GMO Regulatory System in Brazil and Status of Commercial Approvals Reunión GT-5-CAS Marcus Vinícius Segurado Coelho Ministry of Agriculture, Livestock and Food Supply of Brazil
Law nº 11.105, dated March 24th, 2005 Brazilian Biosafety Law Provides for safety norms and inspection mechanisms for activities with GMOs and their by-products * comprehensive review of the 1995 Law
Guidelines The scientific development in biosafety and biotechnology The protection of human, animal and plant life and health The compliance with the Precautionary Principal for environmental protection
GMO - Brazilian Legislation Biosafety Maintenance Risk Assessment CIBIO Biosafety Internal Commission OERF MAPA ANVISA IBAMA CTNBio National Technical Commission CNBS National Biosafety Council Law 11.105/2005 Decree 5.591/2005 CTNBio Normatives Registration and inspection agencies specific areas National interest and socio economic factors
Composition Science Sector Human Health (3) Animal Health (3) Plant Protection (3) Environment(3) National Biosafety Technical Commission Civil Society Customer Protection Health Small Farms Environment Biotecnology Worker Health Governmental MAPA, MCT, MS, MMA MDIC, MRE, MDA MD e MPA
Institutions and Companies Authorized to conduct research with GMOs in Brazil AM: 7 PA:2 CE:4 RN:2 PI:1 PB:2 PE:5 RO:1 MT:2 BA:9 SE:1 AL:1 GO: 4 331 MS: 5 DF: 9 SP:142 MG:25 ES:3 60% Agriculture and livestock RS: 39 PR: 28 SC:10 RJ:25 List and address available at the CTNBio website
Registration and Inspection Bodies Federal Government bodies responsible for the registration and inspections of products and activities with GMO Ministry of Agriculture, Livestock and Food Supply (MAPA) Ministry of Fishery (MAP) Ministry of Environment (IBAMA) Ministry of Health (MS)
Registration and Inspection Bodies Federal Government bodies responsible for the registration and inspections of products and activities with GMO Ministry of Agriculture, Livestock and Food Supply (MAPA) Secretariat of Animal and Plant Health and Inspection
Approach to Safety Evaluation of GM Crops in Brazil Science based Case-by-case In line with CODEX Guidelines (CAC/GL44; CAC/GL45), Cartagena Protocol principles (Annex III) and other guidelines of relevant organizations like FAO and OECD Comparison with the conventional conterpart Multidisciplinary and transparence
Public Participation and Transparency Publication of an abstract of the applications in the National Federal Journal Meetings opened to the public Publication on the internet of the meetings agenda and decisions of CTNBio Publication on the internet of the member expert opinions individually and of the CTNBio Public Meetings prior to the commercial approval
Policy for Biotechnology Development Decree No. 6.041/2007 Objective: establishment of appropriate environment for the development of innovative biotechnology products and processes
Cartagena Protocol/CBD Brazil ratified in 2004 National Competent Authorities defined in 2009 through Decree nº 6.925 Law, regulations and GMOs authorized fully deposited on the Biosafety Clearing House Active participation in the negotiation of the implementation of it articles
GM Crops Authorized in Brazil per crop (36) 18 5 9 12 1 soy cotton corn beans Source: CTNBio
2011 - GM Bean The problem Mosaic Virus 80 100 thousand tons lost per year 200,000 ha with no possibility of cultivation The alternative: EMBRAPA GM Bean Protection against the Mosaic Virus Seeds will be available in 2016 Technology 100% national
GM Crops - Distribution per trait 12 5 5 Source: Celeres
GM Cultivars per Crop in the National Register 1% 57% Milho Soja Algodão 42% Total: 1.128* Cotton: 12 Corn: 640 Soybean: 476
GM Cultivars in the National Cultivars Register 4,4% Cultivares GM Cultivares Convencionais e Espécies 95,6% Total: 29.434 GM Cultivars: 1.281 Conventional Cultivars: 28.153 Source: MAPA - 01/04/2013.
Agricultural Biotechnology Adoption rate in Brazil
GMO Pipeline Field Trails Eucalyptus Rice Sorghum Sugarcane Wheat Wood Quality Yield Increase Sugar Accumulation Insect Resistance Drought Stress Volume Increase Biomass Increase Herbicide Tolerance
Gracias Amigos!!