VKM Report 2017:22 Risk assessment of insect-resistant and herbicide- tolerant genetically modified maize Bt11 for cultivation, import, processing, food and feed uses under Directive 2001/18/EC and Regulation (EC) Opinion of the Panel on Genetically Modified Organisms of the Norwegian Scientific Committee for Food Safety Report from the Norwegian Scientific Committee for Food Safety (VKM) 2017:22 Risk assessment of insect-resistant and herbicide-tolerant genetically modified maize Bt11 for cultivation import, processing, food and feed uses under Directive 2001/18/EC (C/F/96.05.10) and Regulation (EC) No 1829/2003 (EFSA/GMO/RX/Bt11) Opinion of the Panel on Genetically Modified Organisms of the Norwegian Scientific Committee for Food Safety 6.7.2017 ISBN: 978-82-8259-279-6 Norwegian Scientific Committee for Food Safety (VKM) Po 4404 Nydalen N – 0403 Oslo Norway Phone: +47 21 62 28 00 Email: [email protected] www.vkm.no www.english.vkm.no Suggested citations: VKM (2017) Scientific opinion on Risk assessment of insect-resistant and herbicide-tolerant genetically modified maize Bt11 for cultivation, import, processing, food and feed uses under Directive 2001/18/EC (C/F/96.05.10) and Regulation (EC) No 1829/2003 (EFSA/GMO/RX/Bt11) Opinion of the Panel on Genetically Modified Organisms of the Norwegian Scientific Committee for Food Safety, Oslo, Norway. ISBN: 978-82-8259-279-6 VKM Report 2017:22 Risk assessment of insect-resistant and herbicide-tolerant genetically modified maize Bt11 for cultivation, import, processing, food and feed under Directive 2001/18/EC (C/F/96.05.10) and Regulation (EC) No 1829/2003 (EFSA/GMO/RX/Bt11) Authors preparing the draft opinion Richard Meadow (chair), Nana Asare (VKM staff), Knut Tomas Dalen, Merethe Aasmo Finne (VKM staff), Olavi Junttila, Lawrence Kirkendall, Inger Elisabeth Måren, Siamak Yazdankhah (VKM staff) (Authors in alphabetical order after chair of the working group) Assessed and approved The opinion has been assessed and approved by the Panel on Genetically Modified Organisms. Members of the Panel are: Hilde-Gunn Opsahl-Sorteberg (chair), Knut Helkås Dahl, Knut Tomas Dalen, Olavi Junttila, Richard Meadow, Inger Elisabeth Måren, Kåre M. Nielsen, Monica Sanden and Rose Vikse (Panel members in alphabetical order after chair of the panel) Acknowledgment The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has appointed a working group consisting of VKM members to answer the requests from the Norwegian Environment Agency and the Norwegian Food Safety Authority. Project leaders from the VKM secretariat have been Nana Asare and Merethe Aasmo Finne. The members of the working group, Richard Meadow, Olavi Junttila, Lawrence Kirkendall (Panel on Alien organisms and trade in Endangered species (CITES)) and Inger Elisabeth Måren are acknowledged for their valuable work on this opinion. The Panel on Genetically Modified Organisms is acknowledged for comments and views on this opinion. Competence of VKM experts Experts working for VKM, either as appointed members of the Committee or as external experts, do this by virtue of their scientific expertise, not as representatives for their employers or third party interests. The Civil Services Act instructions on legal competence apply for all work prepared by VKM. Table of Contents Sammendrag på norsk ......................................................................................... 11 Abbreviations and glossary .................................................................................. 15 Background .......................................................................................................... 19 Terms of reference from the Norwegian Environment Agency and the Norwegian Food Authority ............................................................................................. 21 Assessment .......................................................................................................... 23 1 Introduction ................................................................................................. 23 2 Literature ..................................................................................................... 25 2.1 Search strategy ................................................................................................... 25 2.2 Relevance screening............................................................................................. 27 3 Molecular characterisation ........................................................................... 28 3.1 Information related to the genetic modification ...................................................... 28 Description of the methods and vectors used for the genetic modification ...... 28 Nature and source of vector(s) used including nucleotide sequences intended for insertion ......................................................................................................... 28 3.2 Information relating to the GM plant ...................................................................... 30 General description of the trait(s) and characteristics which have been introduced or modified ......................................................................................... 30 Information on the sequences actually inserted/deleted or altered................. 31 3.2.2.1 Size and copy number of all detectable inserts, both complete and partial ... 31 3.2.2.2 The Organization and sequence of the inserted genetic material at each insertion site ........................................................................................................ 32 3.2.2.3 In the case of deletion(s), size and function of the deleted region(s) .......... 32 3.2.2.4 Sub-cellular location(s) of insert(s) and methods for its / their insertion ...... 33 Information on the expression of the inserted/modified sequence ................. 33 Genetic stability of the inserted/modified sequence and phenotypic stability of the GM plant ....................................................................................................... 34 3.3 Conclusions ......................................................................................................... 35 4 Comparative assessments ............................................................................ 36 4.1 Production of material for comparative assessment ................................................. 36 4.2 Compositional analysis ......................................................................................... 37 Study 1: Analysis of Bt11 maize grown in greenhouse in Europe (1999) ......... 37 Study 2: Analysis of Bt11 field maize grown in USA (1995) ........................... 39 VKM Report 2017:22 Study 3: Comparison of nutritional composition of fresh and canned Bt-11 sweet maize (North America 1996) ........................................................................ 44 Study 4: Analysis of Bt11 field maize and sweet maize grown in North America (1998) 45 Study 5: Analysis of Bt11 field maize lines treated with herbicide in Europe (1998) 46 Determination of DIMBOA levels in Bt11 maize (field maize and sweet maize) 49 4.3 Agronomic and phenotypic characters.................................................................... 49 4.4 Effect of processing .............................................................................................. 51 4.5 Conclusion........................................................................................................... 52 5 Food and feed safety assessment ................................................................ 53 5.1 Product description and intended use .................................................................... 53 5.2 Toxicological assessment ...................................................................................... 53 Toxicological assessment of the newly expressed protein(s) .......................... 53 Acute toxicity study ................................................................................... 55 Toxicological assessment of the whole plant ................................................ 58 5.3 Allergenicity......................................................................................................... 64 Assessment of allergenicity of the newly expressed protein ........................... 64 Assessment of allergenicity of the GM food or feed ...................................... 65 Assessment of adjuvanticity ....................................................................... 65 5.4 Nutritional assessment of the GM food and feed ..................................................... 66 Interpretation of relevance of animal studies ............................................... 67 5.5 Conclusion........................................................................................................... 68 6 Maize Crop Production in Norway ................................................................ 69 7 Environmental risk assessment .................................................................... 70 7.1 Unintended effects on plant fitness due to the genetic modification .......................... 70 7.2 Potential for gene transfer .................................................................................... 71 Plant to micro-organisms gene transfer ....................................................... 72 Plant to plant gene flow ............................................................................. 73 7.2.2.1 Reproduction biology