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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 Resources. Klaus Ammann. Milan, 17 November 2012. PANEL TITLE. Many obstacles to success. TIME Magazine, July 31, 2000. Milan, 16 - 17 November 2012.

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

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  1. Golden Rice, access to better foodthe difficulties regulationAccess to Global Resources Klaus Ammann Milan, 17 November 2012

  2. PANEL TITLE Many obstacles to success TIME Magazine, July 31, 2000 Milan, 16 - 17 November 2012

  3. 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. PANEL TITLE The reasons of the delay Milan, 16 - 17 November 2012

  4. 1. June 2012 Check for updates at http://www.europabio.org/filter/agricultural/type/position or contact EuropaBio for more info

  5. 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

  6. 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

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

  8. PANEL TITLE Destruction of 30 years of field research Prof. 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 Milan, 16 - 17 November 2012

  9. 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

  10. 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

  11. Results held back for political reasons since March 7, 2006 Data produced by the University of Milan November 13, 2007 - Milan, Italy and Tuskegee, Alabama - via AgBioView, http://www.agbioworld.org , Piero Morandini, Milano, piero.morandini@unimi.it and Roberto Defez, Napoli, defez@igb.cnr.it

  12. 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

  13. The consequences for withholding Golden Rice 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. 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

  14. 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. Bio http://www.ask-force.org/web/Golden-Rice/Moore-Golden-Rice-Crime-20120216.pdf

  15. 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 new culture of learning dialogue

  16. 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

  17. 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 GMOs Ammann, 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

  18. 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

  19. Need for a new question culture Dr. Biljana Papazov Ammann 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. Papazov Ammann, B. (2010) A new Question Culture, Conference Abstract. Biovision Alexandria, Alexandria http://www.bibalex.org/bva2010/speakers/SpeakerDetails.aspx?m=1&sp=XOHvrH47wZRXTXP5lzyEvA==

  20. 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

  21. Extra slides for discussionoriginal presentation of Ingo Potrykus in 15. Eurpean Biotechnology Congress in Istanbul25. September 2012

  22. 15th European Congress on Biotechnology Istanbul 23-26 September 2012 Lessons from the humanitarian Golden Rice project. Ingo Potrykus, Emeritus Plant Sciences ETH Zürich

  23. 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. TIME Magazine, July 31, 2000

  24. 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.‘

  25. Rice as major staple of 2.4 billion does not contain any provitamin A. The consequences: 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.

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

  27. Rice plants have provitamin A in all green tissues exept for the starch-storing tissue we eat – the endosperm. • The alternatives: • Find a rice plant with ‚yellow‘ endosperm. • Apply mutagenesis • Find the ‚switch‘ which inactivates the pathway. • d) Engineer the pathway into the endosperm. The challenge for science: How to get a „vitamin A-rice“.

  28. It was possible to engineer the biochemical pathway into rice such that provitamin A is synthesized and accumulates in the endosperm. PP PP IPP DMAPP PP GGPP Phytoene Phytofluene -Carotene Neurosporene Lycopene The „golden“ colour is a reflection of the presence of provitamin A. The intensity of the colour is a measure of the concentration.

  29. After 13 years of product development: 40 grams of Golden Rice a day can save life and sight.

  30. The key challenges of the project. Development of regulatory clean and agronomic attractive varieties. Work under regulatory conditions. Data for the regulatory dossier and deregulation. Social marketing.

  31. The outstanding challenge for the humanitarian Golden Rice project was GMO-regulation. It delayed deployment for more than ten years! 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.

  32. 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 total USD 33 100 000

  33. The consequences of GMO-specific regulation: 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.

  34. The consequences of GMO-specific regulation (continued): 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.

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

  36. There is no justification for GMO.specific regulation. An OECD publication stated already in 1986 that ‚there is no scientific basis for specific legislation to 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.

  37. Transgenic Plants for Food Security in the Context of Development. NewBiotechnology Vol. 27/5 (2010) 445-718 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.

  38. Scientific results from the Vatican meeting: 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.

  39. 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.

  40. 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.

  41. EMBO reports (2012) 13, 493-497. Risk research on GM crops is a dead parrot: it is time to reaping the benefits of GM. T Fagerström, C Dixelius, U Magnusson, JF Sundström. Stopp worrying; start growing! „In a report from 2010, the EC concluded that biotechnology is not per se riskier than conventional plant breeding technologies.“ „It is time to look at the other side of the equation and gauge the possible benefits of adopting and growing GM crops“. „Not adpting modern breeding tools – including biotechnology – will probably hamper the European agricultural system facing a warmer and more variable climate.“ „The burden of EU legislation for GM technologies is completely out of proportion compared with other science-based endeavours“

  42. 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.

  43. 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.

  44. 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. 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.

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