Arroz Dorado “ Importancia de los transgénicos  en la alimentación mundial:  caso del y avances en trigo transgénico”   Bi...
Equity, a matter of perspective
Marie Claire, April 2000 Are you eating science’s mistakes? Perception  is  reality! Source: J Webster
 
 
 
 
 
Malawi January 2008
 
Stein 2006
Clinical and subclinical VAD Micronutrient Initiative 2004 100 -140 million children suffer from VAD
Sommer et al. Lancet ii:585 (1983) Normal Night  blindness Bitot’s  spot Night blindness + Bitot’s  spot Xerophthalmia sev...
 
Water Protein Minerals Lipids Fiber Carbohydrate
<ul><li>Interventions </li></ul><ul><ul><li>Education  </li></ul></ul><ul><ul><li>Industrial fortification (e.g. butter, o...
The State of the World’s Children 2008 - UNICEF 0 10 20 30 40 60 80 100 Bangladesh Bolivia Haiti India* Cambodia Nepal Eth...
Cost efficiency of biof ortification <ul><li>One-off investment. </li></ul><ul><li>Minimal maintenance costs after initial...
Vitamin A status Population Vitamin requirements Intake with biofortification Intake without biofortification Golden Rice ...
Stein 2006 A cost-efficient solution
Genetically Modified Rice Adoption   :  Impact for Welfare and Poverty Alleviation  K Anderson, LA Jackson, CP Nielsen   W...
Lies, damn lies, yet no statistics ... ... meanwhile, back in the lab! More provitamin A
The principle of provitamin A  production is applicable to other crops, like potato … Control Transgenic Diretto et al 2007
Micronutrients Provitamin A Iron Zinc Protein  Vitamin E Rice Sorghum Cassava Bananas Grand Challenges in Global Health Ha...
Engineering Rice for High Beta-Carotene, Vitamin E, Protein, Enhanced Iron and Zinc  (Bioavailability) Bill & Melinda Gate...
Bioavailability studies : USA and China.   Field testing in India and the Philippines.   Toxicology, allergenicity, and ...
24:1 12:1 2:1 RE Golden Rice Bioavailability from different foodstuffs eat orange!
Assumptions: RNI 400 RE; bioavailability/bioconversion 3:1; retention 80%, baseline 112 RE from other foodstuffs; calculat...
<ul><li>Popular </li></ul><ul><li>Pipeline variety (new traits) </li></ul><ul><li>Used in VAD areas </li></ul>Varietal sel...
3-in-1 Approach : Combining  Golden Rice , bacterial blight resistance and tungro virus resistance genes into new lines Ph...
Sufficient in  Form &  Substance Applicant STRP FPA Applicant  Grace period  of 60 days for  amendments NO Process & evalu...
<ul><li>Cost categories    Range of costs incurred ($) </li></ul><ul><li>Preparation for regulatory phase   20,000 –  50,0...
(Manalo & Ramon 2007) US$ 31.4 m  incl lab and greenhouse studies in the US. USS$ 2.6 m  for field trials, commercial prop...
Orange-fleshed sweetpotato introduction  in southern Africa
Familiarity with seed production and distribution systems Familiarity with  breeders Familiarity with colour Talking to fa...
The  Project <ul><li>Golden Rice  Humanitarian Board </li></ul><ul><li>Golden Rice  Network </li></ul><ul><li>ProVitaMinRi...
Trigo transgénico
Fuentes proteicas
El precio del trigo
Producción, consumo, exportaciones, área sembrada
Tasas de crecimiento del rendimiento (FAOSTAT; Fischer et al., 2009)
Rendimiento de trigo (FAOSTAT; Pardey et al., 2007) t/ha
Rendimiento y fertilizantes (Fischer et al., 2009)
El precio de los insumos
Disponibilidad de fosfato
Pérdidas por estreses bióticos
Rendimiento potencial vs real (Fischer et al., 2009)
Déficit del rendimiento
Rendimiento de la producción de trigo en Australia  Molecular  markers Phenotyping Omics
Incremento del rendimiento en maíz GM Non-GM GM
Declaración trilateral para el desarrollo de trigo transgénico <ul><li>firmada por  </li></ul><ul><ul><ul><ul><ul><li>Cana...
Ensayos con cereales GM en Australia <ul><li>En la Univ de Adelaida, líneas de trigo y cebada con modificaciones genéticas...
El futuro (Fischer et al., 2009)
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Arroz dorado y trigo transgenico

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  • Translational aspects
  • Nominal concordance with opposite outcomes. Another matter of perception and perspective.
  • Focusing primeval fears onto a scapegoat.
  • Polypeas; orangiwis; capsipersicon (capsimatos, topsicum); technicolorflower
  • Food with a bite. It was us, the scientists, who coined the term chimeric genes back in the 1980s.
  • Another perception: GM crops create wealth only for the multinaitonals. Luckily, the huge success with Bt cotton in India, for example, is showing how GM crops can make a huge difference for poor smallholders. In the case of GR, for a long time IP issues were held to be responsible of delays.
  • And yet another perception (fear) : scientists will not stop there.
  • Urbanized populations often have romanticized views of living on and off the land and would like to preserve everything according to their own image of what farming used to be.
  • The problem is of course not just lack of nutritious food.
  • The burden of disease (here measured as DALYs, which not only includes mortaility but also disability).
  • According to the World Health Organization (WHO) clinical to severe sub-clinical vitamin A deficiency (VAD) affects most developing countries. Other micronutrient deficiencies, like Zn, Fe, and I, have a similar distribution pattern, affecting even more developed countries. Combined deficiencies have a devastating effect on human health.
  • There is a clear association between VAD and mortality rate among young children. The severity of VAD correlates with ocular signs, mainly xerophthalmia and its associated symptomatology, eg night blindness and corneal degeneration. There is a 900 percent increment in mortality!! About half of the children that become blind as a consequence of VAD die from various diseases, like measles or malaria, within a year of becoming blind. Thus, VAD blindness is but a symptom of a much severe nutritional deficiency affecting the children.
  • Rice grain composition: high carbohydrate, average protein (-Lys), los minerals, no beta-carotene.
  • Various intervention strategies have achieved notable results in a number of countries, yet even in the best cases approx 30 percent of the population remains VA deficient. Typical interventions are education, industrial fortification, and supplementation. Industrial fortification is a common conduit to administer essential nutrients to an affluent population, eg iodine-enriched salt or vitamin A-enriched margarine. Supplementation consists of providing children with one or two megadoses of vitamin A a year, in capsules. Serum retinol (vit A) levels go down significantly between interventions. These interventions are limited by the logistic requirements of the corresponding distribution networks and the need for centralised processing. They are also affected by geographical limitations, which makes them only partially applicable. Furthermore, the interventions just mentioned require constant funding inputs, which makes them unsustainable in the long term. Only 34% of children under five recevie two annual doses in India. Industrial fortification is hard to achieve in poor, agricultural societies, where the produce is consumed by the farmer and his family or traded locally. This sector of society is often served using the supplementation approach, ie administration of pills and the like. These programmes are usually linked to vaccination campaigns and other health-related services. The logistics behind these efforts make it very hard to achieve acceptable levels of coverage. Urban areas are more accessible to supplementation programmes, but even though the share of urban population is increasing all over the world, most countries with severe VAD are rural societies. Every affected country requires individually tailored programmes and rely mostly on foreign help and government goodwill. This explains why in 1999 only 43 countries, out of 100 countries in need of supplementation, received a 70 percent coverage of one yearly megadose to under-five children.
  • Biofortification represents a viable alternative for micronutrient delivery. In this approach plants produce or accumulate the required nutrients in the edible parts micronutrient-dense). This is traditionally achieved by breeding, unless the desired trait is not available in existing, sexually compatible germplasm. Biofortification offers a sustainable solution, with the potential to complement current interventions and fill in existing coverage gaps left by supplementation programmes. The advantages of biofortification are evident. The generation of a plant variety is a one-off investment. In the case of genetic engineering, the research phase can involve a high initial investment, which must be justified by the expected socio-economic impact. But once a trait has been engineered into a variety it can be easily transferred to any locally adapted variety by traditional breeding. 500 m vitA capsules per year &gt; $500 m Iron &gt; $1 bn in recurrent costs $200 m public investment in iodine fort plus $1.5 bn from private industry
  • The goal is to reduce the proportion of people below RDA. In average 45 percent of under-five children in devleoping countries are not covered by fortification or supplementation programmes. Disability-Adjusted Life Years (DALYs) are used as a measure of mortality + disability due to selected deficiencies, like in this case micronutrients. Although most numbers are based on under-five children, these numbers remind us of the real dimension of the problem. We hope that the same organisations who are campaigning so strongly against GMOs, one day will be strongly supporting approaches like GR, once they understand that this is a sustainable alternative to other approaches. The regulatory equation blows up the theoretical risk and ignores the real benefit. Bt rice (rice expressing the insecticidal Bacillus thuringiensis crystal protein) will improve gains by farmers, but according to this World Bank analysis, gains from improved health will by far surpass farming gains. Projected gains are in the billions of dollars, while expected losses stemming from import bans from Europe would amount to less than 0.5 percent of the projected gains. 70 percent of the world’s poor live in Asia.
  • The costs per DALY under the two scenarios vary between $19.40 and $3.06. This compares very favorably against the costs for supplementation US$134-599/DALY or the benchmarks given by the World Bank ($217, which corresponds to one per capita income) or WHO (US$620 [3 pci] or $2,986 [PPP adjusted]).
  • The regulatory equation blows up the theoretical risk and ignores the real benefit. Bt rice (rice expressing the insecticidal Bacillus thuringiensis crystal protein) will improve gains by farmers, but according to this World Bank analysis, gains from improved health will by far surpass farming gains. Projected gains are in the billions of dollars, while expected losses stemming from import bans from Europe would amount to less than 0.5 percent of the projected gains.
  • We can expect more biofortified crops in the near future.
  • Biofortification is progressing at multiple levels: multiinstitutional, multicrop, multitrait, multistrategy –transgenic and non-transgenic. A number of projects funded through the Grand Challenges in Global Health initiative of the Bill &amp; Melinda Gates Foundation has been so to say catalysed by the GR Project. These projects are applying similar approaches to cassava, banana, sorghum. All projects are geared towards the incorporation of traits to stack together carotenoid production, iron and zinc accumulation, vitamin E and high-quality protein production. These efforts go hand in hand with the HarvestPlus consortium.
  • The last year has witnessed major progress of the GR Project, with the first GR field trial and the arrival of selected GR lines in Asia for introgression. Deregulation will be handled on a country-by-country basis and will involve the usual requirements, although it is hoped that most of the regulatory dossier will be transferable from country to country, eg through the Biosafety Clearinghouse mechanism established by the Convention of Biological Diversity (CBD). Meanwhile, science goes on, and is geared towards tackling other important micronutrient deficiency problems.
  • RNI = 300 RE (DRI-NAS)
  • Clear criteria for variety selection. To reach the target population varieties must be popular or pipeline varieties expected to become popular, especially in VAD-prone areas.
  • BPI, Bureau of Plant Industry; BAFPS, Bureau of Agriculture and Fisheries Product Standards ; FPA, Fertilizer and Pesticide Authority ; BAI, Bureau of Animal Industry. STRP, Scientific and Technical Review Panel; NCBP, Natl Committee of Biosafety of the Philippines; IBC, Insitutional Biosafety Committee.
  • HarvestPlus has gained valuable experience in handling matters of colour perception during the introduction of orange-fleshed sweetpotato (OFSP) into southern Africa. Although OFSP is widely used in South America, African countries have been using only white-fleshed varieties since the crop was introduced into the continent. Village-level campaigns have been very successful in gaining acceptance for OFSP varieties. This is what we should be doing by now with Golden Rice, but we can’t because of regulation.
  • Arroz dorado y trigo transgenico

    1. 1. Arroz Dorado “ Importancia de los transgénicos en la alimentación mundial: caso del y avances en trigo transgénico” Bioseguridad y Biotecnología Moderna Univ Nal La Molina, Diciembre 2010 Jorge E. Mayer, PhD, MIP (Law) Manager Germplasm Enhancement Grains Research & Development Corp, Australia Formerly Golden Rice Project Manager
    2. 2. Equity, a matter of perspective
    3. 3. Marie Claire, April 2000 Are you eating science’s mistakes? Perception is reality! Source: J Webster
    4. 9. Malawi January 2008
    5. 11. Stein 2006
    6. 12. Clinical and subclinical VAD Micronutrient Initiative 2004 100 -140 million children suffer from VAD
    7. 13. Sommer et al. Lancet ii:585 (1983) Normal Night blindness Bitot’s spot Night blindness + Bitot’s spot Xerophthalmia severity Vitamin A status correlated with symptoms and severity of these eye afflictions. In severe cases 900 percent mortality increase! VAD and children mortality: Their eyes tell stories
    8. 15. Water Protein Minerals Lipids Fiber Carbohydrate
    9. 16. <ul><li>Interventions </li></ul><ul><ul><li>Education </li></ul></ul><ul><ul><li>Industrial fortification (e.g. butter, oil, flour) </li></ul></ul><ul><ul><li>Supplementation (capsules) </li></ul></ul><ul><li>Limitations </li></ul><ul><ul><li>Distribution (10-thousands of helpers needed) </li></ul></ul><ul><ul><li>Trained medical personnel lacking </li></ul></ul><ul><ul><li>Centralised food processing required </li></ul></ul><ul><ul><li>Do not reach remote areas </li></ul></ul><ul><ul><li>Economically unsustainable </li></ul></ul>Strategies and their drawbacks
    10. 17. The State of the World’s 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 don’t receive vitamin A supplements Vitamin A supplementation has reached plateau level ($500m)
    11. 18. Cost efficiency of biof ortification <ul><li>One-off investment. </li></ul><ul><li>Minimal maintenance costs after initial R&D phase. </li></ul><ul><li>Biofortified seeds can be distri-buted worldwide and bred into locally adapted varieties using existing channels. </li></ul><ul><li>Compatible with ongoing fortification, supplementation, and education programs. </li></ul><ul><li>Accessible to everybody. </li></ul><ul><li>It is sustainable. </li></ul>
    12. 19. Vitamin A status Population Vitamin requirements Intake with biofortification Intake without biofortification Golden Rice could 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 population’s health status
    13. 20. Stein 2006 A cost-efficient solution
    14. 21. Genetically Modified Rice Adoption : Impact for Welfare and Poverty Alleviation K Anderson, LA Jackson, CP Nielsen World Bank Policy Research Working Paper 3380, August 2004 <ul><li>Gains for developing countries in Asia up to $15.2 bn p.a. </li></ul><ul><li>Unskilled labor productivity increase up to $13.8 bn p.a. </li></ul><ul><li>Export losses due to EU import ban: under 0.5% ! </li></ul>“ ... farm productivity gains could be dwarfed by the welfare gains resulting from the potential health-enhancing attributes of Golden Rice …”
    15. 22. Lies, damn lies, yet no statistics ... ... meanwhile, back in the lab! More provitamin A
    16. 23. The principle of provitamin A production is applicable to other crops, like potato … Control Transgenic Diretto et al 2007
    17. 24. Micronutrients Provitamin A Iron Zinc Protein Vitamin 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 the Bill & Melinda Gates Foundation, are working towards the biofortification of the most important staple crops of developing countries using conventional and modern methods. Golden Rice has inspired new approaches to biofortification
    18. 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 Biosciences University of Freiburg
    19. 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 rice  The Philippines and India. Golden Rice – Long and winding roads
    20. 27. 24:1 12:1 2:1 RE Golden Rice Bioavailability from different foodstuffs eat orange!
    21. 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 by Golden Rice lines with varying levels of  -carotene GR2 GR1
    22. 29. <ul><li>Popular </li></ul><ul><li>Pipeline variety (new traits) </li></ul><ul><li>Used in VAD areas </li></ul>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
    23. 30. 3-in-1 Approach : Combining Golden 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
    24. 31. Sufficient in Form & Substance Applicant STRP FPA Applicant Grace period of 60 days for amendments 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 <ul><li>Submit: </li></ul><ul><li>5 copies of application form </li></ul><ul><li>support docs (techn. dossier; copy </li></ul><ul><li>of PIS & BPI certification that </li></ul><ul><li>reg. at. has undergone satisfactory </li></ul><ul><li>field testing in the Philippines. </li></ul><ul><li>For importation of reg. art.: </li></ul><ul><li>certification for country of import that </li></ul><ul><li>reg. art. is of similar event approved locally </li></ul><ul><li>notification for country of import in accrodance </li></ul><ul><li>with intl agreements on GMOs </li></ul>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 Propagation Application in the Philippines BPI
    25. 32. <ul><li>Cost categories Range of costs incurred ($) </li></ul><ul><li>Preparation for regulatory phase 20,000 – 50,000 (  ) </li></ul><ul><li>Molecular characterization 300,000 – 1,200,000  </li></ul><ul><li>Compositional assessment 750,000 – 1,500,000 </li></ul><ul><li>Animal performance and safety studies 300,000 – 845,000 </li></ul><ul><li>Protein production and characterization 162,000 – 1,725,000 (  ) </li></ul><ul><li>Protein safety assessment 195,000 – 855,000  </li></ul><ul><li>Non-target organism studies 100,000 – 600,000 </li></ul><ul><li>Agronomic and phenotypic assessments 130,000 – 460,000 </li></ul><ul><li>Production of tissues 680,000 – 2,200,000 ? </li></ul><ul><li>ELISA dev, validation and expression analysis 415,000 – 610,000  </li></ul><ul><li>EPA expenses for PIPs (eg EUPs, tolerances) 150,000 – 715,000  </li></ul><ul><li>Environmental fate studies 32,000 – 800,000  </li></ul><ul><li>Herbicide residue study 105,000 – 550,000  </li></ul><ul><li>EU import (detection methods, fees) 230,000 – 405,000  </li></ul><ul><li>Canada costs 40,000 – 195,000  </li></ul><ul><li>Stewardship 165,000 – 1,000,000 ? </li></ul><ul><li>Toxicology (90-day rat)—when done 250,000 – 300,000 </li></ul><ul><li>Facility & management overhead costs 560,000 – 4,500,000  </li></ul><ul><li>Total 6,180,000 – 15,440,000 </li></ul>Kalaitzadonakes et al. 2007 Compliance costs
    26. 33. (Manalo & Ramon 2007) US$ 31.4 m incl lab and greenhouse studies in the US. USS$ 2.6 m for field trials, commercial propagation and post-commercial application Cost of Bt corn development in the Philippines
    27. 34. Orange-fleshed sweetpotato introduction in southern Africa
    28. 35. Familiarity with seed production and distribution systems Familiarity with breeders Familiarity with colour Talking to farmers
    29. 36. The Project <ul><li>Golden Rice Humanitarian Board </li></ul><ul><li>Golden Rice Network </li></ul><ul><li>ProVitaMinRice Consortium </li></ul><ul><ul><li>Univ of Freiburg </li></ul></ul><ul><ul><li>Michigan State Univ </li></ul></ul><ul><ul><li>Baylor College of Med (TX) </li></ul></ul><ul><ul><li>IRRI </li></ul></ul><ul><ul><li>PhilRice </li></ul></ul><ul><ul><li>CLRRI, Vietnam </li></ul></ul><ul><ul><li>Chinese Univ of Hong Kong </li></ul></ul><ul><li>Sponsors </li></ul><ul><ul><li>B&M Gates Foundation </li></ul></ul><ul><ul><li>Syngenta Foundation </li></ul></ul><ul><ul><li>Syngenta Crop Protection </li></ul></ul><ul><ul><li>USAID </li></ul></ul><ul><ul><li>DBT, India </li></ul></ul>Golden Rice
    30. 37. Trigo transgénico
    31. 38. Fuentes proteicas
    32. 39. El precio del trigo
    33. 40. Producción, consumo, exportaciones, área sembrada
    34. 41. Tasas de crecimiento del rendimiento (FAOSTAT; Fischer et al., 2009)
    35. 42. Rendimiento de trigo (FAOSTAT; Pardey et al., 2007) t/ha
    36. 43. Rendimiento y fertilizantes (Fischer et al., 2009)
    37. 44. El precio de los insumos
    38. 45. Disponibilidad de fosfato
    39. 46. Pérdidas por estreses bióticos
    40. 47. Rendimiento potencial vs real (Fischer et al., 2009)
    41. 48. Déficit del rendimiento
    42. 49. Rendimiento de la producción de trigo en Australia Molecular markers Phenotyping Omics
    43. 50. Incremento del rendimiento en maíz GM Non-GM GM
    44. 51. Declaración trilateral para el desarrollo de trigo transgénico <ul><li>firmada por </li></ul><ul><ul><ul><ul><ul><li>Canadá, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Estados Unidos y </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Australia </li></ul></ul></ul></ul></ul><ul><li>Estrategia común de I&D y comercialización </li></ul>
    45. 52. Ensayos con cereales GM en Australia <ul><li>En la Univ de Adelaida, líneas de trigo y cebada con modificaciones genéticas que mejoran la utilización de nutrientes y tolerancia a estreses abióticos (35 genes para mejorar tolerancia a salinidad, sequía, heladas, deficiencia de fósforo, utilización de nitrógeno, asimilación y translocación de zinc). </li></ul><ul><li>En CSIRO, asimilación de carbono bajo sequía y altas temperaturas; almidón modificado y otras modificaciones del grano. </li></ul><ul><li>En Vic DPI, tolerance a estreses ambientales y aumento de fibra dietética. </li></ul>
    46. 53. El futuro (Fischer et al., 2009)

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