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Why EU plans 2-year carcinogenicity study on NK603 maize? Are details of the feed trial same to Gilles-Eric Séralini's research? Thanks a lot.

Submitted by: Bishop


Expert response from GMOAnswers Admin_1

Tuesday, 14/01/2014 21:36

It is difficult, at best, to understand the EU’s rationale for funding any long term feeding studies with GM crops. Presumably, it is because of political pressure created by the sensationalistic media coverage of the feeding trial you’ve referenced[1]. To be clear, this rationale is not scientific because teams of international scientists and regulatory agencies have concluded the Seralini study was not credible, and that it had serious flaws in design and interpretation[2]. Given the serious questions these institutions and individuals have raised about Seralini’s study, it is not readily apparent why the EU would choose to spend millions of Euros on a project that appears to have a flawed premise. In fact, the EU recently published a report stating, “The main conclusions to be drawn from the efforts of more than 130 research projects, covering a period of over more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies” (EC, 2010).


The existing weight of evidence generated for GM crops, including NK603 maize, includes a thorough evaluation of the GM crop compared to its conventional control based on molecular, compositional, phenotypic, and agronomic analyses.  In addition, the transgene donor, delivery process, and transgene product are carefully characterized as part of the safety assessment. This battery of evaluations has been characterized as robust by independent subject matter experts (Ricroch, 2012; Kuiper et al., 2013). In fact, it has led  some of these same experts (Kuiper et al., 2013) and EFSA (2011) to conclude that whole food feeding studies are unnecessary on GM crops that are demonstrated to be substantially equivalent to their conventional comparators by the molecular, compositional, phenotypic, and agronomic analyses. Nonetheless, feeding studies have been routinely conducted with GM crops to expedite the approval process despite an absence of unintended effects in the comparative assessment. Among these whole food studies with GM crops, scientifically reliable feeding studies have not identified any unintended adverse effects (Snell et al., 2012). As a result, the routine conduct of animal feeding studies in a search for unintended adverse effects, which have not been identified in 15+ years of testing, is coming under closer scrutiny. Furthermore, due to the absence of a scientific justification, these studies may also be considered ethically questionable from an animal welfare perspective; especially in light of the repetition of the conduct of such studies in several parts of the world and, of course, of global efforts to reduce, refine, and replace animal testing.


Additional evidence for the safety and wholesomeness of GM crops comes from the livestock industry where dietary components have increasingly come from GM crops. In 2013 herbicide tolerant (HT) soybeans were on 93% of acres and HT soybeans, HT cotton, insect resistant (IR) cotton, IR corn and HT corn, were on at least 75% of acres (USDA, 2013).  With approximately 95% of the livestock being grown for non-organic markets (USDA, 2012), it is safe to presume that most of these animals consume large portions of their diets from GM crops. So, it stands to reason, if GM crops had adverse effects they would have a negative impact on animal production. Van Eenennaam (2013) concluded:


“In 2011 alone approximately 9 billion broiler chickens, weighing over 22.5 billion kg liveweight were produced in the United States. During that year 30 million tonnes of corn and 13.6 million tonnes of soy were used as broiler and breeder poultry feed of which 88% and 94%, respectively, was likely from GE crops. Production parameters, mortality and condemnation rates for the more than 105 billion broilers that have been processed in the US since 2000 are shown in Figure 2. In 2000 approximately 25% of corn and 50% of soy grown in the US was GE and hence poultry diets have likely contained an ever increasing proportion of GE feed from 2000 to 2011. This very large field data set does not reveal overt health problems associated with the consumption of GE feed, but rather shows a continuation of industry trends that were observed prior to the introduction of GE crops.”


Lastly, the EU’s decision to conduct a two year study did not originate with the scientific organization tasked with food safety in the EU. In fact, EFSA’s Scientific Report on designing chronic studies for whole foods opens with the following text, “Upon request from the European Commission…” (EFSA, 2013). As the European Commission (EC) is the executive body of the EU it is responsible for proposing legislation, implementing decisions, upholding treaties, and day-to-day running of the EU; it would be fair to say this project is rooted in politics rather than science. Indeed, key European scientific experts, such as the EC President’s Chief Scientific Advisor Dr. Anne Glover, have indicated that GM crops are no riskier than their conventionally farmed equivalents[3]. EFSA’s Scientific Report on chronic toxicity studies with GM crops also repeatedly says:


“The decision to conduct chronic toxicity and/or carcinogenicity studies with whole food/feed should be taken on a case-by case basis. It should be based on the evaluation of all the available information on the whole food/feed resulting from compositional analyses and any other available nutritional and toxicological studies.” (EFSA, 2013)


With that in mind, how does this Scientific Report change the current paradigm that says animal studies are unnecessary when the molecular, compositional, phenotypic, and agronomic analyses indicate no unintended effects between the GM crop and its conventional control? In short, it doesn’t. Rather the report says that if a group of researchers were to conduct a chronic toxicity and/or carcinogenicity studies with whole food/feed it should follow existing guidelines from the OECD, namely OECD Test Guideline (TG) 453. It is noteworthy that such a study would be very different from the Seralini study in several  critical areas including: 1) performance and documentation compliant with Good Laboratory Principles (GLPs); 2) appropriate statistical power to accomplish the objective of the experiment (Seralini used far fewer animals, 10/sex/group, than recommended by OECD TG 453, 50/sex/group); and 3) utilization of adequate historical control data to appropriately interpret variability among endpoint values between groups and inform the researchers of spontaneous disease rates in the animal model being used in the investigation.  We are unaware of the details of the protocols of carcinogenicity studies proposed for funding by the EU Commission.




EC, 2010. A decade of EU-funded GMO research (2001 - 2010). D.E.B. Directorate-General for Research and Innovation, Agriculture, Food, Unit E2 — Biotechnologies Publications Office of the European Union. Luxembourg.


EFSA. 2013. Considerations on the applicability of OECD TG 453 to whole food/feed testing. EFSA J 11(7):3347


Kuiper, H. A., E. J. Kok, and H. V. Davies. 2013. New EU legislation for risk assessment of GM food: no scientific justification for mandatory animal feeding trials. Plant Biotechnol J.


OECD. 2009. Test No. 453: Combined Chronic Toxicity/Carcinogenicity Studies, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing.


Ricroch, A. E. 2013. Assessment of GE food safety using '-omics' techniques and long-term animal feeding studies. N Biotechnol 30: 349-354.


Seralini, G. E. et al. 2012. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem Toxicol 50: 4221-4231.


Snell, C. et al. 2012. Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: a literature review. Food Chem Toxicol 50: 1134-1148.


USDA. 2012. 2011 Certified Organic Production Survey.


USDA. 2013. Adoption of Genetically Engineered Crops in the U.S.


Van Eenennaam, A., Young, A. 2013. GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations. J Animal Sci Biotech 4:37.



The Belgian Biosafety Advisory Council, the German Federal Office of Consumer Protection and Food Safety and the Federal Institute for Risk Assessment, the Danish National Food Institute, the French Agency for Food, Environmental and Occupational Health & Safety and High Council For Biotechnology, the Italian

National Institute of Health, and the Dutch Food and Consumer Product Safety Authority;