NOTE: Below is a short excerpt from a scientifically rigorous yet hard-hitting statement from ENSSER (European Network of Scientists for Social and Environmental Responsibility) to the misleading and sometimes hysterical criticisms of Seralini's study.

ENSSER's statement is well worth reading in full. As yet it is not available online but we'll let you know as soon as it is.
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ENSSER Statement on Seralini et al. (2012) publication and reactions evoked
Questionable Biosafety of GMOs, Double Standards and, once again, a "Shooting-the-Messenger" style Debate
Cartagena Protocol on Biosafety
05.10.2012 – COP-MOP-6, Hyderabad, India

Summary and Main Issues

The European Network of Scientists for Social and Environmental Responsibility (ENSSER) welcomes the study "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" by a group of research scientists of the French Committee for Research and Independent Information on Genetic Engineering (CRIIGEN), an institutional member of ENSSER. Seralini et al. (2012) report on a two-year, full life-cycle study with rats testing Monsanto's NK603 glyphosate-tolerant GM maize (single trait glyphosate tolerance) and its Roundup co-technology in the journal Food and Chemical Toxicology.

The group of researchers led by Prof. Seralini has published previous toxicology studies on Roundup and its active ingredient glyphosate (Gasnier et al. 2009; Benachour et al. 2007; Benachour & Seralini 2009). The scientists also evaluated historical industry data. These data from feeding trials with rats were submitted in support of the company's dossiers seeking approval for food/feed import. When re-analysing the developer's raw data, they found signs for toxicological effects on rat liver and kidneys after 90 days of feeding with GM maize, including the GM maize NK603 tested in this new study (de Vendomois et al. 2009; Seralini et al. 2007; Seralini et al. 2011).

Repeated calls that regulators should require more rigorous, long-term follow-up studies by the developers have consistently been ignored or rejected on dubious grounds. In 2011, the European Food Safety Authority (EFSA) still rejected mandatory 90-day feeding studies as a requirement for applications for GM food and feed (European Food Safety Authority 2011). The few studies that were carried out by developers are voluntary and apply protocols of their choosing.

Main issues

1. CRIIGEN's research was crucial in finally eliciting a policy response by the European competent authority, the European Commission's Directorate-General SANCO (Health and Consumer Safety) in 2012. In its draft Implementing Regulation on applications for authorisation of genetically modified food and feed (European Commission 2012), the European Commission stated: "toxicological studies with the whole genetically modified food and feed shall be carried out." If adopted, applicants "shall include a 90-day feeding study with whole food and feed in rodents for the assessment of food and feed containing, consisting of or produced from genetically modified plants [...]."

2. After a careful comparative analysis of both industry published data and that of CRIIGEN, ENSSER concludes that most arguments which attempt to invalidate the Seralini et al. study cannot hold up to closer scrutiny. Raised criticisms are to a large extent either wrong or apply double standards. The weak point of the pilot study by Seralini et al. is the number of animals used, which does not allow a statistical analysis of the raw data regarding one parameter measured out of over 30 – mortality. This has been acknowledged by the authors and needs to be considered/remediated in follow-up studies.

3. The controversy and vitriolic attacks evoked by the study reveal one underlying aspect: The lack of appropriate and agreed methodologies for long-term studies to scientifically assess effects of the life-time consumption of GM foods.

4. The development of such methodology and tests, which have been demanded by concerned scientists ever since GM food was announced to be introduced into the international markets, has systematically been blocked by lobby work of industry and associated scientists. International bodies such as the Codex Alimentarius and national governments – including most EU governments and their authorities – accepted instead the concept of substantial equivalence and the concept of familiarity to evade any scientific mandatory testing of GM food for human health safety and to simply declare significant differences found between GMOs and their unmodified parents as ‘biologically irrelevant' in an assumption-based approach.

5. The acceptance of these industry-led constructed models providing the conceptual justification for evading testing of food-related risks associated with the introduction of this new technology and neglecting the clearly formulated demands of European citizens led to the crisis of trust in science & regulations that now come to light with full force.

6. Due to the proven close links between industry and EU risk assessors and the documented disproportional influence on regulations by developers and owners of the technology, it is predictable and expected that these authorities, including EFSA, will not be able to substantially revise their original assessment of GM maize NK603 (and any other application) as their credibility is at stake. This is highlighted for example by the European Parliament (2012) refusing the discharge of the EFSA 2010 budget as long as there is no fundamental change in policy, leadership and guidance.

1  Immediate Responses and Attacks

The publication of this study triggered orchestrated discrediting campaigns against the authors and their work, similar to previous campaigns attempting to discredit other studies finding adverse effects. This strategy has been analysed over many years and extensively described for example in the journal Nature (Waltz 2009) and Hilbeck et al. (2012). While it therefore comes as no surprise, it should be decried as contrary to sound scientific principles, and thus institutional anti-science. ENSSER condemns all ad hominem attacks and arguments and the emotional, often vicious conduct of the debate, like for example those that have gone on record in a recent article on this issue by John Vidal (2012) in the Guardian. Further examples are the press release by the Council for Biotechnology Information (CBI 2012) of the U.S. biotechnology industry and the business magazine Forbes (Miller & Chassy 2012) featuring public sector scientists and a retired regulator with a long personal record of rejecting the U.N. Cartagena Protocol on Biosafety of specific GMO legislation. Miller & Chassy (2012) attack the numerous peer-reviewed publications by CRIIGEN researchers in well-respected international scientific journals: "Seralini has made a specialty of methodologically flawed, irrelevant, uninterpretable – but over-interpreted – experiments intended to demonstrate harm from genetically engineered plants and the herbicide glyphosate in various highly contrived scenarios". For those interested in reading more, we refer to the original articles for the reader to decide whether this style meets their standards.

2  Methodology and results of the Seralini et al. study

In 2010, CRIIGEN acquired external funding and set up this study to further explore the signs of toxicity observed in the experimental data delivered by Monsanto Company. Hence, a toxicology trial was designed with the standard 10 rats per sex (total 20 for both sexes), as recommended by the revised OECD Guidelines 408 (Organisation for Economic Cooperation and Development 1998). The authors did not apply the OECD Guidelines 451 (Carcinogenicity Studies) or 453 (Combined Chronic Toxicity\Carcinogenicity Studies) – as demanded by commentators – because the authors did not intend to conduct carcinogenicity studies in the first place. It was their intent to apply the Guideline 408 methodology in an extended time span.

2.1 Critique of scientific aspects

The most often repeated arguments by critics of Seralini et al are so far:

2.1.1 The use of Sprague Dawley rats that are prone to high natural background cancer-rates

These rats are used routinely in such studies for toxicological and tumour inducing effects, including those by Monsanto as basis for the approval of NK603 maize and other GM crops (Hammond et al., 1996, 2004, 2006; MacKenzie et al., 2007). Most critical commentators of the Seralini et al. study failed to inform their readership about this fact. Seralini at al. used this rat strain to keep their study design as comparable to Monsanto's as possible. Had they used another rat strain and shown adverse effects, the relevance of their results probably would have been challenged on that basis, i.e. the use of different types of rats.

Contrary to the broad claims of commentators, Sprague Dawley rats are also frequently used in long-term toxicity/carcinogenicity studies.

1. The National Toxicology Program of the U.S. Department of Health and Human Ser- vices2 uses this strain in its 2-year studies, uncontested.
2. A brief, quick and still preliminary literature search of peer-reviewed journals revealed that Sprague Dawley rats were used
- in 36-month studies by Voss et al. (2005);
- in 24-month studies by Hack et al. (1995), Klimisch et al. (1997), Minardi et al. (2002),
Soffritti et al. (2006) and Gamez et al. (2007);
- in 18-month studies by Lee et al. (2010); and
- in 12-month studies by Perry et al. (1981), Conti et al. (1988), Morcos & Camilo
(2001), Flamm et al. (2003) and Gutierrez et al. (2011).
Four of these studies had been published in Food and Chemical Toxicology.