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New Plant Breeding Techniques and Risks Associated with their Application.
Abstract and Figures
This study discusses new plant breeding techniques (NPBTs) and in particular issues relevant for the assessment of potential risk of crops developed by NPBTs. Such aspects are an emerging topic in the ongoing biosafety discussions at the European as well as global level.
The report provides an overview of different NPBT approaches and highlights specifics relevant for the consideration of potential adverse effects of the respective NPBT-crops. The study considers whether the current requirements for risk assessment of genetically modified organisms, e.g. as implemented in the EU, would provide an appropriate framework to address the potential risks of NPBT-crops. In addition a set of criteria for the assessment of NPBT-crops is discussed and open questions associated with the risk assessment of NPBT-crops are identified. The study thus provides input for the further discussion how to appropriately address biosafety issues of NPBT-crops for use in agriculture.
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... Zinc finger nucleases (ZFNs) are synthetic nucleases, which consist of two independent subunits and can introduce ds-breaks into target DNA after binding at a specific genomic locus as protein dimers. Similar as described for TALENs each subunit is composed of a DNA-binding domain and a nuclease domain (ECKERSTORFER et al. 2014). ...
... trees, grapevines) or crops with complex genetics, like a high polyploidy status, (e.g. barley) (ECKERSTORFER et al. 2014). Consequently cisgenesis/intragenesis is tested in particular in fruit trees, but also forest trees (e.g. ...
... According to VOGEL (2016) the earliest description of the concept of grafting on GM rootstocks was published in 1991. Testing on genetically engineered rootstock has been carried out on several plant species (references in VOGEL (2016) and (ECKERSTORFER et al. 2014): apple, cherry, grapevine, orange, plum, poplar, walnut, and watermelon. Moreover, the use of genetically engineered rootstocks has been investigated in cucumber, potato, pea, tobacco and tomato (review by (LUSSER et al. 2011a). ...
The question whether new genetic modification techniques (nGM) in plant development might result in non-negligible negative effects for the environment and/or health is significant for the discussion concerning their risk assessment. However, current knowledge to address this issue is limited for most nGMs, particularly for recently developed nGMs, like genome editing, and newly emerging variations of genome editing approaches, e.g. base editing. This leads to uncertainties regarding the risk/safety-status of plants which are developed with a broad range of different nGMs, especially genome editing, and other nGMs such as cisgenesis, transgrafting, haploid induction or reverse breeding.
A literature survey was conducted to identify plants developed by nGMs which might be relevant for future agricultural use. Such nGM plants were analysed for potential risk issues associated either (i) with the traits developed with nGMs and the intended use of the nGM plants or (ii) with unintended changes resulting from the nGMs or other methods applied during breeding.
In the future several traits are likely to become particularly relevant for nGM plants, namely herbicide resistance (HR), resistance to different plant pathogens as well as modified composition, morphology, fitness (e.g. increased resistance to cold/frost, drought, or salinity) or modified reproductive characteristics. Some traits such as resistance to certain herbicides are already known from existing conventional or GM crops. The previous assessment of such GM crops identified specific issues of concern and/or risks, such as the development of herbicide resistant weeds. Other traits contained in nGM plants are novel; meaning they are not present in agricultural plants which are currently cultivated. For some of these traits the underlying physiological mechanisms are not yet sufficiently elucidated. Characteristics of some genome editing applications, e.g. the small extent of genomic sequence change and their higher targeting efficiency, i.e. precision, cannot be considered an indication of safety per se, especially in relation to the novel traits created by such modifications. All nGMs considered in this study can result in unintended changes of different types and frequencies. However, the rapid development of nGM plants can compromise the detection and elimination of unintended molecular changes and the associated effects. Thus it is required to conduct a case-specific premarket risk assessment for nGM plants following the principles and approaches for the previous GMO, including an appropriate molecular characterization to identify unintended changes and/or confirm the absence of unwanted transgenic sequences. The study proposes a stepwise approach how such an assessment should be conducted and outlines which issues should be considered for the assessment.
... The type of donor determines the type of repair, insertion or replacement of a sequence within the DBS, correction of a base or deletion of a sequence. 9,27,30 The mutations lead to either knockout (KO) or knock-in (KI) of a gene or DNA sequence. ...
Novel genome editing techniques allow for efficient and targeted improvement of aquaculture stock and might be a solution to solve challenges related to disease and environmental impacts. This review has retrieved the latest research on genome editing on aquacultured finfish species, exploring the technological progress and the scope. Genome editing has most often been used on Nile tilapia (Oreochromis niloticus Linnaeus), followed by Atlantic salmon (Salmo salar Linnaeus). More than half of the studies have focused on developing solutions for aquaculture challenges, while the rest can be characterized as basic research on fish genetics/physiology or technology development. Main traits researched are reproduction and development, growth, pigmentation, disease resistance, use of trans-GFP and study of the omega-3 metabolism, respectively. There is a certain correlation between the species identified and their commercial relevance, indicating the relevance of most studies for present challenges of aquaculture. Reviewing geographical origin of the research, China has been in the forefront (29 publications), followed by the United States (9) and Norway (7). The research seems not to be dependent on regulative conditions in the respective countries, but merely on the purpose and objectives for the use of genome editing technologies. Some technical barriers identified in the studies are presented together with solutions to overcome these-off-target effects, ancestral genome duplication and mosaicism in F0. One of the objectives for use is the contribution to a more sustainable aquaculture, where the most prominent issues are solutions that contribute to minimizing impact on biodiversity.
... Thus, different sources of potential hazards need to be considered to assess whether applications developed by specific nGM approaches are associated with relevant risks (Eckerstorfer et al., 2014). Such hazards may be associated directly with specific new trait(s) e.g., herbicide resistance traits which are associated with adverse environmental impacts (Schütte et al., 2017). ...
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.
... Moreover, Germany's Central Committee on Biological Safety has classified organisms modified by means of NBTs such as ZFN and ODM as not being genetically modified (Federal Office of Consumer Protection and Food Safety [BVL], 2016), while the Swedish Board of Agriculture has concluded that products of CRISPR/Cas9 should not be subject to European GMO legislation (Umeå Plant Science Centre, 2016). Taking an opposite view, a legal analysis carried out by the German Federal Agency for Nature Conservation concluded that organisms produced using the new techniques fall within the scope of the EU's GMO legislation (BVL, 2016), and the Environment Agency of Austria has indicated that a case-specific risk assessment and the application of precautionary principle is necessary (Eckerstorfer, Miklau, & Gaugitsch, 2014). Beyond Europe, both the US Food and Drug Administration (USDA) and Department of Agriculture (USDA) have already approved the commercial production of a potato that contains no foreign DNA and uses an RNA interference technique to reduce the level of polyphenol oxidase responsible for bruising and browning (Waltz, 2012). ...
New breeding techniques (NBTs) are gaining greater uptake in plant breeding programs around the world, due to their greater precision and potential to reduce varietal development times. As the first products of research begin to enter the commercial domain, some of their technical and conceptual overlaps with GM biotechnology have become the focus of international discussions concerning their regulatory status. This review provides an insight into the mechanisms of NBTs, how their products may/may not differ from existing plant products which themselves may/may not be subject to government regulation, and whether a case can be made for them to fall under/escape GMO regulatory oversight. What is especially obvious is that until there is certainty of their regulatory status in key territories and regions, innovation in plant breeding risks stagnation, and both costly delays in market rollouts and trade disruptions are likely due to incompatible and non-harmonious regulatory practices and policies.
... Breeding techniques allow the creation and maintenance, over many generations, of desirable characteristics for better products. The techniques keep on evolving from previous artificial insemination where an embryo of desirable trait is transplanted from high quality female animal to low quality surrogate mother, to recently discovered technique, genetic engineering of livestock, in which genetic materials are transferred from superior animal to inferior animal (Eckerstorfer and Gaugitsch, 2014). In Tanzania, artificial insemination is practiced to improve animal products quality. ...
Tanzania is third country to have large livestock population in Africa. Despite such livestock wealth Tanzania has, the contribution of leather sector in national GDP is remarkably minimal. More efforts in improving leather value chain is very important to make the sector vibrant. Traditional based animal husbandry practices, poor slaughtering facilities, old technologies in both tanning and leather manufacturing industries are some of constrains along value chain that limit the development of Tanzania leather sector. Intervention by the Government and other leather stakeholders to improve leather value chain should be enhanced.
... Specific aspects relevant for the risk assessment of SDN and ODM crops can be summarized as follows: (i) the kind of DNA/genome or RNA/transcriptome modifications introduced into the host genome, (ii) the kind of traits generated by the application of such techniques, (iii) the presence of exogenous DNA or RNA sequences, and (iv) alteration in gene expression. Although some of these issues have been already addressed by EFSA Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease-3 and other Site-Directed Nucleases with similar function (EFSA, 2012), a more comprehensive analysis has been made by the Austrian Environmental Agency this year (Eckerstorfer et al., 2014). ...
Executive Summary
The new plant breeding techniques provide the emergence of novel products that challenges our current regulations and our management practices of what we traditionally have viewed as a genetically modified organism (GMO). International regulations, such as the Cartagena Protocol on Biosafety, operate with definitions of GMOs that may not be applicable to products arising from some of these new techniques. The question then arises on how society and regulatory bodies should view and regulate the products. This report does not approach that problem per se, but as a crucial step in management, we sum up the current scientific understanding of two new plant breeding techniques, site directed nucleases (SDN) and oligonucleotide directed mutagenesis (ODM). The underlying mode of action of both of these techniques are the plants natural repair systems and how this can be utilized to achieve genomic modifications. Herein also lies the main challenge for risk assessment - our limited knowledge about the function of these systems, factors involved and potential off-target effects.
This report aims at providing an overview of the current status of scientific knowledge concerning SDN and ODM. We have reviewed up to date peer reviewed scientific publications on the mechanisms and natural functions that are utilized by SDN and ODM techniques in an effort to understand potential risks such as unintentional changes in the genome of plants. Finally, recommendations for action are outlined.
SDNs
Site-direct nucleases are enzyme complexes that recognize specific DNA sequences in the genome and cleave them. The cleaved DNA is subsequently repaired by the organisms natural DNA repair systems. Currently, these enzymes are divided into four categories: meganucleases, zinc-finger, TALEN and CRISPR. The end product of the use of SDN techniques will largely depend on the design of the nuclease DNA recognition protein and the available template for repair. This report outlines potential unintended effects derived from the use of SDN that are mainly related to uncertainties regarding DNA target sequence specificity and DNA double-stranded break repair mechanism. There are several factors that influence both DNA binding and DNA repair, unfortunately they are to a large extent not fully understood. The lack of mechanistic understanding is a severe limitation for identifying potential hazards from SDNs and more research in this field is greatly recommended. Identifying unintentional effects in a system which is not fully understood becomes very difficult. However, using comprehensive untargeted profiling methods (such as omics) in order to detect and identify unintentional mutations with methodologies that are available today could minimize the potential hazards from SDN products.
ODM
Oligonucleotide-directed mutagenesis uses oligonucleotides to induce sequence specific mutations of native genomic sequences (i.e. genome editing). The introduced DNA is complementary to the genomic target sequence with the exception of a modification that usually is a deletion, insertion or a mismatch between the introduced synthesized DNA and the genomic DNA. There is scientific dispute on the DNA repair pathways and mechanisms that are induced, but briefly the cells DNA repair mechanisms detects the mismatch and repairs the genomic DNA using the introduced
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modified DNA as a template. There are some reports on collateral and unspecific background mutations as side effects, but several research groups highlighted the uncertainties regarding those studies. Unintended effects that are described as induced by ODMs are related to cellular death, unpredicted mutations, mutation inheritance discrepancies, and others.
In conclusion, the two techniques reviewed in this report are not fully scientifically understood and thus poses many uncertainties connected to mode of action as well as potential unintentional effects. The safety assessment of such products should take into account risks associated with other existing user practices and habits, and the sources and nature of uncertainty that could not be addressed during the preceding steps of the risk assessment.
Finally, several recommendations have been proposed for the development of future research to contribute to the better understanding of the modes-of-action of such techniques and also to seek fulfilling the biosafety knowledge gaps. Overall, the results of this report indicate that biosafety considerations regarding new plant breeding technologies could, in principle, be addressed by the general approach developed for conducting the risk assessment of genetically modified crops. However, it is important to understand that the limitation that resides in the current understanding of these techniques regarding their potential adverse effects. Therefore, according to the requirements of a scientifically based risk assessment and the application of the precautionary principle, further biosafety research is highly recommended.
Objectives and scope
The aim of this report is to provide an assessment and identification of scientific knowledge gaps and uncertainties that are related to two new emerging technologies for plant breeding. In this context, new emerging technologies for plant breeding are mainly about changing the process of creating a new crop rather than changes in the traits carried by these organisms.
Within the site-directed nuclease-based (SDN) group of methods we have focused on the zinc finger technology as well as giving an overview of the other SDNs and oligonucleotide-directed mutagenesis (ODM) techniques. We have chosen not to discuss possible implementation of regulation concerning products resulting from the utilization of these plant-breeding methods.
Because commercialized products from ODM and SDN are not yet available in the market, it is not possible to address realistic risk scenarios, as well as case examples, that are connected to the choice of method used to generate modifications to the host plant genome. In addition, SDN and ODM are methods that promote the integration of foreign DNA or the modification of existing plant DNA. In any given plant modified by SDN or ODM techniques, the connected risk assessment must also take into account the transformation method and possibly the plant regeneration method as well as the inserted or modified DNA. This report does not address those tightly connected methods due to the lack of products available on the marked today resulting from SDNs or ODMs.
As mentioned above, there is a lot of knowledge concerning the mechanism or mode of action of the nucleases and repair mechanisms activated that needs to be uncovered. The purpose of this report is to show in what area these knowledge gaps reside. Therefore, we have reviewed scientific evidence including latest findings concerning unintentional changes in the genome of plants induced by these
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techniques. Finally, the report provides insight into strategies for identification and management of these risks.
In addition, answers to the questions on the regulation of products from these new techniques, whether it falls within GMO legislation or not, were not within the scope of this report. However, this issue should be carefully taken into account not only to comply with national and international regulations but also to evaluate to what extent the precautionary principle should be invoked on products that might fall outside of existing safety regulations. The characteristics of these new crops and products may have adverse impacts in the environment, as well as socio-economic implications that have not yet been fully investigated.
The utilization of ODMs and SDNs is only one step in the generation of the final plant that will be grown in crop fields. Still there is the question of delivery of DNA/proteins to the cell and the generation of a plant from single cells. In addition crossing of the laboratory parental strain into elite crops raises the same issues as when generating elite crops from traditional genetic engineering, albeit with a much more difficult task of monitoring and detection.
In the EU, genetically modified organisms (GMOs) are subject to the authorization require-ments of Directive 2001/18/EC or Regulation (EC) No. 1829/2003. Application for authoriza-tion of a genetically modified plant requires description of identification and detection meth-ods. Those methods are used by control laboratories of the Member States to detect and identify genetically modified plants and to quantify their occurrence in food and feed. In its ruling of July 25, 2018 (C-528/16), the European Court of Justice determined that plants pro-duced with directed mutagenesis (genome editing) are covered by the regulations under Di-rective 2001/18/EC on the release and placing on the market of GMOs. For control laborato-ries this poses specific challenges for detection, identification and quantification of genome-edited plants.
Genome editing techniques allow targeted modifications at predefined sites in the genome of organisms. They belong to the "novel genomic techniques (NGT)", defined as “techniques capable to change the genetic material of an organism and that have emerged or have been developed since 2001”. The possible detection of genome-edited GMOs depends on the type of modification achieved and whether (transgenic) foreign DNA or genome-editing compo-nents may have been integrated into the plant genome. For detection, small mutations (point mutations) pose the greatest challenge. In this report, based on the currently used methods for the detection of classical GMOs, the existing possibilities and challenges for genome-edited plants are discussed.
Detection of even very small sequence differences, such as point mutations, is possible with the current technical equipment of a control laboratory. Optimization steps (primer/probe de-sign, thermal profiles) may be required to increase sensitivity. To transfer detection methods into routine operation, the methods have to be validated. A characteristic-unique modification or the combined detection of multiple modifications in a tested genome may allow the identi-fication of genome-edited plants. Quantification of these analytical results by currently avail-able methods is technically possible using certain approaches.
Accurate information on the modification made is the most important prerequisite for the de-velopment of methods for detection, identification and quantification of genome-edited GMOs. Such information could be gathered from publicly available sources. It is recom-mended combining information from different public documents, including scientific publica-tions, patents and regulatory documents from third countries. This information could be gath-ered in databases maintained by international organizations. Existing databases, such as the Biosafety Clearing House under the Cartagena Protocol on Biosafety or EUginius, could serve as a model for an international database for sharing information on globally marketed NGT products. It is recommended to establish such a database, maintained at the interna-tional level, to provide easy access for control laboratories to all relevant information.
In order to be able to establish the developed methods in the laboratory, and for control pur-poses, reference material is necessary (biological material and derived material; includes the genome-edited plant and/or the parental line/starting material). Upon application for food, feed, or cultivation purposes, the applicant shall provide reference material. For GMO without application, the availability of reference material can be ensured by a central body (e.g., the Joint Research Centre, JRC) in cooperation with the developers. If biological material is not available, plasmids with the corresponding DNA sequences can also be synthesized based on sequence information, if available, and serve as reference material.
Research is needed primarily in method development, characterization of genome editing applications (non-intended modifications, specificities, recognition sequences, etc.), and in the development of databases for pan-genomes to be used in control laboratories in the long term. It is recommended that this work be funded through European research funding pro-grammes and through mandates to JRC and EFSA.
This section provides a short review on perceptions and implementation of the precautionary principle in Bulgaria. It gives an overview of the legal status and applications of the concept and it explores how it is used in policies, strategies and administrative practices.
Plants, animals and microorganisms obtained by any type of genome editing technology (SDN-1, SDN-2, SDN-3, ODM) are regulated through the EU’s GMO regime. A judgment of the European Court of Justice in July 2018 provided regulatory certainty about their GMO status. It ended more than a decade of legal debates.
Abstract: Science of breeding is playing great role from the earlier to current in field of
agriculture to keep up the accessibility of food in the world. It is an art and a science
maybe which ought to also be added a business. Modern plant breeding is a discipline that
is firmly rooted in the science of genetics. As an applied science, breeders are offered
opportunities to apply principles and technologies from several scientific disciplines to
manipulate plants for specific purposes. This short note written on the title of “Plant
Breeding methods: In Brief for students” is most importantly used for under graduating
students taking the course plant breeding and others those interested to know the since of
plant breeding since there is brief and precise idea about the concept of plant breeding.
The material contains twelve chapters which are arranged fluently as the flow of the
theories and advancement of plant breeding. Basically the material focused on the
objectives and methods required to make improved crops. In each chapter there is unit
review and review questions for the understanding of the readers. At the end, there are
somehow discussed modern techniques used in the plant breeding programmes.
Keywords: Plants, Breeding, Methods, Genetics
The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of cisgenic and intragenic plants. The EFSA GMO Panel considers that the Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants are applicable for the evaluation of food and feed products derived from cisgenic and intragenic plants and for performing an environmental risk assessment and do not need to be developed further. It can be envisaged that on a case-by-case basis lesser amounts of event- specific data are needed for the risk assessment. The EFSA GMO Panel compared the hazards associated with plants produced by cisgenesis and intragenesis with those obtained either by conventional plant breeding techniques or by transgenesis. The Panel concludes that similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants. The Panel is of the opinion that all of these breeding methods can produce variable frequencies and severities of unintended effects. The frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case. Independent of the breeding method, undesirable phenotypes are generally removed during selection and testing programmes by breeders. The risks to human and animal health and the environment will depend on exposure factors such as the extent to which the plant is cultivated and consumed.
We investigated the impact of watermelon grafted onto Cucumber Green Mottle Mosaic Virus (CGMMV)-resistant transgenic watermelon rootstock on insects as non-target organisms in a greenhouse in 2005. We quantitatively collected insect assemblages living on leaves and flowers, and we used sticky traps to collect alate insects. We compared the patterns of insect assemblages and community composition, cotton aphid (Aphis gossypii Glover) on watermelon leaves and western flower thrip (Frankliniella occidentalis Trybom) on watermelon male flowers, between CGMMV-resistant transgenic watermelon (TR) and non-transgenic watermelon (nTR). Non-parametric multidimensional scaling (NMS) ordination verified that insect assemblages on leaves and sticky traps were different between TR and nTR (P0.05). Conclusively, TR watermelons appear to have some adverse effects on the population of cotton aphids on leaves and sticky traps, but watermelon male flowers do not show an adverse effect. Further research is required to assess the effect of TR on the aphid and western flower thrip. Life table experiments might support the specific reason for the adverse effects from leaf assemblages. Assessment of non-target impacts is an essential part of the risk assessment of non-target insects for the impact of transgenic organisms.
p>The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of plants developed using the zinc finger nuclease 3 technique (ZFN-3) which allows the integration of gene(s) in a predefined insertion site in the genome of the recipient species. Since other nucleases with a similar function to ZFN are considered in this opinion the term site-directed nuclease 3 (SDN-3) is used to describe the technique rather than ZFN-3 specifically. The EFSA GMO Panel considers that its guidance documents are applicable for the evaluation of food and feed products derived from plants developed using the SDN-3 technique and for performing an environmental risk assessment. However, on a case-by-case basis lesser amounts of event specific data may be needed for the risk assessment of plants developed using the SDN-3 technique. The EFSA GMO Panel compared the hazards associated with plants produced by the SDN-3 technique with those obtained by conventional plant breeding techniques and by currently used transgenesis. With respect to the genes introduced, the SDN-3 technique does not differ from transgenesis or from the other genetic modification techniques currently used, and can be used to introduce transgenes, intragenes or cisgenes. The main difference between the SDN-3 technique and transgenesis is that the insertion of DNA is targeted to a predefined region of the genome. Therefore, the SDN-3 technique can minimise hazards associated with the disruption of genes and/or regulatory elements in the recipient genome. Whilst the SDN-3 technique can induce off-target changes in the genome of the recipient plant these would be fewer than those occurring with most mutagenesis techniques. Furthermore, where such changes occur they would be of the same types as those produced by conventional breeding techniques.</p
This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with (1) problem formulation including hazard identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant, or its compatible relatives, including plant-to-plant gene transfer; (2) plant-to-micro-organism gene transfer; (3) interaction of the GM plant with target organisms and (4) interaction of the GM plant with non-target organisms, including criteria for selection of appropriate species and relevant functional groups for risk assessment; (5) impact of the specific cultivation, management and harvesting techniques; including consideration of the production systems and the receiving environment(s); (6) effects on biogeochemical processes; and (7) effects on human and animal health. Each specific area of concern is considered in a structured and systematic way following the above-mentioned steps (1 to 6). In addition, the guidance document is supplemented with several general cross-cutting considerations (e.g. choice of comparator, receiving environment(s), general statistical principles, long-term effects) that need to be considered in the ERA.
Introduction Induced mutation Interspecific and intergeneric hybridization Tissue culture Plant transformation Molecular markers in plant breeding Think questions