Two new scientific reports on the new gene editing and plant breeding techniques say they’re still GM and still risky, and that their products must carry a GM label

New gene editing and plant breeding techniques are being hyped as more precise and safer than old-style GM techniques, and lobbyists are trying to get the products of these new techniques exempted from Europe’s GMO regulations.

If they succeed, these GM products won’t carry a GM label.

Two excellent new reports explain how these new techniques work, what risks they carry, and why they result in GMOs that must be labelled. The reports are technical but clear and accessible to the non-scientist, and will be useful at the scientific/political level.

We hope too that journalists will read these reports before falling for the GMO lobby’s self-serving hype that the new breeding techniques are precise, predictable, and safe, and shouldn’t be labelled as GM.

1. Genetic engineering in plants and the “New breeding techniques (NBTs)” – Inherent risks and the need to regulate – EcoNexus Briefing
2. Application of the EU and Cartagena definitions of a GMO to the classification of plants developed by cisgenesis and gene-editing techniques – Greenpeace Technical Report
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1. Genetic engineering in plants and the “New breeding techniques (NBTs)” - Inherent risks and the need to regulate

Dr Ricarda Steinbrecher
EcoNexus, December 2015
http://www.econexus.info/sites/econexus/files/NBT%20Briefing%20-%20EcoNexus%20December%202015.pdf

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 (NBTs) 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.

These techniques 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. 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.
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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, 2015
http://www.greenpeace.to/greenpeace/wp-content/uploads/2015/11/Application-of-GMO-definitions-to-plants-developed-by-cisgenesis-and-gene-editing-techniques.pdf

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.