Golden Rice, access to better food the difficulties regulation Access to Global Resources

Golden Rice, access to better food

the difficulties regulation

Access to Global ResourcesKlaus Ammann

Milan, 17 November 2012

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Milan, 16 - 17 November 2012

Many obstacles to success

TIME Magazine, July 31, 2000

• This was 2000, one year after ‚proof-of-concept‘. Everybody expected Golden Rice to be with the farmers by 2002.

• It will be there by 2014. The ‚protesters‘ were a problem, but not a major one. There was, and is, one outstanding problem:

• GMO-regulation.

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Milan, 16 - 17 November 2012

The reasons of the delay

Check for updates at http://www.europabio.org/filter/agricultural/type/position or contact EuropaBio for more info

1. June 2012

Gómez-Galera, S., Twyman, R.M., Sparrow, P.A.C., Van Droogenbroeck, B., Custers, R., Capell, T., & Christou, P. (2012)Field trials and tribulations—making sense of the regulations for experimental field trials of transgenic crops in Europe. Plant Biotechnology Journal, 10, 5, pp 511-523 http://dx.doi.org/10.1111/j.1467-7652.2012.00681.x AND http://www.ask-force.org/web/IP/Gomez-Galera-Field-Trials-Tribulatioins-2012.pdf

Gómez-Galera, S., Twyman, R.M., Sparrow, P.A.C., Van Droogenbroeck, B., Custers, R., Capell, T., & Christou, P. (2012)Field trials and tribulations—making sense of the regulations for experimental field trials of transgenic crops in Europe. Plant Biotechnology Journal, 10, 5, pp 511-523 http://dx.doi.org/10.1111/j.1467-7652.2012.00681.x AND http://www.ask-force.org/web/IP/Gomez-Galera-Field-Trials-Tribulatioins-2012.pdf

European Safety Attitude: let not the Europeans decide about Biosafety in Africa and the Near East, do your own safety assessment http://www.funvblog.com/2011/01/20/weird-safety-for-bicycle/

European safety attitude: a problem for many countries in the developing world

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Milan, 16 - 17 November 2012

Destruction of 30 years of field researchProf. Eddo Ruggini Università di Tusca http://www.freshplaza.it/news_detail.asp?id=48131

“It can be seen as a demolition of a scientific cultural monument,an act of legal vandalism,” says Klaus Ammann from the University of Bern.“

Meldolesi, A. (2012)Destruction of transgenic olive field trial dubbed 'vandalism'. Nat Biotech, 30, 8, pp 736-736 http://www.ask-force.org/web/Fundamentalists/Meldolesi-Destruction-Transgenic-Olive-Field-Italy-2012.pdf

Morandini, P. (2008)Al contadino non far sapere... Polenta, Maggio 2008, pp 3 http://www.botanischergarten.ch/ASK-FORCE-NEWS-Maize-Lombardia/Morandini-polenta_25-04-08.pdf

Marshall, A. (2007)Another Inconvenient Truth.In Europe, no one apparently wants to listen if you have good news about genetically modified organisms (GMOs). Nature Biotechnology, 25, 12, pp 1330 ttp://www.botanischergarten.ch/Bt/Marshall-Inconvenient-Truth-2007.pdf

Results held back for political reasons sinceMarch 7, 2006

Data produced by theUniversity of Milan

November 13, 2007 - Milan, Italy and Tuskegee, Alabama - via AgBioView, http://www.agbioworld.org , Piero Morandini, Milano, [email protected] Roberto Defez, Napoli, [email protected]

The participants represented the following scientific disciplines:

Theology, Philosophy, Law, Sozial Sciences, Development, Economy, Evolution, Ecology, Plant Sciences, Agronomy, Biotechnology, Molecular Biology, Biochemistry, Biosafety, Food safety, Regulation.

All participants agreed that there is no unusual risk from GMOs, that regulation must be changed, and hat there is a moral imperative to make the technology available, as efficiently as possible, to the poor in developing countries.

Potrykus, I. & Ammann, K., eds. (2010)Transgenic Plants for Food Security in the Context of Development, Statement of the Pontifical Academy of Sciences, Vol. 27, open source,

pp 445-717, M. Taussig, New Biotechnology Elsevier, Amsterdam, http://www.sciencedirect.com/science/issue/43660-2010-999729994-2699796 AND on Vatican Website <http://www.vatican.va/roman_curia/pontifical_academies/acdscien/2010/newbiotechnologynov2010.pdf> AND on Host ASK-FORCE: http://www.ask-force.org/web/Vatican-PAS-Studyweek-Elsevier-publ-20101130/Potrykus-Ammann-Conference-Volume-Newbiotechnology-2010.pdf Press release http://www.ask-force.org/web/Vatican-PAS-Studyweek-Elsevier-publ-20101130/Press-Release-PAS-Studyweek-20101127.pdf

400 million rice-depending poor suffer from vitamin A-deficiency.

VAD impairs vision, epithelial integrity,immune response, haemopoiesis,skelettal growth, etc.

It is the major cause for 500 000 blind children and two million death per year.

Rice as major staple of 2.4 billion does not contain any provitamin A.

The consequences for withholding Golden Rice

Sommer, A. & Vyas, K.S. (2012)A global clinical view on vitamin A and carotenoids. The American Journal of Clinical Nutrition, 96, 5, pp 1204S-1206S http://www.ask-force.org/web/Golden-Rice/Sommer-Global-Clinical-View-VA-2012.pdf

Tang, G., Hu, Y., Yin, S.-a., Wang, Y., Dallal, G.E., Grusak, M.A., & Russell, R.M. (2012)Beta-Carotene in Golden Rice is as good as beta-carotene in oil at providing vitamin A to children. The American Journal of Clinical Nutrition, pp http://www.ask-force.org/web/Golden-Rice/Tang-Golden-Rice-as-good-as-oil-2012.pdf

Tang, G., Qin, J., Dolnikowski, G.G., Russell, R.M., & Grusak, M.A. (2009)Golden Rice is an effective source of vitamin A. Am J Clin Nutr, 89, 6, pp 1776-1783 http://www.ask-force.org/web/Golden-Rice/Tang-Golden-Rice-Effective-Source-2009.pdf

Patrick Moore says this is a crime against humanity because they [Greenpeace] are preventing the curing of people who are dying by the hundreds of thousands a year due to vitamin A deficiency.

Moore, P. & Batra, K. (20120216)Greenpeace Founder: Biotech Opposition is Crime Against Humanity. In Biotech Now, Farmer Gene. Biohttp://www.ask-force.org/web/Golden-Rice/Moore-Golden-Rice-Crime-20120216.pdf

What can we do to stop this kind of sterile tennis game pro and con GMOs?(a never ending tie break in Europe)

Rely on good science and try to open our mind in the debate and start a newculture of learning dialogue

Science of transgenic processes

There is no difference between natural mutation and transgenesis on the molecular level

Review on the History and negative consequences

Of the „Genomic Misconception“: its scientifically

wrong to focus in regulation on the process instead on the product (as the Canadians do successfully for years!!

Ammann, K. (20120706)

Genomic Misconception: A fresh look at the biosafety of transgenic and conventional crops, a plea for a process agnostic regulation New Biotechnology, in press, pp 32

http://www.ask-force.org/web/NewBiotech/Genomic-Misconception-20120706-names-def.pdf

Genepeace, not Greenpeace

We need to collaborate with other farming strategies, in particular with integrated and organic farming. Organic farming cannot solve the problems since productivity is not high enough.

The ideal plants for organic farming are GMOsAmmann, K. (2008)

Feature: Integrated farming: Why organic farmers should use transgenic crops. New Biotechnology, 25, 2, pp 101 - 107

http://www.botanischergarten.ch/NewBiotech/Ammann-Integrated-Farming-Organic-2008.publ.pdf

Ammann, K. (2009)

Feature: Why farming with high tech methods should integrate elements of organic agriculture. New Biotechnology, 25, 6, pp 378-388

http://www.botanischergarten.ch/Organic/Ammann-High-Tech-and-Organic-2009.pdf

Adaptive learning processes

Adaptive learning process for sustainability indicator development and application, from (Reed et al., 2006).

Ammann Klaus (20120620)Chapter 27: Advancing the cause in emerging economies In Successful Agricultural Innovation in Emerging Economies (eds Bennett David & Jennings Richard), pp. 27. Cambridge University Press, Cambridge http://www.ask-force.org/web/CUP-Success-GM-crops/Ammann-Advancing-Cause-Emerging-20120802.pdf

Need for a new question culture

The first existential question is: What do we need today - technological progress for the sake of technology, or a human development for the sake of men? The Questions should be oriented towards human reality instead of being based on the curiosity of the researcher or on the interest of industry or mere profit in business. This question culture should ask existential questions oriented towards life in order to get answers relevant to life. This is how we actually can deal with the overarching topic of Biovision 2012: The resonance of knowledge in the society of the 21. Century.

Dr. Biljana Papazov Ammann

Papazov Ammann, B. (2010)A new Question Culture, Conference Abstract. Biovision Alexandria, Alexandriahttp://www.bibalex.org/bva2010/speakers/SpeakerDetails.aspx?m=1&sp=XOHvrH47wZRXTXP5lzyEvA==

Type: GIF

Lagi Marco, Karla Z. Bertrand, & Yaneer Bar-Yam (20110810)Electronic Source: The Food Crises and Political Instability in North Africa and the Middle East, published by: New England Complex Systems Institute: http://necsi.edu/ arXiv:1108.2455, August 10, 2011.<http://necsi.edu/research/social/food_crises.pdf>.AND http://www.ask-force.org/web/Food/Lago-Food-Crises-Political-Instability-20110928.pdf AND http://www.ask-force.org/web/Food/Mac-Slavo-Complexity-Theorists-Predict-Food-Crisis-20110824.pdf

Extra slides for discussionoriginal presentation of Ingo

Potrykus in 15. Eurpean Biotechnology Congress in Istanbul

25. September 2012

15th European Congress on Biotechnology

Lessons from the humanitarian Golden Rice project.

Ingo Potrykus, Emeritus Plant Sciences ETH Zürich

Istanbul 23-26 September 2012

TIME Magazine, July 31, 2000

This was 2000, one year after ‚proof-of-concept‘. Everybody

expected Golden Rice to be with the farmers by 2002. It

will be there by 2014. The ‚protesters‘ were a problem, but not a

major one. There was, and is, one

outstanding problem:

GMO-regulation.

Science May 8, 2008, Martin Enserinck, www.sciencemag.org at April 25, 2008

‚It was supposed to prevent blindness and death from vitamin A deficiency in millions of children. But almost a decade after its

invention, golden rice is still stuck in the lab.‘

Rice as major staple of 2.4 billion does not contain any provitamin

A.

400 million rice-depending poor suffer

from vitamin A-deficiency.

VAD impairs vision,

epithelial integrity,

immune response, haemopoiesis,

skelettal growth, etc.

It is the major cause for 500 000 blind children and two million death

per year.

The consequences:

190 million children & 19 million pregnant women affected

globally.

1–2.5 million deaths p.a. through immune response

suppression.

500,000 per year blinded.

600,000 women die annually from childbirth/VAD related

causes.

23–34% reduction in preschool mortality can be expected from

vitamin A programs reaching children in undernourished

settings. *West KP Jr, Klemm RDW, Sommer A. Vitamin A saves lives. Sound science, sound policy. World Nutrition 2010; 1, 5: 211-229.

The “burden” on public health from vitamin A-deficiency:

The challenge for science:

How to get a „vitamin A-rice“.

Rice plants have provitamin A in all green tissues exept for the starch-storing tissue we eat – the endosperm.

The alternatives:

a) Find a rice plant with ‚yellow‘ endosperm.

b) Apply mutagenesis

c) Find the ‚switch‘ which inactivates the pathway.

d) Engineer the pathway into the endosperm.

It was possible to engineer the biochemical pathway into rice such that provitamin A is synthesized and accumulates in the

endosperm.

The „golden“ colour is a reflection of the presence of provitamin A. The intensity of the colour is a measure of the concentration.

Phytoene

Phytofluene

-Carotene

Neurosporene

Lycopene

PP

PP PP

IPP DMAPP

GGPP

40 grams of Golden Rice a day can save life and sight.

After 13 years of product development:

Development of regulatory clean and agronomic attractive varieties.

Work under regulatory conditions.

Data for the regulatory dossier and deregulation.

Social marketing.

The key challenges of the project.

Deletion of selectable marker: 2 years

Screening for streamlined integration: 2 years

Screening for regulatory clean events: 2 years

Protection against liability problems: 1 year

Transboundary movement of seeds: 2 years

Obligatory sequence greenhouse-field: 1 year

Permission for working in the field: 2 years

Requirement for one-event selection: 2 years

Experiments for the regulatory dosier: 4 years

Deregulation procedure: 1 year

And it required additional financial resources, compared to the development of non-GMO varieties, of ca. USD 30 million.

The outstanding challenge for the humanitarian Golden Rice project was GMO-regulation. It delayed deployment for more

than ten years!

GMO-specific financial investment in product development, social marketing, and deregulation for Philippines/Bangladesh.

Rockefeller Foundation USD 6 200 000

USAid USD 2 000 000

Syngenta Company „in kind“ USD 2 500 000

Syngenta Foundation USD 1 200 000

US NIH USD 1 500 000

Gates Foundation USD 16 200 000

Humanitarian Board „in kind“ USD 2 000 000

IRRI „in kind“ USD 1 000 000

PhilRice „in kind“ USD 500 000

Grand totalGrand total USD 33 100 000USD 33 100 000

GMO-regulaton delays use of GMO-based products for more than ten years and carries a huge financial penalty.

Time and costs for delivery of a GMO-product to the market are so immmense that no public institution nor any small or medium sized private enterprize can afford the necessary investment in personell or funds.

Numerous public GMO-projects, including many from developing country laboratories and with orphan crops, will not make it to the market place.

The damage to life and welfare is enormous and affects the poor and not the rich Western societies responsible for the hostile anti-GMO-attitude.

The consequences of GMO-specific regulation:

There is no scientific justification for the world-wide established GMO-specific regulatory system based on the concept of an „extreme precautionary principle“.

There is, to the contrary, a „moral imperative“ to make GMO-technology available for public good such as nutrition security.

This requires changing regulation from ideology-based regulation of a technology to science-based regulation of traits.

Effective use requires that the public health community recognizes, that micro-nutrient dense food is a cost-effective and sustained intervention against micro-nutrient malnutrition.

The consequences of GMO-specific regulation (continued):

Golden Rice will reach the farmer soon. It 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.

Seeds of agronomically optimized, locally adapted Golden Rice varieties will be provided to the farmer free of charge and

limitations, within the framework of the humanitarian project. The farmer will use part of the harvest for the next sowing and does

not require any additional input.

The expected timeline for release is: 2013 The Philippines, 2014 Bangladesh, 2015 India and Vietnam, 2016 China and Indonesia.

An OECD publication stated already in 1986 that An OECD publication stated already in 1986 that ‚there is no scientific basis for specific legislation to ‚there is no scientific basis for specific legislation to

regulate the use of recombinant DNAorganisms‘regulate the use of recombinant DNAorganisms‘

Since then numerous academies have published that ‚GMO‘s are at least as safe as traditionally developed

non-GM-varieties, e.g.Pontifical Academy of Sciences 2010

European Commission‘s Scientific Advisory Panel 2008

International Union of Food Science and Technology. 2005

Royal Society London, US Natl. Acad. Sciences, Brazilian Acad.Sci., Chinese Acad.Sci., Indian

Acad.Sci., Mexican Acad.Sci., Third World Acad.Sci. 2004.

GM Science Review Panel UK, 2003.

etc., etc. etc.

There is no justification for GMO.specific regulation.

The participants represented the following scientific disciplines:

Theology, Philosophy, Law, Sozial Sciences,

Development, Economy, Evolution, Ecology, Plant

Sciences, Agronomy, Biotechnology, Molecular

Biology, Biochemistry, Biosafety, Food safety,

Regulation.

All participants agreed that there is no unusual risk from GMOs,

that regulation must be changed, and hat there is a moral imperative to make the technology available, as

efficiently as possible, to the poor in developing countries.

Transgenic Plants for Food Security in the Context of Development. NewBiotechnology Vol. 27/5

(2010) 445-718

There is nothing intrinsic about the use of GE technologies for crop improvement that would cause the plants themselves or the resulting food products to be unsafe.

The genetic improvement of crop plants represents a long and seamless continuum of progressively more precise and predictable techniques.

Special efforts should be made to provide poor farmers in the developing world with access to improved GE crop varieties adapted to their local conditions.

GE technology, used appropriately and responsibly, can in many circumstances make essential contributions to agricultural productivity by crop improvemen. These improvements are needed around the world to help improve the sustainability and productivity of agriculture.

Scientific results from the Vatican meeting:

GE technology has already raised crop yields of poor farmers and there is evidence of its generating increased income and employment.

The application of GE technology to insect resistance has led to a reduction in the use of chemical insecticides, lowering the cost of agricultural inputs and improving the health of agricultural workers.

GE technology can combat nutritional deficiencies through modification that provides essential micro-nutrients.

Costly regulatory oversight of GE technology needs to become scientifically defensible and risk-based. This means that regulation should be based upon the particular traits of a new plant variety rather than the technological means used to produce it.

Risk assessments must consider not only the potential risks of the use of a new plant variety, but also the risks of alternatives, if that particular variety is not made available.

Significant public-sector efforts are currently underway to produce genetically improved varieties … that will be of direct benefit to the poor. These efforts should be strongly encouraged.Given these scientific findings, there is a moral imperative to make the benefits of GE technology available on a larger scale to poor and vulnerable populations who want them and on terms that will enable them to raise their standards of living, improve their health and protect their environments.

EMBO reports (2012) 13, 493-497. EMBO reports (2012) 13, 493-497.

Risk research on GM crops is a dead parrot: it is time to Risk research on GM crops is a dead parrot: it is time to reaping the benefits of GM. reaping the benefits of GM.

T Fagerström, C Dixelius, U Magnusson, JF Sundström.T Fagerström, C Dixelius, U Magnusson, JF Sundström.

„„In a report from 2010, the EC concluded that In a report from 2010, the EC concluded that biotechnology is not per se riskier than conventional plant biotechnology is not per se riskier than conventional plant

breeding technologies.“breeding technologies.“„„It is time to look at the other side of the equation and It is time to look at the other side of the equation and gauge the possible benefits of adopting and growing GM gauge the possible benefits of adopting and growing GM

crops“.crops“.„„Not adpting modern breeding tools – including Not adpting modern breeding tools – including biotechnology – will probably hamper the European biotechnology – will probably hamper the European

agricultural system facing a warmer and more variable agricultural system facing a warmer and more variable climate.“climate.“„The burden of EU legislation for GM technologies is

completely out of proportion compared with other science-based endeavours“

Stopp worrying; start growing!Stopp worrying; start growing!

What should we have learned from science about the hazard from transgenic plants?

There is no difference which justifies specific regulation.

What do we know from 25 years of specific „biosafety research?“

There was no GMO-specific hazard.

What do we know from 12 years of world-wide application on over 150 million hectares and by over 20 million farmers?

There is no documented case of harm. The technology has an unprecedented safety track record.

How do our „enlightened societies respond to these facts?

They enforce even tighter regulation and prevent use of a powerful technology for food security and response to

environmental change, especially for public good.

Those opposing plant biotechnology dream of a

„romantic“ agriculture like that on the painting from Pieter Breughel from 1565, an agriculture which

never existed in reality.

Millet‘s picture from 1862 is - in contrast - „honest“ and reminds us that pre-industrial agriculture was, also in Europe, and not so long ago, not at all „romantic“, but back-breaking fight for survival – the same way as it is today for hundreds of millions of poor farmers in developing countries.

Nobody, especially no

„well-fed NGO

activist“, has the right to deny those farmers the

help from technology-

supported agriculture.

Those fighting

GMOs with a political agenda

commit a crime to

humanity and should

be taken responsible.