GM Free Cymru


Open Letter

Dr Herman Koeter
Acting Chief Executive
EFSA Management Board

27th February 2006

Dear Herman


I had not realized that today is the last day for the submission of comments on the Evaluation Report. I have therefore submitted some comments from GM Free Cymru through the EFSA web site, and I hope that these comments will be taken into account by your Management Board and by your consultants when they draw everything together.

There was not much room in the dialogue box for anything other than a few brief comments. So I therefore ask you to pass on to your consultants the following points, for their consideration. They arise partly from our perusal of the EFSA web site and the "opinions" of the GMO Panel, and partly from the presentations by you and your colleagues at our meeting in Parma on 22nd February. That was a very enlightening meeting, and we thank you for the opportunity to attend; but my colleagues and I are now extremely concerned about the manner in which the GMO Panel "conducts its science".

Sadly, we cannot accept that the GMO Panel undertakes "excellent science", and our fundamental concerns are outlined under Appendix A below (our observations and our perceptions as to current practice within the GMO Panel and within the EFSA Management Board). That might be quite enough to be going on with, but we also note the manner in which your scientific attitudes and methods appear to be going down a new route which is nothing short of dangerous. We have made honest assessments of the manner in which EFSA's GMO Panel is shifting its stance, and the trends which we identify below, in Appendix B, should be of profound concern to the European Parliament and to all European consumers.

Minutes, published opinions etc might look impressive and "scientific" at first glance, but we fear that until a wide range of highly unprofessional practices are abandoned, we will continue to see scientific fraud within EFSA on a substantial scale. We do not know why the Panel has got itself into this mess, but we assume it is because Panel members have not exercised due diligence in the assessment of dossiers placed before them, because they are overworked, because they are predisposed to "think positively" about GMOs, and because there are immense political pressures on all of you to deliver positive opinions on GMOs.

We are sure that you are all honest scientists and people of integrity; but we fear that there is a corporate culture within the GMO Panel which leads to bad science and an acceptance of perverted or distorted scientific investigations.

We ask for your detailed response to all of the points made in Appendix A and Appendix B. We also trust that these responses, and the actions which you and your colleagues now propose to take in order to rectify the situation, will feed into the evaluation process.

Yours sincerely,

Dr Brian John
GM Free Cymru


APPENDIX A: current concerns about EFSA’s conduct of Science

1. EFSA uses a great many assumptions in its assessments of GMOs, but never identifies them or justifies them. This is indicative of woolly thinking and bad science. The assumptions are almost always related to the perceived "lack of harm" of GM products.

2. EFSA never recognizes or states the uncertainties which are inevitable in this controversial field of science. In its determination to come to positive opinions on GMOs the GMO Panel appears to pride itself on making robust statements on the applications it considers, no matter how shaky the evidence in the supporting dossiers may be.

3. EFSA makes very premature judgements on GM varieties on the basis of inadequate data -- and then goes into "defensive mode", refusing to revisit past opinions or to take into account new and relevant science.

4. EFSA never makes use of the precautionary principle, and where it is invoked in support of national bans (for example by Austria, Greece, and Hungary) it vigorously opposes those who talk of scientific uncertainties and who urge caution.

5. EFSA's assessments of allergenicity risks falls far short of the standards required, and although it prides itself on making "case by case" assessments, it does not ask for assessments of the actual proteins which are expressed in GM crops.

6. EFSA does not appear to take seriously recent very dramatic and significant research results, for example associated with the GM pea study in Australia.

7. EFSA does not insist on accurate declarations of interest from members of its GMO Panel, so that the Panel is dominated by scientists who have a powerful vested interest in the continuation of the "GM enterprise."

8. There is too much overlap between the memberships of national advisory committees and the GMO Panel, so that members are able both to make recommendations and to assess them. This practice is totally unacceptable.

9. EFSA is apparently quite unconcerned that almost all of the GM science which comes before the GMO Panel is "advocacy science" produced specifically by GMO applicants in order to verify assumptions of safety and in order to obtain consents. this means that the science is at best selective and at worst corrupt. EFSA appears to make no allowance for this, when scepticism is clearly called for.

10. EFSA assesses and accepts a great deal of science (contained in GMO dossiers) which is non-replicable since Monsanto, Syngenta and other applicants will not allow feeding and other experiments to be repeated by independent research teams. (They simply refuse to allow their seeds or other reference materials to be used by others.) Since a fundamental principle of science is that experiments should be replicable, all of this science should therefore be dismissed out of hand.

11. EFSA does not apply the same "standards of scrutiny" to all of the scientific papers which it assesses. Papers which are "reassuring" and which reinforce assumptions of GMO safety are accepted without question, while papers which seem to indicate harm associated with GMOs are subjected to detailed and aggressive examination. This is unscientific and dangerous.

12. The treatment of outside experts by the GMO Panel leaves much to be desired. It is apparent that experts who question the assumptions of the GMO Panel (for example, Dr Arpad Pusztai, employed by the German authorities on the case of MON863) are disregarded, while others are specifically employed by the Panel in order to reinforce its own views.

13. EFSA accepts large numbers of studies which purport to demonstrate nutritional equivalence between GM and non-GM varieties, but fails to take into account the fact that such studies do NOT demonstrate lack of toxic effects following ingestion.

14. EFSA never appears to have questioned the scientifically nonsensical concept of substantial equivalence, which means that it works to a ruling hypothesis that is profoundly dangerous.

15. EFSA does not allow public access to dossiers prior to the forming of its "opinions", nor does it invite informed comment from interested parties. Indeed, it appears to be obsessed with secrecy, and places many obstacles in the way of NGOs and independent experts who wish to assess the quality of GMO applications.

16. The Cartagena Protocol explicitly states that “lack of scientific certainty” about potential risks of biotech products “shall not prevent” a member nation like Hungary from banning the importation of a given biotech product. EFSA appears not to recognize national rights in this area, and seeks always to represent national GM bans as unscientific aberrations.

17. EFSA has obligations under the Aarhus Convention relating to public access to documents, assistance and cooperation with NGOs, and public participation in decision making. To quote the EC: "Public participation is a process that allows for the information provided by those concerned and their views to be taken into account at the earliest possible stage in the political decision-making process." Eight years after the signing of the Convention by the EU, EFSA still appears to be unaware of its provisions or unwilling to take action.


APPENDIX B: perceived trends in EFSA’s scientific methods

1. Terms like "harm" and "adverse effects" are being subtly redefined so that the intentions of Directive 2001/18/EC are being effectively undermined. Zero tolerance of GM pollution is now being replaced by contamination tolerance at whatever level EFSA deems appropriate.

2. Scientific evidence, the basis of all good science, is quietly being moved to one side and replaced by something called "expert judgment" exerted by the so-called experts who work for the GMO Panel.

3. There is no sign that EFSA is prepared to move on such matters as defining assumptions and identifying and listing uncertainties. You, as Acting Executive Director of EFSA, appear to see it almost as a mission to make clear and unequivocal decisions on GMOs and to remove any grey areas from the "opinions" of the GMO Panel.

4. In a grudging acceptance that "risk assessments" have to be done on GMOs, EFSA has devised a cunning plan by which national authorities will bid for risk assessment work, with their bids judged on the basis of competence, resources, past experience etc. In this way, the work can be placed with national authorities whose cooperation can be counted on......

5. Terms like "reassurance studies" and "added value" are now being used by EFSA, emphasising that the GMO Panel is looking for confirmations of the safety of GMOs and is tending to look upon "uncomfortable" studies as having no added value. The ruling hypothesis of "no GM harm" is alive and well.

6. It was clear at the meeting that EFSA accepts routinely the "science" submitted in application dossiers by the GM corporations, in the full knowledge that all submitted papers are produced with advocacy and verification in mind and that all experiments are non-replicable. According to the long-established standards of good science, all of these materials should be rejected.

7. It also became clear at the meeting that EFSA has never asked the GM corporations for unequivocal statements that they will release seeds and other GM reference materials for independent research. The research agenda is therefore controlled and corrupted, with EFSA's connivance.

8. The term "biological relevance" is now being used by EFSA in a none-too-subtle fashion, again in order to lift contamination thresholds. Thus a GMO can be allowed to spread into the environment and to become persistent and invasive, but EFSA can still deem this to be be acceptable if the incident is considered by its GMO Panel to have "no biological relevance."

9. Much work is currently going into "post market environmental monitoring", which is in effect an admission that there are going to be massive unauthorised releases of GMOs into the environment and that another cunning plan needs to be devised for PR purposes. There appears to be no strategy for the prevention of unauthorised releases.

10. The environment is now looked upon by EFSA not as something to be protected but as something in a constant state of flux, with a multitude of changes going on all the time. Thus if GMOs are introduced into wilderness or farmland, that is just another change requiring just another management strategy. Thus the intention of Directive 2001/18/EC is again effectively undermined.