Dr. Dimitri GIOTAKOS 
Directorate-General for the Environment 
European Commission 
B-1049 Brussels 
Belgium 
Dimitri.giotakos@ec.europa.eu 

Markos Kyprianou Commissioner for Health 
European Commission 
Rue de la Loi 200 
B-1049 Brussels 
Belgium 
markos.kyprianou@ec.europa.eu 
00322950285 

Dr. Michael Fluh 
Directorate-General for Health 
European Commission 
Office B232 03/100 
1049 Brussels 
Belgium 
michael.flueh@ec.europa.eu 

Dear Sirs

In 1998 The Royal Society published “Genetically Modified Plants for Food Use” and warned that there is evidence that antibiotic resistance genes may be transferred to non-GM plants.  There is a significant risk that antibiotic resistance genes may progress through the food chain, possibly into pathogenic organisms causing human disease. The Royal Society  supported the UK Government’s advisory bodies in their conclusion that such markers should not continue to be used in the human or animal food chain.

The warning has not gone unnoticed by The British Medical Association (BMA), the professional medical body representing more than 120, 000 British doctors (80% of all medical practitioners). In 1999 the BMA’s Board of Science published “The Impact of Genetic Modification on Agriculture, Food and Health - an interim statement”. Its recommendations were clear for both professional and public opinion: “There should be a ban on the use of antibiotic resistance marker genes in GM food, as the risk to human health from antibiotic resistance developing in micro-organisms is one of the major public health threats that will be faced in the 21st Century. The risk that antibiotic resistance may be passed on to bacteria affecting human beings, through marker genes in the food chain, is one that cannot at present be ruled out.  Because of the potential scale of use of GM material in the environment and in the food chain, there is a need for a considerable strengthening of the UK disease surveillance systems, both in their scope and depth. Disease surveillance and event monitoring procedures will need to be sufficiently robust to deal with the potential emergence of new diseases associated with GM material which will be obscure and difficult to diagnose.“

In the August 2007 issue of “Applied and Environmental Microbiology” American Society for Microbiology  published a report pointing at other sources of antibiotic resistance genes proliferation even more serious than food supply: the migration of antibiotic resistance from animal feeding operations into groundwater, which has broad implications for human and ecological health.  The resistance genes were found diluted in contaminated wells away from the lagoons. But one gene known as tet(C) was found at higher levels in some of the groundwater wells than in the lagoon. Its heightened presence was not consistent with background levels, indicating that something in the environment was amplifying this one gene, which had originated in the lagoon. According to the researchers perhaps the gene had migrated to a new organism, to find a host that was more suited to conditions in the groundwater. "What we are seeing is that the genes can travel a lot further than the bacteria. It's a matter of getting the DNA into the right organism. It's a relay race." 

At a special briefing in the European Parliament in Brussels on 12 June 2007 scientists from six countries joined forces with Members of the European Parliament to call for a Europe wide and worldwide ban on growing GM crops. There I said: “The problems created by genetic engineering are global, it is the proliferation of a kind of biological weapon of mass destruction worldwide.” 

Quod erat demonstrandum.

dr Zbigniew Halat
medical doctor, consultant epidemiologist
CEO of Health Risk Management & Communication
Chairman of The John Snow International Society for Common Sense in Public Health 
President of Association for Protection of Consumers Health
Founder of The Dr Halat Water Institute
Former Deputy Minister of Health in first three non-communist governments of post-war Poland
 

European Medicines Agency 

EMEA/CVMP/56937/2007- Final 
22 February 2007 

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE 
AND COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE 
 

Presence of the antibiotic resistance marker gene nptII in GM plants for food and feed uses 

Background 

In a letter dated 25 January 2007, Mr Robert Madelin from the Directorate General for Health and Consumer Protection of the European Commission informed the EMEA that the Commission was onsidering the authorisation for the placing on the market of the genetically modified potato line EH92527-1 which contains a genetic modification that harbours an nptII gene as a selectable marker. This gene codes for neomycin phosphotranserase, an enzyme that generally confers resistance to several antibiotics, the most relevant ones being kanamycin, neomycin, paromycin, butirosin, gentamicin B and geneticin. In its opinion on the application for placing on the market of the genetically modified potato EH92-527-1, the GMO Panel of the European Food Safety Authority (EFSA) concluded that the use of nptII as a selection marker does not pose a risk to the environment or to human and animal health. 

As indicated in his letter, the Commission representative is seeking confirmation from EMEA as to whether, notwithstanding the WHO classification, the current or possible uses of the antibiotics for which the nptII gene confers resistance are in line with the opinion of the GMO Panel of EFSA indicating that these antibiotics have no or only minor therapeutic relevance in human medicine and only restricted use in defined areas of veterinary medicine and, if not, whether the current or possible medicinal uses might have an impact on the conclusions of the EFSA GMO Panel. 

In his response letter dated 6 February to Mr Robert Madelin, Dr Thomas Lönngren, the executive director of the EMEA commented that the scientific committeees of the EMEA would be able to comment comprehensively in relation to the issue of possible uses of these antibiotics in human an veterinary medicine. However, it was felt to be more appropriate for EFSA to possibly reconsider the conclusions of the panel in view of any new information provided by the EMEA scientific committees. 

CHMP and CVMP overall conclusions 

The following is based on the assumption that the substrate specificity of the product of the nptII gene used as a marker in the potato in question is restricted to neomycin and kanamycin (and geneticin), as stated in the opinion published in the EFSA journal (2004) 48:1-18., and does not extend to gentamicin. This point is important due to different medical uses of these antibiotics. 

1. Human medicines considerations 
The therapeutic relevance of kanamycin and neomycin in human medicine has been addressed by the GMO panel of EFSA. The EMEA/CHMP can add the following points to that opinion. In summary these points consider a more long-term view recognising the potential development in the aminoglycoside class indicating that the role of these medicinal products might become increasingly relevant. 
..• As indicated in the report from the EFSA, Neomycin is indicated in important clinical conditions such as for example in hepatic encephalopathy. 

more: 
EMEA/CVMP/56937/2007
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK 
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47
E-mail: mail@emea.europa.eu http://www.emea.europa.eu