ANIMAL FEEDING STUDIES AND IN VITRO STUDIES IN GMO RISK ASSESSMENT

Transcription

1 ANIMAL FEEDING STUDIES AND IN VITRO STUDIES IN GMO RISK ASSESSMENT Context 2 nd Stakeholder Workshop MAY 2014 European Commission, Madou tower, 1 Place Madouplein, Brussels, Belgium DRAFT AGENDA In the course of the European Commission funded research project GRACE (GMO Risk Assessment and Communication of Evidence) 90-day animal feeding trials, animal studies with an extended time frame as well as analytical, in vitro and in silico studies are conducted on GM maize in order to evaluate comparatively their use in GMO risk assessment. In the stakeholder consultations in December 2012 (first workshop and written consultation) and December 2013 (written consultation only) planning-stage issues relevant to these studies were discussed. The comments received at the occasion of that consultation were addressed when finalising the study plans. Comments and GRACE-team responses are available at This 2 nd stakeholder workshop will provide an opportunity to review the results obtained so far and to discuss their interpretation. The status of approaches alternative to animal testing will also be presented. The consultation is planned at a pivotal moment in the project, allowing adjustments to the final set of studies. To prepare for the consultation, documentation will be provided in advance of the meeting to registered parties and on the GRACE website. Written comments, also from interested parties not able to attend, are welcome until 2 weeks after the stakeholder workshop. Objective The aim of this workshop is to 1) discuss the results of the 90-day studies with GM maize MON810 performed as part of the GRACE project; 2) update on GRACE activities on alternative and complementary studies to animal feeding studies (in vitro, in silico, and analytical studies), and 3) provide information on follow-up and spin-off activities.

2 Agenda 15 April Anticipated Output The feed-back received in the course of the stakeholder consultation will be summarised in a report drafted by the GRACE team and circulated to all participants to ensure that it accurately and fairly reflects their views and comments. A final report will then be prepared based on comments received and published on the GRACE website. Attendance This consultation is open to all stakeholders interested in the safety and impacts of GMOs. This includes but is not limited to GMO risk assessors, risk managers, representatives of all relevant sectors of industry, farmer organisations, civil society organisations and academia. Anyone interested in attending is kindly invited to register by sending name, first name, affiliation and contact address via to GRACE-consultation@perseus.eu before 30 April Attendance is free of charge but registration before the deadline is required according to security rules at Commission buildings. Registration after the deadline will not be possible. GRACE Contacts Dr. Greet Smets (Workshop Coordinator) PERSEUS b.v.b.a Technologiepark 3 B-9052 Zwijnaarde, Belgium GRACE-consultation@perseus.eu Prof. Joachim Schiemann (Overall Project Coordinator) Julius Kühn-Institut (JKI), Federal Research Centre for Cultivated Plants Erwin-Baur-Strasse Quedlinburg, Germany joachim.schiemann@jki.bund.de th This workshop is funded by the European Commission 7 Framework Programme in the context of the large collaborative project GRACE (Grant Agreement No ). For more information on GRACE:

3 Agenda 15 April Travel information Venue: European Commission, Madou tower, 1 Place Madouplein, Brussels, Belgium From the airport By taxi: a taxi from the airport to Madou will cost about 36. By public transport: At the airport take a train to Brussels till Brussel-Centraal/Bruxelles- Central (8.50 ). Take metro line 1 direction Stokkel/Stockel or line 5 direction Herrmann- Debroux to 2 stops further (Kunst-Wet/Arts-Loi). Change lines: line 2 or line 6 direction Elisabeth. Get off the next stop at Madou. Alternatively, take a bus at the central station. Bus 63 direction Duiveltjes or Bus 29 direction Hof ten Berg. The 4th stop is Madou. From train station Brussel-Zuid/Bruxelles-Midi: Take metro line 2 or line 6 direction Elisabeth. Get off 7 stops further at Madou.

4 Agenda 15 April nd GRACE Stakeholder Workshop on Animal Feeding Studies and In Vitro Studies in GMO Risk Assessment Agenda 19 May :30 Registration Possibility for light lunch at canteen (at own expense) 12:30 INTRODUCTION Welcome Patrick Rüdelsheim, Perseus, Ghent, Belgium Update on the GRACE project by the Coordinator Joachim Schiemann, Institute for Biosafety in Plant Biotechnology, Stakeholder and User Involvement in GRACE/ Introduction to the Workshop Armin Spök, IFZ-Inter-University Research Centre for Technology, Work and Culture, Graz, Austria Implementation of the feeding studies: requirements and constraints Ralf Wilhelm, Institute for Biosafety in Plant Biotechnology, 13:45 90-DAY FEEDING STUDIES DESIGN AND ANALYSIS Chair: Armin Spök General design and analysis Pablo Steinberg, University of Veterinary Medicine, Hannover, Germany Maize cultivation María Plá, Center for Research in Agricultural Genomics (CRAG) Barcelona, Spain 15:00 Coffee break

5 Agenda 15 April Agenda 19 May continued 15:30 Analysis of plant material and diets Gijs Kleter, RIKILT-Institute of Food Safety, Wageningen University and Research Centre, The Netherlands Test facility, periodic observations and necropsy Dagmar Zeljenková, Department of Toxicology, Slovak Medical University, Bratislava, Slovakia Haematology and biochemistry Jana Tulinska, Department of Toxicology, Slovak Medical University, Bratislava, Slovakia Histopathology Pablo Steinberg, University of Veterinary Medicine, Hannover, Germany 18:00 Adjourn Day 1

6 Agenda 15 April Agenda 20 May :30 Recapitulation day 1/ launch day 2 Patrick Rüdelsheim, Perseus, Ghent, Belgium 08:45 ALTERNATIVE APPROACHES Chair: Gijs Kleter In vitro studies Ralf Einspanier, Freie Universität, Berlin, Germany Omics studies on plant material Esther Kok, RIKILT-Institute of Food Safety, Wageningen University and Research Centre, The Netherlands Longitudinal metabolomic studies Karine Adel-Patient, Unité INRA d'immuno-allergie Alimentaire, Gif-sur-Yvette, France 10:15 Coffee break 10:45 PROSPECTS AND NETWORKING Chair: Joachim Schiemann Further studies Ralf Wilhelm, Institute for Biosafety in Plant Biotechnology, CADIMA Christian Kohl, Institute for Biosafety in Plant Biotechnology, G-TwYST Pablo Steinberg, University of Veterinary Medicine, Hannover, Germany 12:15 GENERAL DISCUSSION Chair: Armin Spök General discussion Next steps and closing remarks 13:45 End of workshop Possibility for light lunch at canteen (at own expense)