This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified maize MON 863 and the maize hybrid MON 863 x MON 810. The opinion is based on two questions raised by the Commission related to applications for the placing of the maize on the market by Monsanto under the Novel Food Regulation (EC) No 258/97 (EC, 1997) and the Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment (EC, 2001).
In the first question, the GMO Panel was asked to consider the safety of foods and food ingredients derived from MON 863 and MON 863 x MON 810 maize. In the second question the GMO Panel was requested to consider whether there is any scientific reason to believe that the placing on the market of MON 863 and MON 863 x MON 810 maize, for import and processing, is likely to cause any adverse effects on human health and the environment. The questions followed two separate scientific assessments which were initially made by the competent authorities of Germany and subsequently evaluated by all other Member States. An assessment of the MON 863 and MON 863 x MON 810 maize was requested by the Commission because of questions raised by several Member States following the evaluations at the national level. When this is the case, EU legislation requires that EFSA carries out a further assessment and provides an opinion.
In delivering its opinion the Panel considered the applications and additional information provided by the applicant and the specific questions and concerns raised by the Member States. At the request of the Commission, the Panel has provided two separate opinions. However, as both dossiers cover to a large extent the same issues a single risk assessment is provided for both opinions.
The maize MON 863 and the hybrid MON 863 x MON 810 were assessed with reference to their intended use and the appropriate principles described in the guidance document for the risk assessment of genetically modified plants and derived food and feed (EC, 2003). The scientific assessment included the transformation process, the vectors used and the transgenic constructs in the genetically modified plant. Furthermore a comparative analysis of agronomic traits and composition was undertaken and the safety of the new proteins and the whole food/feed was evaluated with respect to toxicology and allergenicity. Both a nutritional and an environmental assessment, including monitoring plans, were undertaken.
MON 863 maize was developed to provide protection against certain coleopteran pests, principally corn rootworm (Diabrotica spp.) by the introduction of a variant Bacillus thuringiensis cry3Bb1 gene expressing an insecticidal protein. The hybrid maize MON 863 x MON 810 was produced by a conventional cross between inbred maize lines MON 863 and MON 810 to combine the rootworm resistance trait in MON 863 with the trait present in MON 810 protecting against lepidopteran pests (Ostrinia nubilalis and Sesamia spp.). MON 810 maize was approved under Directive 90/220/EEC (EC, 1990) by Commission Decision 98/294/EC (EC, 1998a). The use of food and food ingredients from MON 810 maize was notified in 1997 under the Regulation (EC) 258/97 .
Molecular analysis of MON 863 maize demonstrated that only the two expected full-length proteins, Cry3Bb1 and NptII, would be encoded by the insert. With respect to the presence of an intact nptII gene, the GMO Panel recently formulated an opinion (EFSA, 2004) on antibiotic resistance genes in GM plants and concluded that the use of nptII as a selection marker did not pose a risk to the environment nor to human and animal health. DNA sequences at the junctions between the insert and parent genome were determined revealing the presence of mitochondrial DNA at both flanks. The molecular analysis does not differentiate between the integration of insert DNA within a region of mitochondrial DNA that is already present in the nuclear genome and the acquisition of this organelle DNA as part of the primary integration during transformation. The integration of organellar DNA within plant nuclear genome is established as a normal phenomenon and the Panel considers that the resolution of this distinction would not significantly impact on the present safety assessment. Analysis of DNA sequences spanning the junctions identified open reading frames. In the unlikely event that a new peptide or protein is produced as a consequence of the insertion event, bioinformatics analysis showed that these would have no homology to known toxins or allergens. For MON 810 maize, junctions between the insert and the plant genome were delineated and the complete DNA sequence of the insert determined. An apparent inconsistency between the original dossier and newly provided information was resolved. Investigation of the molecular structures of the DNA inserts in MON 863 x MON 810 hybrid confirmed that insert structures and loci of insertion were retained.
Compositional analyses of kernels from MON 863, a non-modified control and commercial lines revealed minor differences in some plant constituents, which were not considered to be biologically significant. Comparison of MON 863, MON 810 and MON 863 x MON 810 hybrid showed a statistically significant difference in the copper content, which is not unexpected given the distinct genetic backgrounds of the single- insert plants and the hybrid. Since the copper levels are within normal ranges of variation, the Panel considers that there is no need for further assessment in the hybrid.
Cry3Bb1 and Cry1Ab levels in kernels of MON 863 x MON 810 hybrid were higher than in MON 863 and MON 810. The ranges were broad and showed overlap between the double- and single-trait hybrids. The Panel concludes that these data do not raise safety concerns.
The Cry3Bb1 protein produced in E. coli was considered by the Panel as equivalent to the plant-derived protein and an acceptable alternative for use in the toxicological testing. Adequate acute toxicity data were provided for both Cry3Bb1 and NptII proteins. An allergy risk evaluation of the Cry1Ab and Cry3Bb1 proteins was carried out from which it was concluded that the probability of allergenicity was very low.
The results of 90-day sub-chronic rodent studies do not indicate adverse effects from consumption of MON 863 and MON 810 and the Panel concludes that there are no concerns over their safety.
Feeding studies conducted on broilers with MON 863, MON 810 and MON 863 x MON 810 showed no adverse effects. The Panel considers that the nutritional properties of these maize lines would be no different from those of conventional maize.
The notification C/DE/02/9 only concerns import and processing. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of the maize lines. The GMO Panel agrees that unintended environmental effects due to the establishment and spread of GM maize will not be different from that of traditionally bred maize. The Panel concludes that the amounts of Cry toxin being distributed onto land in manure would be very low, minimizing the possibility for exposure of potentially sensitive non-target organisms. The monitoring plan provided by the applicant is in line with the intended uses for the GMO.
In conclusion, the Panel considers that the information available for MON 863 addresses the outstanding questions raised by the Member States and considers that MON 863 will not have an adverse effect on human and animal health or the environment in the context of its proposed use. In the case of the hybrid MON 863 x MON 810, while it was considered that it is scientifically valid to use data from the single GM lines MON 863 and MON 810 to support the safety assessment of the hybrid MON 863 x MON 810, the Panel was divided over the need for confirmatory data for the safety assessment of the hybrid, in particular, the need for an additional 90-day rat study with MON 863 x MON 810. Therefore the Panel could not reach agreement on the safety evaluation of the hybrid.