RE: Re-Approval of GM Maize MON810 - We Urge You to Question the European Food Safety

Brussels, 25 April 2008

RE: Re-approval of GM maize MON810 - we urge you to question the European Food Safety Authority (EFSA) on Monsanto’s data

Dear Minister / Director of National Competent Authority

SUMMARY: The only GM crop authorized for cultivation in the EU, the MON810 maize variety, is undergoing re-approval. The re-approval application dossier, however does not answer many scientific concerns and uncertainties that have arisen since its cultivation started in 1998. Effects on biodiversity, soil and water ecosystems have not been tested; the exact composition and concentration of the insecticide protein produced by MON810 has not been updated according to current biotechnological practices; and potential effects on agronomic practises have not been assessed. We urge you to raise questions to EFSA on these issues by 13 May 2008.

You have received the application files for re-approval of the genetically modified maize MON810 from the European Food Safety Authority (EFSA). This variety was approved in 1998 for cultivation in the EU, and according to EU legislation, the company – Monsanto – now needs to seek authorisation for re-approval for a further 10 years.

Member States have only one opportunity to comment on the re-approval request and the deadline for this is 13 May2008. We strongly urge you to question the data submitted by the applicant company. Working with expert scientists, we suggest that the following questions be raised to the European Food Safety Authority.

Specific questions we urge you to ask EFSA:

1.How could MON810 affect biodiversity in the different biogeographical regions in the EU?

Given the diversity of agricultural practices in Europe and the regional variation in species composition and abundance, the potential effects of GM insect-resistant maize on non-target organisms depend on geographical factors. Therefore, environmental risk assessment of MON810 maize in Europe requires an approach that takes into account the different biogeographical regions within the EU (e.g. Pannonian, Black Sea, Steppic region). This is not addressed in the current risk assessment. Indeed, the studies assessing the potential effects on Lepidoptera (butterflies and moths) are not based on species commonly found in the EU, although these studies have documented adverse effects (e.g. Dively et al. 2004). There is potential for adverse effects from MON810 cultivation on butterfly and moth populations, but this has not been assessed.

2.What is the fate of the Bt (Cry1Ab) toxin in soil, and effects on soil health and nutrient cycling in the EU?

Cultivation of MON810 maize will inevitably result in the Bt (Cry1Ab) toxin being released to the soil. Concerns dealing with the persistence, environmental fate and effects of Bt toxins in the soil ecosystem have been expressed in scientific debate, but have not yet been adequately addressed, especially in an EU context (Stotzky, 2004; Marchetti et al. 2007; Zwahlen et al. 2003). Monsanto holds the view that Cry1Ab toxin is rapidly degraded in soil, but this is largely derived from considering studies outside the EU.

3.What protein does MON810 produce?

The new genes inserted into the plant's DNA appear to be merged with products from the plant’s own genes, creating an irregular occurrence. The genes inserted into MON810 produce a variant of mRNA (the intermediary between DNA and proteins) which is likely to produce a protein different to the one tested by Monsanto because it is fused with the protein from the plant’s own genes (Rosati et al. 2008). Therefore, it is not known exactly what toxin is produced by MON810. This invalidates most, if not all, the tests for the environmental safety of MON810, including those for potential adverse effects on non target organisms. The exact nature of the Bt toxin produced by MON810 needs to be identified by Monsanto and the environmental testing repeated.

4.How will cultivation of MON810 affect agronomic practices?

MON810 is significantly more susceptible to a corn leaf aphid than its conventional equivalents (Faria et al. 2007). Aphids are damaging to maize crops. Will this results in increased spraying for aphids?

5.What levels of Bt are present in MON810?

Cry1Ab expression in leaves of MON810 have been found to be substantially different, and highly variable, from those reported by Monsanto (e.g. Nguyen & Jehle, 2007). As the level of Cry1Ab toxins in MON810 tissues affects risk assessment and resistance management plans, more assessment is needed on the average Cry1Ab toxin production in MON810 maize, how it develops during the growing season, and the effects on insect resistance management.

6.Will cultivation of MON810 affect freshwater invertebrates?

MON810 maize pollen and crop residues can be transported to adjacent streams via wind and water. Repeated and large-scale use of MON810 maize therefore may lead to exposure of MON810 maize material to non-target organisms in aquatic environments (Rosi-Marshall et al. 2007). Subsequently, a laboratory study demonstrates significant and negative long-term effects on the model aquatic organism for toxicity tests, Daphnia magna (Bohn et al. 2008). It remains totally unknown whether aquatic invertebrates, and hence ecosystems might be impacted by the cultivation of MON810 maize in Europe. As Monsanto neither delivers exposure data nor hazard data on European freshwater invertebrate species, the environmental risk assessment remains incomplete.

We sincerely hope that your government will raise these questions with EFSA in the interests of the protection of the environment. We believe that the MON810 application for reauthorisation should be refused until the questions above have been answered and the missing scientific evidence is carried out and provided to Member States.

Please do not hesitate to contact us should you wish for further information.

Yours sincerely,

References

Bohn, T, Primicerio, R., Hessen, D.O. & Traavik, T. (2008). Reduced fitness of Daphnia magna fed a Bt-transgenic maize variety. Archives of Environmental Contamination and Toxicology 10.1007/s00244-008-9150-5.

Dively, G.P., Rose, R., Sears, M.K., Hellmich, R.L., Stanley-Horn, D.E., Calvin, D.D., Russo, J.M. & Anderson, P.L. (2004). Effects on monarch butterfly larvae (Lepidoptera: Danaidae) after continous exposure to Cry1Ab-expressing corn during anthesis. Environmental Entomology 33(4): 1116 – 1125.

Faria, C.A., Wäckers, F.L., Pritchard, J., Barrett, D.A. & Turlings, T.C.J. (2007) High susceptibility of Bt maize to aphids enhances the performance of parasitoids of lepidopteran pests. PLoS ONE 2: e600. doi:10.1371/journal.pone.0000600.

Marchetti, E., Accinelli, C., Talame, V. & Epifani, R. (2007). Persistence of Cry toxins and cry genes from genetically modified plants in two agricultural soils. Agronomy for Sustainable Development 27: 231 – 236.

Nguyen , H.T. & Jehle , J.A. (2007). Quantitative analysis of the seasonal and tissue-specific expression of Cry1Ab in transgenic maize MON810. Journal of Plant Diseases and Protection 114(2): 82 – 87.

Rosati, A., Bogani, P., Santarlasci, A. Buiatti, M. 2008. Characterisation of 3´ transgene insertion site and derived mRNAs in MON810 YieldGard maize. Plant Molecular Biology DOI 10.1007/s11103-008-9315-7.

Rosi-Marshall, E.J., Tank, J.L., Royer, T.V., Whiles, M.R., Evans-White, M., Chambers, C., Griffiths, N.A., Pokelsek, J. & Stephen, M.L. (2007). Toxins in transgenic crop byproducts may affect headwater stream ecosystems. Proceedings of the National Academy of Sciences 104: 16204 – 16208.

Stotzky, G. (2004) Persistence and biological activity in soil of the insecticidal proteins from Bacillus thuringiensis, especially from transgenic plants. Plant and Soil 266: 77-89

Zwahlen, C., Hilbeck, A., Gugerli, P. & Nentwig, W. (2003). Degradation of the Cry1Ab protein within transgenic Bacillus thuringiensis corn tissue in the field. Molecular Ecology 12: 765 – 775.