EFSA safety statement was issued without sight of crucial GM rice data (21/9/2006)

Breaking News: EFSA safety statement was issued without sight of crucial GM rice data
Press Notice from GM Free Cymru
21st September 2006

It has been revealed today that the statement issued by the European Food Safety Authority on 15 September relating to the safety of GM contaminated rice was scientifically irresponsible. It was based only upon highly selective data provided to it by Bayer CropScience, with large sections of the key scientific documentation blanked out.

The EFSA statement (1) was carefully worded, implying that they were not satisfied that they had sufficient data for a full scientific assessment of LLRICE 601, the offending variety. They said: "According to the Statement of the Panel issued today there is insufficient data to provide a full risk assessment in accordance with EFSA‚s GM guidance."

Nevertheless, the GMO Panel and EFSA effectively endorsed LL601 as safe to eat, with the words: "........ on the basis of the available molecular and compositional data and on the toxicological profile of PAT proteins, EFSA considers that the consumption of imported long grain rice containing trace levels of LLRICE601 is not likely to pose an imminent safety concern to humans or animals." As EFSA must have anticipated, these latter words were flashed around the world, summarised and simplified, and built into countless press releases as a confirmation that LL601 is safe to eat.

Documentation seen today by GM Free Cymru reveals that Bayer CropScience has withheld crucial data on the molecular characterization of LL601 and on other crucial characteristics from the European regulatory bodies, while at the same time asking for the variety to be authorized retrospectively. The Bayer dossier (2) has about 30 pages blanked out on the grounds that the information is CBI or "confidential business information."

It appears that EFSA's GMO Panel might have asked Bayer for the crucial evidence prior to its meeting on 14th September, but it is now clear that it had not received it when it released its 15th September statement.

To compound the deceit, the EFSA statement cites two "positive scientific assessments" of LLRICE601 in support of its conclusion that the variety will not be harmful if consumed in small quantities. On investigation, it is clear that these assessments are both worthless. One of those was an "informal assessment" made by unnamed members of the ACNFP to the UK Food Standards Agency and never published. That off-the-record advice is entirely unacceptable from a scientific point of view. It has caused a storm of protest from NGOs, and is one of the grounds for the legal action which FoE is taking against FSA. The other "positive assessment" was submitted on 13th September by RIKILT (Institute of Food Safety, Univ of Wegeningen, Netherlands), which is the institute run by the Chairman of EFSA's GMO Panel, Prof Harry Kuiper. That is one cause for concern, but much more important is the fact (admitted by the report's authors) they they have not seen the "censored" material in the Bayer dossier either (4) (5).

Speaking for GM Free Cymru, Dr Brian John said: "We are staggered by these revelations. They show that EFSA had no scientific basis for issuing its statement on the safety of LL601 rice. Bayer has simply refused to give EFSA and the other regulatory bodies key information that might well show that LL601 is unstable and dangerous. We know already that it is failed variety that was discontinued for unspecified reasons in 2001. EFSA should NOT have issued any statement at all in the circumstances, and it should have instructed Bayer to make full release of all the scientific data in its possession. This is another example of a giant GM corporation riding roughshod through the European regulatory process, and another example of the incompetence and corruption of those who are supposed to be looking after the health of the European consumer."

Contact: Brian John
Tel 01239-820470


(1) http://www.efsa.europa.eu/en/science/gmo/statements0/efsa_statement_gmo_LLrice601.html

(2) The Bayer petition can be accessed via EFSA:

(3) The Dutch assessment is here:

(4) Translation from the Dutch on page 3: "Bayer's summary points to several appendixes of which some have not been delivered due to their confidential nature".

(5) Not even the EU governments have seen the "secret" data. In the conclusion of the Dutch report it says this: "Bayer has collected seceral data, especially a molecular characterisation of the genetic modification and an analysis of the composition of the kernels and fenotypical and agronomic features of LL601 in comparison with conventional rice. An extensive summary of these data and the judgment of these data by USDA has been spread to EU member states through the permanent committee in Brussels." NB -- a summary and not the actual data.


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