ISAAA Press Conference Pretoria March 8, 2012Prof. em. Klaus Ammann, University of BernGlobal Status of GM Crop DevelopmentThe Situation in Europe

System map of the principal issues, challenges and feedback loops in the risk management component of the legislation

EPEC-SANCO (2011)Evaluation of the EU legislative framework in the field of cultivation of GMOs under Directive 2001/18/EC and Regulation (EC) No 1829/2003, and the placing on the market of GMOs as or in products under Directive 2001/18/EC Final Report, pp. 137. European Commission DG Sanco

http://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_report_en.pdf

EPEC-SANCO (2011)Evaluation of the EU legislative framework in the field of cultivation of GMOs under Directive 2001/18/EC and Regulation (EC) No 1829/2003, and the placing on the market of GMOs as or in products under Directive 2001/18/EC Final Report, pp. 137. European Commission DG Sancohttp://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_report_en.pdf

http://www.ghkint.com/

The comments from the EPEC-SANCO show the nearly un-surmountable difficulties of European Regulation, due to a disorganized mix of politics and wrong risk conception of GM crops, all this contrary to the food and environmental safety experience worldwide.EPEC-SANCO (2011)Evaluation of the EU legislative framework in the field of cultivation of GMOs under Directive 2001/18/EC and Regulation (EC) No 1829/2003, and the placing on the market of GMOs as or in products under Directive 2001/18/EC Final Report, pp. 137. European Commission DG Sancohttp://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_report_en.pdf

Nonetheless, consultees’ frustration with the risk assessment phase is modest compared to that caused by the risk management stage. The research conducted for this study suggests that it is the lack of decisions, whether positive or negative, that is of particular concern.

The lack of qualified majority is mainly attributed to the polarized views within and among Member States and a significant number of abstentions;

EPEC-SANCO (2011)Evaluation of the EU legislative framework in the field of cultivation of GMOs under Directive 2001/18/EC and Regulation (EC) No 1829/2003, and the placing on the market of GMOs as or in products under Directive 2001/18/EC Final Report, pp. 137. European Commission DG Sancohttp://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_report_en.pdf

This situation gives rise to comments, heard repeated in consultations, that the legislativeframework is not being implemented as intended. Empirically, the risk management aspects of the framework as implemented are not efficient, transparent or, in aggregate, fit for purpose. Consultees agreed that the current situation with GMO authorizations in Europe is not sustainable.

EPEC-SANCO (2011)Evaluation of the EU legislative framework in the field of cultivation of GMOs under Directive 2001/18/EC and Regulation (EC) No 1829/2003, and the placing on the market of GMOs as or in products under Directive 2001/18/EC Final Report, pp. 137. European Commission DG Sancohttp://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_report_en.pdf

Innovation in agbiotech. (a) Location and sector of organizations conducting R&D for the 558 transgenic product quality innovations identified. Private sector consists of corporate and privately held firms. Public sector consists of government research laboratories, universities and nonprofit research institutes. (b) Annual entry, exit and the numbers of innovations active in the R&D pipeline were calculated from observations of the 558 innovations tracked in the primary survey. The number of active innovations stopped growing in 1998, after which those new innovations that entered were more likely to be published and less likely to move toward commercialization. Fig.1 from (Graff et al., 2009b).

Graff, G.D., Zilberman, D., & Bennett, A.B. (2009)The contraction of agbiotech product quality innovation. Nature Biotechnology, 27, 8, pp 702-704 http://www.botanischergarten.ch/Regulation/Graff-Contraction-Agbiotech-Innovation-2009.pdf

But the world has seldom seen a greater discrepancy between the inherent hazard of a product and the level of regulatory burdenimposed on it than exists today for crops improved through biotech. It is important, here, to be very clear: there is no basis in science for regulation specific to crops and foods improvedthrough biotech or ‘GMOs’

Giddings, V., Potrykus, I., Ammann K., & Fedoroff, N. (2012)Confronting the Gordian knot, Opinion. Nature Biotechnology, 30, 3, pp 208-209 http://www.ask-force.org/web/Regulation/Giddings-Confronting-Gordian-Knot-2012.pdf

By any honest reckoning, the level of scrutiny to which crops improved through biotech are subjected is completely unwarranted by the body of knowledge acquired over three decades of experience with such crops, including 15 years in commercial production.

This is true around the world, but nowhere is the chasm between regulatory regime and the implications of facts and experience greater than in Europe. Although Europe is sufficiently wealthy to buy its food, the indirect effects of European regulations and attitudes have had a unconscionably inhibitory effect on the introduction of biotech crops in less developed countries in most need of them, particularly on the African continent.

Giddings, V., Potrykus, I., Ammann K., & Fedoroff, N. (2012)Confronting the Gordian knot, Opinion. Nature Biotechnology, 30, 3, pp 208-209 http://www.ask-force.org/web/Regulation/Giddings-Confronting-Gordian-Knot-2012.pdf

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

Status of overall approvals

47 GM products are authorised in total71 GM products in the authorisation system:• 55 in EFSA• 16 awaiting Commission/Member State action

Background: Since the current authorisation framework is in place (2004)

At any given year more GM applications have been submitted (green box) thanauthorisation decisions were made.

This results in an ever increasing backlog, both in EFSA as in the Commission. Ever more GM products are being cultivated at a rapidly increasing rate in many countries, and the EU has a high import dependency for many relevant crops.

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

Paarlberg, R. (2009)

Starved for Science,

How Biotechnology is kept out of Africa

Harvard University Press; 1 edition (August 5, 2009) Cambridge, USA,

IS: ISBN-10: 0674033477 ISBN-13: 978-0674033474 pp 256

http://www.amazon.com/Starved-Science-Biotechnology-Being-Africa/dp/0674033477/ref=sr_1_1?s=books&ie=UTF8&qid=1331185222&sr=1-1#_