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EU – ANTIBIOTIC MARKER USE SAFE
Statement of the GMO Panel on the safe use of the nptII antibiotic resistance marker
gene in genetically modified plants
European Food Safety Authority (press release), April 13, 2007,
http://www.efsa.europa.eu/en/science/gmo/statements0/npt2.html
The GMO Panel agrees with the EMEA that the preservation of the therapeutic potential of the aminoglycoside group of antibiotics is important. The Panel is also of the opinion that the therapeutic effect of these antibiotics will not be compromised by the presence of the nptII gene in GM plants, given the extremely low probability of gene transfer from plants to bacteria and its subsequent expression.
Furthermore, the GMO Panel considers it very unlikely that the presence of the nptII gene in GM plants will change the existing widespread prevalence of this antibiotic resistance gene in bacterial sources in the environment. The GMO Panel also points to evidence which indicates that integration of the nptII gene would only be one of many mechanisms by which bacteria could become resistant to aminoglycosides such as kanamycin.
Therefore, the GMO Panel reiterates its earlier conclusions (EFSA, 2004) that the use of the nptII gene as selectable marker in GM plants (and derived food or feed) does not pose a risk to human or animal health or to the environment. The GMO Panel also confirms earlier safety assessments of GM plants and derived food/feed comprising the nptII gene.
The GMO Panel emphasizes that the use of antibiotic resistance marker genes in GM plants has been the subject of several reviews (Gay and Gillespie, 2005, Goldstein et al., 2005, Miki and McHugh, 2004, Nap et al., 1992, Nielsen et al., 1998, Ramessar et al., 2007) and expert consultations: Working Party of the British Society for Antimicrobial Chemotherapy (Bennett et al., 2004), FAO/WHO Consultation on Foods Derived from Biotechnology (FAO/WHO, 2000), Scientific Steering Committee
of the European Commission (SSC, 1999) Zentrale Kommission für die Biologische
Sicherheit, DE (ZKBS, 1999), The Advisory Committee on Novel Foods and Processes, UK (ACNFP, 1996).
It has been concluded in these reports that the frequencies of gene transfer from plants to bacteria are likely to be extremely low and that the presence of antibiotic resistance marker genes, and in particular the nptII gene, in GM plants do not pose a relevant risk to human or animal health or to the environment.
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