Environmental Risk Assessment Symposium Mexico City, Mexico - March 2 nd - 3 rd 2011 Problem Formulation in Practice - South America Environmental Risk Assessment of Genetically Modified Plants in Brazil Giancarlo Pasquali Biotechnology Center Federal University of Rio Grande do Sul Porto Alegre, RS, Brazil
Brazilian National Legislation on the Biosafety of Genetically Modified Organisms Law Nr 11,105 March 24 th 2005 Brazilian Biosafety Law Decree Nr 6,925 August 6 th 2009 Cartagena Protocol on Biosafety to the Convention on Biologic Diversity Decree Nr 5,591 November 22 nd 2005 CTNBio Normative Resolutions Normative Instructions CTNBio Communications G.Pasquali CBiot/UFRGS
Brazil s President Minister and Chief of Staff to the President National Biosafety Council (CNBS) National Biosafety Technical Commission (CTNBio) CNBS composed by Ministers of State: 1. Chief of Staff to the President 2. Science & Technology 3. Agrarian Development 4. Agriculture, Farming & Supply 5. Justice 6. Health 7. Environment 8. Development, Industry & Commerce 9. Foreign Affairs 10. Defense 11. Fisheries & Aquiculture G.Pasquali CBiot/UFRGS
National Biosafety Technical Commission (CTNBio) CTNBio is composed by 54 members = 27 full + 27 substitutes All members must have Ph.D. degree Twelve publicly acknowledged specialists in Science & Technology: 3 Specialists in human health 3 Specialists in animal health 3 Specialists in plants 3 Specialists in environment One representative of each ministry: Science & Technology (MCT) Agrarian Development (MDA) Agriculture, Farming & Supply (MAPA) Health (MS) Environment (MMA) Development, Industry & Commerce (MDIC) Foreign Affairs (MRE) Defense (MD) Fisheries & Aquiculture (MPA) One specialist in (indicated by ministry): Consumer s rights (M. Justice) Health (MS) Environment (MMA) Biotechnology (MAPA) Family agriculture (MDA) Worker s health (M. Labour) G.Pasquali CBiot/UFRGS
http://www.ctnbio.gov.br/
CTNBio Normative Resolutions NR 1 06/20/2006 Biosafety Internal Commissions (CIBio) & Biosafety Quality Certificate (CQB) NR 2 11/27/2006 Classification of GMO risks & biosafety levels NR 3 08/16/2007 Instructions for monitoring commercially released GM maize NR 4 08/16/2007 Instructions on distances between commercial areas of GM maize and non-gm maize NR 5 03/12/2008 Commercial release of GMOs & derivatives NR 6 11/06/2008 Instructions for the intended release (field testing) of GM plants & derivatives NR 7 04/27/2009 Instructions for the intended release (field testing) of GM animals and microorganisms (& derivatives) of Risk Class 1 NR 8 07/03/2009 Simplified instructions for the intended release (field testing) of GMOs & derivatives of Risk Class 1 G.Pasquali CBiot/UFRGS
CTNBio Normative Instructions NI 02 09/10/1996 GM plant import for research purposes NI 04 12/19/1996 GMO transport NI 08 07/09/1997 Genetic manipulation & cloning of human beings NI 09 10/10/1997 Gene therapy of human beings NI 13 06/01/1998 GM animal import for research purposes NI 17 11/17/1998 GMO derivatives: import, commerce, transport, storage, handling, consumption, release & discharge NI 18 12/15/1998 Test field and commercial releases of Roundup Ready soybean NI 19 04/19/2000 Instructions for public audiences of CTNBio G.Pasquali CBiot/UFRGS
CTNBio Normative Resolution Nr 5 March 12th 2008 Commercial Release of GMOs and Derivatives ANNEX III EVALUATION OF RISKS TO HUMAN AND ANIMAL HEALTH Organisms consumed as food the focus of this annex is on GMOs or derivatives that are used as food either for human beings or animals employed by humans for feeding or housework. G.Pasquali CBiot/UFRGS
CTNBio RN 5 ANNEX III EVALUATION OF RISKS TO HUMAN AND ANIMAL HEALTH 1. History of the parental organism use in feeding 2. Effects of the GMO on food chain 3. Chemical and nutritional differences in composition of derived foods 4. Alterations relative to animal performance when fed with GMO 5. Recombinant protein stability to digestion and industrial processing 6. Deleterious effects of the GMO in pregnant animals and teratogenic potential G.Pasquali CBiot/UFRGS
CTNBio RN 5 ANNEX III EVALUATION OF RISKS TO HUMAN AND ANIMAL HEALTH 7. Immunological and histological analyses of relevant tissues, especially of the digestive trait 8. Capacity to produce toxins or metabolites able to cause adverse effects to the consumer 9. Toxicological and pharmacological evaluations in experimental animals 10. Similarity of the recombinant products to known allergens G.Pasquali CBiot/UFRGS
CTNBio Normative Resolution Nr 5 March 12th 2008 Commercial Release of GMOs and Derivatives ANNEX IV EVALUATION OF ENVIRONMENTAL RISKS PLANTS G.Pasquali CBiot/UFRGS
CTNBio RN 5 ANNEX IV EVALUATION OF ENVIRONMENTAL RISKS PLANTS 1. Natural area of occurrence of the GM parental organism, its ancestors and wild relatives 2. History of cultivation and use of the GM parental organism in terms of safety to the environment and for human and animal consumption 3. Effects on indicator organisms relevant to ecosystems 4. Ability of the GMO to disperse propagative (spread) or reproductive structures beyond the areas of cultivation and the mechanisms of its dispersal G.Pasquali CBiot/UFRGS
CTNBio RN 5 ANNEX IV EVALUATION OF ENVIRONMENTAL RISKS PLANTS 5. Formation of long-living structures of reproduction 6. Frequency of GMO crossing 7. Effects resulting from horizontal transfer to soil microbiota 8. Impacts on target and non-target organisms 9. Alterations in plant ability to add or remove soil components G.Pasquali CBiot/UFRGS
CTNBio RN 5 ANNEX IV EVALUATION OF ENVIRONMENTAL RISKS PLANTS 10. Alterations in GM plant biodegradability compared to the parental genotype 11. Resistance to chemical agents conferred by the introduced characteristic 12. History of GMO commercial use 13. Alterations in the ability to survive in environments distinct to those occupied by the parental plant G.Pasquali CBiot/UFRGS
GMOs Commercially Released in Brazil Plants Company Submission Decision Delay T304-40 x GHB119 TwinLink Cotton Insect Resistant & Herbicide Tolerant MON89034 TC1507 NK603 Maize Insect Resistant & Herbicide Tolerant MON88017 Maize Insect Resistant & Herbicide Tolerant Bayer S.A. 07/26/2010 02/17/2011 7 Months Monsanto do Brasil Ltda. & Dow AgroSci. Ind. Ltda. Monsanto do Brasil Ltda. N.I. 12/16/2010 - - - - - 04/20/2010 12/16/2010 8 Months GHB614 GlyTol Cotton Herbicide Tolerant Bayer S.A. 03/29/2010 12/09/2010 8 Months Bt11 x MIR162 x GA21 Maize Insect Resistant & Herbicide Tolerant MON89034 x NK603 Maize Insect Resistant & Herbicide Tolerant MON87701 x MON89788 Soybean Insect Resistant & Herbicide Tolerant Syngenta Seeds Ltda. Monsanto do Brasil Ltda. & Dow AgroSci. Ind. Ltda. Monsanto do Brasil Ltda. N.I. 11/18/2010 - - - - - 11/04/2009 11/18/2010 1 Year N.I. 08/19/2010 - - - - - G.Pasquali CBiot/UFRGS March 2011
Plants Company Submission Decision Delay A2704-12 - LibertyLink Soybean Herbicide Tolerant A5547-127 - LibertyLink Soybean Herbicide Tolerant CV127 Soybean Herbicide Tolerant MON531 x MON1445 Cotton Insect Resistant & Herbicide Tolerant TC1507 x NK603 Maize Insect Resistant & Herbicide Tolerant MON89034 Maize Insect Resistant Milho Bt11 x GA21 Maize Insect Resistant & Herbicide Tolerant Bayer S.A. 11/01/2007 02/11/2010 2 Years Bayer S.A 10/31/2008 02/11/2010 2 Years Embrapa Soja & BASF S.A. Monsanto do Brasil Ltda. DuPont do Brasil S.A. (Pioneer) & Dow AgroSciences Industrial Ltda. Monsanto do Brasil Ltda. Syngenta Seeds Ltda. 2009 12/10/2009 - - - - - 04/29/2009 10/15/2009 6.5 Months N.I. 10/15/2009 - - - - - 09/03/2008 10/15/2009 1 Year 04/29/2009 09/17/2009 5 Months G.Pasquali CBiot/UFRGS March 2011
Plants Company Submission Decision Delay MIR162 Maize Insect Resistant MON810 x NK603 Maize Insect Resistant & Herbicide Tolerant MON15985 - Bollgard Cotton Insect Resistant WideStrike Cotton Insect Resistant & Herbicide Tolerant TC1507 Maize Insect Resistant MON1445 - Roundup Ready Cotton Herbicide Tolerant GA21 Maize Herbicide Tolerant NK603 - Roundup Ready 2 Maize Herbicide Tolerant Syngenta Seeds Ltda. Monsanto do Brasil Ltda. Monsanto do Brasil Ltda. Monsanto do Brasil Ltda. Dow Agrosciences Industrial Ltda. Monsanto do Brasil Ltda. Syngenta Seeds Ltda. Monsanto do Brasil Ltda. 12/19/2007 09/17/2009 1 Year 9 Months 04/29/2009 09/17/2009 5 Months 06/28/2007 05/21/2009 2 Years 09/29/2006 03/19/2009 2.5 Years 12/27/2006 12/11/2008 2 Years 10/08/2004 09/18/2008 4 Years 02/21/2006 09/18/2008 2 Years 06/09/2004 09/18/2008 4 Years G.Pasquali CBiot/UFRGS March 2011
Plants Company Submission Decision Delay LLCotton25 - LibertyLink Cotton Herbicide Tolerant Bt11 Maize Insect Resistant Bayer S.A. 05/24/2004 08/21/2008 4 Years Syngenta Seeds Ltda. 07/31/2000 09/20/2007 7 Years T25 - LibertyLink Maize Herbicide Tolerant Bayer S.A. 01/06/1999 05/16/2007 8.5 Years MON810 Guardian Maize Insect Resistant MON531 - Bollgard Cotton Insect Resistant Monsanto do Brasil Ltda. Monsanto do Brasil Ltda. 10/14/1999 08/16/2007 8 Years 06/05/2003 03/17/2005 2 Years (*) Decision suspended by court until 2003. CTNBio inactive until December 2005. 40-30-2 - Roundup Ready Soybean Herbicide Tolerant Monsanto do Brasil Ltda. 06/1998 09/29/1998 4 Months* G.Pasquali CBiot/UFRGS March 2011
Vaccines & Yeast Company Submission Decision Delay Poulvac ST Avian Salmonella typhimurium Vectormune HVT-IBD Marek & Gumboro avian diseases Vectormune HVT-NDV Marek & Newcastle avian diseases Fort Dodge Saúde Animal. Ceva Saúde Animal Ltda. Ceva Saúde Animal Ltda. 05/17/2010 11/17/2010 6 Months 02/27/2009 02/11/2010 1 Year 03/09/2009 02/11/2010 1 Year S. cerevisiae Y1979 Industrial production of farnesene Amyris Brasil S.A. 10/06/2009 02/11/2010 4 Months Vectormune FP-MG Avian fowlpox & Mycoplasma gallisepticum Vectormune FP-MG+AE Avian fowlpox, encephalomyelitis & M. gallisepticum Poulvac E. coli Avian E. coli Ceva Saúde Animal Ltda. Ceva Saúde Animal Ltda. Fort Dodge Saúde Animal Ltda. 02/27/2009 12/10/2009 10 Months 02/27/2009 12/10/2009 10 Months 02/27/2009 10/15/2009 8 Months G.Pasquali CBiot/UFRGS March 2011
Vaccines Company Submission Decision Delay Porcilis Circumvent CVT Pig Postweaning Multissystemic Wasting Syndrome Ingelvac Circoflex Pig PMWS Suvaxyn PCV2 One Dose Pig PMWS Intervet do Brasil Veterinária Ltda. Boehringer Ingelheim Brasil Quím. Farm. Ltda. Fort Dodge Saúde Animal Ltda. 03/03/2008 09/18/2008 6 Months 07/19/2007 06/19/2008 11 Months 05/07/2007 03/13/2008 10 Months PRV-Marker Pig viruses Schering-Plough 06/2002 11/2006 4 Years* Vaxxitek MD/IBD Marek & Gumboro avian diseases Recombitek Pig viruses Merial Saúde Animal Ltda. Merial Saúde Animal Ltda. 12/11/2003 05/12/2004 5 Months 02/1998 05/1998 3 Months (*) This vaccine was NOT APPROVED by the following score: 17 votes in favor of approval versus 4 votes against. CNBS changed CTNBio vote weight (power) thereafter. G.Pasquali CBiot/UFRGS March 2011
Brazilian Amazon Forest Vegetation and Deforestation. The baseline for the Human Pressure analysis was a dataset that combines vegetation (IBGE 1997) and deforestation as of 2001 (INPE 2003). Brazilian Native Vegetation
Areas Planted with Maize in Brazil between 2005 & 2007
Production of Herbaceous Cotton
Production of Sugarcane
Problem Formulation & Environmental Risk Assessment Native vegetation & alien species - Are GM crops more alien? - All GM crops released in Brazil are derived from alien crops. GM contamination of conventional (traditional) crops - How different is GM technology from traditional genetics? - Scientific or cultural problem? Brazilian native crops - Papaya - Cocoa tree - Passion fruit - Peanut - Cashew (nut) - Cassava - Orchid species - Palm tree (açaí) - Pineapple - Brazilian nut - Sapucaia nut - G.Pasquali CBiot/UFRGS
Problem Formulation & Environmental Risk Assessment GM plants under analysis for commercial release in Brazil: - Sugarcane - Common bean - Eucalypt - Rice - Canola - Orange - Papaya Novel genetic traits under analysis for commercial release: - drought tolerance - salt tolerance - faster growth - increased sucrose - increased cellulose - reduced lignin - oil composition - disease (viral, bacterial, fungal) resistance - fiber quality - cold tolerance - G.Pasquali CBiot/UFRGS