Huib de Vriend G- TWYST, Stakeholder Engagement and Communication Strategy, 12 September

2 Acknowledgment and Disclaimer The authors of this document thank all project partners for their valuable contributions and comments on draft versions of this document. This document expresses the view of the G-TwYST consortium, and does not reflect an official opinion of the European Commission. Responsibility for the information and views expressed therein lies entirely with the authors. In the whole document, the acronym G-TwYST has been used to refer to the project. GMP Two Year Safety Testing (G- TwYST) is a Collaborative Project of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities. Grant agreement no: Project duration: 21 April April 2018 Project website: twyst.eu 2

3 Table of contents This Document... 4 Stakeholder Engagement... 4 Wider Context... 4 Stakeholders engagement in G- TwYST... 5 Procedural issues... 6 Communication and Dissemination... 7 Main Communication Channels... 7 Editorial board... 7 Transparency... 8 In research activities... 8 In Stakeholder consultation activities... 8 On the context... 8 Accountability... 9 Scientific robustness... 9 References

4 This Document The long- term safety assessment of genetically modified (GM) food/feed is an important topic in the public controversy and consumer concerns on GM crops in Europe. The main objective of the G- TwYST project is to provide guidance (i) to risk assessors on the conduct and scientific evaluation of and (ii) to risk managers on the scientific value of long- term feeding studies for GMO risk assessment, while at the same time clarifying uncertainties raised through the outcomes and reports from recent (long- term) rodent feeding studies with whole GM food/feed. In order to achieve this goal, G- TwYST will: Perform rat feeding trials with GM maize NK603 and MON810 to test their potential subchronic and chronic toxicity as well as carcinogenicity. Comparatively review recent and ongoing research to draw broader conclusions regarding the risk assessment process of GM food/feed. Develop both criteria to evaluate the scientific quality of long- term feeding studies and recommendations on the added value of long- term feeding trials in the context of the GMO risk assessment process. As a complementary activity - investigate into the broader societal issues linked to the controversy on animal studies in GMO risk assessment. This document describes the principles and procedures for stakeholder engagement, communication and dissemination. It highlights three key principles on which this strategy is based: transparency, accountability and scientific robustness. A draft version was discussed in the Project Kick- Off Meeting on 1-2 Sept This revised final version was subsequently approved by consortium members and published at the project website. More information on G- TwYST can be found at twyst.eu. Stakeholder Engagement Wider Context Stakeholder involvement in research has been promoted under various EU Framework Programmes and defined in more detail in the FP7 Programme (Jolibert & Wesselink, 2012). The core of the EC s agenda for proceeding towards a European Research Area (ERA) is the need and will to address societal needs in order to tackle the Grand Challenges and to foster a global perspective. The ERA intends to allow all actors, both public and private, to co- operate in order to achieve a common global goal that responds to all interests equally (EC 2010). Considering the important role of science as a social institution that produces action- oriented knowledge for shaping of societally relevant future development debates on global governance, responsible research and innovation have been emerging in recent years (Ozolina et al. 2009). Stakeholder engagement was highlighted and given a key role in the concept of Responsible Research and Innovation (RRI) conceptualised as a transparent, interactive process by which societal actors and innovators become mutually responsive to each other with a 4

5 view on the (ethical) acceptability, sustainability and societal desirability of the innovation process and its marketable products (in order to allow a proper embedding of scientific and technological advances in our society) (von Schomberg 2013: 19). Regarding attempts to strengthen the link between science and society, GM plants are facing particular challenges. Over years the R & D and commercial activities on GM crops, food and feed led to controversial debates, polarisation and outright rejection of GM technology (e.g. Bauer & Gaskell 2002, Seifert 2011, Levidow & Boschert 2011). A particular long- standing and intractable dispute has been ongoing in the area of toxicity assessment of GMOs for use in food and feed, including issues such as in what particular cases animal feeding studies should be asked for, how they should be designed and conducted, if these studies should also be looking for long- term effects, and how transparent the scientific data should be. Data from studies published in scientific journals or conducted by applicants for market approval have been interpreted quite differently by members of the scientific community as well as by stakeholders. The fierce dispute led to law suits, policy conflicts, slander, and eventually to polarisation. This controversy has recently been stirred up again by the results of studies published in scientific journals (e.g. Seralini et al. republished 2014) that cast doubt on the safety of GM crops and products. The main issues in this recent controversy are the scientific validity of assessment methods used and how their results should be interpreted (COGEM, 2013). Therefore, knowledge generated in this context needs to be scientifically and socially robust in order to be relevant. Involvement of stakeholders, bringing in a broad range of views and expertise, provides an extended peer community, which can foster such socially robust knowledge. A good and mutually meaningful involvement process including utmost transparency is, therefore, pivotal to the G- TwYST project. Stakeholders engagement in G- TwYST Clarifying aims and constrains The main aims of stakeholder engagement in G- TwYST are to: Better inform about the G- TwYST research, its procedures, standards, limitations and context. Inform and guide the research process and the interpretation of results. Promote trust- building among actors. Stakeholder identification G- TwYST applies a broad definition of stakeholders as all users of, and those (directly and indirectly) affected by or benefitting from, research projects (Jolibert & Wesselink, 2012). G- TwYST, therefore, aims to receive inputs and takes into account the views and inputs of a wide range of stakeholders, including but not limited to: EU- and national competent authorities as well as their advisory bodies. Industry and trade organizations (e.g. EuropaBio, CIAA FEFAC, FEFANA, ESA) including individual companies if major players. Farmers organizations (e.g. Copa- Cogeca, IFOAM, Via Campesina, NFU). 5

6 Other professional organizations (e.g. bee keepers, toxicologists) Contract laboratories for toxicity studies. Civil society organizations (e.g. Greenpeace, FoE, BEUC, Eurogroup for Animals, ENSSER, PRRI). International organisations (e.g. OECD). Academia (in particular researchers working on related issues, e.g. the FP7 project GRACE, the French project GMO90 plus). Schedule and general approach for stakeholder involvement High transparency and involvement of stakeholders at an early stage is an important prerequisite to improve ownership and commitment. The engagement processes have to be efficient in order to make best use of stakeholders time and project resources. In the frame of G- TwYST, stakeholder consultations will be conducted at all key steps of the research project: Planning stage focussing on the draft plans for preparing, conducting and analysing the animal studies. Results stage focussing on results of the animal studies and their interpretation. General conclusions on the scientific value of 2- year studies in the context of GMO risk assessment. On the non- scientific issues underlying the debate - how they relate to science and what can we learn from these insights for the debate. In general the methods used for stakeholder engagement are workshops, written comments to draft documents, online- questionnaires, interviews, and discussion fora in scientific journals. Each key step will comprise a workshop and a written procedure. In order to raise awareness of the G- TwYST results and conclusions and to facilitate and trigger a broader and continuing discussion fora which will be open to commentaries from all stakeholders, will be provided in peer- reviewed scientific journals. Feedback on involvement processes G- TwYST stakeholders will be asked for feedback on all relevant steps, using questionnaires and supplementary interviews, in order to identify challenges, problems and good practices. The results of this feedback will be summarized in a feedback report, and considered in the fine- tuning of engagement tasks. Procedural issues In order to allow for a high level of transparency and accountability, as recommended by the European Commission (EC 2006), G- TwYST developed some procedural rules for its stakeholder involvement activities: 6

7 Openness & Inclusiveness: G- TwYST will ensure that all stakeholders potentially relevant to the specific tasks will be invited for participation and/or written comments. Stakeholders will be approached at each participatory step by invitation and/or announcement on the G- TwYST website and/or through other mechanisms considered as appropriate. Participation in G- TwYST stakeholder workshops will not be restricted for any other reasons than room capacity. If participation needs to be restricted, the selection process will be made transparent and provide for a balanced representation. In order to facilitate open discussions journalists will not have access to stakeholder workshops. Quality assurance & timing: G- TwYST will produce an outline of the planned involvement activity which includes the following information: Reasons and aim(s) of the specific involvement activity; description of stakeholders roles and tasks in the activity (e.g. information/expertise provider, representation of different perspectives, critical reviewers, identification of concerns, making values/worldviews explicit, support decision making etc.). Description of the procedure planned to involve stakeholders, including a timeline (this will represent the basis for the announcement on the G- TwYST website). Stakeholders to be engaged, including a list of potentially relevant groups to be invited. Envisaged utilization and further processing of the inputs gained from stakeholders. Communication and Dissemination Main Communication Channels The G- TwYST website will be the main communication channel providing basic information on the project, on research plans, results, interpretations, and conclusions, preparatory documents and reports on the stakeholder consultations as well as relevant context information (see further down). LinkedIn and fora in scientific journals will be mainly used for additional discussion. The main results of the project will be published as open- access scientific papers which will be put on the project website. In all external activities the major aims of G- TwYST will be clearly communicated. Editorial board G- TwYST has an editorial board that consists of the G- TwYST coordinator, the project manager and the WP7 leaders. The task of the editorial board is to ensure quality and consistency of the project- relevant information envisaged for publication. All members of the LinkedIn Group are free to add new items or discussions. Discussions that do not meet standards of proper behaviour will be removed by the moderator. Members of the editorial board can also suggest removing items or discussions. 7

8 Transparency One of the key principles of G- TwYST is maximum transparency in all research, consultation and communication activities. In research activities A public version of the project plan and description of activities. A description of project partners and their role in G- TwYST. Detailed plans for the animal studies including preparatory steps and subsequent analysis. The results of the animal studies - raw data will be made available via the open- access database CADIMA at Preliminary interpretation and conclusions for GM risk assessment in working documents. A preliminary analysis of wider societal issues and how these are related to scientific issues. Final results, interpretations, and wider conclusions. While in principle all documents will be put on the website and will therefore be public, access to some data or documents might require signing a Non- Disclosure Agreement in order not to jeopardize publication in a peer- reviewed scientific journal. The use and welfare of test animals is a point of special attention. In Stakeholder consultation activities Timely announcement of and broadly circulated invitations to consultation rounds. Aims and procedures of each stakeholder engagement step prior to each step. Preparatory documents (see above). Reports on all consultations including responses of G- TwYST members to stakeholder comments thereby allowing to track how the comments are being considered and processed. The nature and source of comments and recommendations by experts and stakeholders as well as the responses of G- TwYST team members (consultation reports). On the context G- TwYST will keep track of ongoing debate and relevant policy development on toxicity assessment of GM food/feed (e.g. keep record of EFSA decisions and (scientific) publications on GMO food safety studies). These will be dropped in a separate LinkedIn group, where items can be discussed among stakeholders subscribed. 8

9 Accountability G- TwYST is to be operated in an accountable manner. This concerns both stakeholders and the wider public. The project is open to comments by any kind of stakeholder. Task leaders will pay due attention to ensure that stakeholders inputs are accurately captured. Minority interest and input should not be marginalized. Being accountable also means being responsive: G- TwYST partners will comment on all stakeholder inputs and explain its impact on the research protocol. Scientific robustness G- TwYST is striving for scientific robustness and for being in- line with widely accepted toxicity assessment requirements by: The scientific qualifications of the institutions and the experience of the scientists involved. Taking into account OECD guidelines and EFSA recommendations. Phases of the feeding trials will be conducted according to GLP, as specified in the study plans. Performing a power analysis prior to the feeding studies to critically assess proposed sample sizes and meaningful effect sizes. External Scientific Advisory Board will review plans, progress made and results. Scientific peer- review of results. Extended peer- review of research plans and results by stakeholders. The production of scientific knowledge is a very dynamic process. Therefore, in communication activities it is important to be clear on the uncertainties and provisional nature of scientific knowledge. References Bauer MW & Gaskell G (2002). Biotechnology - the Making of a Global Controversy. Cambridge University Press. COGEM (2013). Where there is smoke, is there fire? Responding to the results of alarming studies on the safety of GMOs. Topic Report CGM/ European Commission (2006). Green Paper - European Transparency Initiative - COM(2006) 0194 final. Retrieved November 5, 2013, from lex.europa.eu/lexuriserv/lexuriserv.do?uri=com:2006:0194: FIN:EN:HTML. 9

10 European Commission (2010). Communication from the Commission to the European Parliament, the Council, The European Economic and Social Committee and the Committee of the Regions, Europe 2020 Flagship Initiative - Innovation Union SEC(2010) Jolibert C & Wesselink A (2012). Research impacts and impact on research in biodiversity conservation: The influence of stakeholder engagement. Environmental Science & Policy 22: doi: /j.envsci Levidow L & Boschert K. (2011). Segregating GM Crops: Why a Contentious Risk Issue in Europe? Science as Culture, 20(2): doi: / Ozoliņa Ž, Mitcham C, Stilgoe J, Andanda P, Kaiser M, Nielsen L, Stehr N, Qiu RZ.(2009), Global Governance of Science, Report of the Expert Group on Global Governance of Science to the Science, Economy and Society Directorate, Directorate- General for Research, European Commission, Brussels EUR EN. Seifert F (2011). Sustainability and the EU Controversy on Agri- Biotechnology: Radical Change or Ecological Modernization? International Journal of Technology and Development Studies 2(1):2-29. Séralini GE, Claira E, Mesnage R, Gressa S, Defargea N, Malatesta M, Hennequin C, de Vendômois (2014).. Environmental Sciences Europe 2014, 26:14. Republished study: long- term toxicity of a Roundup herbicide and a Roundup- tolerant genetically modified maize. von Schomberg R (2013). A Vision of Responsible Research and Innovation. In R. Owen, J. Bessant, & M. Heintz (eds.), Responsible Innovation (pp ). John Wiley & Sons, Ltd. Retrieved from ch3/summary 10