1. EFSA publishes initial review on GM maize and herbicide study
2. Seralini's response to EFSA review
3. Controversy over study with genetically engineered maize and Roundup - comment by Testbiotech

NOTE: The European Food Safety Authority has issued its initial review (item 1 below) of Seralini's study, which found GM maize NK603 caused tumours, premature death and organ damage in rats.

EFSA claims there's no need to re-evaluate the safety of the GM maize and concludes that Seralini's study is "of insufficient scientific quality to be considered as valid for risk assessment".

It's not surprising, considering that it was EFSA that claimed this maize was as safe as conventional maize - leading to the EU allowing it into our food and feed supply.

EFSA has also argued against the need for mandatory feeding trials on GMOs and claimed that if they are done, 90 days is enough time to see any ill effects.

All these EFSA decisions are proven false by Seralini's findings. So if EFSA had come out with a decision that found any merit in Seralini's study, EFSA would be condemning many of its own previous decisions, as well as its entire approach to 'regulating' GMOs.

EFSA has refused to tell NGOs the names of the people in the "multi-disciplinary task force" that reviewed Seralini's study. Were they the same people who passed NK603 as safe, and/or the same people who claimed 90-day feeding trials were sufficient to see any ill effects from GMOs?

Seralini's response to EFSA is also given below (item 2).

Item 3 is a response to EFSA's review from Testbiotech, a scientific NGO that has been in the forefront of criticising EFSA's policy and actions on GMOs.
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1. EFSA publishes initial review on GM maize and herbicide study
EFSA
Press Release
4 October 2012
http://www.efsa.europa.eu/en/press/news/121004.htm

The European Food Safety Authority has concluded that a recent paper raising concerns about the potential toxicity of genetically modified (GM) maize NK603 and of a herbicide containing glyphosate is of insufficient scientific quality to be considered as valid for risk assessment.

EFSA's initial review found that the design, reporting and analysis of the study, as outlined in the paper, are inadequate. To enable the fullest understanding of the study the Authority has invited authors Seralini et al to share key additional information.

Such shortcomings mean that EFSA is presently unable to regard the authors' conclusions as scientifically sound. The numerous issues relating to the design and methodology of the study as described in the paper mean that no conclusions can be made about the occurrence of tumours in the rats tested.

Therefore, based on the information published by the authors, EFSA does not see a need to re-examine its previous safety evaluation of maize NK603 nor to consider these findings in the ongoing assessment of glyphosate.

EFSA assessed the paper against recognised good scientific practices, such as internationally agreed study and reporting guidelines.

Per Bergman, who led EFSA's work, said: "Some may be surprised that EFSA's statement focuses on the methodology of this study rather than its outcomes; however, this goes to the very heart of the matter. When conducting a study it is crucial to ensure a proper framework is in place. Having clear objectives and the correct design and methodology create a solid base from which accurate data and valid conclusions can follow. Without these elements a study is unlikely to be reliable and valid."

The Director of Scientific Evaluation of Regulated Products added that the consideration of possible long-term effects of GMOs has been, and will continue to be, a key focus of EFSA's work to protect animals, humans and the environment.

EFSA's preliminary review issued today is the first step in a two-stage process. A second analysis will be delivered by the end of October 2012.  This will take into account any additional information from the study authors, who will be given an opportunity to supply study documentation and procedures to the Authority to ensure the broadest possible understanding of their work. It will also include an overview of Member State assessments of the paper and an analysis from the German authorities responsible for the assessment of glyphosate.

Main findings of Initial Review

The task force, whose members were drawn from the Authority's GMO, pesticide and scientific assessment units, has outlined a list of issues about the paper that would need to be resolved before it could be viewed as well-conducted and properly-reported study.

*The strain of rat used in the two-year study is prone to developing tumours during their life expectancy of approximately two years. This means the observed frequency of tumours is influenced by the natural incidence of tumours typical of this strain, regardless of any treatment. This is neither taken into account nor discussed by the authors.
*The authors split the rats into 10 treatment sets but established only one control group. This meant there was no appropriate control for four sets some 40% of the animals - all of whom were fed GM maize treated or not treated with a herbicide containing glyphosate.
*The paper has not complied with internationally-recognised standard methods known as protocols - for setting up and carrying out experiments. Many of these procedures are developed by the OECD (Organisation for Economic Cooperation and Development).
*For a study of this type, the relevant OECD guideline specifies the need for a minimum of 50 rats per treatment group. Seralini et al used only 10 rodents per treatment set. The low number of animals used is insufficient to distinguish between the incidence of tumours due to chance rather than specific treatment effects.
*The authors have not stated any objectives, which are the questions a study is designed to answer. Research objectives define crucial factors such as the study design, correct sample size, and the statistical methods used to analyse data - all of which have a direct impact on the reliability of findings.
*No information is given about the composition of the food given to the rats, how it was stored or details of harmful substances such as mycotoxins that it might have contained.
*It is not possible to properly evaluate the exposure of the rats to the herbicide as intake is not clearly reported. The authors report only the application rate of the herbicide used to spray the plants and the concentration added to the rats' drinking water but report no details about the volume of the feed or water consumed.
*The paper does not employ a commonly-used statistical analysis method nor does it state if the method was specified prior to starting the study. The validity of the method used is queried and there are questions over the reporting of tumour incidence. Important data, such as a summary of drop outs and an estimation of unbiased treatment effects have not been included in the paper.
*Many endpoints what is measured in the study have not been reported in the paper. This includes relevant information on lesions, other than tumours, that were observed. EFSA has called on the authors to report all endpoints in the name of openness and transparency.
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2. Seralini's response to EFSA review
4 October 2012
French original below; English translation by GMWatch

We expect nothing from EFSA, which is heavily compromised by conflicts of interest on GMOs, as I have written in my book.

In addition, the agency is both judge and jury, in that it authorised the products that we evaluated in our long-term study. We published the results in one of the best toxicology journals in the world.

In authorising these same products, EFSA has worked in a lax manner over a very short time with problematic and totally inadequate data from Monsanto, which it keeps secret in a way that is not normal.

We request that these [Monsanto] data are immediately made public on the internet.
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Nous n'attendons rien de l'EFSA mise lourdement en cause pour conflits d'intérêts sur les OGM comme je l'écris dans mon livre.

De plus l'agence est juge et partie en ayant autorise les produits que nous avons évalués à long terme et dont nous avons publiés les résultats dans une des meilleures revues mondiales de toxicologie.

L'Efsa pour autoriser ces mêmes produits a travaillé de manière laxiste à très court terme avec les données problèmatiques de Monsanto et très très insuffisantes, qu'elle garde anormalement secrètes.

Nous demandons immédiatement un accès public sur internet de ces données.
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3. Controversy over study with genetically engineered maize and Roundup: Still no certainty for consumers
EFSA opinion not sufficient to prove safety of relevant products
Testbiotech media release
Munich/Parma 4.10.2012

The European Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR) published their opinion on a French study that found severe impacts on the health of rats fed with genetically engineered maize or exposed to a low dosage of herbicides. The authorities conclude that the study does not provide final evidence of health risks.

Testbiotech believes that these opinions cannot eliminate severe doubts about the safety of the relevant products. While it is true that the French study does not claim final proof of health hazards it highlights the urgent need for further investigations. According to EU regulations, precautionary measures should come into play if there are sufficiently detailed reasons for doubting the safety of a food product. Thus, the marketing of such products should be stopped until the doubts about their safety are eliminated.

"As long as there are no new data showing that the French researchers are completely wrong, it would be irresponsible to set aside the outcomes of the French study just because of some methodological deficiencies", Christoph Then says of Testbiotech. "Even if this study is not considered to be final evidence of health hazards caused by genetically engineered plants, the burden of proof is now with industry. They have to show that their products are safe. This is not just a theoretical dispute but very much concerns the protection of the consumers."

Testbiotech emphasises that EFSA and BfR have their own vested interests in this discussion. By attacking the French study, the authority is defending its own assessments, claiming the safety of the relevant products. They do not require that companies give evidence about the safety of their products, but assume safety as long as the opposite is not proven.

So far no feeding studies with the genetically engineered plants are requested by the authority, only isolated proteins are tested regarding acute toxicity. Some companies provide data from feeding trials with the plants, which are normally performed for around 90 days only.

Investigations over the life-time of the animals or even including following generations are very rare.

Furthermore, independent risk research can hardly be conducted since the companies can block access to research material or ask the scientists to sign contracts where they agree not to publish anything that is not agreed with the company. There are even some cases where researchers were not able to publish due to intervention by industry.

"It is of extreme importance that these results were published after a peer reviewed process. Those questions being discussed right now should have been answered long time ago," Christoph Then argues.

The measurements made by the French scientists are much more detailed than those normally done by industry. As Testbiotech was informed by the French scientists, the original planning for the study was 90 days but was then prolonged after unexpected observations. Testbiotech demands that further results which are not yet published should now be assessed by the French researchers and properly published to get a full picture about their findings.

Link to the Study from France:
http://www.sciencedirect.com/science/article/pii/S0278691512005637
Link to the opinion of EFSA: http://www.efsa.europa.eu/en/efsajournal/pub/2910.htm
Link to the opinion of BfR:
http://www.bfr.bund.de/de/presseinformation/2012/29/studie_der_universitaet_caen_ist_kein_anlass
_fuer_eine_neubewertung_von_glyphosat_und_gentechnisch_veraendertem_mais_nk_603- 131728.html
Link to a open letter from independent scientists:
http://independentsciencenews.org/health/seralini-and-science-nk603-rat-study-roundup/