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Version 1.1 GMO UNIT SCIENTIFIC PANEL ON GMO Minutes of the 83rd Plenary meeting of the Scientific Panel on GMO Held on 3–4 July 2013, Parma (Agreed on 11 September 2013) Participants Panel members: 1 Andrew Chesson, Patrick du Jardin , Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde- 2 Gunn Opsahl Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Løvik , Antoine 1 Messéan, Hanspeter Naegeli, Kaare Nielsen, Jaroslava Ovesná, Joe Perry , Nils Rostoks and Christoph Tebbe. Hearing experts: None. EFSA: GMO Unit: Jaime Aguilera, Herman Broll, Yann Devos, Zoltán Divéki, Anders Falk, Andrea Gennaro, Ana Gomes, Anna Lanzoni, Yi Liu, Sylvie Mestdagh, Irina Olaru, Claudia Paoletti, Andrea Pericoli, Matthew Ramon and Elisabeth Waigmann. Other EFSA Units/Directorates: none. European Commission observers: Maria Mirazchiyska, Sabine Pelsser (DG SANCO). Observers (in application of the guidelines for observers): none. Others: none. 1. Welcome and apologies for absence The Chair welcomed the participants. Apologies were received from Andrew Nicholas Edmund Birch. 2. Adoption of agenda The agenda was adopted without changes. 1 Attended via teleconference. 2 Attended on 3 July only. European Food Safety Authority – Via Carlo Magno 1/a, 43126 Parma, ITALY Tel: (+39) 0521 036 200 • Fax: (+39) 0521 036 0200 • www.efsa.europa.eu Version 1.1 GMO UNIT 3. Declarations of interest In accordance with EFSA’s Policy on Independence and Scientific Decision-Making Processes regarding Declarations of Interests (DoIs) and the Decision of the Executive Director implementing this Policy, EFSA screened the Annual Declaration of Interest (ADoI) and the Specific Declaration of Interest (SDoI) filled in by the experts invited to the present meeting. No conflicts of interests relating to the issues discussed in this meeting were identified during the screening process or in the Oral Declaration of Interest (ODoI) at the beginning of this meeting. 4. Agreement of the minutes of the 82nd Plenary meeting held on 29–30 May 2013, Parma The minutes of the 82nd GMO Plenary meeting (29–30 May 2013) were adopted and will be published at: EFSA Event: 82nd plenary meeting of GMO Panel 5. Report on written procedures since the 82nd Plenary meeting There have been no written adoptions since the 82nd Plenary meeting. 6. Scientific outputs submitted for discussion and possible adoption 6.1 Application for authorisation of genetically modified cotton MON 88913 and derived food and feed submitted under Regulation (EC) No 1829/2003 by Monsanto (EFSA-GMO-UK-2007-41) (EFSA-Q-2007-085) Cotton MON 88913 contains one insert consisting of the CP4 epsps expression cassette, providing herbicide tolerance. Bioinformatics-supported identification of hazards linked to the formation of new open reading frames caused by the insertion could not be completed due to the use of an outdated toxin database. Genetic stability studies did not raise safety issues. No biologically relevant differences which would raise safety concerns were identified in the composition or agronomic and phenotypic characteristics of plants and seeds obtained from cotton MON 88913 compared with its conventional counterpart and non-genetically modified reference varieties. Based on all the available information, there are no indications that the newly expressed CP4 EPSPS protein in cotton MON 88913 may be allergenic or toxic. Cotton MON 88913 was found to be as nutritious as commercially available varieties and it is unlikely that the overall allergenicity of the whole plant is changed. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton MON 88913 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88913. The EFSA GMO Panel considers, however, that the information available for cotton MON 88913 is not sufficient to reach a final overall conclusion due to the use of an outdated toxin database for bioinformatic analyses. The opinion was unanimously adopted by the Panel and will be published on the EFSA website at: http://www.efsa.europa.eu/en/publications.htm European Food Safety Authority – Via Carlo Magno 1/a, 43126 Parma, ITALY Tel: (+39) 0521 036 200 • Fax: (+39) 0521 036 0200 • www.efsa.europa.eu 6.2 Application for authorisation of genetically modified soybean MON 87769 for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto (EFSA-GMO-UK-2009-76) (EFSA-Q-2009- 00836) The EFSA GMO Panel discussed the draft scientific opinion, with a particular focus on the environmental and food–feed safety-related sections. Further discussion is needed. 6.3 Application for authorisation of genetically modified maize T25 and derived food and feed submitted under Regulation (EC) No 1829/2003 by Bayer BioScience (EFSA-GMO-NL-2007-46) (EFSA-Q-2007-134) and Application for renewal of authorisation for continued marketing of food produced from and feed consisting of or containing maize T25 and maize T25 for food and feed (EFSA-GMO-RX-T25) (EFSA-Q-2007-155) The EFSA GMO Panel discussed the draft scientific opinion, with a particular focus on the assessment of the agronomic and phenotypic datasets. Further discussion is needed. 7. New mandates 7.1 Applications under Regulation (EC) No 1829/2003 None. 7.2 Annual post-market environmental monitoring reports of GM plants None. 7.3 Other requests and mandates Three mandates were received as follows: Self-task mandate of the EFSA GMO Panel to deliver a statement supplementing its environmental risk assessment conclusions and risk management recommendations on maize 59122 for cultivation (EFSA-Q-2013-00607) Mandate for the assessment of the scientific elements supporting the Luxembourg request to take emergency measures on the placing on the market of genetically modified (GM) maize MON 810 seeds for cultivation purposes in the EU (EFSA-Q- 2013-00590) Mandate for the assessment of the scientific elements supporting the Italian request to take emergency measures on the placing on the market of genetically modified (GM) maize MON 810 seeds for cultivation purposes in the EU (EFSA-Q-2013- 00589) 8. Feedback from the Scientific Committee/the Scientific Panel, Working Groups, EFSA and the European Commission 8.1 Scientific Committee and other Scientific Panels None. 3 8.2 Working Groups Risk assessment of stacked events The GMO Panel discussed the risk assessment of stacked events containing multiple herbicide tolerance traits. Retransformants The GMO Panel discussed aspects of the risk assessment of retransformed events and how it should take into consideration the presence/absence of event segregation in the progeny. 8.3 EFSA None. 8.4 European Commission A representative of the European Commission updated the Panel on applications that are undergoing authorisation procedures and on other activities, such as the lawsuit by Testbiotech, ENSSER and Sanbucus against the EC regarding market approval of genetically modified soybean MON 87701 MON 89788. 9. Other scientific topics for information and/or discussion None. 10. Any other business a) Panel members reporting on meetings and/or conferences they attended on behalf of the EFSA None. b) Paper by Carman et al. and other recent publications 3 The EFSA GMO Unit gave a presentation on the recent paper by Carman et al. 2013 , which claimed that gastric inflammation and uterine weight increase occurred in standard commercial pigs fed a GM soy and maize diet for 22.7 weeks in a US farm. It was highlighted that major drawbacks were identified in the study presented by Carman et al. such as the lack of controlled and standardised experimental conditions, of comprehensive characterisation of the GMs/diet, of proper expertise in data generation and interpretation. Taken together, these study limitations led to the generation of incomplete, inaccurate, ambiguous and inconsistent results. The conclusion was that the study presented by Carman et al. is not-compliant with standard practices/guidelines for toxicological assessment and shows several inaccuracies and incompleteness in the experimental settings, methodological approaches and data evaluation. Overall, the study presented is considered unsuitable for concluding on GM plant- related organ toxicity in pigs. 3 Carman J.A, Vlieger HR, Ver Steeg LJ, Sneller VE, Robinson GW, Clinch-Jones CA, Haynes JI, Edwards JW, 2013. A long-term toxicology study on pigs fed a combined genetically modified (GM) soy and GM maize diet. Journal of Organic Systems, 8, 38–54. 4
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