In developing countries 500 000 children per year go blind ...

... and up to 6 000 per day die from vitamin A-malnutrition.

And this will continue year by year, if we do not complement traditional interventions.

Biotechnology: Possibilities, Risks, Ethics and Society

Stockholm, 24 August 2004.

Genetics to change the nutritional composition – the golden rice case.

GMO-technology enables to nutritionally optimise food security crops, but extreme precautionary regulation prevents

the use of this technology in public goods projects to the benefit of the poor in developing countries.

Ingo Potrykus

Professor em., Institute of Plant Sciences, ETH, Zürich, Switzerland.

Genetic engineering can provide traits, which are not easily available with traditional means. Vitamin

A-rice was, and is, not possible without genetic engineering. Even unpolished rice does not

contain provitamin A.

Why genetic engineering in addition to the traditional interventions?

Traditional interventions are effective, but not effective enough. Statistics show that, despite enormous efforts and investments in traditional interventions, we are still faced with 500‘000 blind children caused by vitamin A-deficiency. And there are larger malnutrition problems

for e.g. iron, zinc and other micro nutrients.

Restriction enzymes: a) I-sce I, b) Kpn I. Probe: psy

Restriction enzymes: a) I-sce I, b) Kpn I. Probe: crt I

Restriction enzymes: a) I-sce I, b) Spe I. Probe: cyc

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Reconstruction of -carotene Biosynthetic Pathway in RiceEndosperm by Agrobacterium-Mediated Transformation

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psyGt1 pr nos! 35S pr crtI nos! RBLB

35S! aph 4 cyc35S!35S pr Gt1 prLB RBpZcycH

pZPsCGGPP

Phytoene

Lycopene

-Carotene

phytoene synthase

phytoene desaturase

lycopene cyclase

lycopin-cyclases

Phytoene-synthase

Phytoene-desaturase

Phytoene-desaturase

Carotin-desaturase

Carotin-desaturase

Hydroxylase Hydroxylase

Epoxidase

Neoxanthin-synthase

Erwinia crtI

Erwinia crtI

Erwinia crtI

Erwinia crtI

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Iron bio-availability:

Ferritin, Phytase, Cystein

High-quality protein:

Arg, His, Ile, Leu, Lys, Met, Phe, Thr. Trp, Val

Carotenoids:

-carotene,lutein, zeaxanthin

Vitamin E

Vitamin A

-Oryzanol

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„Golden Rice“ contains the genes necessary to activate the biochemical pathway for provitamin A. The intensity of the colour

represents the concentration.

„Humanitarian Project“:

„Golden Rice“ is a public project. It was designed to reduce malnutrition in developing countries. With support from industry - in a public/private partnership with Syngenta -Golden Rice will be

made available to subsistence farmers in developing countries free of charge and

limitations. It will be their property and they will use part of their harvest for the next sowing. There

will be no new dependencies. Farmers will use their traditional farming systems and they will not

require any additional input.

Philippines: International Rice Research Institute (IRRI)

Philippines: National Rice Research Institute (PhilRice)

Vietnam: Cuu Long Delta Rice Research Institute

India: Department of Biotechnology, New Delhi (DBT)

India: Directorate of Rice Research, Hyderabad (DRR)

India: Indian Agricultural Research Institute, Delhi (IARI)

India: University of Delhi South Campus (UDSC)

India: Tamil Nadu Agricultural University (TNAU)

India: Agricultural University Pantagar (GBPUAT)

India: University of Agricultural Sciences Bangalor

Bangladesh: Bangladesh Rice Research Institute

China: Huazhong Agricultural University, Wuhan

China: Chinese Academy of Sciences, Beijing

China: Yunnan Acad. Agri. Sciences, Kunming

Indonesia: Agency for Agricultural Res.& Dev., Jakarta

Germany: University of Freiburg

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Intellectual Property Rights 2000

Material Transfer Agreements 2001

Freedom-to-Operate 2001

GMO-Competent Partner 2001-2002

Transfer to Indica varieties 2002

„Regulatory Clean Construct“ 2002

„Regulatory Clean Events“ 2003

„Regulatory Clean“ line at 3.2 g/g 2003

First field assessments April-September 2004

Experimental lines at substantially higher levels His

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t 1990 - Science - 1999 1980 – Technology Development - 1990

Product developent 1999 – 200?

Deregulation 2003-2008!!!

1 seed 1 plant 1 000 seeds / 20 g

1 000 000 seeds / 20 kg

1 000 000 000 seeds / 20 t

1 000 000 000 000 seeds / 20 000 t

Each seed has the potential to produce in

two years food for for one year and 100 000 poor...

...and to carry the technology...

...to reduce malnutrition in a sustained and cost-

effective manner.

All a farmer needs, to benefit from the technology, is one

seed.

The potential of 1 GoldenRice rice seed

GMO-regulation alone prevents the farmers accessing this potential.

In 2 years from 1 seed to 20 000 t !

Why do we have ‚GMO-regulation‘?

History: precaution – unpredictable genome alterations.

Experience: no specific risks associated with GMO‘s.

Why do we maintain ‚extreme precautionary‘-regulation?

„To built trust for acceptance of GMO‘s.“

Experience: this does not and can not work.

Why do we not skip the ‚extreme precautionary‘ approach ?

Under the present hysteria nobody has the power to do so?

What price are developing countries paying?

GMO-technology will not help to reduce hunger & malnutrition, and will not contribute to protection of the

environment in developing countries.

PA CHIAMSERAUP

FORTUNA BESAR 15 MARONG UNKNOWNPAROC

BLUE ROSEBPI 76 REXORO SUPREME

KITCHILI SAMBA

SINAWPAGH

UNKNOWNCINA LATISAIL TEXAS RSBR GEB24

PATNA BLUE BONNETPETA

DGWG CP231 SLO 17 BENONG

IR86 CP SLO 17 SIGADIS

IR95IR127

IR8 CHOW SUNG IR262

IR1103 TADUKAN VELLAIKARIR400 TSAI YUAN CHUNG

IR1006 MUDGOTETEP

IR1163 IR238 TN1IR1416 IR1641

IR1402IR22 TKM6 IR746A

IR1704O. nivara

IR1870 IR1614

IR2006 IR579 IR747 IR24/ IR661 IR1721

IR773 A BPI 121 GAM PAI

IR1915 B IR1833 GAM PAI 15 IR1561 IR1737

IR1916 IR833 IR2040

IR2146 IR 2055IR2061

IR5236 IR5338 Ultimate LandracesGAM PAI TSAI YUAN CHUNG

IR5657 DEE GEO WOO GEN BENONGCINA Unknow n

IR18348 LATISAIL CHOW SUNGTADUKAN MUDGO

IR64 KITCHILI SAMBA TETEPPA CHIAM SINAWPAGHSERAUPBESAR 15 UNKNOWN (JAPANESE)NAHNG MON S 4 O. nivara (IRGC 101508)VELLAIKAR MARONG PAROC

CO 18

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Crossing & selection@

Unpredictable & most extensive genome

alterations and their accumulation at every

single step.

@

@New varieties

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PA CHIAMSERAUP

FORTUNA BESAR 15 MARONG UNKNOWNPAROC

BLUE ROSEBPI 76 REXORO SUPREME

KITCHILI SAMBA

SINAWPAGH

UNKNOWNCINA LATISAIL TEXAS RSBR GEB24

PATNA BLUE BONNETPETA

DGWG CP231 SLO 17 BENONG

IR86 CP SLO 17 SIGADIS

IR95IR127

IR8 CHOW SUNG IR262

IR1103 TADUKAN VELLAIKARIR400 TSAI YUAN CHUNG

IR1006 MUDGOTETEP

IR1163 IR238 TN1IR1416 IR1641

IR1402IR22 TKM6 IR746A

IR1704O. nivara

IR1870 IR1614

IR2006 IR579 IR747 IR24/ IR661 IR1721

IR773 A BPI 121 GAM PAI

IR1915 B IR1833 GAM PAI 15 IR1561 IR1737

IR1916 IR833 IR2040

IR2146 IR 2055IR2061

IR5236 IR5338 Ultimate LandracesGAM PAI TSAI YUAN CHUNG

IR5657 DEE GEO WOO GEN BENONGCINA Unknow n

IR18348 LATISAIL CHOW SUNGTADUKAN MUDGO

IR64 KITCHILI SAMBA TETEPPA CHIAM SINAWPAGHSERAUPBESAR 15 UNKNOWN (JAPANESE)NAHNG MON S 4 O. nivara (IRGC 101508)VELLAIKAR MARONG PAROC

CO 18

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Unpredictable & most extensive genome

alterations and their accumulation at every

single step.

The blue box represents the ‚natural‘ rice genome; the barrs indicate the genetic

changes underlying the ,traditional‘

development to a modern rice variety

Mutations

Recombinations Translocations

Deletions

genetically modified genomeEvery modern variety in every crop is intensly

„genetically modified“, and unregulated!

PA CHIAMSERAUP

FORTUNA BESAR 15 MARONG UNKNOWNPAROC

BLUE ROSEBPI 76 REXORO SUPREME

KITCHILI SAMBA

SINAWPAGH

UNKNOWNCINA LATISAIL TEXAS RSBR GEB24

PATNA BLUE BONNETPETA

DGWG CP231 SLO 17 BENONG

IR86 CP SLO 17 SIGADIS

IR95IR127

IR8 CHOW SUNG IR262

IR1103 TADUKAN VELLAIKARIR400 TSAI YUAN CHUNG

IR1006 MUDGOTETEP

IR1163 IR238 TN1IR1416 IR1641

IR1402IR22 TKM6 IR746A

IR1704O. nivara

IR1870 IR1614

IR2006 IR579 IR747 IR24/ IR661 IR1721

IR773 A BPI 121 GAM PAI

IR1915 B IR1833 GAM PAI 15 IR1561 IR1737

IR1916 IR833 IR2040

IR2146 IR 2055IR2061

IR5236 IR5338 Ultimate LandracesGAM PAI TSAI YUAN CHUNG

IR5657 DEE GEO WOO GEN BENONGCINA Unknow n

IR18348 LATISAIL CHOW SUNGTADUKAN MUDGO

IR64 KITCHILI SAMBA TETEPPA CHIAM SINAWPAGHSERAUPBESAR 15 UNKNOWN (JAPANESE)NAHNG MON S 4 O. nivara (IRGC 101508)VELLAIKAR MARONG PAROC

CO 18

NAHNG MON S4

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Mutations

Recombinations Translocations

Deletions

Golden IR 64

IR 64

One relatively precise & defined & minor change in the IR64 genome: why

extrem deregulation requirements?!

genetically modified genome genetically engineered genome

Effect of an ‚extreme precautionary approach to regulation‘ on public goods research for food security in developing

countries:

There are numerous scientists and in public institutions which have capacity, funding and motivation to apply GM-

science successfully to problems in food security.

Very few of those have the capacity, understanding and know-how to develop a product from scientific insight.

Probably, no public institution has the resources, experience, and motivation to carry a single GMO product

accross the hurdles of todays regulatory procedures.

Even with support from the private sector, deregulation of a novel GMO event has become an astronomic task.

If we continue with present regulatory standards, the potential of GM technology for humanitarian uses will not reach the

poor!

January 2004, ISBN 1 904384 07 2

‚The European Union is ignoring a „moral imperative“ to promote genetically modified crops for their great

potential for helping the developing world.‘

‚We believe EU regulators have not paid enough attention to the impact of EU regulations on agriculture

in developing countries.‘

‚The current evidence from safety assessments of GM crops does not suggest any significant risk to people

who eat them.‘ (and to the environment).

‚An excessively conservative interpretation of the precautionary approach ... is fundamentally at odds ...

and essentially impractical.‘

‚To hold to the most conservative interpretation of the precautionary approach invokes the fallacy of thinking that the option of doing nothing is itself without risk.‘

GMO-technology enables to nutritionally optimise food security crops, but extreme precautionary regulation prevents the use of this

technology in public goods projects to the benefit of the poor in

developing countries.

The present radical application of the ‚precautionary principle‘ is immoral. It leads to defined, predictable, and

dramatic damages to life, health, and biodiversity. All risks claimed, so far, inherent to GMO-technology are, in

comparison, minor and they are just hypothetical.

Regulatory regimes affected by this attitude lead to an astronomic waste of financial, intellectual and

mental resources. They are scientifically unjustified, and they prevent the use of GMO-technology in public

goods projects and not in industrial ones.

Those with power in the public & political domain ignoring these facts, those fighting the technology for a

political agenda, and those insisting in extreme precautionary regulations, share responsibility for

future unnecessary suffering and death of millions .

In the early 19th century a Thai

princess celebrated her 18th birthday. She fell into the palace pond ...

... and drowned in front of hundreds of guests. Nobody helped her out of the water. Why? It was „taboo“ to touch a member of the „divine“ royal family!

We believe that we would have saved the princess, however ...

In the early 21st century 500‘000 children per year become blind and 6‘000 per day die from vitamin A-malnutrition.

This could be prevented with the help of „GMO‘s“. However GMO‘s are „taboo“ for our society which prefers to trust

„phantom risks“ instead of scientific evidence.

RDA (Recommended Daily Allowance): 0.3 mg/day for 1-3 year old child, based on 4-month body store.

The average amount needed to prevent deficiency state is ½ of that needed for adequate storage (0.15 mg/day).

Conversion factor to RAE (Retinol Activity Equivalents) is for fruits and vegetables 12:1; for -carotene in oil 2:1.

100 g Golden Rice contain 0.16 mg -carotene, stored in lipid membranes (possibly most comparable to oil).

The amount of available vitamin A depends upon bioavailability (absorption and bioconversion).

Golden Rice has a simple and disgestible food matrix. Assuming, therefore, a 2:1 conversion, 100 g of Golden Rice may provide 50% of the total vitamin A required.

This hypothesis will be tested, with financial support from NIH, by the USDA Human Nutrition Laboratory, in China.

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200 g/day may be sufficient, but we will know only after nutritional studies have been completed.