Genetically Modified Organisms Legislation Research Articles

The application of new breeding technology based on gene editing in pig industry - A review.

Genome/gene-editing (GE) techniques, characterized by a low technological barrier, high efficiency, and broad application among organisms, are now being employed not only in medical science but also in agriculture/veterinary science. Different engineered CRISPR/Cas9s have been identified to expand the application of this technology. In pig production, GE is a precise new breeding technology (NBT), and promising outcomes in improving economic traits, such as growth, lean or healthy meat production, animal welfare, and disease resistance, have already been documented and reviewed. These promising achievements in porcine gene editing, including the Myostatin gene knockout (KO) in indigenous breeds to improve lean meat production, the uncoupling protein 1 (UCP1) gene knock-in to enhance piglet thermogenesis and survival under cold stress, the generation of GGTA1 and CMP-N-glycolylneuraminic acid hydroxylase (CMAH) gene double KO (dKO) pigs to produce healthy red meat, and the KO or deletion of exon 7 of the CD163 gene to confer resistance to porcine reproductive and respiratory syndrome virus infection, are described in the present article. Other related approaches for such purposes are also discussed. The current trend of global regulations or legislation for GE organisms is that they are exempted from classification as genetically modified organisms (GMOs) if no exogenes are integrated into the genome, according to product-based and not process-based methods. Moreover, an updated case study in the EU showed that current GMO legislation is not fit for purpose in term of NBTs, which contribute to the objectives of the EU’s Green Deal and biodiversity strategies and even meet the United Nations’ sustainable development goals for a more resilient and sustainable agri-food system. The GE pigs generated via NBT will be exempted from classification as GMOs, and their global valorization and commercialization can be foreseen.

Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014

Although originally applicable to genetically modified crops, advanced therapy medicinal products (ATMPs), such as gene therapies, that consist of or contain genetically modified organisms (GMOs) and also viral-based vaccines, need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State before a clinical trial can commence. Under the European Clinical Trials Regulation 536/2014 (CTR) due to go live on 31st January 2022, a single electronic clinical trial application dossier will need to be submitted to all the Member States involved in the trial, via the European submission portal (Clinical Trials Information System, CTIS). However, national documents, such as informed consent forms, will still need to be submitted, as part II of the dossier, to each Concerned Member State, also via CTIS. There will be a single coordinated and harmonized assessment of the clinical trial application between the involved Member States, with one country leading the coordination of the assessment (the Reporting Member State). The CTR has as yet not addressed GMO documentation (ERA, common application form, etc) required for an IMP with a genetic component. There is no defined interplay between the CTR and the current GMO legislative framework. There is no specified procedure, nor structure for submission of a GMO application via CTIS, as part of the new single submission and coordinated evaluation procedure for clinical trials defined by the CTR. Upcoming challenges to clinical trial sponsors under the CTR across Member States are identified in this article. Further, national GMO competent authorities are called upon to adopt a pragmatic and simple approach as a first step to facilitate the GMO assessment and its coordination with approval of a clinical trial application.

Genetic techniques for plant breeding

Food Science and TechnologyVolume 35, Issue 3 p. 52-54 FeaturesFree Access Genetic techniques for plant breeding First published: 16 September 2021 https://doi.org/10.1002/fsat.3503_13.xAboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Wayne Martindale and Craig Duckham explore the barriers to the adoption of new genetic breeding techniques that facilitate the selection of desired traits to improve the quality and quantity of food products. Conventional plant breeding Human societies have been engaged in plant breeding since the beginning of agriculture by selecting plants found to be economically or aesthetically desirable and controlling the mating of selected individuals. Genetic variation has had a major impact on one of the UK's most successful crops, wheat. The straw yield, grain yield and quality of wheat has constantly changed over time to meet the market requirements of consumers as well as to utilise plant nutrients and plant protection applications as efficiently as possible. The Broadbalk Experiment at Rothamsted provides a living lab of these interactions and changes over 150 years. What is striking is that most of these improvements to date have been carried out by observable traits and long-term breeding programmes. We are now on the cusp of a revolution, where observational selection can work with new genetic techniques to provide more targeted outcomes for a 21st century food system1-3. Genetic modification of foods In the 1970s, the development of genetic engineering or genetic modification (GM) methods using recombinant-DNA technology offered the potential to enhance agri-food industry breeding programmes for crops, ornamental plants and animals. The aim was to speed up selection of genetic traits rather than relying on classical breeding programmes that selected from randomised mutations induced using radiation or chemicals, followed by recombination between varieties or breeds. Genetically modified organisms (GMOs) are officially defined in EU legislation as ‘organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination’. We are now on the cusp of a revolution, where observational selection can work with new genetic techniques to provide more targeted outcomes for a 21st century food system. One of the first applications of genetic engineering was the use of transgenic bacteria (Pseudomonas syringae) to reduce ice nucleation on the leaves of frost-susceptible crop plants. This was developed as a product called Frostban but was never marketed because of controversy about its safety4. Since then the most commonly commercialised GMOs have been soybean, maize, cotton and oilseed rape. The greatest commercial impact has been observed for insect resistance and herbicide tolerance, which are single, specific gene transfers that provide plant protection5. The approach can also be used for many other traits, such as enhancing the nutritional value of crops and livestock. These developments have all been achieved by introducing genetic material from unrelated species (transgenics) using Agrobacterium tumefaciens-mediated transformation and biolistic or ‘gene gun’ methods. They require expensive selection programmes, which use herbicide, bioluminescence or antibiotic resistance marker genes to identify the successful transfer of the transgene constructs into new crops or livestock. More recently, new plant breeding techniques, known as gene editing, have been developed, which allow much faster and more precise changes to be made within plant DNA than can be achieved by conventional breeding methods. DNA modifications resulting from gene editing can vary in scale from altering a single base, to inserting or removing one or more genes. Gene editing approaches do not use the marker gene technique, which is the basis of many safety concerns around GMOs, and are being considered for classification as conventional plant breeding techniques that sit outside the current EU GMO legislation. Gene editing uses a group of bacterial enzymes called CRISPR Associated Proteins, one of which (Cas-9) has been demonstrated to identify specific gene sequences in plants and animals that then can be cut, modified or switched on or off (gene silencing) by the Cas-9 enzyme6. There is no transgene construct nor typically a need for a selection marker; the Cas-9 approach uses metabolic means to edit genetic codes, it quite literally provides a metabolic toolbox that can target and modify specific existing genetic sequences. It provides the means to engineer the existing metabolism of crops and livestock with the same precision as that of transgenic methods, without the need to insert foreign DNA. Engaging food stakeholders Opposition to the development of transgenic organisms for use in foods and beverages has created a tortuous path for agricultural R&D pipelines developing new crop varieties, animal breeds and ingredients from microbes. It has also damaged consumer confidence in these GM products, particularly in Europe. Research and development in recent years has led to new crop varieties and livestock breeds using (1) rapid selection technologies and (2) scaling opportunities for market entry for the most beneficial products. However, processors and manufacturers of foods and beverages have often not been fully engaged in exploring the potential of such products within their development programmes. This has resulted in barriers to the adoption of these new breeding techniques in the supply chain and concerns about consumer assurance, which is at the heart of any food supply system. The potential benefits of using genetic techniques for product development are often not widely demonstrated to manufacturers or consumers. As a result, there is a lack of assurance, acceptance and application of ingredients produced by these methods, some of which already have a significant legacy of being used in the brewing and baking industries7. Even so, there are some excellent examples of customer engagement by enzyme and ingredient companies. An important demonstrator has been Novozymes’ use of Life Cycle Assessment to measure the benefits of using biotechnology across several products including nutrients and detergents, where standardised validation is in place for GM products8. However, these initiatives to date have been limited and have not had sufficient traction in research or policy arenas. Golden Rice An example of a missed opportunity to communicate the potential benefits of GM technology to consumers is provided by Golden Rice, which accumulates Provitamin A in the grain as a result of genetic transformation9 and has enormous humanitarian potential in reducing blindness (500,000 children per year) and infant mortality (2-3m deaths per year)10. Although the prototype for Golden Rice was developed some 20 years ago, regulatory requirements and associated costs are still standing in the way of its deployment by farmers. Scientific progress in the public sector has thus become detached from product development and the population at large is not benefiting from that progress9. GM in the food chain An example, which demonstrates the potential extent of the issue, is the presence of GM feed in animal production food chains, even though all livestock products are classed as GM free in Europe. This is because the modified genetic attribute (e.g. for herbicide resistance) is not present in the final food product despite it benefitting significantly from other GM materials in the supply chain. This is an important emergent issue in the food industry with respect to custody of responsible data use associated with products. In the case of herbicide resistance, there have been a number of recent cases at the level of State legislature in the USA that have tested this supply chain custody for GM use in foods11. The custody of supply chain data is now more robust than ever and it has been tested with respect to allergen management, financial irregularities, food fraud and so on. The feed example shows the operating environment has moved on regarding use of GM in foods – without a wider discussion of the potential to realise other opportunities and to consider ongoing challenges related to the use of GM in the food system. We can take this chain of custody further, of course, and for example include assays that utilise GM enzyme technology to measure speciation for authenticity and food fraud analysis. Food production would be seriously disrupted if GM free is a requirement for the whole supply chain. These circumstances could be counterproductive to the point of stifling innovation in the food and beverage industries. GM vs gene editing In the UK and the EU, organisms produced using gene editing techniques are classed as GMOs because the precautionary principle is applied, irrespective of the assessment of safety considerations and measurable impacts on the environment and food safety. In the EU, this position is currently under review because other countries, e.g. Japan12, base their food safety legislation on the safety of the end products of breeding programmes and not by the means the genetic changes are brought about. This is all highly controversial because food producers do not want to arouse the same suspicions about gene edited products as have been associated with transgenic products. It is important to consider CRISPR as a suite of gene editing tools that are relevant for tackling the problems of our future food system. Globalisation has seen the rise of agricultural economies in low and middle income countries that have transformed our worldview of agriculture and food. Climate change, coupled with changes in food production methods and a growing population have brought new issues that necessitate a more circular food economy and net carbon neutral outcomes. The 17 UN Sustainable Development Goals clearly build on eradicating hunger and poverty by aligning to fairness and equity in the use of global resources. They will not be achievable without the successful integration of accessible and assured technologies, such as gene editing, to deliver the necessary advances in food production and processing. Conclusions Food and beverage manufacturers are the ‘missing middle’ between agricultural production and retail/consumers; if they are not engaged in attempts to launch new products or ingredients using new genetic technologies, the opportunities will often be limited in scope. A constructive dialogue is needed to engage food manufacturers and consumers with the potential benefits from these technologies, which can help us to address some of the major challenges for the future food system. Gene editing, in particular, offers a fast, precise technique for making changes to the genome. Changes to European legislation governing gene editing could facilitate the introduction of this technology on a much wider basis, provided that consumers are involved and engaged with the potential benefits. Dr Wayne Martindale, Associate Professor in Food Insights and Sustainability at the National Centre for Food Manufacturing, University of Lincoln. Wayne leads the Food Insights and Sustainability Research agenda at NCFM, working with food and beverage manufacturers to deliver a carbon neutral or carbon zero food system. He's a Fellow of IFST and a science champion for nutrition for the STFC Food+ Network, which supports Early Career Researchers. Email wmartindale@lincoln.ac.uk Craig Duckham, Director of CD R&D Consultancy Services Ltd. Craig provides independent advice to businesses on food ingredients’ technologies. He obtained a PhD in Plant Physiology from the University of Nottingham and is a Fellow of IFST. Craig has over 20 years of technical development experience and has published on topics including plant metabolism, microencapsulation and the alternative uses of Brewer's yeast. Email craig.duckham@cdrnd.co.uk Web cdrnd.co.uk References 1Gracia-Romero, A., Kefauver, S.C., Fernandez-Gallego, J.A., Vergara-Díaz, O., Nieto-Taladriz, M.T., Araus, J.L. 2019. UAV and ground image-based phenotyping: a proof of concept with durum wheat. Remote Sensing 11: 1244Google Scholar 2Singh, D., Wang, X., Kumar, U., Gao, L., Noor, M., Imtiaz, M., Singh, R.P., Poland, J. 2019. High-throughput phenotyping enabled genetic dissection of crop lodging in wheat. Frontiers in Plant Science 10: 394Google Scholar 3Ye, H., Huang, W., Huang, S., Cui, B., Dong, Y., Guo, A., Ren, Y., Jin, Y. 2020. Recognition of banana Fusarium wilt based on UAV remote sensing. Remote Sensing 12: 938Google Scholar 4Van Brunt, J. 1987. Environmental release: a portrait of opinion and opposition. Nature Biotechnology 5: 558– 563Google Scholar 5Gilbert, N., 2013. Case studies: a hard look at GM crops. Nature 497: 24Google Scholar 6Strzyz, P. 2020. CRISPR–Cas9 wins Nobel. Nature Reviews Molecular Cell Biology 21: 714Google Scholar 7Nielsen, P.H., Oxenbøll, K.M., Wenzel, H. 2007. Cradle-to-gate environmental assessment of enzyme products produced industrially in Denmark by Novozymes A/S. The International Journal of Life Cycle Assessment 12: 432Google Scholar 8LCA from cradle to grave. https://www.novozymes.com/en/about-us/sustainability/lcaGoogle Scholar 9Al-Babili, S., Beyer, P. 2005. Golden Rice – five years on the road–five years to go? Trends in Plant Science 10: 565– 573Google Scholar 10Golden Rice Humanitarian Board. http://www.goldenrice.org/Content2-How/how4_regul.phpGoogle Scholar 11Adenle, A.A., Morris, E.J., Murphy, D.J., Phillips, P.W.B., Trigo, E. et al. 2018. Rationalizing governance of genetically modified products in developing countries. Nature Biotechnology 36: 137– 139Google Scholar 12Tsuda, M., Watenabe, K.N., Ohsawa, R. 2019. Regulatory Status of Genome-Edited Organisms Under the Japanese Cartagena Act. Frontiers in Bioengineering and Biotechnology 7: 387; https://doi.org/10.3389/fbioe.2019.00387Google Scholar Volume35, Issue3September 2021Pages 52-54 ReferencesRelatedInformation

Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union.

Advanced therapy medicinal products (ATMPs), such as gene therapies that consist of or contain genetically modified organisms (GMOs) need to comply with the European Union (EU) GMO legislation, as implemented in each EU Member State, before a clinical trial can commence. Complying with GMO requirements is complex, varies significantly across EU Member States and is leading to delays to clinical trials with ATMPs. Such delays and varying implementation of the GMO legislation makes the EU less attractive as a region to conduct clinical trials with investigational gene therapies. This is detrimental to EU patients, since their timely access to these transformative potentially curative medicines is delayed. Despite recent initiatives coordinated by the European Commission (EC) to facilitate and reduce discrepancies across the EU regarding the application of the GMO requirements, it remains particularly difficult to conduct multicenter clinical trials with ATMPs containing or consisting of GMOs involving several EU Member States. The recent decision for the EC to temporarily derogate potential coronavirus disease 2019 treatments and vaccines from some provisions of the GMO requirements was made on the basis of a clear recognition of such complexities and resulting delays to clinical development. The Alliance for Regenerative Medicine, the European Federation of Pharmaceutical Industries and Associations, and the European Association for Bioindustries call upon the EC, together with national competent authorities, to exempt ATMPs containing or consisting of GMOs from the GMO legislation. Such a simplification will eliminate the delays currently reported to occur when submitting environmental risk assessments and GMO applications to the national competent authorities. An exemption from GMO requirements will make the EU a more attractive region for clinical development of gene therapies and could accelerate European patients' access to these potentially life-saving medicines. Maintaining a system for GMO assessment that is different across countries may also prevent ATMPs from realizing the full benefits of a harmonized clinical trial approval process under the Clinical Trials Regulation. The undersigned organizations to this publication urge the EC to use its right of initiative to put forward a legislative proposal to exempt ATMPs in clinical development from the EU GMO legislation, within the timeframe proposed in the 2020 EU Pharmaceutical Strategy (by 2022). Implementation of a GMO exemption scheme before the end of the transition period for the Clinical Trial Regulation (the end of 2023) is important to avoid new Clinical Trial Application submissions for ATMPs under the Clinical Trial Regulation having to conduct the whole GMO assessment process in parallel. It is considered that ATMPs pose negligible risk to the environment. Such ATMPs include the following: human somatic cells modified ex vivo; recombinant virus-based vectors, including those containing genome editing nucleic acid sequences (which may also be delivered nonvirally); and bacterial vectors. Outside of controlled storage conditions, gene therapies cannot survive for any appreciable length of time. Upon clinical administration, any recombinant gene therapy viral vector particles that do not enter host cells are diluted within the body and if excreted are in such low multiplicity to no longer be viable or considered infectious to persons, animals, or living organisms within the environment. Any nucleic acids released into the environment are rapidly degraded.

Induced Genetic Variation in Crop Plants by Random or Targeted Mutagenesis: Convergence and Differences.

New Breeding Techniques (NBTs) include several new technologies for introduction of new variation into crop plants for plant breeding, in particular the methods that aim to make targeted mutagenesis at specific sites in the plant genome (NBT mutagenesis). However, following that the French highest legislative body for administrative justice, the Conseil d’État, has sought advice from The Court of Justice of the European Union (CJEU) in interpreting the scope of the genetically modified organisms (GMO) Directive, CJEU in a decision from 2018, stated that organisms modified by these new techniques are not exempted from the current EU GMO legislation. The decision was based in a context of conventional plant breeding using mutagenesis of crop plants by physical or chemical treatments. These plants are explicitly exempted from the EU GMO legislation, based on the long-termed use of mutagenesis. Following its decision, the EU Court considers that the NBTs operate “at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis.” In this paper, we argue that in fact this is not the case anymore; instead, a convergence has taken place between conventional mutagenesis and NBTs, in particular due to the possibilities of TILLING methods that allow the fast detection of mutations in any gene of a genome. Thus, by both strategies mutations in any gene across the genome can be obtained at a rather high speed. However, the differences between the strategies are 1) the precision of the exact site of mutation in a target gene, and 2) the number of off-target mutations affecting other genes than the target gene. Both aspects favour the NBT methods, which provide more precision and fewer off-target mutations. This is in stark contrast to the different status of the two technologies with respect to EU GMO legislation. In the future, this situation is not sustainable for the European plant breeding industry, since it is expected that restrictions on the use of NBTs will be weaker outside Europe. This calls for reconsiderations of the EU legislation of plants generated via NBT mutagenesis.

The EU regulatory framework on genetically modified organisms (GMOs).

The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.

Potential risk evaluation for unintended entry of genetically modified plant Propagating material in Europe through import of seeds and animal feed – the experience of Latvia

ABSTRACTSignificant attention has been drawn to the adventitious and technically unavoidable presence of genetically modified (GM) organisms in the food and feed imported into the European Union (EU), while the potential presence of GM seeds in material for cultivation is less studied. Here we report a study from an EU member state, Latvia, during years 2017–2018 regarding monitoring for the presence of GM seeds in certified seed and animal feed material. Eighty-two and 28 samples of seeds intended for cultivation were analyzed in 2017 and 2018, respectively. One soybean sample contained MON40-3-2 soybean seeds (0.09 ± 0.01%) and one maize sample contained MON810 maize seeds (0.08 ± 0.01%). In addition, 102 samples of feed imported from outside of the EU or produced locally were also analyzed for the presence of genetically modified organisms (GMOs) and viability of grains. One oilseed rape cake sample contained GT73 (1.04 ± 0.01%) and one soybean cake sample contained MON40-3-2 (<0.045%). One sample of declared MON40-3-2 GM soybean cake was confirmed to be positive, with MON40-3-2 content of 94.78 ± 10.01%. One soybean sample submitted by feed producer and originating from Argentina contained 54.9 ± 1.1% of MON40-3-2 and one rapeseed sample originating from Ukraine contained 5.30 ± 3.95% of GT73. Although only two seed samples contained low levels of GMOs authorized in the EU for food and feed uses, this study reinforced the need to maintain regular monitoring programs that assist farmers in their efforts to comply with the current EU GMO legislation.

The evolving EU regulatory framework for precision breeding

Plant breeding has always relied on progress in various scientific disciplines to generate and enable access to genetic variation. Until the 1970s, available techniques generated mostly random genetic alterations that were subject to a selection procedure in the plant material. Recombinant nucleic acid technology, however, started a new era of targeted genetic alterations, or precision breeding, enabling a much more targeted approach to trait management. More recently, developments in genome editing are now providing yet more control by enabling alterations at exact locations in the genome. The potential of recombinant nucleic acid technology fueled discussions about potentially new associated risks and, starting in the late 1980s, biosafety legislation for genetically modified organisms (GMOs) has developed in the European Union. However, the last decade has witnessed a lot of discussions as to whether or not genome editing and other precision breeding techniques should be encompassed by the EU GMO legislation. A recent ruling from the Court of Justice of the European Union indicated that directed mutagenesis techniques should be subject to the provisions of the GMO Directive, essentially putting many precision breeding techniques in the same regulatory basket. This review outlines the evolving EU regulatory framework for GMOs and discusses some potential routes that the EU may take for the regulation of precision breeding.

A Welcome Proposal to Amend the GMO Legislation of the EU

Is the European Union (EU) regulatory framework for genetically modified organisms (GMOs) adequate for emerging techniques, such as genome editing? This has been discussed extensively for more than 10 years. A recent proposal from The Netherlands offers a way to break the deadlock. Here, we discuss how the proposal would affect examples from public plant research.

Why Organic Farming Should Embrace Co-Existence with Cisgenic Late Blight–Resistant Potato

The EU regulation on organic farming does not allow the use of genetically modified organisms (GMOs) which are subject to Directive 2001/18/EC. Mutagenesis using irradiation or chemicals is genetic modification, but the organisms obtained through these techniques are not subject to the provisions of the GMO directive. Such mutants can therefore be used in organic agriculture. Derived from its basic principles, organic farming can only use natural substances to control disease and crops should be resilient, which, in the case of disease resistance, means that durable (horizontal) resistance is preferred to vertical (single gene) resistance. Cisgenesis can achieve such a durable resistance by introducing multiple resistance genes in one step. These multiple-resistant plants only contain natural genes that can also be introduced by breeding. In case cisgenic plants are not subject to the provisions of the GMO legislation, they can even be legally used in organic agriculture. In case they are not exempted from the GMO regulation, the question is: why obstruct a cisgenic potato crop that can hardly be distinguished from a potato crop that is the result of conventional breeding? Among the reasons why organic agriculture does not allow the use of GMOs it is mentioned that genetic engineering is unpredictable, it causes genome disruption and it is unnatural. However, our knowledge of plant genome evolution and breeding has increased dramatically. We now know that breeding is more unpredictable and causes more genome disruption than genetic engineering. Recent field trials have shown the efficacy of cisgenic late blight–resistant potatoes carrying multiple resistance genes. Large-scale growing of such durably resistant potatoes would not only be environmentally beneficial by it would strongly reducing the need for fungicide sprays in conventional potato cultivation and it would also reduce the disease pressure in organic potato cultivation.

Biotech Approaches to Overcome the Limitations of Using Transgenic Plants in Organic Farming

Organic farming prohibits the use of genetically modified organisms (GMOs) inasmuch as their genetic material has been altered in a way that does not occur naturally. In actual fact, there is a conventional identity between GMOs and transgenic organisms, so that genetic modification methods such as somatic hybridization and mutagenesis are equalized to conventional breeding. A loophole in this system is represented by more or less innovative genetic engineering approaches under regulatory discussion, such as cisgenesis, oligonucleotide-directed mutagenesis, and antisense technologies, that are redefining the concept of GMOs and might circumvent the requirements of the GMO legislation and, indirectly, of organic farming.

Systemic risks of genetically modified crops: the need for new approaches to risk assessment

Since more than 25 years, public dialogues, expert consultations and scientific publications have concluded that a comprehensive assessment of the implications of genetic engineering in agriculture and food production needs to include health, environmental, social and economical aspects, but only very few legal frameworks allow to assess the two latter aspects. This article aims to explain the divergence between societal debate and biosafety legislation and presents approaches to bring both together. The article reviews the development of biosafety regulations in the USA and the EU, focussing on diverging concepts applied for assessing the risks of genetically modified organisms (GMOs). The dominant environmental risk assessment methodology has been developed to answer basic questions to enable expedient decision making. As a first step, methodologies that take into account complex environmental and landscape aspects should be applied. Expanding the scope of risk assessment, more holistic concepts have been developed, for example the Organisation for Econonomic Co-operation and Development (OECD) concept of systemic risks which includes socio-economic aspects. International bodies as the OECD, the Convention on Biological Diversity (CBD) and the European Union (EU) have developed the Strategic Environmental Assessment (SEA) as an instrument that includes the additional aspects of risk assessment as demanded by many stakeholders. Interestingly, there had been no attempts yet to link the existing frameworks of GMO risk assessment and SEA. It is recommended to adapt current models of SEA to assess the systemic risks of GMOs. It is also suggested to revise the EU GMO legislation to promote the inclusion of SEA elements.

Applying Precaution in EU Authorisation of Genetically Modified Products—Challenges and Suggestions for Reform

AbstractIn this article, I endeavour to examine concrete challenges that arise with regard to implementation of the precautionary principle in the field of European Union regulation of genetically modified organisms (GMOs). Developed by the European courts into a general legal principle, precaution requires EU regulators to strike a balance between scientific and political legitimacy when taking decisions on risk‐entailing products. Following this understanding, the current GMO legislation creates precautionary governance structures that allow for a broad input into the authorisation process, not only of scientific, but also of ‘other legitimate factors’. At the same time, it can be criticised for narrowly defining precaution as a decision rule, which, if applied correctly, will lead the decision maker to the ‘right’ decision. I argue that this misconception is one of the reasons why, in the current authorisation practice, the EU institutions fail to apply the principle in a balanced way, falling into the extremes of either purely science‐based decision making or a highly politicised precautionary rhetoric. I suggest that in order not to be paralysing, precaution should be understood as a procedural principle that provides for precautionary governance, thus enabling regulators to make appropriate risk choices.

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.

Analytical Challenges: Bridging the Gap from Regulation to Enforcement

An overview is presented of the analytical steps that may be needed to determine the presence of genetically modified organisms (GMOs) or for analysis of GMO-derived produce. The analytical aspects necessary for compliance with labeling regulations are discussed along with bottlenecks that may develop when a plant product or a food sample is analyzed for conformity with current European Union GMO legislation. In addition to sampling and testing, other topics deal with complications that arise from biological and agricultural realities that may influence testing capabilities. The issues presented are intended to serve as elements to examine the different challenges that enforcement laboratories might face.