South Asia Biosafety Conference September 18 19, 2013...

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South Asia Biosafety ConferenceSeptember 18‐19, 2013

Taj Ambassador Hotel, New Delhi, India

Dr. Thiago SouzaEmbrapa Rice & BeansSanto Antônio de Goiás, GO, Brazilthiago.souza@embrapa.br+55 (62) 3533‐2129+55 (62) 8127‐0254

Considerations for the Commercialization of Embrapa’sVirus Resistant Common Bean (Embrapa 5.1)

Overview on the common bean crop in Brazil

Brief history of the Embrapa 5.1 technology

Stewardship Program

Post‐approval field trials for cultivar registration

Seed production (breeders seed, pre-basic and basic seed)

Technical perspectives on commercial release

Outline

Dry Beans ‐ Brazil

Brazil is the second largest producer of dry beans in the world after India

Production in 2011 was estimated at 3.43 million tonnes (US$ 1.98 billion)

FAOSTATS

Source: IBGE (2012), modified by Embrapa Rice and Beans.

Some Embrapa’s common bean cultivars

• Losses in grain production may range from 40 to 100% / 90‐to‐280,000 tonnes per year.• Annual losses would be enough to feed from six to 20 million of adult Brazilians.• At least 200,000 ha became impractical for bean growth in Brazil due to the BGMV; about 10% of the total common bean growing area.

BGMV ‐ Bean Golden Mosaic Virus

Deformation of pods and grains

BGMV ‐ Bean Golden Mosaic Virus

This geminivirus is transmitted by the whitefly (Bemisia tabaci)

BGMV ‐ Bean Golden Mosaic Virus

Santo Antônio de Goiás, GO, Brazil – March 2013

Severe foliar yellow mosaic symptoms

Effective resistance has not been identified in P. vulgaris germplasmover 40 years of conventional breeding efforts in Brazil

Embrapa ‐ Brazilian Agricultural Research Corporation, Brazilian Government.

Dr. Francisco AragãoEmbrapa Cenargen

Dr. Josias FariaEmbrapa Rice & Beans

RNAi Technology

d 35S CaMV nosTintron antisensesense

alça

No new protein

Aragão & Faria (2009) Nature Biotechnology 27: 1086‐1088.

Embrapa’s BGMV Resistant Bean ‐ Event Embrapa 5.1

Transformation Process ‐ Event Embrapa 5.1Method patented by Embrapa

PARTICLE BOMBARDMENT OR BIOLISTICS

Official Biosafety Assessment

CTNBio ‐ National Technical Commission on Biosafety Multidisciplinary consultative body established under the Ministry of Science and Technology to provide technical and advisory support to the Federal Goverment for 

the implementation of the national biosafety policy

Brazilian Biosafety Policy Law (Law No. 11,105/2005)

Molecular characterization Agronomic characterization Environmental risk assessment Nutritional composition analysis  Food security assessment

Event Embrapa 5.1

Biosafety Assessment Project

%

Production of common bean (Phaseolus vulgaris L.) crop in Brazil per State

Leader: Dr. Josias FariaEmbrapa Rice & Beans

Commercial Approval ‐ Sep. 16, 2011CTNBio: http://www.ctnbio.gov.br/

Embrapa’s BGMV Resistant Bean ‐ Event Embrapa 5.1

Cristalina, GO, Brazil – 15/Aug/2013

Field Meeting ‐ Common Bean Farmers

Second largest (by volume) producer of transgenic crops in the world, in 2012 Brazil planted over 36 million ha of transgenic soybean, corn and cotton. 

Source: James (2012).

Brazilian Commercial Approvals(up to September 2013)

TOLERANCE TO HERBICIDES AND INSECT

Soybean:  5 traits

Corn:  19 traits

Cotton:  12 traits

Common bean: Embrapa 5.1

Brazil ‐ Very Attractive Seed MarketEstimated at over US$ 2 billion (third largest market in value) 

BC ProgramTransgene Estability

Credited to Dr. Josias C. Faria

Olathe GM Pérola and BRS Pontal

Event Embrapa 5.1

Backcrossing (BC) Program

Embrapa 5.1 BGMV Resistant BeanCultivar Development

# Genotype Embrapa code Note1 1-4-8-2-3-NIL PÉROLA CNFCT 16201 Transgenic2 1-10-6-1-2-NIL PÉROLA CNFCT 16202 Transgenic3 1-16-10-2-NIL PÉROLA CNFCT 16203 Transgenic4 10-5-6-1-2-NIL PÉROLA CNFCT 16204 Transgenic5 094-NIL Pontal CNFCT 16205 Transgenic6 097-NIL Pontal CNFCT 16206 Transgenic7 107-NIL Pontal CNFCT 16207 Transgenic8 125-NIL Pontal CNFCT 16208 Transgenic9 132-NIL Pontal CNFCT 16209 Transgenic

10 138-NIL Pontal CNFCT 16210 Transgenic11 Pérola BGF7384 Conventional12 BRS Pontal CNFC7813 Conventional13 IPR Eldorado IPREldorado Conventional14 BRB 169 BGF8419 Conventional15 CNFP 15882 CNFP15882 Conventional

Final field trials

Embrapa’s Units: 1) Arroz e Feijão2) Trigo3) Milho e Sorgo4) Agropecuária Oeste5) Cerrados6) Tabuleiros Costeiros7) Rondônia8) Soja9) SPM (6 ETs)10) CTAA11) Semi-Árido

Partners:1) UFLA2) UFV3) UFU4) UFG5) Epamig6) Empaer MT7) EBDA8) IPA9) Cooperativas e Consultores

Final field trials to evaluate the agronomic performance of the bean transgenic linesNational Assay Network

Ensure that “Embrapa 5.1 Technology" WILL NOT get in the market BEFORE its COMMERCIAL RELEASE

Stewardship Program

Stewardship Program

Detailed guidance on best practices to ensure containment, segregation, control and traceability 

of transgenic materials

Trainings on best practices for different activities

Stewardship Program

Almost 100 employees trained since 2011

Transgenic seed collection (seed bank)

Stewardship Program

GPS coordinates

10m

Field Trials ‐ Sowing

Stewardship Program

Field Trials ‐ Harvesting

Stewardship Program

Stewardship ProgramClean‐up Protocol

# Loc Season Trial ID Location State

1 First/2012 F11VCT001 Santo Antônio de Goiás GO2 First/012 F11VCT002 Anápolis GO3 Second/2012 F11VCT003 Santo Antônio de Goiás GO4 Third/2012 F11VCT005 Sete Lagoas MG5 Third/2012 F11VCT007 Ponta Grossa PR6 Third/2012 F11VCT008 Santo Antônio de Goiás GO7 Third/2012 F11VCT009 Brasília DF8 First/2013 F11VCT011 Londrina PR9 First/2013 F11VCT013 Santo Antônio de Goiás GO10 First/2013 F11VCT012 Brasília DF11 First/2013 F11VCT006 Sete Lagoas MG12 First/2013 F11VCT010 Dourados MS

Final Field Trials ‐ Finalized 

Three field trials in course - Season: Second/2013

# Genotype Embrapa code Note Status1 1-4-8-2-3-NIL PÉROLA CNFCT 16201 Transgenic Potential2 1-10-6-1-2-NIL PÉROLA CNFCT 16202 Transgenic No selected3 1-16-10-2-NIL PÉROLA CNFCT 16203 Transgenic No selected4 10-5-6-1-2-NIL PÉROLA CNFCT 16204 Transgenic SELECTED5 094-NIL Pontal CNFCT 16205 Transgenic Potential6 097-NIL Pontal CNFCT 16206 Transgenic Potential7 107-NIL Pontal CNFCT 16207 Transgenic SELECTED8 125-NIL Pontal CNFCT 16208 Transgenic Potential9 132-NIL Pontal CNFCT 16209 Transgenic Potential

10 138-NIL Pontal CNFCT 16210 Transgenic No selected11 Pérola BGF7384 Conventional12 BRS Pontal CNFC7813 Conventional13 IPR Eldorado IPREldorado Conventional14 BRB 169 BGF8419 Conventional15 CNFP 15882 CNFP15882 Conventional

Final Field Trials ‐Main Conclusions 

Ponta Grossa, PR, Brazil – December 2012

Santo Antônio de Goiás, GO, Brazil ‐ August 2013

Seed Production is on Schedule(breeders and pre‐basic seed)

Technical target for the commercial release: 2015/2016 ‐ 50,000 ha (25%) 

Handle large growing areas for agronomic performance observation and certified seed production following the Stewardship Program is 

challenging…

We’re still working on the business plan for the Embrapa 5.1 technology...

Backcrossing (BC) Program Assisted byMolecular Markers

Doador x Recurrent

4 months

PCR F1 x Recurrent

4  months

PCR BC1F1 x Recurrent

4  months

PCR BC2F1 x Recurrent

4  months

PCR + FP BC3F1 >99% (93,75%)

4  months

PCR BC3F2 Homozigosity

4  months

BC3F2:3

24  months

%GR = 100 x [1‐(0,5)n+1]

Development of new transgenic bean cultivars

Embrapa common bean cv. BRS Estilo

Research ScientistAdriane WendlandHelton PereiraLeonardo MeloLuis Cláudio de FariaThiago Souza

Senior Research AssistantJose Luis CabreraMariana CruzickNilda Pessoa

Research AssistantJoão Donizete PuríssimoMarcos AtaídePaulo FernandoVicente Henrique

Embrapa’s Common Bean Breeding Team

Thank you!Dr. Thiago SouzaEmbrapa Rice & BeansSanto Antônio de Goiás, GO, Brazilthiago.souza@embrapa.br+55 (62) 3533‐2129+55 (62) 8127‐0254