Response to questions from Mr Christian Stücken (Bavarian television)
Quedlinburg, 10 December 2014
Dear Mr Stücken,
The EU project GRACE has a number of independent objectives, which are described at http://www.grace-fp7.eu/.
In terms of the topic area addressed in your questions, the core objective of GRACE is to describe in detail and test an experiment design for animal toxicology trials, and to assess the scientific value of such studies compared with alternative methods that do not involve animal trials. The publication cited by Testbiotech is a preliminary step along this path – it is not yet possible to draw conclusions from it with regard to the above-mentioned objectives.
GRACE takes account of the widespread interest in and controversy surrounding animal toxicology trials in the context of GMO risk assessments by striving for maximum transparency, planning for broad participation of external experts and stakeholders right from the start of the project, and facilitating their participation throughout. Both when it came to drawing up the study plans and discussing the (initial) results, more than 700 stakeholders and scientists were invited to take part in workshops and to submit written comments (including Testbiotech). More than 80 people from a total of 58 stakeholder organisation in a wide range of sectors and EU countries took up these invitations. In addition to the contributions during the workshops, we have so far received more than 480 detailed written comments. These comments have been/are being assessed by us with written comments to see how they contribute to the project objectives and whether they can be implemented during the project. All this is documented in detail in writing and can be found on the project website. GRACE has published the raw data from the first completed animal trials and these are available to anyone who is interested in carrying out their own checks and analyses. We will be following the same approach for all subsequent animal trials.
Following publication of the initial results, people have also been given the opportunity to exchange views on alternative methods, evaluations and interpretations via a discussion forum in a scientific journal. With this level of transparency and with the comprehensive participation options it offers, GRACE far exceeds previous practice in order to ensure that the data are reliable and robust and to ensure a broad expert – and, ultimately, socio-political – basis for their interpretation. Any potential conflicts of interest are, of course, reported in a transparent manner in the scientific publications in line with usual practice in academic research. Membership of scientific associations, participation in workshops organised by the industry, co-authorship of scientific publications with scientists from the non-publicly financed domain, and membership of the editorial board of a scientific journal are not classed as conflicts of interest. Because of the transparency and associated verifiability of the project activities – from the planning and implementation of the trials to the interpretation of the resulting data – any influence on our research work can be ruled out.
GRACE wants to actively promote discussion with stakeholders and external experts in the forums set up for this purpose (workshops, written comments – responses from the GRACE team, public discussion forum in a scientific journal) throughout the project so as to enable an open, transparent discussion on a factual level. A discussion in the media based on interim results is not useful at this point in time and is not something the project is striving for.
In addition to the general questions answered above, you ask specific questions of Ms Schmidt, Mr Steinberg and myself, which I will respond to below:
I am a co-founder and member of the International Society for Biosafety Research (ISBR) and was a member of its Board of Directors from 2002 to 2012 and served as its President from 2004 to 2008. My active membership of ISBR, whose aims are described on its website (“The mission of ISBR is to promote the practice and application of science in the fields of agricultural biotechnology and environmental risk analysis. In particular ISBR aims to encourage research which supports the safe and effective use of biotechnology in agriculture and food production and assists the development of the relevant policy and regulation.”) does not result in any financial advantages for myself or for the research work of my institute and therefore does not create any conflict of interests with my functions as Coordinator of GRACE and co-author of GRACE-based publications.
The publication by Zeljenkova et al. (2014) provides the following conflict-of-interest statement for Ms Schmidt as co-author: “Kerstin Schmidt provides consulting services in the field of biostatistics and has advised national and European authorities, biotech and pharmaceutical companies as well as research institutions, also in the context of GMO risk assessment.” The biotech and pharmaceutical companies mentioned here include Monsanto.
Mr Steinberg is definitely not a member of ILSI. Because of his expertise in the field of chemically induced carcinogenesis, ILSI asked him to contribute part of a chapter on the carcinogenic chemical furan for a paper entitled “A framework to determine the effectiveness of dietary exposure mitigation to chemical contaminants” (Food and Chemical Toxicology volume 74C: pages 360–371, 2014). Co-authorship of a paper of this kind does not represent a conflict of interests. Mr Steinberg is a member of the Editorial Board of the journal Archives of Toxicology, but was excluded entirely from the review process for the Zeljenkova et al. (2014) publication. Archives of Toxicology was chosen for the publication of papers from the GRACE project based solely on two facts: it is a journal with a high impact factor, and it was prepared to publish a series of papers on the safety of genetically modified plants, following a positive review, and to set up a public discussion forum on the topic.
Prof. Dr. Joachim Schiemann
GRACE involves stakeholders in research planning and drawing of conclusions. Read here for more information.
New Stakeholder Consultation Reports:
Consultation on Good Review Practice in GMO Impact Assessment