THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
‘New Breeding Techniques’ Qualify as Genetic Modification and Need Regulation
Over the last decade, there have been rapid developments in genetic engineering techniques including the increasing ability to make more complex changes to the genetic makeup and metabolic pathways of living organisms. One such new field of genetic engineering is the so-called ‘new breeding techniques’ (NBTs) or ‘new plant breeding technologies’ (NPBTs).
Currently, the European Commission is deciding whether or not the products of these techniques, when applied to plants, are covered by the EU laws on GMOs. The NBTs being considered are: zinc finger nuclease technology, oligonucleotide directed mutagenesis, cisgenesis/intragenesis, RNA-dependent DNA methylation, grafting (onto a GMO rootstock), reverse breeding, and agro-infiltration. Industry claims that these techniques and their products do not qualify as GMOs.
A report by Exonexus scrutinises these NBTs and finds that all of them, despite claiming great precision, are found to have off-target effects with unpredictable consequences and that they each carry inherent risks and uncertainties (Item 1). These effects include new environmental and health concerns beyond those associated with older GM techniques. The briefing concludes that there is a scientific case for classifying all these techniques as GM and regulating their use with as much rigour as previous and current GM techniques.
A fundamental concept in defining a GMO within both the Cartagena Protocol on Biosafety and the EU is that the genetic material has been directly modified using modern biotechnology, with an emphasis on the use of in vitro techniques. Another report by Greenpeace examines the definition of a GMO in this context, with a focus on whether plants developed using two NPBTs termed as “gene editing” (i.e. oligonucleotide directed mutagenesis (ODM)) and site-directed nuclease (SDN) as well as cisgenesis would qualify for exemption from EU GMO regulations (Item 2). The report concludes that these techniques are modern biotechnologies and should therefore be classified and regulated as GMOs.
The writers argue that there is little similarity between the processes of traditional mutagenesis and gene-editing techniques and therefore comparisons with the former do not provide a basis to exempt plants produced by these techniques from the EU GMO regulations. They recommend maintaining the current process-based approach to GMO assessment in the EU, which provides a basis for assessing any potential risks to food, feed and environmental safety arising from any unexpected and unpredictable effects. Exempting these techniques from GMO regulation would mean that such unexpected effects would remain undetected and unassessed, and that seeds, crops and food/feed produced through these techniques would not be labelled, impairing consumer choice.
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Third World Network
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Item 1
GENETIC ENGINEERING IN PLANTS AND THE NEW BREEDING TECHNIQUES (NBTS) – INHERENT RISKS AND THE NEED TO REGULATE
Dr. Ricarda A. Steinbrecher
EcoNexus
http://www.econexus.info/sites/econexus/files/NBT%20Briefing%20-%20EcoNexus%20December%202015.pdf
Summary and Conclusions
Over the last 5-10 years there have been rapid developments in genetic engineering techniques (genetic modification). Along with these has come the increasing ability to make deeper and more complex changes in the genetic makeup and metabolic pathways of living organisms. This has led to the emergence of two new fields of genetic engineering that overlap with each other: synthetic biology and the so-called New Breeding Techniques (NBTs). As regards NBTs, it is of concern that many efforts seem designed primarily to avoid having to go through the regulatory process for GMOs, whilst choosing names that make it difficult for the public to see that genetic engineering (genetic modification) is being used. This goes alongside efforts to weaken the precautionary principle, which is there to guard against adopting technologies that are considered likely to bring negative impacts on human and/or environmental health in the future. Currently there is a list of 7 “new” genetic engineering techniques before the European Commission, which is deciding whether or not the products of these techniques, when applied to plants, are covered by the EU GMO laws. Claims are being made by the industry either that they are not GMOs according to the current legal definition of a GMO, are made by techniques exempted from coverage, or that the final product, even if genetic engineering was used at some point during its development, does not contain GM material and so is no longer a GMO. The EC is currently working on the legal interpretation, as are many lawyers from industry and civil society. It is important to be aware – both in terms of legal interpretation and of risks – that some of these techniques may also be used in combination with each other or the same technique may be used several times over in order to achieve the intended effect. This briefing looks at these 7 techniques from the scientific rather than the legal perspective and aims to help readers to better understand the techniques and the inherent risks associated with them. Whilst examining the likely unintended effects it has become evident that all of the techniques claiming great precision are also found to have off-target effects with unpredictable consequences. In fact, so called precision is actually a very imprecise notion and does not equate to predictability. In conclusion, the seven new genetic engineering techniques referred to as NBTs each bring their own set of risks and uncertainties. Whilst many of these are the same as with older GM techniques there are also serious additional concerns, such as the potential environmental and health impacts of RNA dependent DNA methylation (RdDM). Equally a new degree of uncertainty and risk of unintended effects arise from the use of gene editing techniques (ZFN and ODM as well as CRISPR and TALENs). This briefing concludes that there is a scientific case for classifying all these techniques as GM and regulating their use with as much rigour as previous and current GM techniques.
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Item 2
APPLICATION OF THE EU AND CARTAGENA DEFINITIONS OF A GMO TO THE CLASSIFICATION OF PLANTS DEVELOPED BY CISGENESIS AND GENE-EDITING TECHNIQUES
Janet Cotter, Dirk Zimmermann and Herman van Bekkem
Greenpeace Research Laboratories Technical Report (Review) 07-2015
Executive Summary
In the EU, regulations have been devised to mandate the assessment of risks to the environmental, human food and animal feed safety arising from genetically modified organisms (GMOs). However, there is currently debate over whether, or which of, the new plant breeding techniques (NPBTs) under development would be classified as producing GMOs and whether any exemptions might apply. Here, we examine whether the NPBTs collectively termed “gene editing” techniques, i.e. oligonucleotide directed mutagenesis (ODM) and site-directed nuclease (SDN) techniques fall into the classification of a GMO within the EU. The grounds for any possible exemption of GM plants developed through cisgenesis from the EU GMO regulations are also discussed.
The techniques used to create a GMO are not exhaustively defined by the EU regulations. In the regulations, examples are given of techniques used at the time the regulations were devised in 2000/1. Although recombinant DNA has, to date, been the agent of direct modification in all commercially grown GM crops, in both the EU and Cartagena Protocol definitions, there is also an emphasis on the use of in vitro techniques where the modification is induced by heritable material that has been prepared outside the organism. In this analysis, we find that ODM and SDN techniques fall into the category of direct modification using in vitro techniques, and hence would be classified as a GMO according to the EU and Cartagena definitions. We find little similarity with traditional mutagenesis in the process of the modification, and argue that exemption based on a similarity to mutagenesis is not valid.
Like traditional genetic engineering techniques (including those used for cisgenesis/intragenesis), unintended changes to plant chemistry arising from the use of gene-editing techniques may result from: unforeseen interactions between the new or altered gene(s) and the plant’s endogenous genes; genomic irregularities arising from the genetic engineering process itself and unintended alterations to plant biochemical pathways arising from the changed or new function(s) of the altered or novel gene(s). Maintaining the EU process-based approach to GMO regulation (as distinct from product- or trait-based regulations) is important because it provides a basis for assessing any potential risks to food, feed and environmental safety arising from both intended and unintended changes to the plant arising from the genetic engineering process. Unintended changes could impact food, feed and environmental safety but there would be no requirement for these to be detected and assessed under a product based approach, or if such plants are exempt from the GMO regulations. Exemption from the EU GMO regulations would also exempt products of NPBTs from GMO labelling requirements, which could restrict, or remove, consumer choice.