Following a complaint made by Testbiotech and the Corporate Europe Observatory (CEO) [http://www.testbiotech.org/en/node/354] the European Ombudsman has reacted and forwarded relevant questions to EFSA. EFSA now has to respond by the end of August. Further, on initiative of the Green Party, the European Parliament has adopted a paragraph during its process of budget control stating that the Parliament “urges EFSA to ensure that all former officials, in accordance with Art. 16 of the European Staff Regulations, inform EFSA about taking up new positions outside the institutions. If these activities could lead to a conflict with the legitimate interests of the institution, EFSA must take the appropriate measures".
In a follow up to a Testbiotech report on maize 1507 which identified adverse effects in model test organisms [http://www.testbiotech.org/node/355], all EU governments were informed directly by mail. Further contacts were made with other authorities in order to trigger a proper evaluation of these findings that were omitted from the EFSA's opinions.
Testbiotech prepared an analysis of the draft EFSA guidelines for the environmental risk assessment of genetically engineered plants. The main criticism is the lack of empirical data due to the EFSA’s narrow approach. They also chose to ignore the step by step approach required by EU legislation. Testbiotech forwarded its own analyses to EFSA during the consultation process (see text as submitted at [http://www.efsa.europa.eu/en/events/event/gmo100617.htm?WT.mc_id=EFSAHL0... and is now expecting the final edits to be published shortly. EFSA is holding a technical meeting with Member States on the guidance document on June 17. This will be webcast live on EFSA's website.
As it was explained by EFSA to Testbiotech, the GMO Panel will discuss a revised version of the ERA guidance document in September with adoption and publication no later than November 10.
New EFSA opinions:
EFSA has adopted opinions on applications from Syngenta on stacked events combining Bt11, GA 21 and MIR604 for use in food and feed [http://www.efsa.europa.eu/en/panels/gmo.htm]. These crops are tolerant to two herbicides (glufosinate and glyphosate) and also express two different insecticidal Bt-toxins (a modified version of the cry3A gene as well as Cry1Ab).
Despite the complexity of possible interference between the various gene constructs, EFSA only performed very superficial risk assessment:
(1) They only used data from one field site in the US to determine the level of gene expression in the stacked events and no investigations of the interactions between gene expression and environment were carried out. (2) For purposes of comparison there was an evaluation of substantial equivalence data from ten field sites which showed several significant differences in the composition of the plants. Not all of them were consistent over all the field sites therefore indicating interactivity of the plant's genome with environmental conditions. There was no further investigation of these differences.. (3) There was no request for data on changes in the activity of the plant genes and interference with metabolic profiles in the plants. (4) No empirical tests were carried out to investigate a potential immune response in mammals despite the use of a marker gene belonging to a protein family and linked to allergenicity. (5) There was no requirement for feeding studies to use whole plants to investigate potential toxic or anti-nutritious effects. (6) No empirical study was required for testing synergies and interactivity between the introduced proteins, residues from spraying and potential unintended gene products.
Overall EFSA opinions are based mostly on presumptions and considerations, but not on empirical scientific investigations. In general, when assessing the risks of stacked events, EFSA seems to assume that higher levels of complexity (combination of various gen constructs in one plant) require even less scientific scrutiny. See also report of Testbiotech [http://www.testbiotech.org/en/node/180]
The consultation process for the opinions of EFSA is open until 19 June 2010
Further, EFSA has published a scientific opinion on the revised molecular characterisation for Rf3 oilseed rape.
EFSA started a call for new scientific data on cloning of livestock:
Also see Testbiotech report on cloning [http://www.testbiotech.org/en/node/382]