Genetically Modified Organisms GMO - Update on Approval, Planting and Detection Ulf Rathjens 16.02.2018 www.eurofins.de
Commercial Planting of GMOs 90% of global planting area in USA, Brazil, Argentina, India, Canada, China EU: Only MON810 corn approved for commercial planting Most EU member states prohibited GMO planting Planting in Spain, Portugal, (Czech Republik, Slovakia, Romania) Increase of GM Crops in Countries with Highest Production 1996-2016 M ha 180 160 140 120 100 80 60 40 20 USA Brazil Argentina India Canada China 0 96 98 00 02 04 06 08 10 12 14 16 year 2
Commercial Planting of GMOs >99% of the global GM planting area is shared by four crops: Maize, Soybean, Cotton, Canola Global Adoption Rates (%) for Principal Biotech Crops, 2016: by Crop (Million Hectares) In addition, regional commercial planting of GMOs from other plants Sugarbeet, Alfalfa, Papaya, Zucchini (Squash), Tomato, Carnation, Sweet Pepper, Poplar, Eggplant, Potato etc. Accidental release of GMO, contamination of seeds in the past years: Maize, Rice, Linseed, Papaya, Petunia M ha 250 200 150 100 50 0 Maize Soybean Canola Cotton non-gm GM Crop Type Figures based on ISAAA Brief 52: Global Status of Commercialized of Biotech/Crops 2016 3
Facts & Figures GM Soybean Planted in more than 10 countries Global planting area 91.4 M ha 14 approved events in the EU 1 with 0.1% tolerance (feed) 3 pending EU approvals Customer information GM-soy www.eurofins.de/gmo-soy 4
Commercial Planting of GMOs Please do not hesitate to contact us for our actual customer information on GM-Soy, GM-Corn, GM-Canola, GM-Cotton, which are updated in regular intervals UlfRathjens@eurofins.de 5
Facts & Figures GM Soybean Planting of GM soybean GM and non-gm planting area (Countries with more than 1 M ha GM soybean planting, 2016) M ha 35 30 25 20 15 10 non-gm GM 5 0 USA Brazil Argentina Paraguay Canada Uruguay Bolivia Country 6
Facts & Figures GM Soybean Russia Commercial production: Russia does not cultivate any GE crops, including GE seed production Export: Some soybean meal exports from Russia may have GE lines. [ ] is the major exporter of soybean meal in Russia, and its soybean meal is primarily a result of crushing of imported soybeans. Therefore, Russia s soybean meal exports may contain GE lines http://gain.fas.usda.gov/recent%20gain%20publications/agricultural%20biotechnology%20annual_moscow_russia n%20federation_7-9-2015.pdf Ukraine Zhanna Pastovenska (Ministry of Economy of Ukraine), 2007: So far, no GMO is registered for commercial planting in Serbia and the Ukraine BUT Results of several laboratories in Ukraine, [ ] clearly showed that in Ukrainian fields it is possible to find out GM soybean with resistance to RoundUp [ ] Rumours on illegal planting: GM-soy 40 70% of soy planting area Romania Commercial planting of GM soy before EU membership (2006: ~ 100.000 ha) Still positive findings 7
Facts & Figures GM Soybean New GM soy events are entering the market Not detectable with common screening methods Commercial planting in different stacked events New screening-strategies needed to cover all new events 8
GM Soy Commercialization GMO EU approval status planting GTS 40-3-2 app. + MON89788 app. + MON87701 app. + MON87708 app. + MON87705 app. + A2704-12 app. + A5547-127 app. + CV127 app. + FG72 app. + 305423 app. + 356043 app. MON87769 app. DAS-68416-4 DAS-44406-6 DAS-81419-2 SYHT0H2 MON87751 app. app. pend., 0,1% feed pend. pend. The table lists all GMOs with EU authorization and pending approvals app.: pend.: approved for food and feed in the EU pending approval in the EU 0,1% feed: tolerated in feed in a proportion no higher than 0,1% according to Regulation (EC) No. 619/2011 planting: commercial or closed loop planting in one or more countries according to CropLife International and other sources 9
Detection of GM Soybean GMO EU approval status 35S NOS FMV ABII SAMs/als CV127 CsVMV GTS 40-3-2 app. + + MON89788 app. + + MON87701 app. + MON87708 app. + MON87705 app. + + A2704-12 app. + A5547-127 app. + CV127 app. + FG72 app. + MON87769 app. + 305423 app. + 356043 app. + DAS-68416-4 app. + DAS-44406-6 app. + DAS-81419-2 pend., 0,1% feed + SYHT0H2 pend. + + + MON87751 pend. + 10
Detection of GM Soybean Recommended Detection Package CaMV 35S Promoter Detection of important GMOs such as Roundup Ready soybean and relevant LibertyLink events. The optimized Eurofins GeneScan 35S promoter method also detects related promoter elements, e.g. present in Optimum GAT (event 356043) NOS Detection of Roundup Ready (GTS-40-32) and Balance (event FG72) soybean AgroBorder II Covers more approved soybean events than the FMV promoter detection method Event 305423 Specific detection of Enlist (event 305423) soybean Event CV127 Specific detection of Cultivance soybean (event CV127) CsVMV modification Detection of the following three soybean events: DAS-68416-4, DAS-44406-6, DAS-81419-2 11
Detection of GM Soybean Recommended Detection Package CaMV 35S Promoter Quantification Detection of important GMOs such as Roundup Ready soybean and relevant LibertyLink events. The optimized Eurofins GeneScan 35S promoter method also detects related promoter elements, e.g. present in Optimum GAT (event 356043) NOS Detection of Roundup Ready (GTS-40-32) and Balance (event FG72) soybean AgroBorder II Quantification Covers more approved soybean events than the FMV promoter detection method Event 305423 Specific detection of Enlist (event 305423) soybean Recommendation for products known to contain traces of GM-soy Combination of Event CV127 Specific detection of Cultivance soybean (event CV127) direct quantification of most dominant GM-Soy CsVMV modification Detection of the following three soybean events: DAS-68416-4, DAS-44406-6, DAS-81419-2 qualitative detection of less dominant GM-Soy 12
Facts & Figures GM Corn Planted in over 15 countries Global planting area 60.6 M ha 14 approved events in the EU 5 with 0.1% tolerance (feed) 10 pending EU approvals EU Commercial planting of MON810 (Spain, Portugal, Czech Republic, Slovakia) Customer Information GM Corn www.eurofins.de/gmo-corn 13
Facts & Figures GM Corn Planting of GM corn GM and non-gm planting area (Countries with more than 1 M ha GM corn planting, 2016) M ha 40 35 30 25 20 15 10 non_gm GM 5 0 USA Brazil Argentina South Africa Canada Country 14
GM Corn Commercialization GMO EU approval status planting Bt11 app. + GA21 app. + TC1507 app. + DAS-59122-7 app. + T25 app. + MIR604 app. + MON810 app. + MON88017 app. + MON89034 app. + NK603 app. + MIR162 app. + DAS-40278-9 app. + MON87460 MON87427 app. app. Genetically modified corn with valid EU approval planting: commercial or closed loop planting in one or more countries according to CropLife International and other sources 15
GM Corn Commercialization GMO EU approval status 3272 pend., 0,1% feed event 5307 VCO-01981-5 DP-098140-6 MON87411 MON87403 DP-004114-3 MZHG0JG MON87419 MZIR098 pend., 0,1% feed pend., 0,1% feed pend. pend. pend. pend. pend. pend. pend. planting Bt 176 exp., 0,1% feed disc. MON863 exp., 0,1% feed disc. LY038 withdr. Genetically modified corn with pending or expired EU approval pend.: exp.: withdr.: pending approval in the EU approval expired application for authorization withdrawn 0,1% feed: tolerated in feed in a proportion no higher than 0,1% according to Regulation (EC) No. 619/2011 disc.: discontinued commercial planting according to CropLife International and other sources, contaminations with this GMO can not be excluded 16
35S NOS ABII Event VCO-01981-5 Event DAS-40278-9 LY038 Detection GM Corn GMO EU approval status Planting Bt11 appr. + + + GA21 appr. + + TC1507 appr. + + DAS-59122-7 appr. + + T25 appr. + + MIR604 appr. + + MON810 appr. + + MON88017 appr. + + + + MON89034 appr. + + + + NK603 appr. + + + MIR162 appr. + + DAS-40278-9 appr. + + MON87460 appr. + + + MON87427 appr. + + + 17
35S NOS ABII Event VCO-01981-5 Event DAS-40278-9 LY038 Detection GM Corn GMO EU approval status 3272 pend., 0,1% feed + event 5307 pend., 0,1% feed + VCO-01981-5 pend., 0,1% feed + Event 98140 pend., 0,1% feed + MON87411 pend. + + MON87403 pend. + + DP-004114-3 pend. + MZHG0JG pend. + + MON87419 pend. + MZIR098 pend. + + Bt 176 exp., 0,1% feed + MON863 exp., 0,1% feed + + LY038 withdr. + 18
Detection of GM Corn Recommended Detection Package CaMV 35S / NOS / (ABII) - Screening Optimized 35S promoter method detects also related promoter elements, as present e.g. in Optimum GAT corn (event DP-098140-6) NOS terminator detection for important corn events with no 35S promoter element such as GA21, MIR162, MIR604 and others AgroBorder II screening provides additional information about GMOs and covers upcoming corn events such as MON87419 corn Plus Specific detection of GM corn events not covered by screening elements VCO-01981-5 DAS-40278-9 LY038 19
Next Generation GMOs Genetically Modified Apple Arctic TM first Commercialized GM Apple Developed by Okanagan Specialty Fruits Reduced browning Approval in the US and in Canada Available in the US since 2017 as Golden Delicious, Granny Smith and Fuji Apples 20
Next Generation GMOs Genetically Modified Salmon AquAdvantage -Salmon the First GM Animal Approved for Food developed by AquaBounty Technologies Approved for food in Canada and the US Sold for human consumption in Canada in 2017 Assay for the detection of genetically modified salmon available 21
Broad and Cost Efficient Testing Customer Demand Formulation / Raw Materials Legal Framework in Country of Destination Commercial Planting in Country of Origin Combination of PCR targets should cover relevant GMOs Special Requirements 22
Broad and Cost Efficient Testing Potential Botanical Impurities Customer Demand Accidential Release of GMO Formulation / Raw Materials Legal Framework in Country of Destination Commercial Planting in Country of Origin Combination of PCR targets should cover relevant GMOs Special Requirements 23
Eurofins GeneScan > 100 different PCR methods for GMO detection GMO Screening GMO Identification GMO Quantification Identification of plant species: Corn Soy Canola Cotton many other Quantification of admixture / Botanical impurities Result: E.g. mass % soy flour in flour-sample (maize) Very short TAT lead time - (same day service available) Competent consultation & tailored customer agreements Molecular Biology is our Core Business International Competence Centre for GMO testing of Eurofins 24
Contact If you have questions, please contact T: +49 40 49294 3403 UlfRathjens@eurofins.de The information included in this publication is based on our current knowledge and was thoroughly verified. Nevertheless there is no guarantee for it to be up-to-date, complete and correct. Eurofins is not to be held liable for damages or injury, which are connected to the use of this information. Especially the confirmation of legal details is up to the user. All offers are non-binding and without obligation. 25