A Recent Apr 2016 Court Ruling in France indicated 4 studies submit in defense of MON 810 dangers by the Ag Minister were Rejected. The studies referenced were Plos One July 2013 and Jan 2014, Ecological Modelling Feb 2013 and Journal of Hematology and Thromboembolic Diseases Mar 2013.Question is Can you talk about these studies and why they may have been rejected and are these pertinent studies the Non GMO crowd rely on as proof of dangers?

Expert response from GMOAnswers Admin_1

Monday, 27/06/2016 19:18

Thanks for your question which raises some very significant points for discussion. Before I get into the details of the studies you mentioned, it is important to address the larger question of when and why are studies reviewed, and to clarify the impact of said studies on the ruling of the Council of State dated April 15, 2016.

 

In this respect, importantly the studies themselves were not “rejected” at all by the Council of State; rather the Court carefully reviewed these four studies and ruled that they could not substantiate the existence of a significant risk jeopardizing human or animal health or the environment (see par.10 of the ruling). In light in particular of those four studies which failed to evidence a risk for human health, the Council of State ruled that the decision of the French Minister of Agriculture to prohibit MON 810 had no legal grounds and should consequently be annulled.

 

It is therefore not correct to allege that the four studied mentioned above were “rejected.”

 

To the next point, the review of scientific studies comprises a major component in the progression toward making conclusions on the safety of Mon 810 or any GM crop. A consensus on safety is reached following the review by U.S. and multiple global regulatory agencies, independent scientists publishing in peer-reviewed journals on the safety of this and/or other GM products, and GLP data provided by the company that developed the product. In the case of MON 810, Monsanto evaluated safety and efficacy both during its development and while stewarding its release.

 

Regulatory agencies, including the European Food Safety Authority (EFSA), assessed MON 810 and concluded positively on its safety. EFSA’s conclusion took into account all available literature specific to MON 810 on topics ranging from the molecular characterization and food-feed safety assessment to environmental risk assessment and risk management (EFSA, 2012). Regarding the current ruling and in support of their opinion from 2012, EFSA stated it had found “no new scientific publication” to challenge their previous conclusions. As for Monsanto, we consider every study about our products to be important and review every study we are aware of. After review we might conclude the design/conduct of a published study does not support the author’s conclusions or we might also determine that the results indicate that additional review and follow-up is needed (For more on this topic see, Do we review studies on our products? Yep – we wouldn’t be doing our jobs if we didn’t).

 

Monsanto routinely sends the results of our literature review pertaining to MON 810 to EFSA. To date, the information in these literature review reports has not revealed any adverse effects that could be related to the cultivation of MON 810. As part of this process, the four papers mentioned were assessed and we concluded they do not bring any new scientific evidence demonstrating a risk to animal or human health or the environment. A brief summary of some of the reasons why are below:

1. Campagne et al., (Plos One, 2013. 8, 1-7) evaluated resistance of Busseola fusca to the Bt toxin to maize grown in South Africa and whether the inheritance was dominant or recessive. After review it was concluded that the Busseola pest is not present in the EU. Furthermore, after 15 years of planting Bt maize on over 1.7 million hectares in South Africa, the level of resistance is remains low.
2. Zhou et al., (Plos One, 2014. 9, 1-7.) exposed two species of spiders to fruit flies reared on either a Cry1Ab containing diet or control flies exposed to an untreated diet. The authors reported some differences that were within the natural variability for this type of study. Nothing from the study supports that Cry proteins can be transferred to or negatively impact non-target organisms (i.e. spiders).
3. Holst et al. (Ecological Modelling 2013. 250: 126–133) studied the potential effects of the Bacillus thuringiensis (Bt) protein in pollen on larvae from the herbivorous lepidopteran butterfly Inachis io. However, the authors use a mathematical model that was not appropriate to predict the potential for realistic risk.
4. Mezzomo et al. (J Hematol Thromb Dis 2013. 1:104) evaluated the hematotoxic and genotoxic effects in mice fed high doses of Bt spore-crystals and the authors conclude that spore-crystal administrations provoked selective hematotoxicity. However, owing to several fundamental experimental design flaws, it is impossible to discern if the findings were caused by the Cry protein. Furthermore, the study did not establish dose dependence (increased toxicity with increased dose) and did not establish any biological relevance.

In summary, GM crops were studied and evaluated for safety during development and that evaluation continues during cultivation. Safety conclusions are reached following assessment of all studies regardless of their source and assessment is performed by regulatory agencies, independent scientists and companies like Monsanto. To date, studies continue to be conducted on Mon 810 and these studies have not changed the opinion of EFSA and other regulatory authorities that Mon810 is safe for people, animals and the environment.