Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?
In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.
Breyer
Didier
D
Scientific Institute of Public Health, Division of Biosafety and Biotechnology, Brussels, Belgium. didier.breyer@iph.fgov.be
Herman
Philippe
P
Brandenburger
Annick
A
Gheysen
Godelieve
G
Remaut
Erik
E
Soumillion
Patrice
P
Van Doorsselaere
Jan
J
Custers
René
R
Pauwels
Katia
K
Sneyers
Myriam
M
Reheul
Dirk
D
D000818:Animals; D030801:Animals, Genetically Modified; D005062:European Union; D005818:Genetic Engineering / Q000331:legislation & jurisprudence* / Q000379:methods*; D033161:Government Regulation; D007391:International Cooperation; D016296:Mutagenesis; D030821:Plants, Genetically Modified