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Progress onRegulatoryProcess inArgentinaGladys HuergaDirectorate of BiotechnologySecretary of Agriculture,Livestock and FisheriesMinistry of Agriculture, Livestockand Fisheries


ARGENTINE POSITION IN THEGLOBAL CONTEXTLONG HISTORY AS AGRICULTURAL PRODUCERLARGE EXPORTER OF AGRIFOOD PRODUCTSHIGH ADOPTION OF GM CROPSGLOBAL AREA PLANTED WITH GMO 2011 (source ISAAA)USA 69 M.haBrasil 30.3 M.haArgentina 23.7 M.haIndia 10.6 M.ha


ADOPTION OF GMO IN ARGENTINA• 1991: FIRST COUNTRY IN AMERICA TO DEVELOPGMO REGULATIONS• 1996: FIRST COMMERCIAL APPROVAL FOR A GMCROP (DEREGULATION)• 2005: FIRST TRIAL WITH GM ANIMAL UNDERCONTROLED CONDITIONS


• TO ASSESSAIM OF OGM REGULATIONIN ARGENTINA– THE BIOSAFETY OF THE AGROECOSYSTEM• DURING EXPERIMENTAL TRIALS.• FOR GMO DEREGULATION.– THE SAFETY OF FOOD AND FEED• TO KEEP– SUSTAINABILITY OF THE AGROECOSYSTEM• TO AVOID– LOOSING OF EXPORT MARKETS


MARKETING OF A GMPO3 STEPS TO DEREGULATIONMAGYP RESOLUTION N° 763/11• ASSESSMENT OF THE BIOSAFETY FOR THEAGROECOSYSTEMCONABIA & Biotechnology Directorate – SAGYP) – Res. Nº701/11• ASSESSMENT FOR FOOD & FEED USECTAUOGM & Agrifood Quality Directorate – SENASA –Res. Nº 412/02• DETERMINATION OF POSSIBLE EFFECTS IN THEMARKETING OF THE GMO –Agrifood Markets Directorate– MAGYP –Res. Nº 510/11


WHAT DOES ARGENTINA REGULATE? GMPO- CONFINED EXPERIMENTAL TRIALS• RESEARCH IN BIOSAFETY GREENHOUSE (FOR GMPO ORIGINATED IN ARGENTINA)• RESEARCH AND DEVELOPMENT• REQUIREMENT FOR DEREGULATION- COUNTER-SEASON SEED PRODUCTION• MAIZE• SOYBEAN GMAO- CONFINED EXPERIMENTAL TRIALS GMM- CONFINED EXPERIMENTAL TRIALS


ASSESSMENT OF GMPOBIOSAFETY FOR THE AGROECOSYSTEMRESOLUTION N° 701/11• 1ST PHASE ASSESSMENT:EXPERIMENTAL CONDITIONS FOR EXPERIMENTAL TRIALS.• FAVOURABLE ASSESSMENT FOR AUTHORIZATION OF THE RELEASE• 2ND PHASE ASSESSMENT:EFFECTS OF THE GMPO CROP UNDER CURRENT AGRICULTURALPRACTICES.• FAVOURABLE ASSESSMENTFOR COMMERCIALIZATION


• THE GMPO CARACHTERISTICS.BIOSAFETY CRITERIA• THE RELEASE SITE AND AGROECOSYSTEM CARACHTERISTICS.• ADEQUATE EXPERIMENTAL CONDITIONS.• TRANSPORT .• PACKAGING.ASSESSMENT OF THE GMPOEXPERIMENTAL TRIALS• PLANTING/SOWING.– PLANTING REMNANTS MANAGEMENT• HARVEST.– HARVESTED GM MATERIAL MANAGEMENT– HAVERST RESIDUES TREATMENT• FINAL DISPOSITION OF THE GMPO.– STORAGE, DESTRUCTION, EXPORT FOR RESEARCH PURPOSE


FAVOURABLE ASSESSMENT OF THE APPLICATIONREQUESTED FOR EXPERIMENTAL TRIALAUTHORIZATION GRANTED BY SAGYP


MONITORING OF THE RELEASEINSPECTIONS (monitoring)VERIFICATION OF BIOSAFETY CONDITIONSVERIFICATION OF COMPLIANCEADOPTION OF MEASURES TO RESTABLISHBIOSAFETY (if needed)


ASSESSMENT OF GMPOBIOSAFETY FOR THE AGROECOSYSTEMRESOLUTION N° 701/11• 1ST PHASE ASSESSMENT:DONE TO DETERMINE IF THE EXPERIMENTAL CONDITIONS OFFEREDARE ACCEPTABLE FOR EXPERIMENTAL TRIALS.• FAVOURABLE ASSESSMENT FOR AUTHORIZATION OF THE RELEASE• 2ND PHASE ASSESSMENT:DONE TO DETERMINE THE EFFECTS OF THE GMOP CROP ON THEAGROECOSYSTEM UNDER CURRENT AGRICULTURAL PRACTICES.• FAVOURABLE ASSESSMENTFOR COMMERCIALIZATION


ASSESSMENT OF THE GMPO• GENETIC MODIFICATION• EXPRESSION OF THE INTRODUCED GENES• SEGREGATION & STABILITY OF THE PHENOTYPE• POSSIBLE INTERACTIONS OF THE BIOLOGICAL ACTIVITY OF THEEXPRESSED SEQUENCES WITH OTHER HABITUAL BIOLOGICALPROCESSES IN THE PLANT• POSSIBLE INTERACTIONS BETWEEN ALL THE PRODUCTSGENERATED BY THE EXPRESSION OF THE INSERTED SEQUENCESPRESENT IN THE GMPO• PHYSICAL AND CHEMICAL CHARACTERISTICS OF THE PRODUCTSOF EXPRESSION- THERMOSTABILITY OF THE NEWLY-EXPRESSED PROTEINS- DIGESTABILITY & STABILITY OF PROTEINS EXPRESSED (SPEED OFDEGRADATION, FRAGMENTS OF HIGH MOLECULAR WEIGHT)


ASSESSMENT OF THE GMPOIN COMPARISSON WITH THE NO-GM• GERMINATIVE POWER AND DORMANCY• AGRONOMIC PARAMETERS• SUSCEPTIBILITY OF FACTORS OF ABIOTIC STRESS• PRESENT OR POTENTIAL ADAPTATIVE ADVANTAGES OF THE GMPO OF THEAGROECOSYSTEM (ADVANTAGES)• MULTIPLICATION MODE AND RATE• NATURAL PROPAGATION FORMS• SUSCEPTIBILITY OF PESTS• SURVIVAL CAPACITY (VOLUNTEER PLANTS)• POTENTIAL TO ACQUIRE WEED CHARACTERISTICS. CONSIDER POSSIBLE SELECTIONPRESSURES• YIELD


ASSESSMENT OF THE GMPOIN COMPARISSON WITH THE NO-GM• EFFECTS OF THE GMPO ON THE FLORA, FAUNA AND MICROBIALPOPULATION• EFFECTS OF THE GMPO O N NON-TARGET ORGANISMS• EFFECT OF THE GMPO ON SPECIES AND ECOLOGIC INTERACTIONSRELEVANT FOR THE LOCAL AGROECOSYSTEM• EFFECTS DERIVED FROM THE AGRONOMIC PRACTICES (IF THEREWERE)• MANAGEMENT OF POTENTIAL UNDESIRED EFFECTS (FOREXAMPLE, DEVELOPMENT OF PEST RESISTANCE)• PROPOSAL FOR THE “FOLLOW-UP RESEARCH PROGRAM” TOMONITOR THE LONG-TERM EFFECTS ON THE ENVIRONMENT


COMMERCIALIZATION OF GMPODEREGULATION PROCESSSECRETARIAT OF AGRICULTURE, LIVESTOCK &FISHERIESTECHNICAL OPINION FOR EACH ASSESSMENT STEPNON-BINDING OPINIONS• BIOSAFETY FOR THE AGROECOSYSTEM (CONABIA& Biotechnology Directorate – SAGPYA)• SAFETY FOR FOOD & FEED USE (CTA & AgrifoodQuality Directorate - SENASA)• POTENTIAL EFFECTS ON THE MARKET


SAFETY FOR FOOD & FEED USERESOLUTION N° 412/02 - SENASA» FOR HUMANS» FOR ANIMALS» FOR PROCESSING


ASSESSMENTSTHE COMMITTEES• NATIONAL ADVISORY COMMITTEE ONAGRICULTURAL BIOTECHNOLOGY (CONABIA)• TECHNICAL ADVISORY COMMITEE ON GMO USE- TECHNICAL & SCIENTIFIC BASIS- INTERDISCIPLINARY & MULTIDISCIPLINARY- TRANSPARENCY IN INTERESTS MANAGEMENT- CONSENSUS


COMMERCIALIZATION OF GMPODEREGULATION PROCESSTECHNICAL OPINIONResolution Nº 510/11EFFECTS OF THE HAVING THE GMPOIN THE MARKETEXPORT MARKETSDOMESTIC MARKETS


MARKET PERMITS1996 – UP TODAY27 EVENTSSOYBEAN – 4COTTON – 3MAIZE - 20


UPDATE OF THE REGULATORYFRAMEWORKGOALS• TO ADAPT THE REGULATORY FRAMEWORK TO TECHNOLOGICCHANGES• TO MAKE THE ADMINISTRATIVE PROCESS MORE AGILE• TO PROVIDE EASY ACCESS TO ASSESSMENT PROCEDURES• TO SYNCRONIZE DIFFERENT ASSESSMENT STAGES• TO AVOID REQUIRING REPEATED INFORMATION (WHEN POSSIBLE)


REVISION• IMPORTANCE OF THE REGULATORY FRAMEWORK• DEVELOPMENT OF BIOTECHNOLOGY• ASSESSMENTS• DEREGULATION OF GMPO• IMPROVEMENT OF THE REGULATIONS


www.minagri.gob.ar/Biotecnología AgropecuariaMANY THANKS!06-11-2012

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