Should Novel Organisms Developed Using Oligonucleotide-mediated Mutagenesis Be Excluded from the EU Regulation?
Didier Breyer, Philippe Herman, Annick Brandenburger, Godelieve Gheysen, Erik Remaut, Patrice Soumillion, Jan Van
Doorsselaere, René Custers, Katia Pauwels, Myriam Sneyers and Dirk Reheul
INFORMATION SYSTEMS FOR BIOTECHNOLOGY
ISB News Report pp. 9-12 (Nov. 2009) at http://www.isb.vt.edu/news/2009/Nov09.pdf
(Thanks to Drew Kershen. )
In the European Union, genetically modified organisms (GMO) and genetically modified microorganisms (GMM) are defined respectively according to Directives 2001/18/EC1 on deliberate release of GMO and 2009/41/EC2 on the contained use of GMM. The definition of a GMO is both technology and process-oriented. A novel organism will fall under the scope of the GMO Regulation only if it has been developed with the use of certain techniques. The EU Directives therefore include annexes that give additional information regarding the techniques that result in genetic modification, that are not considered to result in genetic modification, or that result in genetic modification but yield organisms that are excluded from the scope of the Directives.
The underlying idea is that some processes of genetic modification are potentially associated with risks. This approach is now challenged with the emergence of new techniques for which it is not always clear whether the resulting organisms shall be subject to the prevailing European GMO legislation or not. In a recent paper published in Environmental Biosafety Research 3, we discussed in detail regulatory and safety issues associated with the use of Oligonucleotide mediated mutagenesis and provided scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation of GMOs.
Oligonucleotide-mediated Mutagenesis
Oligonucleotide-mediated mutagenesis (OMM) is a technique used to correct or to introduce specific mutations at defined sites of an episomal or chromosomal target gene. OMM is also referenced in the literature under other names, e.g., targeted nucleotide exchange, chimeraplasty, Oligonucleotide mediated gene repair, or targeted gene repair. OMM is mediated through the introduction of a chemically synthesized oligonucleotide (single-stranded DNA oligonucleotide, chimeric RNA/DNA or DNA/DNA, RNA oligonucleotide) with homology to the target gene, except for the nucleotide(s) to be changed. The mechanisms of action at the molecular level are poorly understood, but DNA repair enzymes are involved, and the process involves primarily the activation of the mismatch repair and/or nucleotide excision repair…..continued at link
References
EC (2001) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Off. J. Eur. Union L 106: 1-38
EC (2009) Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms. Off. J. Eur. Union L 125, 75-97
Breyer D, Herman P, Brandenburger A, Gheysen G, Remaut E, Soumillion P, Van Doorsselaere J, Custers R, Pauwels K, Sneyers M & Reheul D (2009) Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge? Environ Biosafety Res. DOI: 10.1051/ebr/2009007
BASF (2009) BASF and Cibus achieve development milestone in CLEARFIELD® Production System. http://www.basf.com/group/
pressrelease/P-09-119 (accessed August 25th 2009)
Nielsen KM (2003) Transgenic organisms – time for conceptual diversification? Nature Biotechnology 21, 227-228
COGEM (2006) New techniques in plant biotechnology (COGEM Report CGM/061024-02). Commissie Genetische Modificatie, The Netherlands. http://www.cogem.net/ (accessed August 25th 2009)
Jacobsen E, Schouten HJ (2008) Cisgenesis, a new tool for traditional plant breeding, should be exempted from the regulation on genetically modified organisms in a step by step approach. Potato Research 51, 75-88
