Brazil and the development of international scientific biosafety testing guidelines for transgenic crops

Under the umbrella of the International Organisation of Biological Control (IOBC), an international working group of public sector scientists entitled on "Transgenic Organisms in Integrated Pest Management and Biological Control" has been organized. The group will develop scientific principles and detailed scientific guidelines for biosafety testing of transgenic crops. The key elements of this project are: (1) An international initiative including expert scientists from leading research institutions in developed and developing countries; (2) coordination of the development and implementation of the guidelines as a dynamic process, which will include scientific and technical capacity building and communication among scientists and between scientists and policy makers; (3) rapid serial publication of sections of the guidelines as they are completed; and (4) rapid and timely revision of previously published sections. The guidelines will be constructed on a case-by-case basis and will have no regulatory legitimacy themselves.     

The structuring of GMO release and evaluation in EU law

Genetically modified organisms (GMOs) and their behavior in the environment are complex and can only be assessed if the different components are distinguished. This article examines, how by EU law the real causation processes from the GMO release to various endpoints are dissected, individually analysed and then again viewed in their entirety. In addition, the articles includes, how the intellectual process of assessment is divided into the steps of tiered generation, shared submission and structured evaluation of relevant knowledge. The framework proposed for such an examination allows to identify strengths and weaknesses of GMO risk assessment in the EU.     

Advances in development of transgenic pulse crops

It is three decades since the first transgenic pulse crop has been developed. Todate, genetic transformation has been reported in all the major pulse crops like Vigna species, Cicer arietinum, Cajanus cajan, Phaseolus spp, Lupinus spp, Vicia spp and Pisum sativum, but transgenic pulse crops have not yet been commercially released. Despite the crucial role played by pulse crops in tropical agriculture, transgenic pulse crops have not moved out from laboratories to large farm lands compared to their counterparts - 'cereals' and the closely related leguminous oil crop - 'soybean'. The reason for lack of commercialization of transgenic pulse crops can be attributed to the difficulty in developing transgenics with reproducibility, which in turn is due to lack of competent totipotent cells for transformation, long periods required for developing transgenics and lack of coordinated research efforts by the scientific community and long term funding. With optimization of various factors which influence genetic transformation of pulse crops, it will be possible to develop transgenic plants in this important group of crop species with more precision and reproducibility. A translation of knowledge from information available in genomics and functional genomics in model legumes like Medicago truncatula and Lotus japonicus relating to factors which contribute to enhancing crop yield and ameliorate the negative consequences of biotic and abiotic stress factors may provide novel insights for genetic manipulation to improve the productivity of pulse crops.     

转基因作物生物安全:科学证据

通过对美国Web of Science数据平台的全部转基因作物生物安全SCI论文的检索,研究了有关转基因作物生物安全的科学证据。得出科学家比消费者更关心转基因技术的安全性;批准商业化生产的转基因技术经过了有史以来最为严格的生物学安全检验与检测,并建立了有史以来最为严格的监管体系;在所发表的全部9333篇转基因生物安全论文中,90%以上的论文证明转基因技术的安全性与传统非转基因作物无显著差异;而对于所有得出转基因食品不安全结论的论文的追踪研究发现,其研究结论被证明是在错误的研究材料或方法条件下得出的。     

Population dynamics,hunting nature on insect pests and existence of symbiotic bacterial microbes among leading transgenic cotton spiders

The genetically modified cotton holding Bt proteins, is noxious to bollworms larvae but very little is known about its impact on population of non-target spiders within the field. Studies conducted with the aim to identify spiders along with their abundance, prevalence pattern, preying habit on insect pests in Bt cotton (L280, Cry2Ab4) and commonness of symbiotic bacteria in these spiders. Spiders collections were made via vial tapping/jarring, from May to end of October (2018). In total, 13,342 spiders were recorded during the entire cropping season. Least relative abundance was in May (0.28%), highest in August (30.39%) while ahead decline was observed, reached to 12% in October. The 27 species were verified, least richness was in May (3 species), high in August (19 species), later in the end, reduced to 7 species. High abundance was of Hylyphantes graminicola (68.56%) and Neoscona theisi (19.98%). Existence of H. graminicola and Pardosa astrigera observed during the whole cropping season. Presence of seven guilds among spiders had a diverse nature of hunting insect pests and on number of species existed in the crop, maximum was from direct hunting habit. Composition and community structure of microbiota varied as of spider species. Proteobacteria was the most abundant bacterial phylum and topmost genus was Wolbachia in observed spiders. Five groups of bacteria distinguished across 4 clusters of spiders depending on core community of symbiotic bacterial genera. This effort is an initial step to get knowhow about spiders in Bt cotton, which will facilitate future research studies concerning spiders.     

Regulatory and associated political issues with respect to Bt transgenic maize in the European union

Legislation at the national level in Europe as well as that developed by the European Union (EU) generally permits release and commercialization of genetically modified organisms (GMOs). However, only 10 plant/event combinations were registered as of 2002: three maize events (Bt176, Mon810, and Bt11), with the other seven divided among carnation (3), oil-seed rape (2), tobacco (1), and raddiccio (1). Of these, only one maize event (Bt176) has been registered as a legal variety, and this was in Spain, where 22,000ha have been planted annually since 1998. In this paper, we first provide an overview on the complexity of EU GMO legislation. Then we discuss the minor role that results of EU-funded biosafety research have had on governmental policy. Finally, we provide information about initiatives for post-commercialization monitoring plans of Bt maize in Europe. As a result of the slow progress to date, we conclude that commercialization of GMOs will be seriously delayed in the EU for the next several years.     

Recent Advances in Biological Control of Pest Insects by Using Viruses in China

Insect viruses are attractive as biological control agents and could be a feasible alternative to chemical insecticides in the management of insect infestations. This review describes recent advances in the development of wild-type and genetically modified viruses as insecticides. A new strategy of application of insect viruses in China is reviewed. Also, the assessment of biosafety of genetically modified Helicoverpa armigera Nucleopolyhedovirus (HearNPV) is emphasized as a case-study.     

Recent advances in biological control of pest insects by using viruses in China

Insect viruses are attractive as biological control agents and could be a feasible alternative to chemical insecticides in the management of insect infestations. This review describes recent advances in the development of wild-type and genetically modified viruses as insecticides. A new strategy of application of insect viruses in China is reviewed. Also, the assessment of biosafety of genetically modified Helicoverpa armigera Nucleopolyhedovirus (HearNPV) is emphasized as a case-study. Foundation itims: The 863 projects (2006AA10A210) from MOST.     

The current state of GMO governance: Are we ready for GM animals?

Given the history of GMO conflict and debate, the GM animal future is dependent on the response of the regulatory landscape and its associated range of interest groups at national, regional and international levels. Focusing on the EU and the USA, this article examines the likely form of that multi-level response, the increased role of cultural values, the contribution of new and existing interest groups and the consequent implications for the commercialization of both green and red GM animal biotechnology.     

Definition and feasibility of isolation distances for transgenic maize cultivation

A major concern related to the adoption of genetically modified (GM) crops in agricultural systems is the possibility of unwanted GM inputs into non-GM crop production systems. Given the increasing commercial cultivation of GM crops in the European Union (EU), there is an urgent need to define measures to prevent mixing of GM with non-GM products during crop production. Cross-fertilization is one of the various mechanisms that could lead to GM-inputs into non-GM crop systems. Isolation distances between GM and non-GM fields are widely accepted to be an effective measure to reduce these inputs. However, the question of adequate isolation distances between GM and non-GM maize is still subject of controversy both amongst scientists and regulators. As several European countries have proposed largely differing isolation distances for maize ranging from 25 to 800 m, there is a need for scientific criteria when using cross-fertilization data of maize to define isolation distances between GM and non-GM maize. We have reviewed existing cross-fertilization studies in maize, established relevant criteria for the evaluation of these studies and applied these criteria to define science-based isolation distances. To keep GM-inputs in the final product well below the 0.9% threshold defined by the EU, isolation distances of 20 m for silage and 50 m for grain maize, respectively, are proposed. An evaluation using statistical data on maize acreage and an aerial photographs assessment of a typical agricultural landscape by means of Geographic Information Systems (GIS) showed that spatial resources would allow applying the defined isolation distances for the cultivation of GM maize in the majority of the cases under actual Swiss agricultural conditions. The here developed approach, using defined criteria to consider the agricultural context of maize cultivation, may be of assistance for the analysis of cross-fertilization data in other countries.     

Gene flow assessment in transgenic plants

In most of the important crops in the world, gene flow between cultivars and between wild and weedy relatives has always taken place. Factors influencing this gene flow, such as the mating system, mode of pollination, mode of seed dispersal and the particular characteristics of the habitat where the crops grow, are difficult to evaluate and in consequence, the quantification of gene flow is not easy. Transgene flow from engineered crops to other cultivars or to their wild and weedy relatives is one of the major concerns in relation to the ecological risks associated with the commercial release of transgenic plants. With transgenic crops it is important to quantify this gene flow and to try to establish strategies to control or minimise it, taking into account the possible ecological effect of the newly introduced genes, whether advantageous or disadvantageous. The use of transgenic plants has proven to be an effective tool to quantify the gene flow to other cultivars of the same species or to wild and weedy relatives in all crops analysed. Here we review the major studies in this area, and conclude that the potential risk of gene flow has to be assessed case by case and caution is necessary when making general conclusions.     

Genetically modified crops for the bioeconomy: meeting public and regulatory expectations

As the United States moves toward a plant-based bioeconomy, a large research and development effort is focused on creating new feedstocks to meet biomass demand for biofuels, bioenergy, and specialized bioproducts, such as industrial compounds and biomaterial precursors. Most bioeconomy projections assume the widespread deployment of novel feedstocks developed through the use of modern molecular breeding techniques, but rarely consider the challenges involved with the use of genetically modified crops, which can include hurdles due to regulatory approvals, market adoption, and public acceptance. In this paper we consider the implications of various transgenic crops and traits under development for the bioeconomy that highlight these challenges. We believe that an awareness of the issues in crop and trait selection will allow developers to design crops with maximum stakeholder appeal and with the greatest potential for widespread adoption, while avoiding applications unlikely to meet regulatory approval or gain market and public acceptance. The views presented here are those of the authors and do not necessarily represent the views of the US government.     

我国转基因植物研发形势及发展战略

当前,发达国家及跨国种业集团在功能基因组学、转基因技术和转基因产品研发方面进展显著,转基因产业发展势头强劲,已成为近年来持续保持高速增长的新兴产业。我国高度重视转基因植物研发及产业化,整体水平领先于发展中国家,但与国际转基因生物产业快速发展和我国衣业发展对转基因产品的需求相比,在转基因技术和产品创新、产业化机制以及支撑条件等方面尚存在较多制约因素。基于系统比较分析,建议我国进一步加强转基因植物研发能力建设,夯实转基因育种基础,突破转基因核心技术,培育转基因植物新品种,加强产学研紧密结合,培育具有自主创新能力和市场竞争力的大型企业,与此同时加强科普宣传,营造良好的社会氛围,推进我国生物育种战略性新兴产业的快速发展。     

Ingestion and excretion of two transgenic Bt corn varieties by slugs

The release of transgenic Bacillus thuringiensis (Bt) corn expressing various Cry endotoxins has raised concern that these endotoxins are disseminated in the food web and may adversely affect non-target beneficial organisms, such as predators and organisms of the decomposer food web. We therefore investigated in a laboratory study, whether the Cry1Ab and Cry3Bb1 protein from Bt corn could potentially be transferred to such organisms by measuring the Cry protein content in the two common agricultural slug pests Arion lusitanicus and Deroceras reticulatum and their feces. We measured Cry1Ab and Cry3Bb1 protein concentration in leaves, intestines, and feces of corn leaf-fed slugs using ELISA and determined how much of the ingested protein is excreted by the slugs. Cry3Bb1 concentration in leaves of DKC5143Bt corn was significantly higher than Cry1Ab concentration in leaves of N4640Bt corn. While slugs were feeding on corn leaves, the Cry3Bb1 and Cry1Ab proteins were found in intestines and feces of both slug species. Bt protein concentrations in intestines of Cry3Bb1 corn-fed slugs were in both slug species higher than in Cry1Ab corn fed slugs, whereas no differences between Cry3Bb1 and Cry1Ab protein in feces were found. After slugs had ceased feeding on Bt corn, Cry1Ab was detectable in fresh slug feces for a significantly longer time and often in higher amounts than the Cry3Bb1. Our results indicate that both Cry proteins are likely to be transferred to higher trophic levels and to the decomposer food web. Since different Bt proteins seem to vary in their degradation, they have different transfer probabilities. This should be considered in risk assessments for non-target arthropods.     

Community response to transgenic plant release: predictions from British experience of invasive plants and feral crop plants

The ten-ten rule can be used to predict the community consequences of releasing GMOs. This, combined with data on the feral state of British crop plants, predicts that almost all GMOs will become at least casual, that more than 10% will establish, and about 10% of those will become pests. Which constructs will fall into which category cannot be predicted from their characters. In particular, Baker characters have no predictive value for weediness. The fourteen most troublesome invasive plant pests show a remarkably diverse set of characters. GMOs, being mainly derived from crop plants, and in some cases with genes that are likely to enhance survival, can be expected to have an appreciable effect on nonagricultural ecosystems, once a range of different constructs have been released. Familiarity is unlikely to be an effective defence against new ecological effects.     

A statistical approach to quantification of genetically modified organisms (GMO) using frequency distributions

Background

According to Regulation (EU) No 619/2011, trace amounts of non-authorised genetically modified organisms (GMO) in feed are tolerated within the EU if certain prerequisites are met. Tolerable traces must not exceed the so-called ‘minimum required performance limit’ (MRPL), which was defined according to the mentioned regulation to correspond to 0.1% mass fraction per ingredient. Therefore, not yet authorised GMO (and some GMO whose approvals have expired) have to be quantified at very low level following the qualitative detection in genomic DNA extracted from feed samples. As the results of quantitative analysis can imply severe legal and financial consequences for producers or distributors of feed, the quantification results need to be utterly reliable.

Results

We developed a statistical approach to investigate the experimental measurement variability within one 96-well PCR plate. This approach visualises the frequency distribution as zygosity-corrected relative content of genetically modified material resulting from different combinations of transgene and reference gene Cq values. One application of it is the simulation of the consequences of varying parameters on measurement results. Parameters could be for example replicate numbers or baseline and threshold settings, measurement results could be for example median (class) and relative standard deviation (RSD). All calculations can be done using the built-in functions of Excel without any need for programming. The developed Excel spreadsheets are available (see section ‘Availability of supporting data’ for details). In most cases, the combination of four PCR replicates for each of the two DNA isolations already resulted in a relative standard deviation of 15% or less.

Conclusions

The aims of the study are scientifically based suggestions for minimisation of uncertainty of measurement especially in —but not limited to— the field of GMO quantification at low concentration levels. Four PCR replicates for each of the two DNA isolations seem to be a reasonable minimum number to narrow down the possible spread of results.

Electronic supplementary material

The online version of this article (doi:10.1186/s12859-014-0407-x) contains supplementary material, which is available to authorized users.