18. Juni 2010Lecture at the BOKU for Biosafety Class of Prof. Dr. Margit Laimer

Regulation of GM crops and the Cartagena Protocol

Em. Prof. Ammann, University of Bern

Biodiversity Convention and Biosafety Protocol

Convention on Biological Diversity (1992):• Aim: Conservation and sustainable use of biological

diversity, and fair and equitable sharing of the benefits of using genetic resources, including by access genetic resources and transfer of technologies

• Article 8 (“In situ conservation of biodiversity” ): Obligation to develop National Biosafety Systems

• Article 19 (“Handling biotechnology and distribution of its benefits”):- promote and advance priority access to biotechnology - Consider a protocol on biosafety – this became the CPB

• Governing body: Conference of the Parties (COP)

Biodiversity Convention and Biosafety Protocol

Cartagena Protocol on Biosafety (2000):• Aim: to contribute to biosafety and specifically focusing on

transboundary movements• Advance Informed Agreement procedure for transboundary

movement of LMOs intended for release in the environment of receiving country

• Procedure for LMOs intended for food, feed, processing in the receiving country

• Biosafety Clearing House Mechanism• Capacity Building • Governing body: Meeting of the Parties (MOP) –

sometimes also called COP/CMOP

Recommended readings:the available ASK-FORCE contributions from Klaus Ammann:http://www.botanischergarten.ch/ASK-FORCE-Summary/ASK-FORCE-SuAbout an infamous. extreemely polemic author activist against GMO crops and its regulation, see a complete rebuttal in http://academicsreview.org

Aerni, P., Rae, A., & Lehmann, B. (2009)Nostalgia versus Pragmatism? How attitudes and interests shape the term sustainable agriculture in Switzerland and New Zealand. Food Policy, 34, 2, pp 227-235 http://www.sciencedirect.com/science/article/B6VCB-4V1MFKR-1/2/b72610f6397bc5572a076cbe0ae3e599

Chassy, B. & Parrott, W. (2009) Is This Study Believable? Examples from Animal Studies with GM Foods. . In In Agricultural Biotechnology, , pp. 9, University of California, Davis, Davis, California http://www.agribiotech.info/details AND http://www.botanischergarten.ch/Peer-Review/Chassy-Parrott-Believable-2009.doc

Chassy, B.M. (2009)Global Regulation of Transgenic Crops. In Molecular Genetic Approaches to Maize Improvement, pp. 107-124 http://dx.doi.org/10.1007/978-3-540-68922-5_9

Graff, G., Hochman, G., & Zilberman, D. (2009)The Political Economy of Agricultural Biotechnology Policies. In AgBioForum, Vol. 12, pp. 1-13http://www.agbioforum.org/v12n1/v12n1a04-graff.htm AND http://www.botanischergarten.ch/Regulation/Graff-Political-Economy-Policies-2009.pdf

Herman, R.A., Chassy, B.M., & Parrott, W. (2009)Compositional assessment of transgenic crops: an idea whose time has passed. Trends in Biotechnology, In Press, Corrected Proof, pp http://www.sciencedirect.com/science/article/B6TCW-4X26XP1-1/2/bcfd547d5f12695fc76c4fc5886ba9fc AND http://www.botanischergarten.ch/Regulation/Herman-

Compositional-Analysis-2009.pdf

Nickson, T.E. (2008)Planning Environmental Risk Assessment for Genetically Modified Crops: Problem Formulation for Stress-Tolerant Crops. Plant Physiology, 147, pp 494-502 http://www.botanischergarten.ch/Regulation/Nickson-Planning-Stress-2008.pdf

Qaim, M. & Stein, A.J. (2008)Economic consequences of Golden Rice. In Invited presentation at the Fourth Conference of the European Plant Science Organisation, Toulon (Cote d'Azur), Francehttp://www.epsoweb.org/catalog/conf2008.htm AND http://www.botanischergarten.ch/Golden-Rice/Qaim-Economic-Consequences-Epso-Abstract-2008.pdf

Raybould, A.F. (2010)Reducing uncertainty in regulatory decision-making for transgenic crops: More ecological research or shrewder environmental risk assessment? GM crops, 1, 1, pp 1-7 http://www.landesbioscience.com/journals/gmcrops/article/9776 AND http://www.botanischergarten.ch/Regulation/Raybould-Reducing-uncertainty-2010.pdf

Ricroch, A., Bergé, J., & Kuntz, M. (2009)Is the German suspension of MON810 maize cultivation scientifically justified? electronic prepublicatoin 23.6.2009 open access. Transgenic Research, pp http://dx.doi.org/10.1007/s11248-009-9297-5 AND http://www.botanischergarten.ch/Regulation/Ricroch-German-Suspension-Scientifically-2009.pdf AND

http://www.botanischergarten.ch/Regulation/Ricroch-Supplement-Material-2009.doc

Shelton, A., Naranjo, S., Romeis, J., Hellmich, R., Wolt, J., Federici, B., Albajes, R., Bigler, F., Burgess, E., Dively, G., Gatehouse, A., Malone, L., Roush, R., Sears, M., & Sehnal, F. (2009)

Setting the record straight: a rebuttal to an erroneous analysis on transgenic insecticidal crops and natural enemies. Transgenic Research, 18, 3, pp 317-322 http://dx.doi.org/10.1007/s11248-009-9260-5 open access AND http://www.botanischergarten.ch/Bt/Shelton-Setting-Record-Straight-Lovei-2009.pdf

Shelton, A.M., Naranjo, S.E., Romeis, J., Hellmich, R.L., Wolt, J.D., Federici, B.A., Albajes, R., Bigler, F., Burgess, E.P.J., Dively, G.P., Gatehouse, A.M.R., Malone, L.A., Roush, R., Sears, M., Sehnal, F., Ferry, N., & Bell, H.A. (2009)

Appropriate Analytical Methods Are Necessary to Assess Nontarget Effects of Insecticidal Proteins in GM Crops Through Meta-Analysis (Response to Andow et al. 2009). Environmental Entomology, 38, 6, pp 1533-1538

<Go to ISI>://WOS:000272581400002 AND http://www.botanischergarten.ch/Bt1/Shelton-Appropriate-Analytical-Methods-2009.pdf

Roster of Experts CP: 487 Mailing list ISBR: 59212

CP RoE vs. ISBR mailing list

Werner Arber, Nobel Laureate 1978:

Interestingly, naturally occurring molecular evolution,i.e. the spontaneous generation of genetic variants hasbeen seen to follow exactly the same three strategies as those used in genetic engineering14. These three strategies are: (a) small local changes in the nucleotide sequences,(b) internal reshuffling of genomic DNA segments, and(c) acquisition of usually rather small segments of DNA

from another type of organism by horizontal gene transfer.

Arber, W. (2002) Roots, strategies and prospects of functional genomics. Current Science, 83, 7, pp 826-828 http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf

Arber, W. (2002) Roots, strategies and prospects of functional genomics. Current Science, 83, 7, pp 826-828 http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf

Werner Arber, Comparison, with publications

However, there is a principal difference between the procedures of genetic engineering and those serving in nature for biological evolution. While the genetic engineer pre-reflects his alteration and verifies its results, nature places its genetic variations more randomly and largely independent of an identified goal.And after ca. 10 years of safety assessmenttransgenic crops are distributed to the millionsin a short time.

Arber, W. (2002) Roots, strategies and prospects of functional genomics. Current Science, 83, 7, pp 826-828 http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf

Arber, W. (2002) Roots, strategies and prospects of functional genomics. Current Science, 83, 7, pp 826-828 http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf

Arber, However principal differences: Prereflection and short time distribution of successful traits

Batista, R., Saibo, N., Lourenco, T., & Oliveira, M.M. (2008)Microarray analyses reveal that plant mutagenesis may induce more transcriptomic changes than transgene insertion. Proceedings of the National Academy of Sciences of the United States of America, 105, 9, pp 3640-3645 http://www.botanischergarten.ch/Genomics/Batista-Microarray-Analysis-2008.pdf

geneticallystabletransgenic

geneticallystablemutant

geneticallyunstabletransgenic

geneticallyunstablemutant

Institute of Radiation Breeding Ibaraki-ken, JAPAN http://www.irb.affrc.go.jp/

100m radius

89 TBqCo-60 source at the center

Shielding dike 8m high

Gamma Field for radiation

breeding

BetterBetter

spaghettis, whiskyspaghettis, whisky

1800 new plants1800 new plants

Radiation breeding as field experiments

Real Frankenfood

Worldwide:

all pasta is made fromradiation mutateddurum wheatTriticum durum

Figure 4. Web site pages addessing the 'Frankenfood' and 'Frankenstein food' issues at Monsanto, the Times, and the Friends of the Earth Web sites.jcmc.indiana.edu/vol8/issue4/hellsten.html

History of websites mentioning Frankenfood

Frankenfood: Sic transit gloria mundi...

Leydesdorff, L. & Hellsten, I. (2006)Measuring the meaning of words in contexts: An automated analysis of controversies about 'Monarch butterflies,' 'Frankenfoods,' and 'stem cells'. Scientometrics, 67, 2, pp 231-258 http://www.botanischergarten.ch/Food/Leydesdorff-Measuring-Frankenfood-2006.pdf AND http://www.botanischergarten.ch/Food/Hellsten-Frankenfood-2003.pdf

PRRI letter to the executives of the Convention on Biological Diversity (CBD),

method of transformation itself is neutral,

GMOS are as safe as its conventional counterpart with respect to potential effects on the environment, taking also into account human health

PRRI letter : http://www.pubresreg.org/index.php?option=com_docman&task=doc_download&gid=490

“Compositional studies comparing transgenic crops with non-transgenic crops are almost universally required by governmental regulatory bodies to support the safety assessment of new transgenic crops. theoretical and empirical evidence suggesting that such studies are no more necessary for evaluating the safety of transgenic crops than they are for traditionally bred crops

Herman, R.A., Chassy, B.M., & Parrott, W. (2009)Compositional assessment of transgenic crops: an idea whose time has passed. Trends in Biotechnology, In Press, Corrected Proof, pp http://www.botanischergarten.ch/Regulation/Herman-Compositional-Analysis-2009.pdf

A conceptual framework is proposed by IFPRI/ISNAR in 2002,

Process-based triggers are the rule in almost all countries

While such a product-based approach to defining the object of regulation is truest to the scientific principle that biotechnology is not inherently more risky than other technologies

McLean, M.A., Frederick, R.J., Traynor, P.L., Cohen, J.I., & Komen, J. (2002) A Conceptual Framework for Implementing Biosafety: Linking Policy, Capacity, and Regulation, ISNAR, International Service for National Agricultural Research pp 1-12 ISNAR Briefing Papers Washington DC. (Report)ftp://ftp.cgiar.org/isnar/publicat/bp-47.pdf AND http://www.botanischergarten.ch/Regulation/McLean-Conceptual-Framework-ISNAR-47-2002.pdf

European Safety Attitude: let not the Europeans decide aboutBiosafety in Africa, do your own safety assessment

another kind of risk attitude

Linden, A. & Fenn, J. (2003) Understanding Gartner's Hype Cycles, Gartner Research pp 12 Strategic Analysis Report (Report)http://carbon.cudenver.edu/~jgerlach/emergingtechnologyOL/FirstReadings/HypeCycleIntro.pdf AND http://www.botanischergarten.ch/Discourse/Linden-HypeCycle-2003.pdf see also http://www.gartner.com/it/products/research/methodologies/research_hype.jsp and another example http://www.readwriteweb.com/archives/gartner_hype_cycle_2009.php AND http://www.botanischergarten.ch/Discourse/MacManus-Gartner-hype-cycle-2009.pdf

The often critizised DEFICIT MODEL:

Its not to discard altogether the traditional deficit model, rather to combine it with the contextual approach, thus emphasizing the complex and interacting nature of the knowledge-attitude interface.

Sturgis, P. & Allum, N. (2004)Science in society: re-evaluating the deficit model of public attitudes. Public Understanding of Science, 13, 1, pp 55-74 <Go to ISI>://WOS:000221338100004 AND http://www.botanischergarten.ch/Discourse/Sturgis-Science-SocietyDeficit-Model-2004.pdf

Sturgis, P., Cooper, H., & Fife-Schaw, C. (2005)Attitudes to biotechnology: estimating the opinions of a better-informed public. New Genetics and Society, 24, 1, pp 31-56 <Go to ISI>://WOS:000228159800003 AND http://www.botanischergarten.ch/Discourse/Sturgis-Attitudes-Biotechnology-2005.pdf

Sturgis, P., Roberts, C., & Allum, N. (2005)A different take on the deliberative poll - Information, deliberation, and attitude constraint. Public Opinion Quarterly, 69, 1, pp 30-65 <Go to ISI>://WOS:000227413300003 AND http://www.botanischergarten.ch/Discourse/Sturgis-Different-Take-Deliberative-2005.pdf

Osseweijer, P. (2006)A new model for science communication that takes ethical considerations into account - The Three-E Model: Entertainment, Emotion and Education. Science and Engineering Ethics, 12, 4, pp 591-593 http://www.botanischergarten.ch/Ask-Force/Osseweijer-EEE-2006.pdf

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Number of patents granted from 1980 – 2003 in plant genetic engineering

Lo, S.-c. (2009)Scientific linkage of science research and technology development: a case of genetic engineering research. Scientometrics, ONLINE, pp 1-12 http://dx.doi.org/10.1007/s11192-009-0036-8 AND http://www.botanischergarten.ch/Scientometrics/Lo-Scientific-Linkage-Sience-Research-2008.pdf

“The acreage cultivated with genetically modified crops in the exporting countries has considerably increased over the last few years and will continue to do so. We therefore believe that the existing regulatory situation, in combination with the foreseen limitation in the scope of the technical solution, is precipitating the European Community towards serious food and feed supply problems.”

Economy will finally push acceptance

Strange BedfellowsIn Europe and in some developing countries a “strange bedfellows” constellation of concentrated economic interests (including incumbent agrochemical manufacturers, certain farm groups, and environmental protest activists) act in rational self-interest to negatively characterize GM technology in the public arena and to seek regulations that block or slow its introduction

Graff, G., G. Hochman, et al. (2009) The Political Economy of Agricultural Biotechnology Policies. AgBioForum 12, 1-13 DOI: http://www.agbioforum.org/v12n1/v12n1a04-graff.htm AND http://www.botanischergarten.ch/Regulation/Graff-Political-Economy-Policies-2009.pdf

Delhi, India — Three 'cows' and three 'sheep', on behalf of 1600 dead cattle, sought an audience with the Minister of Agriculture Mr. Sharad Pawar this morning to present a memorandum (1) drawing his attention to the mysterious deaths of cattle in Warangal, Andhra Pradesh. Activists dressed as cows and sheep held up a banner asking, "Did GM Crops Kill Us? Don't Legalise GM food!"

Often missguidedForeign Aid:

Too muchEco-Imperialism

• Making sure the samples tested are comparable samples. • Testing composition to make sure the tests and controls

are comparable. • The need for an acceptable balanced and nutritious diet.• Why the dose is important.• What statistics do and don’t tell us.• Following internationally agreed guidelines (OECD etc.)• The importance of peer review and scientific publication,• Guidelines for dealing with conflicting information.• Ethical considerations.

General rules for scientific work in biosafety assessment

Chassy, B. & Parrott, W. (2009)Is This Study Believable? Examples from Animal Studies with GM Foods. . In In Agricultural Biotechnology, , pp. 9, University of California, Davis, Davis, California http://www.agribiotech.info/details AND http://www.botanischergarten.ch/Peer-Review/Chassy-Parrott-Believable-2009.doc

The launch of the Global Business Ethos Declaration was held on 6 October 2009 at the United Nations headquarters in New York, hosted by the UN Global Compact,the Swiss Mission to the United Nations, the Global Ethic Foundation, and the Novartis Foundation for Sustainable Development.http://www.novartisstiftung.org/platform/content/element/3177/Newsletter_3-09_2.pdf

Statement From Michael Hansen, CEO Of Elsevier's Health Sciences Division, regarding Australia Based Sponsored Journal Practices Between 2000 And 2005

Philadelphia, PA, 7 May 2009

It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures.

This was an unacceptable practice, and we regret that it took place.

http://www.genepeace.ch/

Demonstration ofSwiss Researchers

Amish farmers in biotech-debate: subsequent partial adoptionof transgenic crops: 1999, see: http://www.ifpri.org/2020conference/PDF/summary_ammann.pdf

Bauer de Jonghe in Holland, produziert Gemüse im Bio-Standard ohne PestizideFoto Claus Lange, Text Michael Miersch Weltwoche 06 2003

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 AND DOI: http://dx.doi.org/10.1016/j.nbt.2008.08.012

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.sciencedirect.com/science/article/B8JG4-4WKTX50-1/2/1698b7149ed724fd0a49b3ae49f234ab AND http://www.botanischergarten.ch/Organic/Ammann-High-Tech-and-Organic-2009.pdf

Ammann, K. & van Montagu, M. (2009)Organotransgenesis arrives. New Biotechnology, 25, 6, pp 377-377 http://www.sciencedirect.com/science/article/B8JG4-4W7YY1F-1/2/28740dfca05cf12bb3b973b4f4568ccb AND http://www.botanischergarten.ch/NewBiotech/Ammann-Montagu-Editorial-Oranotransgenesis-arrives-2009.pdf

unfortunately, planning problems in the field of green biotechnology have now evolved into wicked problems with complex structures and no obvious causal chains

Ammann, K. & Papazova Ammann, B. (2004)Factors Influencing Public Policy Development in Agricultural Biotechnology. In RISK ASSESSMENT OF TRANSGENIC CROPS. (ed S. Shantaram), Vol. 9, pp. 1552. Wiley and Sons, Hoboken, NJ, USA.P. Christou & H. Klee Handbook of Plant Biotechnologyhttp://www.botanischergarten.ch/Wiley/Factors-Discourse-Wiley.pdf

Rittel, H.W.J. & Webber, M.R. (2005)Dilemmas in a general theory of planning. Policy Sciences, 4, 2, pp 155-169 http://dx.doi.org/10.1007/BF01405730 AND http://www.botanischergarten.ch/Discourse/Rittel-Dilemmas-2005.pdf

Some thoughts about regulation, the GM debate and discourse methods

Solving wicked problems needs new, second generation system approaches in communication and decision making

to respect different kinds of knowledge is better than the stakeholder concept

factual knowledgedeontic knowledgeexplanatory knowledge instrumental knowledgeprocedural knowledgeconceptual knowledgetraditional knowledge

only those should participate

who are part of the problem

Kahane, A. (2004) Solving Tough Problems: An Open Way of Talking, Listening, and Creating New Realities Berrett-Koehler Publishers, San Francisco, IS: 1-57675-293-3, 150 p. www.bkconnection.com

My derrière hurts !!!

What ??

Dialogue between the Biotech Pro‘s and Con‘s

Dialogue

some comments for the debate following the contributionsof the biosafety class of Prof. Margit Laimer

from June 18, 2010

Indica Rice IR64, wildtype,

no provitamin A

Indica Rice IR64, transgenic,

„regulatory clean“,provitamin A at 0.8 g/g

GoldenRice with much higher provitamin A is scientifically possible

The Golden Rice Debate

If these GoldenRice seeds were derived from traditional technology, they could have been passed to breeders in 1999 and they would be in the hands of the farmers since early 2003 .

As these seeds are, however, GMO‘s they have to pass numerous hurdles before they can be used by breeders, and many more before they can be passed on to the farmers –

if they reach them at all.

To the European society this does not matter: the blind children do not live amongst us and „life of a butterfly in Europe is more important than life of a child“ in Southeast Asia.

http://biotecnologiebastabugie.blogspot.com/2008_03_01_archive.html

Propaganda lie, for many years on the Greenpeace website: 9kg daily consumption necessary, actually 260g are enough

Mukherjee, A., Speh, D., Dyck, E., & Diez-Gonzalez, F. (2004)Preharvest evaluation of coliforms, Escherichia coli, Salmonella, and Escherichia coli O157 : H7 in organic and conventional produce grown by Minnesota farmers. Journal of Food Protection, 67, 5, pp 894-900 http://www.botanischergarten.ch/Organic/Mukherjee-Preharvest-Coliforms-2004.pdf

A clear case of human mortality caused by organic farming

Islam, M., Doyle, M.P., Phatak, S.C., Millner, P., & Jiang, X.P. (2005)Survival of Escherichia coli O157 : H7 in soil and on carrots and onions grown in fields treated with contaminated manure composts or irrigation water. Food Microbiology, 22, 1, pp 63-70 http://www.botanischergarten.ch/Organic/Islam-Survival-ColiO157H7-2005.pdf

Islam, M., Doyle, M.P., Phatak, S.C., Millner, P., & Jiang, X.P. (2005)Survival of Escherichia coli O157 : H7 in soil and on carrots and onions grown in fields treated with contaminated manure composts or irrigation water. Food Microbiology, 22, 1, pp 63-70 http://www.botanischergarten.ch/Organic/Islam-Survival-ColiO157H7-2005.pdf

• Representation of diverse and relevant voices in the biosafety policy process;• Kenya must develop home-grown biotechnology and biosafety capacity in order to instil “ownership” of thinking into the minds of scientists and policy makers,thereby enhancing public trust;• The Kenyan regulatory policy development process should take advantage of integrating the political and social “blind spots” assumed or taken for granted inthe “ad-hoc” policy implementation process. A hypothetical consensus-building system oriented approach is recommended if benefits from life sciences are to

become sustainable.

Kingiri, A. & Ayele, S. (2009)Towards a smart biosafety regulation: The case of Kenya. Environ. Biosafety Res., 8, 3, pp 133-139 http://www.botanischergarten.ch/Regulation/Kingiri-Towards-Smart-Biosafety-Regulation-2009.pdf

more on the Kenyan situation of regulation of GM crops

Sengooba, T., Grumet, R., Hancock, J., Zawedde, B., Kitandu, L., Weebadde, C., Karembu, M., Kenya, E., Meredia, K., Nampala, P., Ochanda, J.O., Quemada, H., & Rubindamayugi, M. (2009)Biosafety education relevant to genetically engineered crops for academic and non-academic stakeholders in East Africa. Electronic Journal of Biotechnology, 12, 1, pp 1-13 http://www.botanischergarten.ch/Discourse/Sengooba-Biosafety-Education-East-Africa-2009.pdf

Aumaitre, A. (2004)Safety assessment and feeding value for pigs, poultry and ruminant animals of pest protected (Bt) plants and herbicide tolerant (glyphosate, glufosinate) plants: interpretation of experimental results observed worldwide on GM plants. Italian Journal of Animal Science, 3, 2, pp 107-121 http://www.botanischergarten.ch/Bt/Aumaitre-Safety-Assessment-2004.pdf

Bt maize contains less cancer causing mycotoxins, therefore the Bt maize is healthier than conventional maize