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GM Micro-organisms containing an antibiotic resistance gene and approved or notified for marketing under Directive 90/220/EEC
(Last revised: December 4, 2002)
The most widely-used selectable marker in genetically-modified micro-organisms
(GMMs) is the resistance to antibiotics.
The risk of a possible escape of an antibiotic marker gene from a GMM to other
bacteria is significantly higher than the risk associated to the release of
transgenic plants tagged with an antibiotic resistance gene.
The last risk should be carefully evaluated on the basis of the genetics of
the marker (mobile genetic elements, chromosomal location), the targeted environment(s)
and the existence of a antibiotic-based selective pressure, the therapeutic
importance of the antibiotic or any other relevant criteria for protection of
human, animal or plant health and the environment .
The use of marker genes in GMOs as well as the methodologies available for
their monitoring have been subject to many studies carried out under successive
EC Framework Programmes for Research and Technological Development since 1985
(a comprehensive review of the results of EC-supported research into the safety
of Genetically Modified Organisms is available from the DG
Research Web Site).
The only GMM-based product containing an antibiotic resistant gene and approved
for commercialisation in Europe consists in a diagnostic kit to be used in the
dairy industry for rapid detection of antibiotic residues in milk. The genetically modified Streptococcus thermophilus strain
T102 is however contained in vials throughout the test and has no free entry
to the environment. The chloramphenicol acetyltransferase gene located on the
plasmid (pMJ723) harbouring the lux genes originates from the Streptococcus
agalactiae plasmid pIP501. This CAT determinant belongs to the pC221 subgroup
of CAT variants.
TABLE 1: GMM carrying an antibiotic resistance gene that has been notified and
approved for marketing in the European Union.
|
Application number |
Compagny |
GMO |
Traits |
Antibiotic resistance gene |
GenBank accession no. |
Commercial application |
EU decision |
|
C/FI/96/1NA |
Valio Oy |
Streptococcus thermophilus T102 |
Constitutive light production (affected by antibiotic residues) |
cat (chloramphenicol acetyltransferase) |
Diagnostic kit |
|