Current situation of the development, validation and implementation of GMO detection methods in Brazil

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Current situation of the development, validation and implementation of GMO detection methods in Brazil Regina M. Sartori Coelho Ministry of Agriculture, Livestock and Food Supply of Brazil

GMO Regulaments in Brazil Decree No. 5.591/05 regulates the LAW No. 11.105/2005 It establishes safety norms and inspection mechanisms for activities that involve GMO Decree No. 4.680/2003 regulates the LAW No. 8.078/1990 It establishes the rules for GMO labeling Normative Resolutions of National Biosafety Technical Commission CTNBio Risk analysis and approval of GMO release

Authorized GMOs in Brazil 29 6 12 1 1 soybean cotton maize bean eucaliptus Source: CTNBio, Oct 2015

Importation Controls Previous authorization for import (seed) Importers have to declare about GMO traits Document inspection Marketing monitoring random sampling

GMO Inspection in Brazil Authorized events Research, Exclusion (cotton) and Coexistence (maize) Areas Food and feed labeling Non authorized events Field Import Seeds Food and feed

GMO Inspection GM MaizeX Non GM Maize Co-existence Areas GM Non GM GM Non GM Non GM

GMO Inspection MON 810

GMO Inspection Cotton GMO Exclusion Area Allowed Not Allowed

GMO Inspection Tocantins, Brazil: 01/13 02/13 03/13 04/13 05/13 06/13 6 samples (bulk) SAMPLES

GMO Inspection in Brazil 2012 2013 2014 2015 FIGURE 1. Evolution of samples collection sites to monitor GMO cultivation according to Brazilian legislation of exclusion zones, coexistence and unauthorized GMO.

Official Laboratories MAPA s Central Coordenation Private Labs Lanagro /PA Lanagro /SP Lanagro /RS Lanagro /GO Lanagro /MG Lanagro /PE

Private Laboratories Expertise Areas Food, Feed, Beverage and Fertilizer Quality Credentialed Labs Recognized Labs Total 53-21 Animal and Plant Diagnostic 347 6 351 Veterinary Medicine 1-1 Food Microbiology 26 27 53 GMO Detection 2-2 Food Residues 17-17 Animal Genetic Identity 12-12 Others 172 181 TOTAL 468 33 673 Source: MAPA, Oct 2015

GMO Analysis PCR Method ISO/IEC 17025:2005; ISO/IEC 21570:2005; ISO/IEC 21569:2005 ISO/IEC 21571:2005; ISO/IEC 24276:2006; ENGL 2008, 2009, 2011; EURL-GMFF/ENGL 2011. Only Validated Methods

GMO Analysis Year Validated Methods in LANAGRO-GO 2012 1 2013 9 2014 17 ISO/IEC 17.025 acreditation is required for GMO laboratories.

GMO Analysis Demand

Maize Soybean Cotton Food Feed Peanut Rice Potato Sugarcane Rapeseed Carnation Eucalyptus Bean Feed Flax Popcorn grain Sorghum Tobacco Tomato Wheat Papaya GMO Analysis Demand Type of Analysed Samples LANAGRO-GO 1000 100 10 1

GMO Analysis GMO Finder To verify compliance to brazillian legislation, we use screening methods including the sequences 35S, NOS, PAT, BAR, CTP4EPS PS, PFMV, NPTII.

GMO Analysis Screening GMO Event Plant P35S T- nos CTP2- CP4EPS PS bar 35S-pat NptII FMV Ga21XMON810 Maize + + - - - - - MON863XMON810 Maize + + - - - + - MON87460 Maize + + - - - + - MON89034 Maize + + - - - - + CERA - http://www.cera-gmc.org/?action=gm_crop_database GMO Finder http://www.lgl.bayern.de

GMO Analysis Event-specific Detection ISO/IEC 21569:2005 q PCR, cpcr EU-RL GMFF validation process http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx Event-specific Quantification EU-RL GMFF validation process http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx ISO/IEC 21570:2005 q PCR - CT analysis Specific Parameters: R2; curve slope; reaction efficiency

GMO Analysis

GMO Analysis

RESULTS Central Coordination

Challenges Detection of Third generation (near-intragenics), and Fourth generation (intragenics and cisgenics) of GMOs. The availability of certified reference materials For most events currently released, there aren t proficiency programs available to check the laboratories performance. Use of Digital PCR to qualify reference materials Use of Sequencing to identify unauthorized GM events in the future.

Thank You www.agricultura.gov.br facebook.com/minagricultura twitter.com/min_agricultura youtube.com/minagriculturabrasil regina.sartori@agricultura.gov.br maria.trindade@agricultura.gov.br Ministry of Agriculture, Livestock and Food Supply of Brazil