This document provides the opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified insect-resistant maize 59122 (Unique Identifier DAS-59122-7) developed to express the CRY34Ab1, CRY35Ab1 and PAT proteins.
In delivering its opinion the GMO Panel considered the application EFSA-GMO-NL-2005-12, additional information provided by the applicant (Pioneer Hi-Bred International, Inc. and Mycogen Seeds, c/o Dow Agrosciences LLC) and the scientific comments submitted by the Member States. The scope of the application is for food and feed uses, import and processing of maize 59122 and does not include cultivation. The GMO Panel assessed maize 59122 with reference to the intended uses and the appropriate principles described in the Guidance document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed. The scientific assessment included molecular characterization of the inserted DNA and expression of the target proteins. 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 nutritional quality, potential toxicity and allergenicity. An assessment of environmental impacts and the post market environmental monitoring plan were undertaken.
Maize 59122 was transformed by Agrobacterium-mediated gene transfer technology and expresses CRY34Ab1, CRY35Ab1 and PAT proteins. The molecular characterisation data established that maize 59122 contains a single insert of the T-DNA. The structure of the insert in maize 59122 was determined by Southern analysis and DNA sequencing. No vector backbone sequences were detected. BLAST sequence analysis revealed that border regions of the maize event 59122 show significant homology to maize genomic DNA and EST sequences. None of the EST sequences showed homology to known toxin or allergen encoding sequences. Analysis of ORFs spanning the two junction regions was performed by bioinformatic analysis and no novel ORFs with sequence similarity to known toxins or allergens were identified.
The GMO Panel is of the opinion that the molecular characterisation of the DNA insert and flanking regions of maize 59122 does not raise safety concerns, and that sufficient evidence for the stability of the insert structure was provided.
Based on the results of compositional analysis of samples from a representative range of environments and seasons, the GMO Panel concludes that forage and kernels of maize 59122 are compositionally equivalent to those of conventional maize, except for the presence of CRY34Ab1, CRY35Ab1 and PAT proteins. In addition, field trials did not show indications for unexpected changes of agronomic performance and phenotypic characteristics.
The CRY34Ab1, CRY35Ab1 and PAT proteins induced no adverse effects in acute and repeated dose oral toxicity studies in rodents. In addition, these proteins are rapidly degraded in simulated gastric fluid and inactivated during heat treatments.
A 90-day feeding study of rats fed a diet including kernels from maize 59122 at a level of 35% indicated no adverse effects. A feeding study of broilers did not indicate differences in the nutritional value of maize 59122 versus the non-GM comparator. These animal studies support the findings of the compositional analysis of no effect beyond the intended introduction of the CRY34Ab1, CRY35Ab1 and PAT proteins.
The application EFSA-GMO-NL-2005-12 concerns food and feed uses, import and processing of maize 59122. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of maize 59122. There are no indications of increased likelihood of establishment or survival of feral maize plants in case of accidental release into the environment of 59122 seeds during transportation and processing. Also, the low levels of environmental exposure through other routes indicate that the risk to target and non-target organisms is likely to be extremely low. The scope of the monitoring plan provided by the applicant is in line with the intended uses of maize 59122.
In conclusion, the GMO Panel considers that the information available for maize 59122 addresses the scientific comments raised by the Member States and that maize 59122 is as safe as its non genetically modified counterparts with respect to potential effects on human and animal health or the environment. Therefore the GMO Panel concludes that maize 59122 is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.