“Importancia de los transgénicos en la alimentación mundial: caso dely avances en trigo transgénico”

Bioseguridad y Biotecnología ModernaUniv Nal La Molina, Diciembre 2010

Jorge E. Mayer, PhD, MIP (Law)

Manager Germplasm EnhancementGrains Research & Development Corp, Australia

Formerly Golden Rice Golden Rice Project ManagerProject Manager

Equity, a matter

of perspect

ive

Marie Claire, April 2000

Are you eating science’s

mistakes?

Perception is reality!

Source: J Webster

MalawiJanuary 2008

Stein 2006

Clinical and subclinical VADClinical and subclinical VAD

Micronutrient Initiative 2004100 -140 million children suffer from VAD

0

5

10

15

20

25

30

35

40

45

50

Mor

tali

ty (

per

1,00

0 ch

ild in

terv

als)

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 storiesVAD and children mortality: Their eyes tell stories

Water

Protein

MineralsLipidsFiber

Carbohydrate

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

The State of the World’s Children 2008 - UNICEF

010

2030

40

60

80

100

Bangla

desh

Bolivia

Haiti

India

*

Cambo

dia

Nepal

Ethiop

ia

Philipp

ines

Burun

di

S

A

Per

cen

t o

f ch

ildre

n c

ove

red

In average, 38 percent of the children don’t receive vitamin A supplements

Vitamin A supplementation has reached plateau level ($500m)Vitamin A supplementation has reached plateau level ($500m)

• 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.

Cost efficiency of biofortification

Vitamin A status

Po

pu

lati

on

Vitamin requirements

Intake with biofortification

Intake withoutbiofortification 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 statusImpact on population’s health status

Stein 2006

A cost-efficient solutionA cost-efficient solution

Gains for developing countries in Asia up to $15.2 bn p.a. Unskilled labor productivity increase 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 …”

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

Lies, damn lies, yet no statistics ...

... meanwhile, back in the lab!

Mo

re p

rovi

tam

in A

The principle of provitamin A The principle of provitamin A production is applicable to otherproduction is applicable to othercrops, like potato …crops, like potato …

ControlControl TransgenicTransgenic

Diretto et al 2007

Micronutrients

Provitamin A

Iron

Zinc

Protein

Vitamin E

Micronutrients

Provitamin A

Iron

Zinc

Protein

Vitamin E

RiceRice

SorghumSorghum

CassavaCassava

BananasBananas

Grand Challenges in Global Health

Grand Challenges in Global Health

HarvestPlus CGIAR

HarvestPlus CGIAR

RiceRice

MaizeMaize

WheatWheat

CassavaCassava

BeansBeans

SweetpotatoSweetpotato

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

Golden Rice has inspired new approaches to biofortification

Engineering Rice for High Beta-Carotene, Vitamin E, Protein, Enhanced Iron and Zinc

(Bioavailability)

Bill & Melinda Gates Foundation

ProVitaMinRice ConsortiumProVitaMinRice Consortium

Peter BeyerCenter for Applied Biosciences University of Freiburg

Bioavailability studies : USA and China. Bioavailability studies : USA and China.

Field testing in India and the Philippines. Field testing in India and the Philippines.

Toxicology, allergenicity, and substantial equivalence.Toxicology, allergenicity, and substantial equivalence.

Introgression into local varieties. Introgression into local varieties.

Regulatory dossiers in India, Bangladesh, the Philippines, Vietnam, Nepal, Africa, etc.

Regulatory dossiers in India, Bangladesh, the Philippines, Vietnam, Nepal, Africa, etc.

Addition of iron, zinc, high-quality protein, vit E. Addition of iron, zinc, high-quality protein, vit E.

Information, seed multiplication, and distribution.Information, seed multiplication, and distribution.

Product development and regulatory approval of nutritionally optimized rice The Philippines and India.

Product development and regulatory approval of nutritionally optimized rice The Philippines and India.

Golden Rice – Long and winding roadsGolden Rice – Long and winding roads

24:1

12:1

2:1

RE

Golden RiceGolden Rice

Bioavailability from different foodstuffsBioavailability from different foodstuffs

eat o

rang

e!

0

50

100

150

200

250

300

350

400

450

500

1 2 4 8 16 32

µg/g ß-carotene for different GR lines

Per

cen

t R

NI (

WH

O/F

AO

)

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

Contribution to vitamin A status by Golden Rice lines with varying levels of -carotene

GR2

GR1

Year

Rank 2000 2002 2004 2006

I Swarna IR64 IR64 IR64

II IR64 BPT5204 IR36 Swarna

III BPT5204 Jaya BPT5204 IR36

IV IR36 Swarna Swarna MTU1010

V Jaya IR36Vijetha/

JayaBPT5204

• Popular• Pipeline variety (new traits)• Used in VAD areas

Varietal selection for introgressionVarietal selection for introgression

3-in-1 Approach : Combining Golden Rice, bacterial blight resistance and tungro virus resistance genes into new lines3-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

Sufficient in Form &

Substance

Applicant

STRP

FPA

Applicant

BPI

Gra

ce p

erio

d

of

60

da

ys f

or

am

en

dm

en

ts

NO

Process &evaluate within5d from receipt

YES

30d for report submission

Risk assessmentevaluation

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 thatreg. at. has undergone satisfactoryfield testing in the Philippines.

For importation of reg. art.:• certification for country of import thatreg. art. is of similar event approved locally• notification for country of import in accrodancewith intl agreements on GMOs

BAFPS

BAI

Shall publish PIS in 2 papers+ invite comments within 30d

Report within 30d

For feed

AllReport within 30d

Report within 30d

Release for Propagation Application in the PhilippinesRelease for Propagation

Application in the Philippines

Cost categories Range of costs incurred ($)

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

• Molecular characterization 300,000 – 1,200,000 • Compositional assessment 750,000 – 1,500,000 • Animal performance and safety studies 300,000 – 845,000• Protein production and characterization 162,000 – 1,725,000 ()• Protein safety assessment 195,000 – 855,000 • Non-target organism studies 100,000 – 600,000• Agronomic and phenotypic assessments 130,000 – 460,000• Production of tissues 680,000 – 2,200,000 ?• ELISA dev, validation and expression analysis 415,000 – 610,000 • EPA expenses for PIPs (eg EUPs, tolerances) 150,000 – 715,000 • Environmental fate studies 32,000 – 800,000 • Herbicide residue study 105,000 – 550,000 • EU import (detection methods, fees) 230,000 – 405,000 • Canada costs 40,000 – 195,000 • Stewardship 165,000 – 1,000,000 ?• Toxicology (90-day rat)—when done 250,000 – 300,000• Facility & management overhead costs 560,000 – 4,500,000 • Total 6,180,000 – 15,440,000

Kalaitzadonakes et al. 2007

Compliance costsCompliance costs

(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 PhilippinesCost of Bt corn development in the Philippines

Orange-fleshed sweetpotato introduction in southern Africa

Orange-fleshed sweetpotato introduction in southern Africa

Familiarity with seed production and distribution systems

Familiarity with breeders

Familiarity with colour

Talking to farmersTalking to farmers

The ProjectThe Project

• Golden Rice Humanitarian Board

• Golden Rice Network• 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

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

(Fischer et al., 2009)

Rendimiento potencial vs real

Déficit del rendimiento

Rendimiento de la producción de trigo en Australia

Molecular markersPhenotyping

Omics

Incremento del rendimiento en maíz GM

Non-GM

GM

Declaración trilateralpara el desarrollo de trigo transgénico

firmada por

» Canadá,

» Estados Unidos y

» Australia

Estrategia común de I&D y comercialización

Ensayos con cereales GM en Australia• 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).

• En CSIRO, asimilación de carbono bajo sequía y altas temperaturas; almidón modificado y otras modificaciones del grano.

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

El futuro

(Fischer et al., 2009)