Genetically modified food products: development of safety asseessment system in Russia

The paper gives an overview of basic approaches to assessing safety of genetically modified organisms (GMOs) that are used in food products manufacturing. It contains data on overall volumes of GMOs production in the world and outlines basic trends in development of GMOs safety assessment in the Russian Federation. In Russia a system for GMOs safety assessment was first created on the basis of domestic experience accumulated via medical and biological research on protein products of microbiological synthesis taking into account all the approaches that existed in the world. A combined algorithm was substantiated; the algorithm includes examinations of GMOs properties and obligatory examinations in vivo: toxicological ones performed via a chronic experiment on rats; allergic ones performed via a modeling experiment on rats; immunologic and genotoxic ones performed via experiments on mice. The system was developed further as, first of all, there was a search for biomarkers that allow to make toxicological research more sensitive; secondly, reproductive functions and offspring development were studied. Experts confirmed that parameters of apoptosis activity could be used as biomarkers; reproductive functions and offspring development were studied over several generations; the most sensitive parameters of rats' reproductive functions were determined under modeled toxic exposure; experts examined an influence exerted on reproductive functions by the seasonal factor and studied prenatal and postnatal development of offspring. New requirements to conducting medical and biological assessment of GMOs were formulated. Starting from 2011, reproductive toxicity of GMOs has been an obligatory part in the state certification of new GM products. Requirements to safety assessment of GMOs with combined features have been developed on the basis of domestic and international experience; these requirements correspond to regulation principles for GMOs application in food products

Assessment of the impact of genetically modified LibertyLink® maize on reproductive function and progeny development of Wistar rats in three generations

This publication presents the assessment of the impact of genetically modified (GM) LibertyLink® maize on reproductive function, prenatal and postnatal progeny development of Wistar rats over three generations. The animals were divided into two groups, which were fed with rodent diet with inclusion of GM LibertyLink® (‘test’ group) and non-GM near-isogenic counterpart (‘control’ group) maize varieties. The maize was included into the diet at maximum possible level (between 32 and 33%) not causing nutritional imbalance or metabolic disturbance for the experimental animals. Data analysis showed no impact of LibertyLink® maize on the animals’ fertility: the observed mating efficiency in both groups was within the normal expected range values under the given experiment conditions. The comparison of progeny prenatal development in the generations F0–F2 has not shown any differences between the groups. Analysis of the physical development of the F0–F2 progeny or pups body weight and length progress did not show any abnormalities. The average number of pups per litter in the control and test groups was within the expected range of variations. Therefore, the results should be considered as direct evidence of the lack of any reproductive toxicity of LibertyLink® maize (a.k.a. T25 maize)