GMO Regulatory System in Brazil and Status of Commercial Approvals

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1 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

2 Law nº , 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

3 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

4 GMO - Brazilian Legislation Biosafety Maintenance Risk Assessment CIBIO Biosafety Internal Commission OERF MAPA ANVISA IBAMA CTNBio National Technical Commission CNBS National Biosafety Council Law /2005 Decree 5.591/2005 CTNBio Normatives Registration and inspection agencies specific areas National interest and socio economic factors

5 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

6 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: 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

7 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)

8 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

9 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

10 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

11 Policy for Biotechnology Development Decree No /2007 Objective: establishment of appropriate environment for the development of innovative biotechnology products and processes

12 Cartagena Protocol/CBD Brazil ratified in 2004 National Competent Authorities defined in 2009 through Decree nº Law, regulations and GMOs authorized fully deposited on the Biosafety Clearing House Active participation in the negotiation of the implementation of it articles

13 GM Crops Authorized in Brazil per crop (36) soy cotton corn beans Source: CTNBio

14 GM Bean The problem Mosaic Virus 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

15 GM Crops - Distribution per trait Source: Celeres

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17 GM Cultivars per Crop in the National Register 1% 57% Milho Soja Algodão 42% Total: 1.128* Cotton: 12 Corn: 640 Soybean: 476

18 GM Cultivars in the National Cultivars Register 4,4% Cultivares GM Cultivares Convencionais e Espécies 95,6% Total: GM Cultivars: Conventional Cultivars: Source: MAPA - 01/04/2013.

19 Agricultural Biotechnology Adoption rate in Brazil

20 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

21 Gracias Amigos!!