Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures.

INTRODUCTION: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA. AREAS COVERED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan. EXPERT OPINION: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.

Proficiency of European GMO control laboratories to quantify MON89788 soybean in a meat pâté matrix.

GMO control laboratories in the EU routinely monitor the presence and content of genetically modified organisms (GMOs) in food and feed products collected from the EU market. As the vast majority of GMOs comprize genetically modified plants, most control samples have a plant-based origin. For the first time, a pilot proficiency test was organised requiring the analysis of GMOs in a meat matrix. Meat pâté, a product in which soybean is occasionally identified, was spiked with GM soybean event MON89788, homogenised by mixing, aliquoted in sachets and frozen. The assigned value was determined by two independent expert laboratories. Several DNA extraction methods were tested and proved to be insufficient for the removal of PCR inhibitors present in the DNA extracts, resulting in a GM content underestimated by at least 30%. This problem was solved either by using hot-start qPCR chemistry or by applying the same method in a digital PCR format. A total of 52 laboratories participated in the study. They were requested to verify the presence of any GM soybean in the test item and to quantify the GM event(s) identified by their method of choice. All but one laboratory identified the MON89788 soybean event present in the pâté matrix. The majority of the quantitative results reported were below the assigned value, but did not deviate more than 50% from it. This study demonstrated the proficiency of most GMO control laboratories for the analysis of GMOs in a meat-based product. It also shows that method optimisation for GMO analysis in meat products is nevertheless advisable.

Assessing Effects of Genetically Modified Plant Material on the Aquatic Environment Using higher-tier Studies.

Genetically modified organisms are used extensively in agriculture. To assess potential side effects of genetically modified (GM) plant material on aquatic ecosystems, only a very small number of higher-tier studies have been performed. At the same time, these studies are particularly important for comprehensive risk assessment covering complex ecological relationships. Here we evaluate the methods of experimental higher-tier effect studies with GM plant material (or Bt toxin) in comparison to those well-established for pesticides. A major difference is that nominal test concentrations and thus dose-response relationships cannot easily be produced with GM plant material. Another important difference, particularly to non-systemic pesticides, is that aquatic organisms are exposed to GM plant material primarily through their feed. These and further differences in test requirements, compared with pesticides, call for a standardisation for GM-specific higher-tier study designs to assess their potentially complex effects in the aquatic ecosystems comprehensively.

Identification of Fish Species and Targeted Genetic Modifications Based on DNA Analysis: State of the Art.

Food adulteration is one of the most serious problems regarding food safety and quality worldwide. Besides misleading consumers, it poses a considerable health risk associated with the potential non-labeled allergen content. Fish and fish products are one of the most expensive and widely traded commodities, which predisposes them to being adulterated. Among all fraud types, replacing high-quality or rare fish with a less valuable species predominates. Because fish differ in their allergen content, specifically the main one, parvalbumin, their replacement can endanger consumers. This underlines the need for reliable, robust control systems for fish species identification. Various methods may be used for the aforementioned purpose. DNA-based methods are favored due to the characteristics of the target molecule, DNA, which is heat resistant, and the fact that through its sequencing, several other traits, including the recognition of genetic modifications, can be determined. Thus, they are considered to be powerful tools for identifying cases of food fraud. In this review, the major DNA-based methods applicable for fish meat and product authentication and their commercial applications are discussed, the possibilities of detecting genetic modifications in fish are evaluated, and future trends are highlighted, emphasizing the need for comprehensive and regularly updated online database resources.

Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies.

Genetic modification of living organisms has been a prosperous activity for research and development of agricultural, industrial and biomedical applications. Three decades have passed since the first genetically modified products, obtained by transgenesis, become available to the market. The regulatory frameworks across the world have not been able to keep up to date with new technologies, monitoring and safety concerns. New genome editing techniques are opening new avenues to genetic modification development and uses, putting pressure on these frameworks. Here we discuss the implications of definitions of living/genetically modified organisms, the evolving genome editing tools to obtain them and how the regulatory frameworks around the world have taken these technologies into account, with a focus on agricultural crops. Finally, we expand this review beyond commercial crops to address living modified organism uses in food industry, biomedical applications and climate change-oriented solutions.

Facile design of multifunction-integrated linear oligonucleotide probe with multiplex amplification effect for label-free and highly sensitive GMO biosensing.

Well-defined structures and compositions of nucleic acids afford oligonucleotide probes with unique chemical properties and biological functions for various biosensing applications. Herein, a unique and special oligonucleotide probe, named multifunction-integrated linear oligonucleotide probe (MI-LOP), was facile designed and reported for label-free and turn-on fluorescent detection of the codon component of genetically modified organisms (GMOs). The MI-LOP contains four different functional regions including recognition of target, serving as polymerization template, and creating polymerization primer-linked G-quadruplex (PP-G-quadruplex). Without the aid of any other oligonucleotides, the introduction of target DNA can make each function of the MI-LOP executed one-by-one, during which the species of target DNA, target analogue, and PP-G-quadruplex can be cyclically utilized and in turn induce a multiplex signal amplification responsible for substantial collection of the G-quadruplex moieties under isothermal conditions. The stable G-quadruplexes can combine with N-methyl mesoporphyrin IX (NMM) and function as efficient fluorescence light-up probes, rapidly leading to a dramatic increase in the fluorescence intensity for the amplified detection of the target codon component. Our results strongly demonstrate that the developed MI-LOP with multiplex amplification effect confers the sensing strategy a high sensitivity and specificity for quantitative and qualitative detection of the target codon. And it has also been successfully applied for analyzing target codon in the complex extractions of soybean. The achievements highlight the significance of using oligonucleotide probes as promising analytical tools to promote the basic biochemical research and help in food and environmental analysis.

Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies

Genetic modification of living organisms has been a prosperous activity for research and development of agricultural, industrial and biomedical applications. Three decades have passed since the first genetically modified products, obtained by transgenesis, become available to the market. The regulatory frameworks across the world have not been able to keep up to date with new technologies, monitoring and safety concerns. New genome editing techniques are opening new avenues to genetic modification development and uses, putting pressure on these frameworks. Here we discuss the implications of definitions of living/genetically modified organisms, the evolving genome editing tools to obtain them and how the regulatory frameworks around the world have taken these technologies into account, with a focus on agricultural crops. Finally, we expand this review beyond commercial crops to address living modified organism uses in food industry, biomedical applications and climate change-oriented solutions.

PEG-Delivered CRISPR-Cas9 Ribonucleoproteins System for Gene-Editing Screening of Maize Protoplasts.

Clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9 technology allows the modification of DNA sequences in vivo at the location of interest. Although CRISPR-Cas9 can produce genomic changes that do not require DNA vector carriers, the use of transgenesis for the stable integration of DNA coding for gene-editing tools into plant genomes is still the most used approach. However, it can generate unintended transgenic integrations, while Cas9 prolonged-expression can increase cleavage at off-target sites. In addition, the selection of genetically modified cells from millions of treated ones, especially plant cells, is still challenging. In a protoplast system, previous studies claimed that such pitfalls would be averted by delivering pre-assembled ribonucleoprotein complexes (RNPs) composed of purified recombinant Cas9 enzyme and in vitro transcribed guide RNA (gRNA) molecules. We, therefore, aimed to develop the first DNA-free protocol for gene-editing in maize and introduced RNPs into their protoplasts with polyethylene glycol (PEG) 4000. We performed an effective transformation of maize protoplasts using different gRNAs sequences targeting the inositol phosphate kinase gene, and by applying two different exposure times to RNPs. Using a low-cost Sanger sequencing protocol, we observed an efficiency rate of 0.85 up to 5.85%, which is equivalent to DNA-free protocols used in other plant species. A positive correlation was displayed between the exposure time and mutation frequency. The mutation frequency was gRNA sequence- and exposure time-dependent. In the present study, we demonstrated that the suitability of RNP transfection was proven as an effective screening platform for gene-editing in maize. This efficient and relatively easy assay method for the selection of gRNA suitable for the editing of the gene of interest will be highly useful for genome editing in maize, since the genome size and GC-content are large and high in the maize genome, respectively. Nevertheless, the large amplitude of mutations at the target site require scrutiny when checking mutations at off-target sites and potential safety concerns.

The Introduction of Thousands of Tonnes of Glyphosate in the food Chain-An Evaluation of Glyphosate Tolerant Soybeans.

Glyphosate-tolerant (GT) soybeans dominate the world soybean market. These plants have triggered increased use of, as well as increased residues of, glyphosate in soybean products. We present data that show farmers have doubled their glyphosate applications per season (from two to four) and that residues of late season spraying of glyphosate (at full bloom of the plant) result in much higher residues in the harvested plants and products. GT soybeans produced on commercial farms in the USA, Brazil and Argentina accumulate in total an estimated 2500-10,000 metric tonnes of glyphosate per year, which enter global food chains. We also review studies that have compared the quality of GT soybeans with conventional and organic soybeans. Feeding studies in Daphnia magna have shown dose-related adverse effects (mortality, reduced fecundity and delayed reproduction) of glyphosate residues in soybeans, even at glyphosate concentrations below allowed residue levels. We argue that GT soybeans need to be tested in fully representative and realistic contexts. However, the current risk assessment system has only required and received data from field trials with beans that were sprayed with much lower doses of glyphosate as compared to contemporary commercial farms. This has left knowledge gaps and a potentially serious underestimation of health risks to consumers.

Transgenic Plant Detection Using an AuNPs Based SPR Biosensor.

The intensive development and commercialization of genetically modified plants observed over the last decade has led to the development of transgenic detection methods that are rapid and sensitive. Among the strategies used for the detection/monitoring of genetically modified organisms (GMOs), surface plasmon resonance (SPR) meets the necessary criteria. This optical technique measures the changes in the refractive index in the vicinity of thin metal layers (i.e., gold) in response to biomolecular interactions occurring at a flat metal‒solution interface. Additionally, it allows the application of functionalized gold nanoparticles (AuNPs) in SPR research to enhance the signal intensity. In the present study, an SPR method, enhanced by the application of AuNPs, was developed to detect transgenic tobacco plants carrying a Streptococcus mutans antigen. The basis for the detection of the target DNA was the hybridization between the genomic DNA isolated from the leaves, stems, and roots of the transgenic tobacco and the biotinylated oligonucleotide probes immobilized onto a streptavidin (SA) sensor chip. SA-functionalized AuNPs coated with a second type of biotinylated probe were applied to increase the sensitivity of the detection method. Analysis of the results indicated that the constructed SPR-based sensor chip can potentially recognize complementary standard fragments (nonamplified genomic DNA) at concentrations as low as 1 pM. Thus, nonamplified transgenic DNA was detected using a label-free and real-time AuNPs-enhanced SPR biosensing method. This unique approach could be used to detect GMOs with high efficiency, even at a low detection limit, high repeatability, and with less time and a lower cost needed for each analysis.

Ultrafast, universal and visual screening of dual genetically modified elements based on dual super PCR and a lateral flow biosensor.

In this study, a cascade screening system has been developed combining Dual Super Polymerase Chain Reaction (DSPCR) with the universal Lateral Flow Biosensor (LFB) for the ultrafast, universal and visual screening of dual GM elements, taking P-35s × T-nos for example. In the design of DSPCR for universal screening, gene-specific forward primers were labelled with biotin and gene-specific reverse primers were tagged with Cy5 and digoxin, respectively. In 2.5-min, DSPCR effectively amplified the dual target fragments through our prototype facility. Then, through specific antigen-antibody binding, a universal lateral flow biosensor exported visually dual-amplified results simultaneously without cross contamination. After optimization, the detection limit allowed 0.05% GM maize, corresponding to nine copies in maize. The entire detection process could be achieved in 10 min without any large-scale instrumentation. This method may be useful for the ultrafast, universal and visual screening of dual GM elements (P-35s × T-nos) in GM crop lines and is expected to be of great promise for rapid GMO screening and point-of-care tests.

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2016-128).

Soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 (four-event stack soybean) was produced by conventional crossing to combine four single events: MON 87751, MON 87701, MON 87708 and MON 89788. The GMO Panel previously assessed the four single events and did not identify safety concerns. No new data on the single events have been identified that would lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological and allergenicity assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the four-event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack soybean, as described in this application, is as safe as and nutritionally equivalent to the non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable seeds of the four-event stack soybean into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack soybean. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack soybean is as safe as the non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 87427 × MON 89034 × MIR162 × MON 87411 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-144).

Maize MON 87427 × MON 89034 × MIR162 × MON 87411 (four-event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the four-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable grains of the four-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack maize and its subcombinations are as safe as its non-GM comparator and tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward.

A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome-edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case-by-case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process-based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.

Application of DNA- and Protein-Based Detection Methods in Agricultural Biotechnology.

DNA- and protein-based detection methods are widely used tools for monitoring biotechnology-derived crops and their products globally. Agricultural biotechnology companies, food/feed suppliers and supply chains, diagnostic testing companies, and regulatory authorities heavily rely on these two technologies for product development, seed production, compliance, and contractual needs. The primary use of DNA- and protein-based detection methods is either to verify the presence or absence of genetically engineered (GE) materials or to quantify the amount of GE material present in a product. This review describes key parameters of DNA- and protein-based detection methods, and thorough assessment of their applications and their advantage and limitations in agricultural biotechnology are discussed in detail. The review highlights the principle and considerations of detection method selection, which will equip users to choose suitable technology and obtain reliable test results. The review also compares the compatibility of the two technologies in GE product testing using a case study.

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.

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.

The contribution of transgenic and genome-edited animals to agricultural and industrial applications.

For centuries, animal breeders have intentionally selected the parents of the next generation based on their concept of the 'ideal' animal. The dramatic differences seen in the appearance and productivity of different breeds show the power of such selection on DNA sequence variations. Unfortunately, the global furore over the use of modern biotechnologies to introduce desired genetic variations into animal breeding programmes, and the regulatory uncertainty associated with these recombinant DNA techniques, has effectively precluded the use of these technologies in food animal breeding programmes. Ironically, many of these early transgenic animal applications targeted traits that favoured sustainability, such as disease resistance and decreased environmental impact. As a consequence, transgenic animals have had little opportunity to affect global agriculture, and only a handful of pharmaceutical applications have been successfully commercialised. New developments in genome editing hold considerable promise for targeting traits that improve both animal health and welfare, and frequently involve no introduction of DNA sequences from other species. Nonetheless, future global regulation and public acceptance of such methods remain uncertain. Proposals to regulate genome-edited animals based solely on the process used to influence DNA sequence variations (i.e. intentional genome editing) and any potential attendant risks, with no counterbalancing consideration of the ensuing benefits or risks associated with conventional selection programmes, will potentially forestall the use of genome editing in animal breeding programmes. No activity can survive a risk-only evaluation, and there are considerable opportunity costs associated with preventing breeders' access to safe technologies in order to achieve genetic improvements in livestock populations.

Pendant des siècles, les éleveurs ont exercé une sélection des reproducteurs au sein de leurs troupeaux afin de donner naissance à de nouvelles générations d'animaux correspondant à leur conception de l'animal d'élevage « idéal ¼. Les différences d'aspect et de productivité constatées entre les différentes races démontrent l'importance des effets de cette sélection sur les mutations des séquences d'ADN. Malheureusement, l'indignation planétaire suscitée par le recours aux biotechnologies modernes pour introduire des traits d'amélioration génétique chez les animaux d'élevage et les incertitudes sur la réglementation applicable aux techniques de l'ADN recombiné ont eu pour effet d'exclure l'utilisation de ces technologies dans les programmes d'élevage d'animaux destinés à la consommation humaine. L'ironie de la chose est que la plupart des premières applications recourant aux animaux transgéniques visaient à introduire des traits favorisant un élevage durable, par exemple des traits induisant une résistance contre certaines maladies ou permettant de diminuer l'impact environnemental des élevages. En conséquence, les conditions n'étaient guère réunies pour que les animaux transgéniques contribuent à transformer l'agriculture mondiale et seules quelques rares applications pharmaceutiques, ont pu être mises au point et commercialisées avec succès. Les récents développements de l'édition génomique ouvrent des voies extrêmement prometteuses pour cibler des traits permettant d'améliorer la santé et le bien-être des animaux, très souvent sans qu'il soit nécessaire d'introduire des séquences d'ADN provenant d'autres espèces. Néanmoins, des incertitudes subsistent sur l'évolution de la réglementation mondiale en la matière et sur l'acceptation sociale de ces méthodes à l'avenir. On peut donc s'attendre à ce que l'utilisation de l'édition génomique dans les programmes de sélection animale sera devancée par des propositions visant à la réglementer ; ces propositions ne prendront en compte que le processus induisant une modification ciblée de séquences d'ADN et les risques potentiels qui lui sont associés, sans les contrebalancer par un examen des bénéfices apportés ni des risques inhérents aux programmes de sélection classiques. Aucune activité ne peut survivre à une évaluation basée exclusivement sur les risques ; par ailleurs, les coûts d'opportunité induits par le fait d'empêcher les éleveurs d'accéder à des technologies sûres pour améliorer le patrimoine génétique des populations d'animaux d'élevage sont considérables.

Durante siglos, los criadores de animales han seleccionado intencionadamente a los progenitores de la siguiente generación en función de su concepción de animal «idóneo¼. Las espectaculares diferencias de aspecto externo y productividad que se observan entre las distintas razas ponen de manifiesto el poder de esta selección ejercida sobre las variaciones de secuencias de ADN. Lamentablemente, el clamor mundial contra el empleo de las modernas biotecnologías para introducir las variaciones genéticas deseadas en los programas de producción animal, sumado a las incertidumbres reglamentarias existentes en torno a esas técnicas de ADN recombinante, han obstaculizado el uso eficaz de estas tecnologías en programas de cría selectiva de animales destinados a la producción alimentaria. Irónicamente, muchas de esas primeras aplicaciones de animales transgénicos tenían que ver con rasgos que favorecían la sostenibilidad, como la resistencia a enfermedades o la reducción del impacto ambiental. Como consecuencia, apenas ha habido ocasión de que los animales transgénicos influyan en la agricultura mundial y solo se han comercializado con éxito un puñado de aplicaciones farmacéuticas. Las últimas novedades surgidas en la edición genómica parecen bastante prometedoras para actuar sobre rasgos que mejoren tanto la salud como el bienestar de los animales, a menudo sin que ello requiera la introducción de secuencias de ADN de otras especies. Sin embargo, sigue reinando la incertidumbre acerca del grado de aceptación pública y la futura reglamentación de tales métodos a escala mundial. Lo más probable es que las propuestas de reglamentar la cuestión de los animales obtenidos por edición genómica atendiendo únicamente al proceso empleado para obtener variantes de secuencias de ADN (esto es, la edición genómica deliberada) y a los eventuales riesgos conexos (sin tener en cuenta, en contrapartida, los consiguientes beneficios o riesgos asociados a los programas de selección convencionales) desemboquen en la imposibilidad de aplicar la edición genómica a programas de cría selectiva de animales. No hay actividad alguna que pueda superar el filtro de una evaluación basada únicamente en el riesgo, y el hecho de impedir que los criadores accedan a tecnologías seguras para lograr la mejora genética de sus poblaciones de ganado entraña importantes costos de oportunidad.

Exposure of livestock to GM feeds: Detectability and measurement.

This review explores the possibilities to determine livestock consumption of genetically modified (GM) feeds/ingredients including detection of genetically modified organism (GMO)-related DNA or proteins in animal samples, and the documentary system that is in place for GM feeds under EU legislation. The presence and level of GMO-related DNA and proteins can generally be readily measured in feeds, using established analytical methods such as polymerase chain reaction and immuno-assays, respectively. Various technical challenges remain, such as the simultaneous detection of multiple GMOs and the identification of unauthorized GMOs for which incomplete data on the inserted DNA may exist. Given that transfer of specific GMO-related DNA or protein from consumed feed to the animal had seldom been observed, this cannot serve as an indicator of the individual animal's prior exposure to GM feeds. To explore whether common practices, information exchange and the specific GM feed traceability system in the EU would allow to record GM feed consumption, the dairy chain in Catalonia, where GM maize is widely grown, was taken as an example. It was thus found that this system would neither enable determination of an animal's consumption of specific GM crops, nor would it allow for quantitation of the exposure.

Normative Criteria and Their Inclusion in a Regulatory Framework for New Plant Varieties Derived From Genome Editing.

Any legal regulation has to take into account fundamental interests and concerns, whether of private or public nature. This applies in particular to the politically and socially sensitive question of regulating plant biotechnology. With the advent of new breeding techniques, such as genome editing, new challenges are arising for legislators around the world. However, in coping with them not only the technical particularities of the new breeding techniques must be taken into account but also the diverse and sometimes conflicting interests of the various stakeholders. In order to be able to draft a suitable regulatory regime for these new techniques, the different interests and concerns at play are identified. Subsequently, a determination is made on how these interests relate to each other, before regulatory concepts to reconcile the conflicting demands are presented. The examined normative criteria, which can have an impact on regulatory decisions regarding genome edited plants and products derived from them, include: industry interests, farmer interests, public opinion, consumer rights and interests, human health and food safety, food security, environmental protection, consistency, and coherence of the regulatory framework and ethical or religious convictions. Since those interests differ from country to country depending on the respective political, economic, and social circumstances, the respective legislator has the task of identifying these normative criteria and must find a suitable balance between them. To this end, a concept is developed on how the different interests can be related to each other and how to deal with conflicting and irreconcilable demands. Additionally, a legislator may have recourse to a number of further analyzed regulatory measures. An approval or notification procedure can be used for a risk assessment or a socio-economic evaluation. Coexistence measures and labeling provisions are able to reconcile interests that are at odds with each other and the precautionary principle can justify certain safeguard measures. As a result, the individual country-specific regulatory outcomes regarding genome edited plants are likely to be as manifold as the interests and regulatory measures at hand.