EXCERPT: "...in relation to public safety, I would specifically highlight the situation regarding MON 863. I also refer to the concerns raised in a French study last year (4). In spite of these concerns, the supporting Monsanto dossier held by EFSA, and the report on a 90-day rat feeding study, are treated as secret, as is a review document by Dr Arpad Pusztai, commissioned by the German competent authority. His review has not been released and he is effectively "gagged" and prevented from either revealing his findings verbally or issuing copies of his report."
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OPEN LETTER TO

Geoffrey Podger Esq
Executive Director
European Food Safety Authority
14 March 2005

Dear Mr Podger,

EFSA Opinions, Secrecy and the Public Interest

Thank you for your letter dated 10 February 2005 in which you referred me to The EFSA Journal, 99, 1-94; and in which you sought to clarify the EFSA position in relation to the work of Dr Stanley Ewen and Dr Arpad Pusztai (1).

Having perused the "Guidance document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed" it is clear that:

1. Guidance given to the biotech corporations is effectively advice on how to obtain "a positive opinion."

2. Following receipt of the applicant's dossier by the relevant national competent authority, the EFSA then takes advice from the Scientific Panel and agrees an "opinion".

3. The EFSA is extremely reluctant to set its own research parameters or to conduct or commission independent studies.

4. The EFSA accepts substantial equivalence and safety as already established, even where hybrids are created from two or three GM lines.

In our view this whole process is complacent, is designed to facilitate the introduction of GM crops and foods, and to assist GM developers to extend their influence and to increase their profits. The process also acts against the public interest in that the dossiers submitted by applicants can be labelled as "commercially confidential" and therefore kept away from independent scrutiny. In consequence, one presumes that only your Scientific Panel members are able to view full dossiers.

You will undoubtedly be aware that the Aarhus Convention demands openness within the European Commission on GMO matters. This is especially important since the European Commission now admits (2) that:

1. The science on GMOs is constantly evolving and that "new risk considerations sometimes arise spontaneously and change the scope of the risk assessment"

2. Concerns about antibiotic resistant genes and secondary effects on beneficial insects are "legitimate scientific concerns"

3. Member states should be able to determine their own level of protection.

Given the foregoing, the recent discovery by Greenpeace (3) that there is no effective monitoring by the EFSA, or anybody else, following the commercialisation or import of MON810 and its 17 related varieties now listed, is of grave concern.

However, in relation to public safety, I would specifically highlight the situation regarding MON 863. I also refer to the concerns raised in a French study last year (4). In spite of these concerns, the supporting Monsanto dossier held by EFSA, and the report on a 90-day rat feeding study, are treated as secret, as is a review document by Dr Arpad Pusztai, commissioned by the German competent authority. His review has not been released and he is effectively "gagged" and prevented from either revealing his findings verbally or issuing copies of his report. The lack of openness, transparency and inclusiveness in this process is against the public interest, and is completely unacceptable.

Clearly if individual GM maize varieties cannot be publicly demonstrated as being safe to eat, the EFSA assumption regarding the safety of double or triple hybrids can have no scientific validity whatsoever. We are fully aware that one of the "hallmarks" of genetic modification is its unpredictability, and that one of the characteristics of a GM variety is its potential for instability.

I would be very grateful for your comments.

Yours Sincerely
Ian Panton
GM Free Cymru

References:
(1) http://www.efsa.eu.int/science/gmo/gmo_guidance/660_en.html
(2) http://www.foeeurope.org/biteback/Ombudsman/index.htm
(3) http://www.greenpeace.org/press/release?item_id=745983&campaign_id=
(4) http://www.crii-gen.org/m_fs_axbis.htm
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To make comments to the EU Commission go to
http://europa.eu.int/comm/food/food/biotechnology/authorisation/public_comments_en.htm
There is a guide to EU regulations on the GeneWatch website at http://www.genewatch.org/CropsAndFood/Regulations/Regs_Flowchart.htm
To see what dossiers are available go to http://www.efsa.eu.int/science/gmo/gm_ff_applications/catindex_en.html