1.Arroz Dorado Importancia de los transgnicosen la alimentacin mundial:caso del y avances en trigo transgnico Bioseguridad y Biotecnologa Moderna Univ Nal La Molina, Diciembre 2010 Jorge E. Mayer,PhD, MIP (Law) Manager Germplasm Enhancement Grains Research & Development Corp, Australia FormerlyGolden RiceProject Manager

2. Equity, a matter of perspective 3. Marie Claire, April 2000 Are you eating sciences mistakes? Perceptionisreality! Source: J Webster 4. 5. 6. 7. 8. 9. Malawi January 2008 10. 11. Stein 2006 12. Clinical and subclinical VAD Micronutrient Initiative 2004 100 -140 million children suffer from VAD 13. Sommer et al. Lancet ii:585 (1983) Normal Nightblindness Bitotsspot Night blindness + Bitotsspot Xerophthalmia severity Vitamin A status correlated with symptoms and severity of theseeye afflictions. In severe cases 900 percentmortalityincrease! VAD and children mortality: Their eyes tell stories 14. 15. Water Protein Minerals Lipids Fiber Carbohydrate 16.

Interventions

• Education

• Industrial fortification (e.g. butter, oil, flour)

• Supplementation(capsules)

Limitations

• Distribution (10-thousands of helpers needed)

• Trained medical personnel lacking

• Centralised food processing required

• Do not reach remote areas

• Economically unsustainable

Strategies and their drawbacks 17. The State of the Worlds Children 2008 - UNICEF 0 10 20 30 40 60 80 100 Bangladesh Bolivia Haiti India* Cambodia Nepal Ethiopia Philippines Burundi SA Percent of children covered In average, 38 percent of the children dont receive vitamin A supplements Vitamin A supplementation has reached plateau level ($500m) 18. Cost efficiency of biof ortification

One-off investment.

Minimal maintenance costs after initial R&D phase.

Biofortified seeds can be distri-buted worldwide and bred into locally adapted varieties using existing channels.

Compatible with ongoing fortification, supplementation,and education programs.

Accessible to everybody.

It is sustainable.

19. Vitamin A status Population Vitamin requirements Intake with biofortification Intake without biofortification Golden Ricecould reduce VAD by more than half Zimmermann & Qaim 2004 (Philippines); Zimmermann & Ahmed 2006 (Bangladesh);Stein, Sachdev & Qaim 2006 (India); Anderson et al 2004 (SE Asia) Impact on populations health status 20. Stein 2006 A cost-efficient solution 21. Genetically Modified Rice Adoption :Impact for Welfare and Poverty AlleviationK Anderson, LA Jackson, CP Nielsen World Bank Policy Research Working Paper 3380, August 2004

Gains for developing countries in Asia up to$15.2 bn p.a.

Unskilledlaborproductivityincrease up to$13.8 bn p.a.

Export losses due to EU import ban: under 0.5% !

... farm productivity gains could be dwarfed by the welfare gains resulting from the potential health-enhancing attributes of Golden Rice 22. Lies, damn lies, yet no statistics ... ... meanwhile, back in the lab! More provitamin A 23. The principle of provitamin Aproduction is applicable to other crops, like potato Control Transgenic Diretto et al 2007 24. Micronutrients Provitamin A Iron Zinc ProteinVitamin E Rice Sorghum Cassava Bananas Grand Challenges in Global Health HarvestPlus CGIAR Rice Maize Wheat Cassava Beans Sweetpotato International programs, most notably those supported by theBill & Melinda Gates Foundation, areworking towardsthebiofortification of the most important staple crops of developing countries using conventional and modern methods. Golden Ricehas inspired new approaches to biofortification 25. Engineering Rice for High Beta-Carotene, Vitamin E, Protein, Enhanced Iron and Zinc(Bioavailability) Bill & Melinda Gates Foundation ProVitaMinRice Consortium Peter Beyer Center for Applied BiosciencesUniversity of Freiburg 26. Bioavailability studies : USA and China. Field testing in India and the Philippines. Toxicology, allergenicity, and substantial equivalence. Introgression into local varieties. Regulatory dossiers in India, Bangladesh, the Philippines, Vietnam, Nepal, Africa, etc. Addition of iron, zinc, high-quality protein, vit E. Information, seed multiplication, and distribution. Product development and regulatory approval of nutritionally optimized riceThe Philippines and India. Golden Rice Long and winding roads 27. 24:1 12:1 2:1 RE Golden Rice Bioavailability from different foodstuffs eat orange! 28. Assumptions: RNI 400 RE; bioavailability/bioconversion 3:1; retention 80%, baseline 112 RE from other foodstuffs; calculated for 200 g rice in a rural Bangladesh environment (84% rice in the diet) Contribution to vitamin A status byGolden Ricelines with varying levels of -carotene GR2 GR1 29.

Popular

Pipeline variety (new traits)

Used in VAD areas

Varietal selection for introgression BPT5204 MTU1010 IR36 Swarna IR64 Vijetha/ Jaya IR36 Jaya V Swarna Swarna IR36 IV BPT5204 Jaya BPT5204 III IR36 BPT5204 IR64 II IR64 IR64 Swarna I 2006 2004 2002 2000 Year Rank 30. 3-in-1 Approach : CombiningGolden Rice , bacterial blight resistance and tungro virus resistance genes into new lines Phenotypic and molecular selection for GR trait Screening for bacterial blight resistance Screening for tungro resistance Sexual hybridization Selection for good agronomic traits PhilRice 31. Sufficient inForm &Substance Applicant STRP FPA ApplicantGrace periodof 60 days foramendments NO Process & evaluate within 5d from receipt YES 30d for report submission Risk assessment evaluation For PIPs For public consultation 90d from acceptance Report within 30d

Submit:

5 copies of application form

support docs (techn. dossier; copy

of PIS & BPI certification that

reg. at. has undergone satisfactory

field testing in the Philippines.

For importation of reg. art.:

certification for country of import that

reg. art. is of similar event approved locally

notification for country of import in accrodance

with intl agreements on GMOs

BAFPS BAI Shall publish PIS in 2 papers + invite comments within 30d Report within 30d For feed All Report within 30d Report within 30d Release for PropagationApplication in the Philippines BPI 32.

Cost categoriesRange of costs incurred ($)

Preparation for regulatory phase 20,000 50,000( )

Molecular characterization300,000 1,200,000

Compositional assessment750,000 1,500,000

Animal performance and safety studies300,000 845,000

Protein production and characterization162,000 1,725,000( )

Protein safety assessment195,000 855,000

Non-target organism studies100,000 600,000

Agronomic and phenotypic assessments130,000 460,000

Production of tissues680,000 2,200,000?

ELISA dev, validation and expression analysis415,000 610,000

EPA expenses for PIPs (eg EUPs, tolerances)150,000 715,000

Environmental fate studies32,000 800,000

Herbicide residue study105,000 550,000

EU import (detection methods, fees)230,000 405,000

Canada costs40,000 195,000

Stewardship165,000 1,000,000?

Toxicology (90-day rat)when done250,000 300,000

Facility & management overhead costs560,000 4,500,000

Total6,180,000 15,440,000

Kalaitzadonakes et al. 2007 Compliance costs 33. (Manalo & Ramon 2007) US$ 31.4 mincl lab and greenhouse studies in the US. USS$ 2.6 mfor field trials, commercial propagation and post-commercial applicationCost of Bt corn development in the Philippines 34. Orange-fleshed sweetpotato introductionin southern Africa 35. Familiarity with seed production and distribution systems Familiarity withbreeders Familiarity with colour Talking to farmers 36. TheProject

Golden RiceHumanitarian Board

Golden RiceNetwork

ProVitaMinRice Consortium

• Univ of Freiburg

• Michigan State Univ

• Baylor College of Med (TX)

• IRRI

• PhilRice

• CLRRI, Vietnam

• Chinese Univ of Hong Kong

Sponsors

• B&M Gates Foundation

• Syngenta Foundation

• Syngenta Crop Protection

• USAID

• DBT, India

Golden Rice 37. Trigo transgnico 38. Fuentes proteicas 39. El precio del trigo 40. Produccin, consumo, exportaciones, rea sembrada 41. Tasas de crecimiento del rendimiento (FAOSTAT; Fischer et al., 2009) 42. Rendimiento de trigo (FAOSTAT; Pardey et al., 2007) t/ha 43. Rendimiento y fertilizantes (Fischer et al., 2009) 44. El precio de los insumos 45. Disponibilidad de fosfato 46. Prdidas por estreses biticos 47. Rendimiento potencial vs real (Fischer et al., 2009) 48. Dficit del rendimiento 49. Rendimiento de la produccin de trigo en AustraliaMolecularmarkers Phenotyping Omics 50. Incremento del rendimiento en maz GM Non-GM GM 51. Declaracin trilateral para el desarrollo de trigo transgnico

firmada por

• • • • Canad,

• • • • Estados Unidos y

• • • • Australia

Estrategia comn de I&D y comercializacin

52. Ensayos con cereales GM en Australia

En la Univ de Adelaida, lneas de trigo y cebada con modificaciones genticas que mejoran la utilizacin de nutrientes y tolerancia a estreses abiticos (35 genes para mejorar tolerancia a salinidad, sequa, heladas, deficiencia de fsforo, utilizacin de nitrgeno, asimilacin y translocacin de zinc).

En CSIRO, asimilacin de carbono bajo sequa y altas temperaturas; almidn modificado y otras modificaciones del grano.

En Vic DPI, tolerance a estreses ambientales y aumento de fibra diettica.

53. El futuro (Fischer et al., 2009)