The progress with biotech crops looks impressive, however the increase is based on only two traits and four species, all developed and deregulated by the private sector in the U.S. and subsequently adopted by developing countries.

This slide is from 2004; there is no principle change up to now! Why?

Novel cases from the public sector have little chance to contribute to this optimistic scenario in the near future, if present regulation is maintained.

XIII Edition of ICABR Conference Ravello, 18-20 June 2009.

GMO-projects for public goods are faced with prohibitive conditions.

Ingo Potrykus, Emeritus Plant Sciences, ETH Zürich.

Chairman Humanitarian Golden Rice Project & Network.

PP IPP

PP DMAPP

PP GGPP

Phytoene

Phytofluene

ζ-Carotene

Neurosporene

Lycopene

One of the most instructive excamples is ‚Golden Rice‘, a public goods project aimed at the reduction vitamin A-malnutrition in rice-dependent poor populations. Engineering the biochemical pathway into rice required the use of GMOtechnology. The „golden“ colour is a reflection of the presence of provitamin A. The intensity of the colour is a measure of the concentration.

Rice as major staple does not contain any provitamin A. The consequences: 400 million rice-depending poor suffer from vitamin A-deficiency (VAD). VAD impairs vision, epithelial integrity against infections, immune response, haemopoiesis, skelettal growth, etc. VAD is the major cause for blindness and death of millions of children. Public and philanthropic institutions are engaged in traditional interventions to reduce this heavy health burden. These traditional interventions are not effective enough. Despite substantial investments in e.g. free distribution of vitamin A capsules, we are still faced with e.g. 500‘000 blind children per year. And there are larger malnutrition problems for e.g. iron and zinc.

Why do rice-depending poor societies suffer from vitamin A-malnutrition? Recommended daily nutrient intake (WHO) in%

140% 120% 100%

luxurious recommendation for the West

80% 60%

50% suffient to prevent malnutrition

40% 20% 0% women

children

fruit, vegetable fish, fowl Situation for standard diet.

Sources and amount of provitamin A for poor and rice-dependent (H Bouis, 2005, unpublished.) in Southeast Asia. Excample Bangladesh. populations Contribution to food energy: fish, fowl (5%), vegetable, fruit (15%), rice (80%).

How much provitamin A does Golden Rice contain and how much rice have people to eat per day? Consequences when changing the diet to Golden Rice. Recommended daily nutrient intake (WHO) in% 140%

120% 100% 80%
60% 40% 20%

Golden Rice 1 2 µg line

Plant Sources

Animal source

0% Women Children
50% suffient to prevent malnutrition (H Bouis, 2005, unpublished.)

Even rice lines with a relatively low provitamin A content would have a substantial health benefit.

How much provitamin A does Golden Rice contain and how much rice have people to eat per day? Consequences when changing the diet to Golden Rice. Recommended daily nutrient intake (WHO) in% 140% Golden Rice 2 120% 8 µg line

100% 80%
60% 40% 20% 0% Women Children
50% suffient to prevent malnutrition

Golden Rice 1 2 µg line

Plant Sources

Animal source Rice lines available with 2-30 µg provitamin A

(H Bouis, 2005, unpublished.)

Golden Rice would have the potential to cure vitamin A-deficiency as soon as the normal diet would be changed to Golden Rice.

A.J. Stein, H.P.S.Sachdev, M.Qaim, Nature Biotechnology 24 (10), 2006

Potential Impact and Cost Cost-effectiveness of Golden Rice in India.

Which impact do we expect e.g. for India? Annual burden of vitamin A-deficiency in India: Lives lost: 71 600 DALYs lost: 2 328 000 Potenial annual impact of Golden Rice: Lives saved: 5 500 to 39 700 DALYs gained: 204 000 to 1 382 000 Cost-effectiveness per DALY‘s saved WHO standard: $ 620 - 1‘860 World Bank benchmark: $ 200 Supplementation costs: $ 134 - 599 Golden Rice: $ 3 – 19

GM Rice Adoption: Impact for Welfare and Poverty Alleviation. K Anderson, LA Jackson, CP Nielsen. Journal of Economic Integration 20 (4) 2005

Projected gaines from Golden Rice technology adoption by developing Asia would amount to $ 15.2 billion per year. The major economic effect is based on enhanced productivity through improved health of Asian unskilled labor, in $ billion: China 7.209; India 2.528; Other S+SE Asia 4.140.

This Worldbank study indicates, that use of GM-technology would have a large positive impact on welfare and poverty alleviation in develooping countries.

Seeds of agronomically optimized, locally adapted Golden Rice varieties will be provided to the farmer free of charge and limitations, within the framework of a humanitarian project. The farmer will use part of the harvest for the next sowing and does not require any additional input.

Golden Rice will complement, not replace traditional interventions. It is, however, more cost-effective and therefore more sustainable. The trait is in the seed. Once a variety has been developed, there are no further recurrent costs as with industrial fortification and distribution.

Consequences of the requirements of present GMO-regulation on the humanitarian Golden Rice project: a) for GMO-Product Development Repetition of the same experiment with „regulatory clean“ technology, until a „regulatory clean“ transformation event is found, to provide the basis for product development: 4-8 years of intensive experimental work of an entire team with no chance for publication, and difficult to finance! b) for GMO-Deregulation Detailed molecular analysis and biosafety studies in every possible aspect, to exclude any hypothetical risk: 5 years of intensive experimental work of a team with no chance for publication, and difficult to finance! Conditions a) and b) are so demanding with regards to financial resources and time, that no public institution or small or medium private enterprize can afford to develop a GM-product. This leads to a ‚de-facto monopoly‘ for the exploitation of the technology for commercial benefits by a few potent agbiotec industries.

GMO-Regulation delayed use of ‚Golden Rice‘for many years. Deletion of selectable marker: unjustified

2 years

Screening for streamlined integration: unjustified

2 years

Screening for regulatory clean events: unjustified

2 years

Transboundary movement of seeds: unjustified

2 years

Obligatory sequence greenhouse-field: unjustified

1 year

Permission for working in the field: unjustified

2 years

Requirement for one-event selection: unjustified

2 years

Experiments for the regulatory dosier: only partly justified

4 years

Deregulation procedure: only partly justified

1 year

Delay of Golden Rice for one year costs a minimum of 40‘ 000 lives!

Further lessons learned from the humanitarian Golden Rice project. The public sector has the competence for proof-of-concept work, but is totally incompetent for product development.

Further lessons learned from the humanitarian Golden Rice project. The public sector has competence for proof-of-concept work, but is totally incompetent for product development. The public sector needs partnership with the private sector for exploitation of its achievements in science and technology.

Further lessons learned from the humanitarian Golden Rice project. The public sector has competence for proof-of-concept work, but is totally incompetent for product development. The public sector needs partnership with the private sector for exploitation of its achievements in science and technology. There is a lot of goodwill in the public and private sector to apply the technology to the benefit of the poor in altruistic projects .

Further lessons learned from the humanitarian Golden Rice project. The public sector has competence for proof-of-concept work, but is totally incompetent for product development. The public sector needs partnership with the private sector for exploitation of its achievements in science and technology. There is a lot of goodwill in the public and private sector to apply the technology to the benefit of the poor in altruistic projects . A financial return of ca. US$ 50 million is required to justify the investment for one GMO-product.

Further lessons learned from the humanitarian Golden Rice project. The public sector has competence for proof-of-concept work, but is totally incompetent for product development. The public sector needs partnership with the private sector for exploitation of its achievements in science and technology. There is a lot of goodwill in the public and private sector to apply the technology to the benefit of the poor in altruistic projects . A financial return of ca. US$ 50 million is required to justify the investment for one GMO-product. This is beyond the financial capacity for any public goods project.

Further lessons learned from the humanitarian Golden Rice project. The public sector has competence for proof-of-concept work, but is totally incompetent for product development. The public sector needs partnership with the private sector for exploitation of its achievements in science and technology. There is a lot of goodwill in the public and private sector to apply the technology to the benefit of the poor in altruistic projects . A financial return of ca. US$ 50 million is required to justify the investment for one GMO-product. This is beyond the financial capacity for any public goods project. This situation is exacerbated by the negative attitude of NGO‘s, development aid organization, and governments.

Further lessons learned from the humanitarian Golden Rice project. The public sector has competence for proof-of-concept work, but is totally incompetent for product development. The public sector needs partnership with the private sector for exploitation of its achievements in science and technology. There is a lot of goodwill in the public and private sector to apply the technology to the benefit of the poor in altruistic projects . A financial return of ca. US$ 50 million is required to justify the investment for one GMO-product. This is beyond the financial capacity for any public goods project. This situation is exacerbated by the negative attitude of NGO‘s, development aid organization, and governments. The public goods potential is blocked by regulation. Requirements are so demanding that no public institution or small/medium private enterprize can afford to develop a product.

The lessons … , continued. Food security for developing countries requires, besides the best of traditional agriculture, the best of novel technologies.

The lessons … , continued. Food security for developing countries requires, besides the best of traditional agriculture, the best of novel technologies. There is a moral imperative to make these technologies available to the poor, including its application to orphan crops.

The lessons … , continued. Food security for developing countries requires, besides the best of traditional agriculture, the best of novel technologies. There is a moral imperative to make these technologies available to the poor, including its application to orphan crops. In the entire history of GMO technology development and application there is not a single case of harm, which could be used to argue for maintenance of this regulatory situation. There is no technology with a comparable saftey track record.

The lessons … , continued. Food security for developing countries requires, besides the best of traditional agriculture, the best of novel technologies. There is a moral imperative to make these technologies available to the poor, including its application to orphan crops. In the entire history of GMO technology development and application there is not a single case of harm, which could be used to argue for maintenance of this regulatory situation. There is no technology with a comparable saftey track record. Present GMO-regulation is not preventing risks, but is causing enormous social and economic harm – especially to the poor and underprivileged.

The lessons … , continued. Food security for developing countries requires, besides the best of traditional agriculture, the best of novel technologies. There is a moral imperative to make these technologies available to the poor, including its application to orphan crops. In the entire history of GMO technology development and application there is not a single case of harm, which could be used to argue for maintenance of this regulatory situation. There is no technology with a comparable saftey track record. Present GMO-regulation is not preventing risks, but is causing enormous social and economic harm – especially to the poor and underprivileged. There is no scientific justification for present regulation.

The lessons … , continued. Food security for developing countries requires, besides the best of traditional agriculture, the best of novel technologies. There is a moral imperative to make these technologies available to the poor, including its application to orphan crops. In the entire history of GMO technology development and application there is not a single case of harm, which could be used to argue for maintenance of this regulatory situation. There is no technology with a comparable saftey track record. Present GMO-regulation is not preventing risks, but is causing enormous social and economic harm – especially to the poor and underprivileged. There is no scientific justification for present regulation. The required change in regulation, and in public/political perception requires leadership, not opportunism.

The social and economic losses due to regulation have, so far, been calculated only for the case of Golden Rice and in the context of a delay for deployment of ten years.

The social and economic losses due to regulation have, so far, been calculated only for the case of Golden Rice and in the context of a delay for deployment of ten years. There is also high-iron-, high zinc-, high protein- rice, followed by the same in maniok, banana, sorghum; and there are further projects on nutritionally improved crops.

The social and economic losses due to regulation have, so far, been calculated only for the case of Golden Rice and in the context of a delay for deployment of ten years. There is also high-iron-, high zinc-, high protein- rice, followed by the same in maniok, banana, sorghum; and there are further projects on nutritionally improved crops. And there is drought-, salt-, flooding-, virus-, bacterialfungal-, insect-, nematode-resistance, not only with the major crops but also with orphan crops, and there is improved exploitation of natural resources.

The social and economic losses due to regulation have, so far, been calculated only for the case of Golden Rice and in the context of a delay for deployment of ten years. There is also high-iron-, high zinc-, high protein- rice, followed by the same in maniok, banana, sorghum; and there are further projects on nutritionally improved crops. And there is drought-, salt-, flooding-, virus-, bacterialfungal-, insect-, nematode-resistance, not only with the major crops but also with orphan crops, and there is improved exploitation of natural resources. A conservative ‚estimate‘ of the social and economic costs, assuming ten years of delay, adds up to losses of tens of millions of lives and hundreds of billions of US$.

The social and economic losses due to regulation have, so far, been calculated only for the case of Golden Rice and in the context of a delay for deployment of ten years. There is also high-iron-, high zinc-, high protein- rice, followed by the same in maniok, banana, sorghum; and there are further projects on nutritionally improved crops. And there is drought-, salt-, flooding-, virus-, bacterialfungal-, insect-, nematode-resistance, not only with the major crops but also with orphan crops, and there is improved exploitation of natural resources. A conservative ‚estimate‘ of the social and economic costs, assuming ten years of delay, adds up to losses of tens of millions of lives and hundreds of billions of US$. However, most projects will not just be delayed; they will never make it to the marketplace, adding the loss of all the investment into proof-of-concept work and ending up at even more astronomic social and economic losses.

What than is so dangerous with transgenic plants that we accept regulations that are responsible for such astronomic social and economic losses? Why do we have ‚GMO-regulation‘? History: precaution was sensible at the beginning of technology development. Key argument: the technology leads to ‚unpredictable genome alterations‘. Experience: from 20 years of regulatory oversight and biosafety research there is scientific consensus that there is no specific risks associated with GMO‘s. Why do we maintain ‚extreme precautionary‘ regulation? Answer: ‚To built trust for acceptance of GMO‘s‘. Experience: This did not and this can not work. The only argument left to defend GMO-regulation are the ‚unpredictable genome alterations‘ attributed to ‚genetic engineering‘. Let‘s have a look at this argument!





PA CHIAM FORTUNA


@

SERAUP BESAR 15

@

BPI 76




•




M ARONG PAROC

•

REXORO




UNKNOWN

BLUE ROSE SUPREM E




@

KITCHILI SAM BA

SINAWPAGH

• • •

• •
• • •
• •
•



• • • • • • • • • • • • •
• • • • • • • • •
• • • • • • • • • • •

• • • IR 64





CINA

@

@

@

LATISAIL

TEXAS PATNA

RSBR

@ CP231

PETA

@

DGWG

@

IR86

@

@

IR8

CHOW SUNG

• •

@

SLO 17

NM S 4

@

IR127

@

TSAI YUAN CHUNG

M UDGO

CO 18

@

TETEP

@

IR238

BENONG

SIGADIS

VELLAIKAR

IR400

IR1163

BLUE BONNET

@

NAHNG M ON S4

IR95

TADUKAN

IR1006

GEB24

CP SLO 17

IR262

IR1103

@

UNKNOWN

@

@

TN1

@

IR1416

IR1641

IR1402

@

IR22

TKM 6

IR746A

@

O. nivara

IR1870

@

IR2006

@

IR1614

@

@

IR579

IR773 A

@

@

BPI 121

IR1915 B

@

@

IR5236

@

@

GAM PAI 15

IR833

IR1561

@

@

@

Ultimate Landrace

IR18348

Crossing & selection

IR1721

@

IR1737

@

IR 2055

IR2061

@

New varieties

IR24/ IR661

IR2040

@

IR2146

IR5657

@

IR747

GAM PAI

IR1833

IR1916

@

IR1704

IR64

@

IR5338

Ultimate Landraces

GAM PAI DEE GEO WOO GEN CINA LATISAIL TADUKAN KITCHILI SAMBA PA CHIAM @ SERAUPBESAR 15 NAHNG MON S 4 VELLAIKAR

TSAI YUAN CHUNG

BENONG and each Every step Unknow n component is CHOW SUNG MUDGO unpredictableTETEP and leads to SINAWPAGH uncontrolled genome UNKNOWN (JAPANESE) O. nivara (IRGC 101508) alterations! MARONG PAROC

PA CHIAM




FORTUNA




SERAUP BESAR 15


@







M ARONG PAROC

BPI 76

BLUE ROSE SUPREM E

REXORO

Mutations

Ultimate Landrace

‚original‘ rice genome

UNKNOWN




KITCHILI SAM BA

@




SINAWPAGH

@





CINA

@ UNKNOWN

LATISAIL

TEXAS PATNA

PETA

@




DGWG

GEB24

@ CP231 @

@

Recombinations

Translocations

IR86

@ @ IR8

RSBR




CHOW SUNG




TADUKAN

IR1006




Inversions










M UDGO

SIGADIS

NM S 4

IR127

@

TETEP

@

IR238

@

IR1416

BENONG

TSAI YUAN CHUNG

CO 18

@

IR1163

@







VELLAIKAR

IR400

@

NAHNG M ON S4

IR262

IR1103

SLO 17

CP SLO 17

IR95

BLUE BONNET

@

@

TN1

@

IR1641

IR1402

@

IR22

TKM 6

@ IR2006

IR1614

@ IR773 A

@ @ IR5236

IR1916

@

IR1833

IR2061

@

@ @ IR18348

IR64

‚genetically modified‘ natural genome

IR1561

@

IR833

@

@

@

IR 64

IR747

IR24/ IR661

IR1721

GAM PAI

GAM PAI 15

IR2146

IR5657

@

@




@

BPI 121

IR1915 B

IR1704

@ IR579

@

@

Deletions




O. nivara

IR1870

IR746A

@

IR1737

@

IR2040

@ IR5338

IR 2055

The same breeding tree with of the GAM PAIa representation TSAI YUAN CHUNG DEE GEO WOO GEN BENONG unpredictable CINA Unknow n and LATISAIL CHOW SUNG uncontrolled modifications TADUKAN MUDGO KITCHILI SAMBA TETEP of the genome: PA CHIAM SINAWPAGH Ultimate Landraces

SERAUPBESAR 15

UNKNOWN (JAPANESE)

NAHNG MON S 4breeding (IRGC 101508) O. nivara Traditional leads to VELLAIKAR MARONG PAROC massive ‚genetic modifications‘!

PA CHIAM







FORTUNA


@

SERAUP BESAR 15

BPI 76

CINA

UNKNOWN

BLUE ROSE SUPREM E

REXORO

Mutations

Ultimate Landrace








M ARONG PAROC










@ SINAWPAGH

KITCHILI SAM BA

@

LATISAIL

TEXAS PATNA

PETA

@




DGWG

@

Recombinations

IR86

RSBR

GEB24 BLUE BONNET

@ CP231 @

@SLO 17

Translocations

@ CP SLO 17

@ @ IR8




CHOW SUNG

IR1103 IR1006

IR1163







TADUKAN







IR95 IR262




IR400

M UDGO

VELLAIKAR

IR238

@

@

IR1416

IR1402 IR22

@

BENONG

SIGADIS

@

NAHNG M ON S4 NM S 4

IR127

@

TSAI YUAN CHUNG

@

TN1

@

TKM 6




IR1641 IR746A IR1704

IR1870




IR1614

@ IR2006

@ @

@

@

BPI 121

IR1915 B

@ @

IR1916




@ IR1833

@

@

IR833

@

IR2146

@

IR747

GAM PAI 15

IR1561

@

@ IR18348

IR64

genetically modified genome

IR1721

@

IR 64

Golden IR 64

@

IR1737

@ This precise additional modification is used to Ultimate Landraces justify GMO regulation! GAM PAI TSAI YUAN CHUNG IR2040

@ IR5338

@ IR5657

IR24/ IR661

GAM PAI

IR2061 IR5236

@

Deletions

O. nivara

IR579 IR773 A

@




CO 18

TETEP

@

@

UNKNOWN

IR 2055

DEE GEO WOO GEN CINA LATISAIL TADUKAN KITCHILI SAMBA PA CHIAM SERAUPBESAR 15 NAHNG MON S 4 VELLAIKAR

BENONG Unknow n CHOW SUNG MUDGO TETEP SINAWPAGH UNKNOWN (JAPANESE) O. nivara (IRGC 101508) MARONG PAROC

genetically engineered genome

An ‚ultimate landrace‘, as selected by indigineous farmers. Types of genetic modification as natural consequence of traditional breeding: mutation, recombination, translocation, transposition, inversion, deletion, all ‚unpredictable‘ and ‚uncontrolled‘ and more extreme than ‚genetic engineering‘. Traditional variety, as developed by early traditional breeding. Modern, highly productive variety, as developed by state-of-the-art traditional breeding and as in use by organic as well as industrial farming - without any regulation.

‚Unpredictable genome modifications‘ in traditional and GMO breeding.

Modern ‚GMO‘ variety, as developed by state-ofthe-art traditional breeding and genetic engineering. Permission for use only after most restrictive ‚extreme precautionary regulation‘. Nothing justifies specific GMO-regulation!

The paradox of GMO GMO-regulation

An ‚original‘ rice genome, as evolved in evolution.

Take-home lessons: The social costs of GMO-regulation are astronomic. The economic costs of GMO-regulation are immense. GMO-regulation did not prevent any harm. GMO-regulation has no scientific justification. GMO-regulation disadvantages the poor. GMO-regulation cripples one of the most important technological innovations. GMO-regulation prevents that the critical citicen can experience the benefits from the technology. Developing countries are working on a way out of this dead-end road; Europe is left behind.