title: Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?
abstract: 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.
authors.affiliation: Scientific Institute of Public Health, Division of Biosafety and Biotechnology, Brussels, Belgium. didier.breyer@iph.fgov.be
authors.forename: Didier
authors.initials: D
authors.lastname: Breyer
authors.forename: Philippe
authors.initials: P
authors.lastname: Herman
authors.forename: Annick
authors.initials: A
authors.lastname: Brandenburger
authors.forename: Godelieve
authors.initials: G
authors.lastname: Gheysen
authors.forename: Erik
authors.initials: E
authors.lastname: Remaut
authors.forename: Patrice
authors.initials: P
authors.lastname: Soumillion
authors.forename: Jan
authors.initials: J
authors.lastname: Van Doorsselaere
authors.forename: René
authors.initials: R
authors.lastname: Custers
authors.forename: Katia
authors.initials: K
authors.lastname: Pauwels
authors.forename: Myriam
authors.initials: M
authors.lastname: Sneyers
authors.forename: Dirk
authors.initials: D
authors.lastname: Reheul
mesh_terms: 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