EFSA Public Access
European Food Safety Authority
16th September 2006
Protest re EFSA's refusal of full disclosure of information on LLRICE601
Thank you for sending some documentation relating to LLRICE601 on 15th September 2006 -- I note that it came on the same day that your GMO Panel put its press statement about the "safety" of this variety onto the EFSA web site. We have of course seen all of this material before (except Robert Madelin's letter), since it is available publicly from the APHIS web site and elsewhere in the USA.
We note that you are withholding all of the 30 or so pages and diagrams classified by APHIS as CBI, presumably because you have been asked by Bayer to do so. You inform us that this material will be treated as secret for at least another 15 days. We hereby object to this decision on the grounds that it is against the public interest, and ask you to release this material IMMEDIATELY.
We remind you that there is virtually nothing in the Bayer / USDA documents which can properly be referred to as a scientific case relating to the safety of LL601 for human or animal consumption. There are no safety tests or feeding trials. The documentation relates almost entirely to environmental impacts and agronomic performance, which is why it was submitted by Bayer to USDA and not to FDA. While we congratulate EFSA for declaring that the GMO Panel has inadequate data for "a full risk assessment in accordance with EFSA’s GM guidance", we still find it extraordinary that the Panel felt able to make a positive "provisional assessment" about the safety of LL601 on the basis of so little evidence.
The similarity between LL601 and LL62 is cited as a reason for this confident assertion, but we remind you that LL62 is being assessed by EFSA for animal feed use only, and not for human consumption. Work on that variety is far from complete, and it is extraordinary and slapdash to use that variety as the basis for a judgement on a failed and discontinued variety like LL601. It is disingenuous of you to pretend that because you have looked at PAT proteins in other varieties, and decided that they are relatively safe, therefore the synthetic PAT protein and molecular characteristics peculiar to LL601 are no cause for concern. There is something seriously wrong with LL601, which is presumably why 2,000 tonnes of it were dumped into a hole in the ground in Texas in 2001. And it does appear, from the data which colleagues have been able to examine, that it is a low-yielding variety and is subject to shattering on a much greater scale than the other LL lines tested. Does that tell us why contamination has occurred on such a vast scale in the USA? Does that tell us that there is some genetic instability or defect in LL601 which is currently being kept under wraps?
It is in the public interest that the answers to these questions must be discovered as soon as possible. If the GMO Panel will not do that, other scientists should be given the opportunity. After all, this illegal contaminant is out there at this moment, on supermarket shelves and in people's diets. And EFSA appears, not for the first time, to be set on protecting a GM corporation (in this case, Bayer CropScience) rather than protecting the consumer.
It now appears that we are seeing a precise repeat of what happened with MON863. In that case, you hid important research information just because Monsanto asked you to, until you were forced by a German court ruling to accept that the public interest and the "right to know" override the commercial interests of a seed owner. You have a precedent there, and a court ruling that should give you guidance in this case, but you are apparently dismissing it as irrelevant.
Even more to the point here, we are dealing with a seed owner which has broken the law, which has allowed an illegal variety of rice to contaminate food supplies both in the US and in Europe, and which has a history of "contamination incidents" behind it. Bayer CropScience has clearly learnt nothing from the Starlink fiasco. So why do you now protect the company and effectively promote its interests?
We therefore ask you to remove all CBI classification from the documents in your possession IMMEDIATELY, and to send us the full version of Bayer's LL601 Revised Extension Petition.
Because this is a matter of the greatest possible public interest, we are treating this as an Open Letter, which we will place on our web site and circulate within the scientific community.
Dr Brian John
GM Free Cymru
16th September 2006