GM maize. Stakeholder Consultation on Animal Feeding Studies and in-vitro Studies in GMO Risk Assessment. (3-4 December 2012, Vienna)

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1 Human Health Environment Socio-Economy GM maize Stakeholder Consultation on Animal Feeding Studies and in-vitro Studies in GMO Risk Assessment (3-4 December 2012, Vienna)

2 Top countries growing GMOs (>97% of global GM area) Country % GM area USA 43 Brazil 19 Argentina 15 India 6.6 Canada 6.5 China 2.4 Paraguay 1.7 Pakistan 1.6 South Africa 1.4 Global biotech area 17 countries growing 50,000 ha, or more, biotech crops Almost 17 million farmers, 29 countries, 160 million hectares in 2011: a sustained increase of 8% (12 million ha over 2010) Other countries growing GMOs (<3% of global GM area) Country % GM area Uruguay 0.81 Bolivia 0.56 Australia 0.43 Philippines 0.37 Myanmar 0.19 Burkina Faso 0.19 Mexico 0.13 Spain 0.06 Colombia Chile Honduras Portugal Czech Republic Poland <0.05 Egypt Slovakia Romania Sweden Costa Rica Germany Europe: maize except Sweden and Germany: potato International Service for the Acquisition of Agro-Biotech Applications (ISAAA),

3 Million hectares Global adoption rates for principal biotech crops Distribution by crop (ha, 2011) Distribution by trait (ha, 2011) 159 insect resistance 13% others insect resistance and herbicide tolerance 27% herbicide tolerance 60% International Service for the Acquisition of Agro-Biotech Applications (ISAAA),

4 EU adoption Main cultured GM crop in the EU: insect resistant maize (MON810) Among 6 MON810 growing countries in the EU, Spain had the highest area in 2011 (97,300 ha: 82% of hectarage in the EU): mainly in Aragón and Catalunya NE Catalonia Empordà (2011: 73 % GM maize) Departament d Agricultura, Ramaderia i Pesca, Alimentació i Medi Natural (DAAM),

5 MON810 is resistant to corn borer Historically there is high incidence of corn borer (lepidopteran insects Sesamia nonagroides and Ostrinia nubilalis) in l Empordà Number of corn-borer larvae per plant year 5

6 MON810 is resistant to corn borer Historically there is high incidence of corn borer (lepidopteran insects S. nonagroides and O. nubilalis) in l Empordà...economic consequences Wind speed (mean and maximum) in m/s day Fusarium infection 6

7 MON810 is resistant to corn borer MON810: constitutive expression of a synthetic gene encoding insecticidal protein CryIA(b) from Bacillus thuringensis Molecular characterisation Single transgene insertion of ~3,500 bp P-35S truncated CryIA(b) 5 ihsp70 3 Stop Maize yield (conventional and MON810) Number of corn-borer larvae per plant Kg/ha (14% moisture) year E.E.A. Mas Badia, Empordà,

8 MON810 commercial varieties MON810 is commercialized in many different varieties Catalonia (2011): Others (28%) PR31N28 (23%) PR33N44 (3%) DKC6451YG (6%) PR33P67 (12%) DKC6667YG (13%) PR33Y72 (15%) Departament d Agricultura, Ramaderia i Pesca, Alimentació i Medi Natural (DAAM),

9 MON810 commercial varieties MON810 is commercialized in many different varieties Introgression of the transgene into an appropriate line Commercial maize seeds (GM and conventional) are hybrids Conventional hybrid obtaining process Transgenic line Inbred line Parental I Inbred line Parental II Conventional hybrid Transgenic hybrid Transgenic hybrid obtaining process Conventional and transgenic hybrids are near-isogenic varieties Palaudelmàs, 2009 (near-isogenic: identical genome except for the transgene and a certain unknown amount of other genomic differences) 9

10 GRACE: maize for animal feeding trials GRACE reconsiders the gain in quality and information of animal feeding trials for assessing the safety of GM food and feed 90-day feeding studies alternative approaches (in vitro, based on cell culture and in-deep study of the GM crop using profiling technologies) extended feeding trials Selection of GM maize and non-gm near-isogenic varieties The same crops to be used for animal feeding and in vitro testing studies Inclusion of additional controls: conventional varieties NE Catalonia Empordà (2011: 73 % GM maize) 10

11 GRACE: selection of MON810 varieties Variety GMO Company FAO cycle DKC6667YG MON810 Monsanto (Dekalb) 700 DKC Monsanto (Dekalb) 700 PR33D48 MON810 Pioneer Hi-Bred 700 PR32T16 - Pioneer Hi-Bred 700 DKC Monsanto (Dekalb) 700 DKC Monsanto (Dekalb) 700 PR32T83 - Pioneer Hi-Bred 700 PR33W82 - Pioneer Hi-Bred 600 SY Nepal - Koipesol Semillas 600 Commercial MON810 and nearisogenic conventional pairs Commercial conventional varieties (4 x animal feeding trials) All varieties are widely grown in the region and, for GRACE, were grown under the usual cultural practices, with NO insecticide normal pre-emergence herbicide HARNESS GTZ (4l/ha); where needed, postemergence herbicide (ELITE PLUS 0.6 l/ha or CALLISTO a 1 l/ha) normal fertilization (600 kg/ha of NPK) 11

12 Grown in isolated fields (Mas Badia Experimental Agricultural Station) 12

13 Grown in isolated fields (Mas Badia Experimental Agricultural Station) Other varieties 13

14 Nº of captures / ha Nº of Nº captures de Captures / ha MON810 Monitoring of agronomic, morphologic, phenologic and health parameters (visually as usual, but data analysis in progress) - S. nonagrioides and O. nubilalis: very small - viruses (MDMV and MRDV): no observed - fungal infections: no significant infection observed - Monitoring of developmental growth stages, specially flowering and maturity: as expected - Yield: very good ( kg/ha) DKC conventional varieties Sesamia Nonagrioides Ostrinia Nubilalis 14

15 Rainfall (mm) Temperature (ºC) Maize Kernels removed from the cobs on site by machine Meteorological data (rainfall, temperature, thermic integral ) available since 1984 Rainfall (mean ) Rainfall (2011) Temperature (mean ) Temperature (2011) E.E.A. Mas Badia, Empordà,

16 Maize Drying ( ~10% moisture) and milling of the whole batch of each variety: - sample for omics: lyophilise and distribute - sample for composition analyses (specialised company) - prepare and analyse the diets (specialised company) Cereals and cereal products. Sampling. ISO Diet preparation will be done in deliberation with the company s nutritionists ensuring that the nutritional balance of the diets is maintained and that no confounding factors are introduced that could induce physiological effects in the test animals The raw material and the prepared diets will be characterized for: - compositional parameters (proximates, micronutrients) - certain contaminants (e.g. metals, pesticides) - certain toxins (mycotoxins) - microbiological quality 16

17 Maize: PR33D48 (MON810) 17