Dear Dr Then,
Thank you for your letter dated 18 November 2014.
In your letter you are responding to the open letter published by the GRACE Consortium on 10 November 2014 in response to the report and press release dated 7 November 2014 and issued by your organization on its website. In these documents, you criticize a recently published scientific article (Zeljenková et al., 2014) on 90-day feeding studies with diets containing genetically modified MON810-maize varieties and their comparators performed within the EU-funded GRACE project. In your letter you also ask me for further clarifications and actions:
1) You ask to withdraw the publication and subject it to further evaluation.
Response: The authors of Zeljenková et al. (2014) and the GRACE Consortium do not see any reason to withdraw the publication.
I) The publication has undergone a standard peer-review process before it was published in the Archives of Toxicology. The editors of the Archives of Toxicology might respond to your allegations concerning conflicts of interest you raised in your letter.
II) In a Letter to the Editor of the Archives of Toxicology (DOI 10.1007/s00204-014-1375-7) published in the same issue as Zeljenková et al. (2014) the coordinators of the projects GRACE, G-TwYST, and GMO90+ described a coordinated publication strategy in order to increase the transparency of the studies performed in the projects and to invite stakeholders to discuss the data generated in the frame of a scientific debate in an open-access journal. We invited the Editor-in-chief of the Archives of Toxicology to develop with us a process facilitating a transparent and tailored scientific discussion about the results of the research projects to be published. In response to our Letter to the Editor the editors of the Archives of Toxicology decided to provide the platform for an open discussion allowing everyone to publish scientific arguments. The editors invite letters/commentaries up to 2000 words which may contain up to ten references. The scientific arguments will be published unchanged; however, commentaries with personal attacks will not be published.
The authors of Zeljenková et al. (2014) and the GRACE Consortium invite you to take part in this transparent and tailored scientific discussion to be started in the January issue of the Archives of Toxicology. The senior author of Zeljenková et al. (2014), Prof. Dr. Pablo Steinberg, sent a Letter to the Editor to Prof. Dr. Jan Hengstler in response to your report and press release dated 7 November 2014 and issued by Testbiotech on its website. You will find the Letter to the Editor in the Annex.
2) You ask to name the experts who participated in the peer review process before publication.
Response: As you should know the identity of the experts who participated in the peer review process of a manuscript before publication is not disclosed to the authors of the publication.
3) You ask that data derived from the one year feeding study with MON810 carried out by the GRACE team are published as soon as possible. “According to international OECD guidance, data from chronic feeding studies on biochemical and haematological parameters have to be assessed after three and six months. The one year feeding study started at the beginning of 2014. Therefore, some of these data should be already available.”
Response: As you have mentioned correctly the GRACE team is carrying out a one-year feeding study with maize MON810. In line with the respective OECD guidance samples have been taken after three and six months and have been / are analyzed in respect to clinical biochemistry and haematology parameters. As you should know, disclosure of data before the termination of a study performed under GLP conditions would conflict with the required double blinding of the study. In the Study Plan for the one-year study No 311957- C/14/ GLP, which has been extensively discussed with stakeholders and published on the GRACE website, the following is stated in the Chapter “Diet formulation, sampling and analysis”: “Diets are coded in ‘double blind’ fashion by the diet-producing company (Mucedola srl.). Samples of the diets are coded with different codes than the diets themselves. The coding scheme is shared with Gijs Kleter (the company’s contact within the GRACE consortium). It is to be kept confidential and therefore not to be distributed further among consortium members during the course of the animal experiments and analyses of samples derived from these experiments, and the code is to be broken after termination of these activities when analytical and experimental data have been recorded and stored.”
In addition to my responses above the authors of Zeljenková et al. (2014) and the GRACE Consortium cannot accept the allegation expressed in your press release dated 7 November 2014: “Now it looks as though the outcome was manipulated to eradicate doubts concerning the safety of these products.”
The allegation that we have tried to manipulate the results of our feeding trials published in Zeljenková et al. (2014) cannot be substantiated by any facts:
I) As stated in Zeljenková et al. (2014), on the GRACE website and during the whole stakeholder involvement process a key objective of GRACE is to conduct 90-day animal feeding trials, animal studies with an extended time frame as well as analytical, in vitro and in silico studies on genetically modified maize in order to comparatively evaluate their use in GM plant risk assessment. It is not the aim of the GRACE project to provide data on the safety of maize MON810 and to draw conclusions on the safety of genetically modified plants in general. Therefore, there is no reason to manipulate the data obtained or the interpretation of our data. Our final conclusion in Zeljenková et al. (2014) that the results obtained show that the MON810 maize at a level of up to 33 % in the diet did not induce adverse effects in male and female Wistar Han RCC rats after subchronic exposure, independently of the two different genetic backgrounds of the event, is the result of thorough discussions in the GRACE Consortium and based on a broad expertise. Other experts might draw different conclusions and therefore we are facilitating a transparent and tailored scientific discussion in the Archives of Toxicology where different interpretations can be presented and discussed.
II) All raw data generated in the course of our studies published by Zeljenková et al. (2014) are freely accessible. In addition, we are offering interested parties the possibility to compare the original data (in form of print outs etc.) with the raw data published. Consequently, the allegation that we have tried to manipulate the results of our feeding trials can be completely rejected.
With best regards,
Prof. Dr. Joachim Schiemann
Coordinator GRACE Project
Head of the Institute for Biosafety in Plant Biotechnology
Julius Kühn-Institut, Federal Research Centre for Cultivated Plants
