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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 ...

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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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...Version gmo unit scientific panel on minutes of the rd plenary meeting held july parma agreed september participants members andrew chesson patrick du jardin achim gathmann jurgen gropp lieve herman hilde gunn opsahl hoen sorteberg huw jones jozsef kiss gijs kleter martinus lovik antoine messean hanspeter naegeli kaare nielsen jaroslava ovesna joe perry nils rostoks and christoph tebbe hearing experts none efsa jaime aguilera broll yann devos zoltan diveki anders falk andrea gennaro ana gomes anna lanzoni yi liu sylvie mestdagh irina olaru claudia paoletti pericoli matthew ramon elisabeth waigmann other units directorates european commission observers maria mirazchiyska sabine pelsser dg sanco in application guidelines for others welcome apologies absence chair welcomed were received from nicholas edmund birch adoption agenda was adopted without changes attended via teleconference only food safety authority carlo magno a italy tel fax www europa eu declarations interest accordance with...

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