GM Free Cymru

Correspondence with the Commission about EFSA, December 2012

This correspondence started with a complaint from GM-Free Cymru about the extraordinary (and even bizarre) tactics employed by EFSA in its frantic attempt to discredit the long-term Seralini study on the toxic effects of NK603 maize and Roundup herbicide. We laid some serious charges at EFSA's door, and after a delay of two months the Commission sprang to EFSA's defence, reiterating the tired old point that DG-SANCO has total confidence in everything EFSA does and in all their decisions and recommendations relating to GMOs. This correspondence overlapped with the departure of John Dalli, the arrival of Tonio Borg, and Brian's appearance at the Petitions Committee on 3rd December. Here is the correspondence, for the record.

(3) Sent to Commissioner Tonio Borg DG-SANCO European Commission Brussels

Trefelin, Cilgwyn, Newport, Pembrokeshire SA42 0QN Wales.

19th December 2012

Dear Commissioner Borg,

Thank you for your response (dated 11th December) to my message of 9th October addressed to President Barroso. I note that it was signed by Joanna Darmanin, your Head of Cabinet.

I fear that our concerns about the unhealthy relationship between DG-SANCO and EFSA are not at all allayed by the contents of your letter. I refer to the following points:

1. In your first paragraph, you refer to the "independent assessments" of the Seralini study conducted by the various national risk assessment agencies of Germany, Netherlands, France, Denmark and Belgium. They may well have ben mandated by their national governments to conduct the assessments. That is not the point at issue. The point we are trying to make is that these agencies were effectively hand-picked by EFSA because they could be guaranteed to follow the line which they agreed during their teleconference and no doubt during other conversations of which we have no record. How were the views of the other 22 national governments and safety agencies canvassed? We know for a fact that not all of them by any means would have agreed with the EFSA assessment, and indeed even within the countries which you mention there have been "official" expressions of concern at the hasty and unscientific tactics used by EFSA to discredit a ground-breaking study in a peer-reviewed journal.

2. Your second paragraph is disingenuous. You know full well that you are referring to the "published findings of the SELECTED Member State evaluations" and ignoring any dissenting or precautionary ones. The point about the release of the experimental data is a very strange one, since you know that Prof Seralini and his team will not release their experimental data until and unless EFSA does the same. EFSA claimed recently that it HAD released into the public domain all the experimental data in its possession relating to the NK603 feeding trials -- but it transpired that there was no trace, in this "released data", of the material relating to toxicity studies. So either EFSA is telling a lie, or it has never had this data in its possession. If it has not seen the data, it is culpable, for there is no way that NK603 should have been recommended for approval simply on the basis of assurances of "no harm" from Monsanto. (We remind you that Monsanto has a long history of scientific fraud, which is of great concern to us but not, apparently, to EFSA.) We also remind you that a German court has recently agreed that the public (ie independent toxicity experts) cannot see the original Monsanto toxicity studies on Roundup herbicide -- so this culture of evasion and secrecy is something that we all have a right to be very concerned about.

3. Your comments on the independence of EFSA are noted, and we hope that matters might have improved -- but it is clear to us that many MEPs still have grave reservations about EFSA's independence and impartiality, following the revolving doors and ILSI scandals. Perhaps you would be wise to have reservations too -- and to have a healthy scepticism about EFSA intentions and opinions.

4. You say that you have confidence in the high level of protection for human and animal health which us ensured by the EU regulatory framework. My colleagues and I do not agree with that, which is why I have submitted two petitions to the EU Parliament's Petitions Committee -- one based on EFSA's apparent lack of real concern for public health, and the other (from a group of scientists) based upon the many deficiencies in the Draft Implementing Regulation which you are currently assessing. That Regulation MUST be changed dramatically, to remove discretion from EFSA and to make long-term safety studies mandatory.

5. We are very disappointed indeed that you see no need to suspend the work of DG-SANCO on GM varieties in the pipeline, and no need to conduct any reassessment of authorisations already given. That is extraordinary, given that hundreds of scientists from within the scientific community have now examined the Seralini study in detail and have chosen to disagree with the EFSA assessment. They have argued that the Seralini study shows something of huge importance for public health; that at the very least the study must be carefully repeated and if possible improved; and that in the meantime the Precautionary Principle must be given due respect by the Commission and EFSA. That must mean a "freeze" in the GM approvals process and a re-examination of the NK603 approval and others as well where there are doubts.

Finally, with reference to your vote of confidence in EFSA's honesty and competence, we will agree to disagree. However, I would like to remind you that the Commission is in a very dangerous situation here, arising from the "symbiotic" relationship which DG-SANCO has with EFSA. We have always thought that the relationship is far too close, with EFSA providing a quite improper input into the drawing up of the rules to which it is required to work. We have complained about that many times before. If you remain as close to that rather discredited organization as you appear to be, you should be aware that charges of incompetence and wilful negligence (relating to the evidence of harm repeatedly found in the scientific literature on GMOs -- but ignored or dismissed by EFSA) will be laid at the door of DG-SANCO as well. As I have said before, that gives rise to an intolerable situation in which you and EFSA, having refused to hear repeated warnings from other scientists about GMO dangers, and having refused to see the evidence that is all too apparent to others, resort to the desperate protection of corporate and personal reputations and career prospects instead fulfilling your task of looking after the citizens of Europe.

Yours sincerely,

Brian John GM-Free Cymru



(2) From the EUROPEAN COMMISSION Cabinet of Commissioner Tonio Borg Head of Cabinet

11th December 2012

Dear Mr John,

I refer to your email of 9 October 2012 related to EFSA's statement on the Séralini et al study. The Commissioner has asked me to reply on his behalf.

First, I would like to emphasise that the following national risk assessment agencies have conducted their own independent assessment of this study: the "Bundesinstitut für Risikobewertung", the "Bundesamt für und Verbraucherschutz Lebensmittelsicherheit" in Germany, the "Volksgezondheid Rijksinstituut voor Milieu" in the Netherlands, the "Danmarks Tekniske Universitet Fødevareinstituttets" in Denmark and most recently the "Haut Conseil des Biotechnologies" and "l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail" in France and the "Conseil de Biosécurité" in Belgium. I would also like to stress that contrary to the statement in your email the risk assessment agencies in France, Germany, Belgium and the Netherlands were all mandated by their national authorities to conduct these assessments. The published findings of the Member State evaluations show that the experimental data presented in the publication can neither confirm the conclusions presented therein, nor question the safety of maize NK603 and Glyphosate. I must also stress that these agencies like EFSA have repeatedly requested that the authors of the study submit the detailed data on which the conclusions were based, but without success to date. On 29 November 2012 EFSA published its final evaluation of the study, which concludes along the same line as the above Member State evaluations.

Concerning the independence of EFSA and the several highly critical remarks made in your email, I would like to stress that Regulation (EC) 178/2002 establishing the EFSA as independent authority imposes strict requirements on independence and potential conflicts of interest. To comply with these requirements, EFSA has established rules including internal reporting policy interests of its experts (annual returns and published oral statement at the beginning of each meeting) and has procedures to identify and address potential conflicts of interest. These rules are reviewed regularly by EFSA and continually reinforced by the adoption of new tools to ensure the best independence of its opinions.

I would also like to highlight the European Court of Auditors in a recent opinion recognised that EFSA is applying some of the most advanced policies and procedures for declaring, assessing and managing potential conflicts of interest. As regards the working procedures of EFSA for the assessment of the Séralini study I would refer you directly to EFSA.

I am confident in the high-level of protection of human and animal health and the environment ensured by the EU regulatory framework. Therefore, I do not see the need to suspend on-going assessments of GM soybeans or conduct the re-assessment of authorised ones. EFSA will continue to monitor the studies, which have been published in order to conduct its assessment, such as the recent study by Séralini et al on NK603. In conclusion, I would like to make it clear that the Commission does not share your allegations concerning scientific malpractice and your negative views on EFSA's work on the assessment of GMOs.

Yours sincerely,

Joanna Darmanin

(1) Open Letter: EFSA's rebuttal unit and the Seralini research

Sent to: President Jose-Manuel Barroso European Commission Brussels

cc Commissioner John Dalli

9th October 2012

Dear Mr Barroso

EFSA's rebuttal unit and the Seralini research

You are aware of the recent publication of a peer-reviewed paper by Professor Gilles-Eric Seralini and colleagues which demonstrated serious chronic toxic effects on rats fed with small quantities of GM maize NK603 in their diets, and minute traces of Roundup in their drinking water. As soon as it was published, it was widely recognized that the research had very serious implications for public health; and on that basis we congratulate the Commission for requesting an urgent review of the paper by EFSA. We had our doubts about the wisdom of asking for an EFSA "opinion" -- but assumed that the organization would be able to undertake an impartial assessment of the work and to recommend a course of action to the Commission.

What has emerged in the last few days is deeply shocking. Far from seeking the views of impartial and independent scientists, EFSA slipped immediately into "rebuttal" mode, appointing a "multidisciplinary task force" made up of the very officials who have been writing positive GM opinions for years, led by Per Bergman.There was no way that this team could afford to find any merit at all in the Seralini study, for to have done so would have involved an admission to serious shortcomings in the GM assessment process over the past decade or more.

More seriously, we know from the minutes of a teleconference held on 28 September (1) that EFSA has tried, from the beginning, to orchestrate a pan-European response to the Seralini paper by heading off dissent and agreeing a set of criticisms of the paper -- many of which are frankly absurd (2). It has consulted with representatives of four member states (France, Germany, Netherlands and Belgium) while apparently remaining unconcerned about scientific responses from those member states which have serious doubts about the safety of GM crops and foods. This "orchestration" and shaping of orthodox scientific opinion is deeply disturbing, for it involves both scientific corruption and a conspiracy to suppress honest science. In short, Professor Seralini and his colleagues are being portrayed as scientific heretics or mavericks who are either incompetent or dishonest.

And more seriously still, the man who was asked to "front up" this rebuttal unit was none other than Andrew Chesson -- who was instrumental in giving the "green light" to NK603 in 2003, and who was personally implicated in the vicious campaign against Arpad Pusztai in 1998 which led to him being dismissed and gagged -- simply because he found toxic effects associated with the consumption of GM potatoes. Even more amazingly, Andrew Chesson agreed to take on this role, sweeping away in an instant any pretence that the EFSA review might be scientifically sound and impartial.

We now have to conclude that EFSA is an organization which is completely out of control. It appears to have no awareness of scientific ethics, no awareness of public concerns or sensibilities, and an unquenchable belief in its own inviolability and infallibility. Further, we have to conclude that EFSA's GMO panel has simply become an arm of the GM industry, defending the safety of GM products no matter what evidence is staring it in the face, and even orchestrating a grubby little campaign of its own which is designed to destroy the scientific reputations of Professor Seralini and his colleagues.

As we have pointed out before, EFSA is acting in a manner which is criminally irresponsible, since it is again placing the interests of the GM industry and the careers of its own officials above the health of the people of Europe. Please will you take immediate strong action to stop this abuse at its heart? At the very least, we request the removal of Catherine Geslain-Lanéelle, who has allowed this appalling situation to develop (3). Then we request an immediate moratorium on all GM consents pending a full investigation of the Seralini findings and a repeat of his experiments. And finally we request the winding up of the GMO Panel, which has connived since the setting up of EFSA in the wilful promotion of the interests of the GM industry and the abandonment of the Precautionary Principle.

We look forward to hearing from you regarding the action which you now propose to take.

Yours sincerely,

Dr Brian John on behalf of GM-Free Cymru



(2) Questionable Biosafety of GMOs, Double Standards and, Once Again, a "Shooting-the-Messenger" Style Debate ENSSER Statement on Seralini et al. (2012) publication and reactions evoked

(3) This is typical of her comments to the press: