Final Health and Environmental Risk Assessment of Genetically Modified Maize MON 89034

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency has requested the Norwegian Food Safety Authority to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectorial responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant genetically modified maize MON 89034 (Unique Identifier MON-89Ø34-3) from Monsanto Company is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 30 October 2009 (Application EFSA/GMO/NL/2007/37, Commission Decision 2009/813/EC).   Genetically modified maize MON 89034 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environmental Agency related to the EFSAs public hearing of the application EFSA/GMO/NL/2007/37 in 2007 (VKM 2008a). VKM has also been requested to issue a preliminary scientific opinion on the safety of the genetically modified maize MON 89034 for cultivation, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMO/BE/2011/90 (VKM 2012a). At the request from the Norwegian Environment Agency the VKM GMO Panel also submitted a final environmental risk assessment of MON 89034 for food and feed uses in 2013 (VKM 2013). Finally, maize MON 89034 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2008b, 2009a,b, 2010a,b).   The food/feed and environmental risk assessment of maize MON 89034 is based on information provided by the applicant in the applications EFSA/GMO/NL/2007/37 and EFSA/GMO/BE/2011/90, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant.    The VKM GMO Panel has evaluated MON 89034 with reference to its intended uses in the European Economic Area (EEA) and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c).   The scientific risk assessment of maize MON 89034 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms and effects on biogeochemical processes.  It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms.   The genetically modified maize MON 89034 was developed to provide protection against certain lepidopteran target pest, including European corn borer (Ostrinia nubilalis) and Mediterranean corn borer (Sesamia nonagrioides). Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis, a common soil bacterium. Cry1A.105, encoded by the cry1A.105 gene, is a chimeric protein made up of different functional domains derived from three wild-type Cry proteins from B. thuringiensis subspecies kurstaki and aizawai. The Cry2Ab2 protein is encoded by the cry2Ab2 gene derived from B. thuringiensis subspecies kurstaki.   Molecular characterization:  Appropriate analyses of the transgenic DNA insert, its integration site, number of inserts and flanking sequences in the maize genome, have been performed. The results show that only one copy of the insert is present in maize MON 89034. Homology searches with databases of known toxins and allergens have not indicated any potential production of harmful proteins or polypeptides caused by the genetic modification in maize MON 89034. Southern blot analyses and segregation studies show that the introduced genes cry1A.105 and cry2Ab2 are stably inherited and expressed over several generations along with the phenotypic characteristics of maize MON 89034. The VKM GMO Panel concludes that the molecular characterisation of maize MON 89034 does not indicate a safety concern.  Comparative assessment:  Comparative analyses of maize MON 89034 to its non-GM conventional counterpart have been performed during multiple field trials in representative areas for maize cultivation in USA, Argentina and Europe (2004, 2005 and 2007). With the exception of small intermittent variations, no biologically significant differences were found between maize MON 89034 and the conventional non-GM control. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 89034 is compositionally, agronomical and phenotypically equivalent to its conventional counterpart, except for the introduced characteristics.  Food and feed risk assessment:  A 90-day subchronic feeding study on rats, as well as whole food feeding studies on broilers and feedlot steers have not indicated any adverse effects of maize MON 89034 and shows that maize MON 89034 is nutritionally equivalent to conventional maize. The Cry1A.105 and Cry2Ab2 proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE-mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.  Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105 or Cry2Ab2 proteins will introduce a toxic or allergenic potential in food or feed based on maize MON 89034 compared to conventional maize.  Environmental risk assessment:  Considering the intended uses of maize MON 89034, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MON 89034.   Maize MON 89034 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MON 89034. Maize is the only representative of the genus Zea in Europe and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue.  Overall conclusion:  Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105 and Cry2Ab2 proteins will introduce a toxic or allergenic potential in food or feed derived from maize MON 89034 compared to conventional maize.   The VKM GMO Panel likewise concludes that maize MON 89034, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.