Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis

Andersson, Hans; Arpaia, Salvatore; Bartsch, Detlef K.; Casacuberta, Josep; Davies, Howard V.; Jardin, Patrick du; Flachowsky, Gerhard; Herman, Lieve; Jones, Huw; Kärenlampi, Sirpa; Kiss, J.; Kleter, Gijs; Kuiper, H.A.; Messéan, Antoine; Nielsen, Kaare Magne; Perry, J. N.; Pöting, Annette; Sweet, Jeremy; Tebbe, Christoph C.; Wal, Jean‐Michel

doi:10.2903/j.efsa.2012.2561

Cited by 120 publications

(33 citation statements)

References 161 publications

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“…EFSA has already conducted an initial evaluation for some nGM applications, i.e., plants developed through cisgenesis, intragenesis, and SDN-3 type applications of genome editing, as to whether and how specific risk issues should be considered for such nGM plants (EFSA–Panel on GMOs, 2012a,b). These studies should be revisited and used as input to develop robust risk assessment approaches for such applications.…”

Section: Risk Assessment Considerationsmentioning

confidence: 99%

An EU Perspective on Biosafety Considerations for Plants Developed by Genome Editing and Other New Genetic Modification Techniques (nGMs)

Eckerstorfer

Dolezel

Heissenberger

et al. 2019

Front. Bioeng. Biotechnol.

101

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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 regulation. However, current knowledge to address this issue is limited for most nGMs, particularly for recently developed nGMs, like genome editing, and their newly emerging variations, 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 are relevant for future agricultural use. Such nGM plants were analyzed for hazards associated either (i) with their developed traits and their use or (ii) with unintended changes resulting from the nGMs or other methods applied during breeding. Several traits are likely to become particularly relevant in the future 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 GM crops and their previous assessments identified issues of concern and/or risks, such as the development of herbicide resistant weeds. Other traits in nGM plants are novel; meaning they are not present in agricultural plants currently cultivated with a history of safe use, and their 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 novel traits created by such modifications. All nGMs considered here 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 effects. Thus, a case-specific premarket risk assessment should be conducted for nGM plants, including an appropriate molecular characterization to identify unintended changes and/or confirm the absence of unwanted transgenic sequences.

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Section: Risk Assessment Considerationsmentioning

confidence: 99%

An EU Perspective on Biosafety Considerations for Plants Developed by Genome Editing and Other New Genetic Modification Techniques (nGMs)

Eckerstorfer

Dolezel

Heissenberger

et al. 2019

Front. Bioeng. Biotechnol.

101

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“…Consequently, the question of whether non-transgenic plants should be excluded from the strict regulation of genetic engineering existed already before the advent of genome editing (Schouten et al, 2006; Conner et al, 2007, 351; Rommens et al, 2007, p. 402; Jacobsen and Schouten, 2008; Waltz, 2011, p. 677; European Food Safety Authority, 2012a). Therefore, genome editing does not only raise exclusively new regulatory questions, but is also used to put regulatory issues, which have existed before, on the agenda again.…”

Section: Demand For a Regulatory Overhaulmentioning

confidence: 99%

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

Hamburger

2018

Front. Bioeng. Biotechnol.

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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.

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“…Cisgenesis is very similar to breeding as, in both cases, only genes from the sexually compatible gene pool of the recipient plant are introduced. The European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms concluded that similar hazards can be associated with cisgenic and conventionally bred plants [22]. In case of cisgenesis, only the selected genes are introduced into the cultivar, without unwanted genes for toxicity or other undesirable traits such as bad taste.…”

Section: Cisgenesis Is Very Similar To Breeding the Main Differencesmentioning

confidence: 99%

“…Despite the fact that the EFSA Panel on Genetically Modified Organisms concluded that similar hazards can be associated with cisgenic and conventionally bred plants, their conclusion is that the same GMO legislations and procedures can be applied towards transgenic and cisgenic organisms [22]. It remains to be decided if current regulatory discussions will consider that cisgenic plants are not subject to the requirements of the GMO legislation because the same gene combination could, in principle, also be obtained by conventional breeding.…”

Section: Can Cisgenic Lbr Potatoes Not Be a Gmo?mentioning

confidence: 99%

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

Gheysen

Custers²

2017

Sustainability

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Abstract: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.

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Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis

Cited by 120 publications

References 161 publications

An EU Perspective on Biosafety Considerations for Plants Developed by Genome Editing and Other New Genetic Modification Techniques (nGMs)

An EU Perspective on Biosafety Considerations for Plants Developed by Genome Editing and Other New Genetic Modification Techniques (nGMs)

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

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

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