Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts

Thorben Sprink,Frank Hartung,Joachim Schiemann,Dennis Eriksson

doi:10.1007/s00299-016-1990-2

Thorben Sprink, Frank Hartung + Show 2 more

Open Access

https://doi.org/10.1007/s00299-016-1990-2

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Abstract

Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.

Highlights

The development of plant breeding methods in modern times is always preceded by scientific progress
In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be interpreted more in relation to the resulting product
Scientific progress has since provided us with a wealth of knowledge about the genetic structure of, inter-relationship between, and exchange of genetic material between a multitude of organisms from all major kingdoms, such as plants, animals, fungi and bacteria

Summary

Introduction

The development of plant breeding methods in modern times is always preceded by scientific progress. Besides providing the same legal interpretation, it includes RdDM as a genetic engineering technique (Spranger 2015; Table 1) Both legal analyses interpret the Directive 2001/18/EC as strictly process-based and state that all NPBTs make use of recombinant DNA and have to be regulated as GMOs, regardless of whether a stable transformation occurred or the ability of the nucleic acid to replicate in a living cell. The oligonucleotides used in the ODM technique, with the exception of one or a few nucleotides, are identical to the corresponding site in the genome of the treated plant cells and, do not represent new combinations in the sense of new arrangements of genomic sequences.’’ In addition, the BVL interprets the Directive 2001/18/EC as both process- and product-based: ‘‘It cannot be derived from the wording of Article 2(2) that the GMO definition covers only the process by which the genetic modification is induced. This valuable procedure will save an enormous waste of time and effort for both developers/researchers and regulators (Whelan and Lema 2015) and will provide the legal certainty which is missed in Europe to date

Conclusions and perspectives

Compliance with ethical standards