Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize 1507 x NK603 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2004/05)

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorised in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. 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 and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary.  The insect-resistant and herbicide-tolerant genetically modified maize 1507 x NK603 from Pioneer Hi-Bred International, Inc. og Mycogen Seeds (Unique Identifier DAS-Ø15Ø7-1 x MONØØ6Ø3-6) is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 24 October 2007 (Commission Decision 2007/703/EC).   Genetically modified maize 1507 x NK603 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMOs), commissioned by the Norwegian Food Safety Authority related to the EFSAs public hearing of the application EFSA/GMO/UK/2004/05 in 2005 (VKM 2005a). In addition,  maize 1507 x NK603 has been assessed by the VKM GMO Panel commissioned by the Norwegian Environment Agency and NFSA in connection with the national finalisation of the procedure of the notification in 2008 (VKM 2008). 1507 x NK603 has also been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2004, VKM 2005b, VKM 2007a, VKM 2009, and VKM 2012a).   The food/feed and environmental risk assessment of the maize 1507 x NK603 is based on information made available on the EFSA website GMO Extranet, and relevant peer-reviewed scientific literature.  The VKM GMO Panel has evaluated 1507 x NK603 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 2006, 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the postmarket environmental monitoring of GM plants (EFSA 2011c).   The scientific risk assessment of maize 1507 x NK603 includes 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 emphasised 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 stack 1507 x NK603 was produced by conventional breeding between inbred lines of maize containing the 1507 and NK603 events. The hybrid was developed to provide protection against certain lepidopteran target pests, and to confer tolerance to glufosinate-ammonium and glyphosate herbicides.  Molecular Characterization:  Southern blot and PCR analyses have indicated that the recombinant inserts in the parental maize events1507 and NK603 are retained in the stacked maize 1507 x NK603. Genetic stability of the inserts has previously been demonstrated in the parental events. Protein measurements show comparable levels of Cry1F, PAT and CP4 EPSPS proteins in the stacked maize 1507 x NK603 and the parental lines. Phenotypic analyses also indicated stability of the insect resistance and herbicide tolerance traits.   The VKM Panel on GMO considers the molecular characterisation of maize 1507 x NK603 and its parental events 1507 and NK603 as adequate.   Comparative Assessment:  Comparative analyses of the compositional, agronomic and phenotypic characteristics of maize stack 1507 x NK603 and near-isogenic comparators were performed during multiple field trials in Chile and Europe in 2002/2003. With the exception of small intermittent variations, the results show no indications of unwanted unintentional effects, and that maize stack 1507 x NK603 is compositionally, agronomically and phenotypically equivalent to its comparators, with the exception of the introduced insect resistance and herbicide tolerance traits.  Food and Feed Risk Assessment:  Whole food feeding studies on rats have not indicated any adverse effects of the parental maize lines 1507 and NK603. No rodent whole food feeding study has been performed on the stacked maize 1507 x NK603; the applicant has however provided a nutritional feeding study performed on broilers. No adverse effects were observed in the study. Bioinformatics analyses have not revealed expression of any known ORFs in the parental maize lines, and none of the newly expressed proteins show resemblance to any known toxins or IgE allergens. Nor have the newly expressed proteins been reported to cause IgE mediated allergic reactions. Some studies have however indicated a potential role of Cry-proteins as adjuvants in allergic reactions.  Acute and repeated dose toxicity tests in rodents have not indicated toxic effects of the Cry1F, PAT or CP4 EPSPS proteins. However, these tests do not provide any additional information about possible adverse effects of maize 1507 x NK603.  Based on current knowledge, the VKM GMO Panel concludes that the stacked maize 1507 x NK603 is nutritionally equivalent to conventional maize varieties, and that it is unlikely that the newly expressed proteins introduce a toxic or allergenic potential in food and feed derived from maize 1507 x NK603 compared to conventional maize.  Environmental Risk:  Considering the intended uses of maize 1507 x NK603, 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 1507 x NK603.   Maize 1507 x NK603 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 1507 x NK603. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The risk of gene flow from occasional feral GM maize plants to conventional maize varieties is negligible. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered to be an issue.  Overall Conclusion:  The VKM GMO Panel has not identified toxic or altered nutritional properties in maize 1507 x NK603 or its processed products compared to conventional maize. Based on current knowledge, it is also unlikely that the Cry1F protein will increase the allergenic potential of food and feed derived from maize 1507 x NK603 compared to conventional maize varieties. The VKM GMO Panel likewise concludes that maize 1507 x NK603, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.