EXTRACT: ...speaker after speaker demonstrated a deep mistrust of EFSA and called for reforms in its membership and in its operational methods. Your GMO Panel is widely viewed as being "in the pocket" of the biotechnology industry, and as a body which exists not for the protection of the public but for the facilitation of GMO consents. This perceived industry bias has caused concern within the EC and in the European Parliament, and although EFSA committed itself more than a year ago to greater transparency and dialogue with stakeholders, we see little sign of any change.
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EFSA IS ASKED TO BLOCK ALL NON-REPLICABLE SCIENCE
GM Free Cymru, 18th May 2007
GM Free Cymru has written to EFSA with a request that its traditional dependence upon non-replicable or advocacy science (conducted by the applicants for GMO approvals) should be abandoned forthwith, and should be replaced by a policy of only considering tests and experiments that are genuinely replicable.
The Background: Applications for GMO release/marketing consents in Europe are received by one or another of the "competent authorities" or member states and are then passed through to EFSA for its scientific assessment and advice. EFSA deals with the application dossier and invites and receives comments and sometimes detailed submissions from the member states these comments often come from the advisory committees such as ACRE in the UK. EFSA publishes a "Guidance Document of the Scientific Panel on GMOs for the Risk Assessment of GM Plants and Derived Food and Feed" which provides information on the form in which information should be submitted, and the main types of evidence expected. The latest edition of this advice was adopted in May 2006. There are 105 pages. It is here:
http://www.efsa.europa.eu/etc/medialib/efsa/press_room/publications/scientific/1497.Par.0005.File.dat/gmo_guidance%20gm%20plants_en.pdf
Samples of the GMO which is the subject of the application have to be provided for analysis at the EU's Joint Research Centre, so that the transformation event can be verified and so that reference or "control" material can be held for checks against future monitoring / contamination events. There is no other requirement for samples to be provided for independent research or repeat experiments. All of the onus is placed upon the applicant for the provision of the evidence required for the full dossier, as laid out in long annexes.
There is no requirement placed on an applicant to have the research done by independent laboratories or scientists; there is no requirement for "verification" studies to be undertaken by a government institute (as in Russia); and there is no requirement placed on an applicant for the provision of reference or sample materials to be made available to genuinely independent bona fide researchers. This is a recipe for corruption, and explains why so much of the research submitted in dossiers is not only non-replicable but is also cynically manipulated to hide "unwelcome" health and safety effects.
There is no legal obstacle to EFSA amending its Guidance at any time, or adding additional requirements to be met by applicants. Indeed, EFSA flags up on its web site the fact that the Guidance Document is constantly under review and is open for improvement.
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Prof Harry Kuiper
Chair, GMO Panel
European Food Safety Authority
Largo N. Palli 5/A
I - 43100 Parma
Italy
18th May 2007
OPEN LETTER
Dear Harry
A Proposal for Urgent Action on GM Science
As you are aware, GM Free Cymru has, on many occasions in the past, raised with EFSA the overwhelming emphasis placed by you and other regulators and advisory committees on "advocacy science" when you are considering the health, safety and environmental impacts of GM crops and products (1). Our concerns were brought into sharp focus when we recently attended the 3rd European Conference of GMO-Free Regions in Brussels, when speaker after speaker demonstrated a deep mistrust of EFSA and called for reforms in its membership and in its operational methods. Your GMO Panel is widely viewed as being "in the pocket" of the biotechnology industry, and as a body which exists not for the protection of the public but for the facilitation of GMO consents. This perceived industry bias has caused concern within the EC and in the European Parliament, and although EFSA committed itself more than a year ago to greater transparency and dialogue with stakeholders, we see little sign of any change. The statements on openness, transparency and independence on the EFSA web site have done nothing to allay our fears.
We appreciate that this sorry situation is not entirely of EFSA's own making, in that you have no funds for extensive independent laboratory research and in that you can only make scientific judgments on the basis of what is presented to you in dossiers or in ancillary pieces of research which you may request. However, as we have seen from the fiascos associated with MON863 and MON810, the instinct of those who are applying for GMO consents is always to present the "best" possible case (through the use of corrupt science and in-house data manipulation if needs be), to seek to prevent open access to their dossiers, and to dismiss any criticism or questioning of their methods or research findings. They systematically vilify or patronise those who conduct (with great difficulty) genuinely independent research. Corporations such as Monsanto routinely block such independent research by denying access to their GM materials by any researchers whom they deem to be "unfriendly." Their research is therefore non-replicable, in contravention of one of the oldest principles underpinning scientific endeavour. We have documented many such cases (2), and Monsanto, Syngenta and other companies have never denied their behaviour in this respect. Jeffrey Smith's new book contains many more examples of the manner in which the GM corporations have twisted science for their own ends.
As long as EFSA's GMO Panel allows itself to be associated with this sort of scientific corruption, it will not win any increase in approval or trust from NGOs, consumer groups and the general public. May we suggest one very simple way out of this profoundly depressing situation? EFSA should issue a simple statement (3) along these lines:
"In the interests of public safety, EFSA will not consider any dossier or any other research material submitted in support of an application for a GMO approval unless (a) it is accompanied by a signed declaration to the effect that the scientific research (including full data sets) will be open to public scrutiny and peer review; and (b) it is accompanied by a signed declaration that repeat, additional or extended experiments by bona fide independent researchers and laboratories will be facilitated through the provision of GM reference materials as appropriate."
Such a statement issued by EFSA, and strictly adhered to, would in our view go a long way towards the restoration of confidence in the GMO Panel -- and it would, for the first time, allow truly replicable science to become a part of your operations. If Monsanto or any of the other corporations should refuse to sign these two simple declarations, we can draw our own conclusions as to the honesty of their science and the safety of their GMOs.......
We ask you to take this proposal to your GMO Panel as a matter of urgency, and also to seek the approval of EFSA as a whole.
We are treating this as an Open Letter, and hope that other organizations and individuals will (if they have not done so already) ask you to make this simple and entirely legal step, in the interests of sound science, public safety and environmental protection.
We look forward to hearing from you with confirmation that you will take this matter forward.
Yours sincerely,
Dr Brian John
GM Free Cymru
Trefelin, Cilgwyn, Newport, Pembs SA42 0QN, Wales
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NOTES
(1) http://www.gmfreecymru.org/pivotal_papers/manipulation.htm
http://www.gmfreecymru.org/pivotal_papers/corruption.htm
http://www.gmfreecymru.org/pivotal_papers/greenpeace.htm
http://www.gmfreecymru.org/pivotal_papers/syngenta.htm
(2) http://www.gmfreecymru.org/pivotal_papers/manipulation.htm
(3) We would of course accept that certain very limited information (relating to DNA, gene sequences etc) should remain as commercially confidential information. But the CBI label has been grossly misapplied in the past, by EFSA among others, against the public interest -- and it is time that the regulators, rather than the GMO consent applicants, made the decisions as to what material genuinely deserves protected status.