Suchergebnisse

The long history of safety associated with the introduction of new plant varieties indicates that (i) risks to the environment presented by crop plants are low, (ii) field testing before commercial use and the institutional assessments and decisions on which plants or varieties to grow as crops have been sound, and (iii) management practices in place have been sufficient to mitigate any risks associated with a new variety. Nevertheless, the use of recombinant DNA technologies to produce genetically modified (GM) plants has led to the development of governmental/institutional regulations around the world that are applied specifically to assessing the safety of such plants and products thereof. From the very early stages of genetic engineering a close relationship between basic research, biosafety research, regulation and product development has been established. The European Food Safety Authority (EFSA) is the keystone of EU risk assessment regarding food and feed safety. In close collaboration with national authorities and in open consultation with its stakeholders, EFSA provides independent scientific advice and clear communication on existing and emerging risks. The EFSA Panel on genetically modified organisms provides independent scientific advice on the safety of (i) GMOs such as plants, animals and micro-organisms, on the basis of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and (ii) genetically modified food and feed, on the basis of Regulation (EC) No 1829/2003 on genetically modified food and feed. The GMO Panel carries out risk assessments in order to produce scientific opinions and advice for risk managers. Its risk assessment work is based on reviewing scientific information and data in order to evaluate the safety of a given GMO. This helps to provide a sound foundation for European policies and legislation and supports risk managers in taking effective and timely decisions.

Biosafety regulatory frameworks are intended to serve as mechanisms for ensuring the safe use of biotechnology products without imposing unacceptable risk to human health or the environment, or unintended constraints to technology transfer. In several regulatory systems GMO risk assessment has been separated from GMO risk management. As a consequence, risk assessment can be performed on a purely scientific basis, whereas risk management can take additional aspects (e.g. socio-economic or ethical) into consideration. For instance, the European Food Safety Authority (EFSA), the keystone of European Union risk assessment regarding food and feed safety, provides independent scientific advice and clear communication on existing and emerging risks in close collaboration with national authorities and in open consultation with its stakeholders. Risk management measures are not within the remit of EFSA, and remain the responsibility of the European Commission and Member States. © ISBR, EDP Sciences, 2007.

Several new plant breeding techniques (NPBTs) have been developed during the last decade, and make it possible to precisely perform genome modifications in plants. The major problem, other than technical aspects, is the vagueness of regulation concerning these new techniques. Since the definition of eight NPBTs by a European expert group in 2007, there has been an ongoing debate on whether the resulting plants and their products are covered by GMO legislation. Obviously, cover by GMO legislation would severely hamper the use of NPBT, because genetically modified plants must pass a costly and time-consuming GMO approval procedure in the EU. In this review, we compare some of the NPBTs defined by the EU expert group with classical breeding techniques and conventional transgenic plants. The list of NPBTs may be shortened (or extended) during the international discussion process initiated by the Organization for Economic Co-operation and Development. From the scientific point of view, it may be argued that plants developed by NPBTs are often indistinguishable from classically bred plants and are not expected to possess higher risks for health and the environment. In light of the debate on the future regulation of NPBTs and the accumulated evidence on the biosafety of genetically modified plants that have been commercialized and risk-assessed worldwide, it may be suggested that plants modified by crop genetic improvement technologies, including genetic modification, NPBTs or other future techniques, should be evaluated according to the new trait and the resulting end product rather than the technique used to create the new plant variety.

Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.

New plant-breeding techniques have been boosting plant breeding, since only a few years but already first promising products are pushing to the market. In contrast to this, in many countries, the current Directives regulating genetically modified organisms have been established more than 25 years ago, especially in the European Union being based on clear differentiation between transgenic plants and conventional breeding. Therefore, the question arises if these Directives are suitable to face the new challenge of genetic engineering or if there is a need for updated regulations.

Genome editing and modification techniques enable breeders to create single point mutations and to insert or delete new DNA sequences at a specific location in the plant genome thus for the first time making possible the precise modulation of traits of interest with unprecedented control and efficiency. The advent of genome editing has evoked enthusiasm but also controversy, creating regulatory and governance challenges worldwide. Plant genome editing could play a key role in developing crops that will contribute significantly to attaining multiple Sustainable Development Goals provided that accompanying the rapid scientific progress also policy and governance problems will be solved. Today, several countries, most of which located in the Americas, have adapted legislations to these technologies or released guidelines supporting the use of genome editing. Other countries are debating the path to come either because there is no clarity on the legal classification or due consensus is hampered by a renewed GMO debate. In recent years (2017–2020), eight countries have introduced guidelines clarifying the legal status of genome edited products and many of those are actively committed to international harmonization of their policies. In this chapter which is mainly based on a recent up-to-date review published by Menz et al. (Front Plant Sci 11(588027), 2020) we provide an overview on the current and potentially future regulatory environment for genome edited plants at national and international level.

Genetically modified (GM) maize expressing the insecticidal protein Cry1Ab from Bacillus thuringiensis (Bt maize) is the only GM crop planted commercially in the European Union (EU). Cultivation in accordance with Directive 2001/18/EC demands post-market environmental monitoring (PMEM) to ensure the detection and prevention of adverse effects on the environment possibly deriving from commercial cultivation. Based on a seminar organized in Berlin, Germany, in April 2008 by the EU-funded Biosafenet project, the present paper reflects on experiences and hurdles faced during the implementation of PMEM for Bt maize. It reviews and reconsiders PMEM programs of Bt maize in view of existing experiences from cultivation, current monitoring activities initiated by Member States and applicants, proposed monitoring strategies and methods as well as potential environmental impacts of cultivation. Future challenges will arise from large-scale and cumulative cultivation of various events. This will demand optimized organization structures for data collation and integration to support further decision-making and management.

In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the FDA in 2012, the commercialization of medicinal or industrial products produced in the field has yet to emerge in either Europe or the US. In the current paper, we discribe the regulatory environment in Europe and the US surrounding GM crops, and provide case studies for experimental field releases of PMP and PMI producing plants in both regions. Suggestions for reducing the regulatory burden for GM plants will be discussed, also in light of the emerging new technologies to modify the genetics of plants. Since regulations surrounding the commercialization of GM crops are very costly and not appropriate for most of the PMP/PMI applications in Europe, we propose that amendments to the EU Directive 2001/18/EC are necessary to allow for the commercialization of products from GM plants without the need of an 'authorization'. To fully acknowledge the overall outcome of adopting plants to produce PMP/PMI, the conclusion is that broader and more balanced legislative oversight is needed in Europe; while specific legislation is not needed in the US.

In addition to or as substitution for a regulated isolation distance, conventional maize (Zea mays L.) border rows at the genetically modified (GM) maize field edge are considered as feasible measure to ensure coexistence between GM and conventional or organic maize. Therefore, we examined the effectiveness of 9-m- and 18-m-wide non-GM maize borders at the GM maize field edge on outcrossing rates into a neighboring non-GM maize field. One field experiment each was conducted in 2008 at three sites in Germany using a field orientation representing a worst-case scenario concerning wind direction. In each case, the distance between GM and non-GM maize fields was 51 m. At two sites, sizes of GM and non-GM maize fields were 0.8 ha, respectively, and at the third site 0.5 ha (GM) and 0.3 ha (non-GM). The GM percentages of individual samples taken at recipient field depths between 0 and 90 m were quantified by real-time polymerase chain reaction. Overall, no pollen-mediated gene flow reducing effect of border rows was observed in the present study, although synchrony of anthesis between GM maize and border row maize was given at each site. Calculated GM contents of the total non-GM fields harvest were always below the European Union labeling threshold of 0.9%. In consequence, planting 9-m- or 18-m-wide conventional maize border rows at the GM field edge is no reliable coexistence measure, at least if combined with an isolation distance.

The most reliable and practicable measure in assuring coexistence in respect to pollen-mediated gene flow from genetically modified (GM) to conventional maize (Zea mays L.) is an isolation distance separating GM and non-GM fields. Therefore, we tested distances between 24 and 102 m at three sites in northern Germany using a field orientation representing a worst case scenario concerning wind direction. During the 3 yr of field trials the highest levels of gene flow occurred at the site and year with the longest flowering synchrony and the strongest wind blowing constantly from the GM to the non-GM field. It was shown that the GM content of a neighboring non-GM maize field is mainly determined by wind speed and direction as well as by non-GM maize field depth. Based on the maximum outcrossing data obtained it can be concluded that for non-GM maize fields being 200 m deep or more an isolation distance of 50 m is sufficient to keep the GM content of the total fields grain harvest below the European Union (EU) labeling threshold of 0.9%. However, non-GM grain maize fields with smaller field depth require larger isolation distances or additional coexistence measures. In most cases discarding 6 m of the GM maize facing non-GM maize field edge has proven to be such a valuable measure. In silage maize production 50 m isolation distance is adequate even for non-GM maize field depths down to 50 m. We recommend flexible separation distances in dependence on non-GM maize field depth to comply with EU coexistence requirements

How to best assess potential health, environmental and other impacts of genetically modified organisms (GMOs) and how to interpret the resulting evidence base have been long-standing controversial issues in the EU. As a response, transparency and inclusiveness became a major focus of regulatory science activities in the GMO impact area. Nevertheless, nearly three decades of controversies resulted in a heavily polarized policy environment, calling for further efforts. Against this backdrop the EU funded project GRACE explored the value of evidence synthesis approaches for GMO impact assessment and developed an evidence synthesis framework with a strong emphasis on openness, stakeholder engagement, transparency, and responsiveness to tackle regulatory science challenges. This framework was tested and implemented in the course of 14 systematic reviews or maps conducted on selected review questions spanning potential health, environmental, and socioeconomic impacts of GMOs. An inclusive development and prioritisation of review questions is of key importance in evidence synthesis as it helps to provide a better link between stakeholder demands and concerns and policy relevant outcomes. This paper, therefore, places a particular focus on the stakeholder involvement strategy developed and experiences gathered during this particular step in the course of the GRACE project. Based on this experience, possible lessons for future engagement exercises in highly controversial fields of regulatory science are discussed.

How to best assess potential health, environmental and other impacts of genetically modified organisms (GMOs) and how to interpret the resulting evidence base have been long-standing controversial issues in the EU. As a response, transparency and inclusiveness became a major focus of regulatory science activities in the GMO impact area. Nevertheless, nearly three decades of controversies resulted in a heavily polarized policy environment, calling for further efforts. Against this backdrop the EU funded project GRACE explored the value of evidence synthesis approaches for GMO impact assessment and developed an evidence synthesis framework with a strong emphasis on openness, stakeholder engagement, transparency, and responsiveness to tackle regulatory science challenges. This framework was tested and implemented in the course of 14 systematic reviews or maps conducted on selected review questions spanning potential health, environmental, and socioeconomic impacts of GMOs. An inclusive development and prioritisation of review questions is of key importance in evidence synthesis as it helps to provide a better link between stakeholder demands and concerns and policy relevant outcomes. This paper, therefore, places a particular focus on the stakeholder involvement strategy developed and experiences gathered during this particular step in the course of the GRACE project. Based on this experience, possible lessons for future engagement exercises in highly controversial fields of regulatory science are discussed.