The European Food Safety Authority (EFSA) held a consultative workshop in Brussels on 31 March 2011 to discuss the views of stakeholders on its draft guidance for the selection of Genetically Modified (GM) plant comparators. The workshop brought together various interested parties, including representatives from academia, industry, non-governmental organisations (NGOs), the European Commission, the European Parliament and scientific experts from EFSA. The meeting was also available to the public via a live webcast which was viewed by more than 900 people.
The aim of the workshop was to allow those who had commented in the recent written public consultation on the draft guidance to further elaborate and discuss their views and to engage directly with scientific experts from EFSA’s Panel on Genetically Modified Organisms (GMO Panel) and Working Group on Comparators. The outcomes from the written public consultation as well as discussions during the workshop will be taken into consideration by the EFSA GMO Panel as it works to finalise the guidance document.
The workshop began with a wide-ranging debate on the concept of substantial equivalence, giving context to the regulatory environment in which EFSA operates when carrying out risk assessment of GMOs. The second half of the workshop was dedicated to discussing EFSA’s draft guidance document on the selection of comparators.
EFSA’s Executive Director, Catherine Geslain-Lanéelle, welcomed workshop participants in a short video message from Parma. The meeting was chaired by EFSA Director of Risk Assessment Dr Riitta Maijala and the proceedings were opened by MEP José Bové, Vice-Chair of the European Parliament Committee on Agriculture and Rural Development. The discussions were moderated by Dr Helmut Gaugitsch from the Austrian Environmental Agency.
Dr Maijala stressed the importance of stakeholder consultation and public debate in the development of EFSA’s guidance documents: “The questions, remarks and contributions put forward in our stakeholder workshop are very welcome and, together with the comments from the recent public consultation, will serve to enhance the scientific and technical quality of EFSA’s final guidance document on the selection of comparators. EFSA is grateful to all those who assisted us in advancing our work on this important topic.”
In line with EFSA’s commitment to open dialogue, MEP José Bové was invited to the workshop to share his views on GMO Risk Assessment.
Session 1: Setting the Scene – The Concept of Substantial Equivalence
In the first session, participants held a general discussion on the concept of substantial equivalence. Dr Sébastien Goux, Policy Officer for the Commission’s Directorate General for Health & Consumers, outlined the current regulatory environment for GMO risk assessment in the European Union. Dr Hartmut Meyer from the European Network of Scientists for Social and Environmental Responsibility (ENSSER) spoke about the advantages and disadvantages of different approaches to environmental risk assessment of GM plants. Dr Peter Kearns from the Organisation for Economic Co-operation and Development (OECD) gave an overview of the historical perspective regarding the concept of substantial equivalence. Their presentations were followed by a broad discussion with workshop participants.
Session 2: Exchanging views on EFSA’s Draft Comparator Opinion
In the second session, a series of four discussions was held to explore comments made during the public consultation on the draft guidance document for the selection of comparators. Each discussion focussed on different areas of the document, including the risk assessment of single events, stacked events, stacked events from methods other than conventional crossing of plants and risk assessment when no comparator is available.
In all discussions, members of the EFSA GMO Panel and Working Group on Comparators introduced the relevant chapters of the draft guidance document and summarised the comments received during the public consultation. The EFSA presentations were followed by short interventions from a selection of individuals and organisations who had contributed to the written public consultation. This gave contributors an opportunity to elaborate their views on the draft guidance, creating a basis for an informative scientific debate amongst the audience.
The EFSA GMO Panel will consider all written comments made during the public consultation as well as those expressed in discussions during the workshop as it finalises the guidance document on selection of comparators. EFSA will also prepare a report of the workshop.
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