Plants Developed by New Genetic Modification Techniques—Comparison of Existing Regulatory Frameworks in the EU and Non-EU Countries

The development of new genetic modification techniques (nGMs), also referred to as “new (breeding) techniques” in other sources, has raised worldwide discussions regarding their regulation. Different existing regulatory frameworks for genetically modified organisms (GMO) cover nGMs to varying degrees. Coverage of nGMs depends mostly on the regulatory trigger. In general two different trigger systems can be distinguished, taking into account either the process applied during development or the characteristics of the resulting product. A key question is whether regulatory frameworks either based on process- or product-oriented triggers are more advantageous for the regulation of nGM applications. We analyzed regulatory frameworks for GMO from different countries covering both trigger systems with a focus on their applicability to plants developed by various nGMs. The study is based on a literature analysis and qualitative interviews with regulatory experts and risk assessors of GMO in the respective countries. The applied principles of risk assessment are very similar in all investigated countries independent of the applied trigger for regulation. Even though the regulatory trigger is either process- or product-oriented, both triggers systems show features of the respective other in practice. In addition our analysis shows that both trigger systems have a number of generic advantages and disadvantages, but neither system can be regarded as superior at a general level. More decisive for the regulation of organisms or products, especially nGM applications, are the variable criteria and exceptions used to implement the triggers in the different regulatory frameworks. There are discussions and consultations in some countries about whether changes in legislation are necessary to establish a desired level of regulation of nGMs. We identified five strategies for countries that desire to regulate nGM applications for biosafety–ranging from applying existing biosafety frameworks without further amendments to establishing new stand-alone legislation. Due to varying degrees of nGM regulation, international harmonization will supposedly not be achieved in the near future. In the context of international trade, transparency of the regulatory status of individual nGM products is a crucial issue. We therefore propose to introduce an international public registry listing all biotechnology products commercially used in agriculture

Scale Implications for Environmental Risk Assessment and Monitoring of the Cultivation of Genetically Modified Herbicide-Resistant Sugar Beet: A Review

Genetically modified herbicide-resistant (GMHR) sugar beet (Beta vulgaris L.) has been cultivated in the US for several years and an application has been submitted for cultivation in Europe. Concerns have been raised about how GMHR sugar beet cultivation might impair the agro-environment. European legislation for GM plants requires, prior to their commercial import and/or cultivation, a stepwise reduction of the containment and a gradual increase in the scale of release. Experimental results gained during this procedure enter an environmental risk assessment; after the GM plant approval, a systematic monitoring of potential adverse environmental effects is required. We collected information on sugar beet biology and cultivation and the HR technology. We categorised the literature findings, evaluated the evidence of agro-environmental effects and indicated adverse effects. The impacts are directly and indirectly linked to sugar beet biology and/or to the HR technology. Most likely are a) adverse herbicide effects on field organisms, aquatic communities and soil microbial communities, b) persistence of the GM plant triggered by a potential selective advantage and/or genetic drift after hybridisation of GMHR cultivated, feral and weed beet with neighbouring beets and wild relatives, c) the increase of HR in weeds and subsequent increase and/or change in the herbicide application regime after several years of glyphosate application, and d) decline in agrobiodiversity (weed communities, herbivores, pollinators and beneficial species). Our study reveals a lack of experimental data on potential agro-environmental effects. This suggests that the principle of a stepwise scale increase of release is inadequately applied to the GMHR sugar beet approval process. The adverse effects identified should prompt further research experiments to gain information for the ERA and/or specific monitoring activities at the respective identified spatial scale levels

A new ecotoxicological test method for genetically modified plants and other stressors in soil with the black fungus gnat Bradysia impatiens (Diptera): current status of test development and dietary effects of azadirachtin on larval development and emergence rate

Abstract Background Few suitable and standardized test methods are currently available to test the effects of genetically modified plants (GMP) on non-target organisms. To fill this gap and improve ecotoxicological testing for GMP, we developed a new soil ecotoxicological test method using sciarid larvae as test organisms. Results Bradysia impatiens was identified as a candidate species. Species of the genus Bradysia occur in high numbers in European agroecosystems and B. impatiens can be reared in the laboratory in continuous culture. A functional basic test design was successfully developed. Newly hatched larvae were used as the initial life stage to cover most of the life cycle of the species during the test. Azadirachtin was identified as a suitable reference substance. In several tests, the effects of this substance on development time and emergence rate varied for different temperatures and test substrates. The toxicity was higher at 25 °C compared to 20 °C and in tropical artificial soil compared to coconut fiber substrate. Conclusions and outlook Results suggest that the developed test system is suitable to enter a full standardization process, e.g., via the Organisation for Economic Co-operation and Development. Such a standardization would not only assist the risk assessment of GMP, but could include other stressors such as systemic pesticides or veterinary pharmaceuticals reaching the soil, e.g., via spreading manure. The use of sciarid flies as test organisms supports recommendations of EFSA, which stressed the ecological role of flies and encouraged including Diptera into test batteries

Assessing the potential risks of transgenic plants for non-target invertebrates in Europe: a review of classification approaches of the receiving environment

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Ranking matrices as operational tools for the environmental risk assessment of genetically modified crops on non-target organisms

For the operationalization of the structured, stepwise selection procedure for non-target testing organisms integrated into the new EFSA guidelines for environmental risk assessment of GM plants practicaltools – i.e. ranking matrices – were developed. These tools – some of them are new and some are refinedfrom older ones – were tested using the GM case crop of TC 1507 maize. The selection procedure consists of six steps. The strategy builds on identifying the important ecological functions for the particularcropping system and compiling a species lists according to their ecological functions and presence inthe specific receiving environments. Subsequently, the species numbers are reduced in a systematic,stepwise fashion to a relevant and practical number of testing organisms and/or processes.Four ecological functional categories were selected: herbivory, pollination, natural enemies and soilorganisms/processes. Based on these categories, the relevant species were chosen and subjected to theselection steps. Out of a total of 33 herbivores, 73 pollinators/pollen feeders, 48 natural enemies and77 soil organisms/processes we started with in Step 1, 15 herbivores, 10 pollinators 17 natural enemyspecies and 9 soil organisms/processes were selected as relevant and suited for a testing program at theend of the selection procedure in Step 4.Although the ranking tools will continue to need further refinement, we could demonstrate that thisprocedure allows to swiftly select the most important suite of species and processes from a large numberof organisms. This expert-driven process increases ecological realism and transparency in risk assessment and tailors it to the particular receiving environment, thus, overcoming important deficienciesof the current approach that has attracted persistent criticism. We recommend balancing ecologicalrequirements with practicability criteria and realism in the test strategy. At present, the ranking isabundance-oriented and, thus, excludes rare and/or endangered species that are sensitive to disturbances. We suggest additional selection criteria to strengthen nature conservation and off-field aspects