Since first embarking on the road of risk management options for the regulation of recombinant DNA (rDNA) activities and use in 1978, the European Union (EU) has largely failed to create a regulatory and policy environment regarding genetically modified (GM) crops and their cultivation that is (a) efficient, (b) predicable, (c) accountable, (d) durable or (e) interjurisdictionally aligned.
* The opinions expressed herein are strictly those of the authors. The authors have written this article in their personal capacity. The views expressed do not represent the views of their colleagues, their current or past employers, the National University of Ireland Galway, the Government of Canada or any other organization or body. The authors have no personal financial interests in any commercial organization that might financially benefit from the publication of this article.
1 Commission Proposal for a Regulation of the European Parliament and the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory COM (2010) 375.
2 Galloux, Jean-Christophe, Prat, Helene Gaumont and Stevers, Ester, “Europe”, in Durant, John, Bauer, Martin W. and Gaskell, George (eds), Biotechnology in the Public Sphere: A European Sourcebook (London: Science Museum 1998), pp. 177 et sqq., at p. 180.
3 Berg, Paul, Baltimore, David, Boyer, Herbert W. et al., “Potential Biohazards of recombinant DNA Molecules”, 185(4148) Science (1974), p. 303 .
4 European Commission Proposal for a Council Directive establishing Safety Measures against the Conjectural Risks associated with recombinant DNA Work – C301/5-7 (1978).
5 Cantley, Mark, “The Regulation of Modern Biotechnology: A Historical and European Perspective. A Case Study in How Societies Cope with New Knowledge in the Last Quarter of the Twentieth Century”, in Brauer, Dieter (ed.), 12 Biotechnology: Legal Economic and Ethical Dimensions (Weinheim: Wiley-VCH Verlag 1995), pp. 501 et sqq., at p. 513.
6 Fredrickson, Donald, The recombinant DNA Controversy: A Memoir: Science, Politics, and the Public Interest 1974–1981 (Washington: ASM Press American Society for Microbiology 2001), at p. 246.
7 Health and Safety (Genetic Manipulation) Regulations (1978). SI 1978, No. 752.
8 Council Recommendation Concerning the Registration of Work involving recombinant Deoxyribonucleic Acid (DNA), COM 82/472/ EEC of 30 June 1982 Official Journal, L 213, p. 15.
9 Cantley, “The Regulation of Modern Biotechnology”, supra note 5, at p. 2.
10 EU Commission Communication to the Council entitled Biotechnology in the Community, COM (83) 672 – 3 October 1983.
11 OECD, Recombinant DNA Safety Considerations (Paris 1986).
12 Sehnal, František and Drobník, Jaroslav, “White Book genetically modified Crops – EU Regulations and Research Experience from the Czech Republic (Prague: Academy of Sciences of the Czech Republic 2009), at p. 12.
13 The European Community and the Regulation of Biotechnology: An Inventory. European Commission 1986, BRIC/1/86.
14 EU Commission Communication to the Council entitled A Community Framework for the Regulation of Biotechnology, COM (86) 573.
15 EU Commission Proposal for a Council Directive on the contained Use of genetically modified Microorganisms and Proposal for a Council Directive on the deliberate Release to the Environment of genetically modified Organisms, COM (88)160.
16 Minutes from the 40th meeting of the Council of the EMBO, 1st October 1988: “… any legislation should focus not on the technique but on the safety or otherwise of the products generated with it. … Over the last 15 years, experience has shown that recombinant DNA methods, far from being inherently dangerous, are an important tool both for understanding properties of life and for developing applications valuable to humankind and the environment. EMBO strongly believes that there is no scientific justification for additional specific legislation regulating recombinant research per se. Any rules or legislation should only apply to the safety of products according to their properties, rather than according to the methods used to generate them”.
17 Sehnal and Drobník, “White Book genetically modified Crops” supra note 12, at p. 4.
18 Cantley, “The Regulation of modern Biotechnology”, supra note 5, at p. 2.
20 Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms OJ 1990 L 117/15 and Council Directive 90/219/EEC on the contained use of genetically modified organisms.
21 Grace Skogstad, “Supranational Regulation and Contested Accountability: The Case of GMO Risk Regulation in the European Union”, EUI Working Paper SPS No. 2008/07(2008).
22 Lee, Maria, “Multi-level Governance of Genetically Modified Organisms in the European Union: Ambiguity and Hierarchy”, in Bodiguel, Luc and Cardwell, Michael (eds), The Regulation of Genetically Modified Organisms: Comparative Approaches (Oxford: Oxford University Press 2010), pp. 101 et sqq., at p. 104.
23 Morris, Shane and Adley, Catherine, “Evolving European GM Regulation: An Example of Biopolitics at Work”, 18(8) Trends in Biotechnology (2000), pp. 325 et sqq., at p. 326.
24 Ewen, Stanley and Pusztai, Arpad, “Effect of Diets containing genetically modified Potatoes expressing Galanthus Nivalis Lectin on Rat small Intestine”, 354(9187) The Lancet (1999), pp. 1353 et sqq.
25 Losey, John, Rayor, Linda, Carter, Maureen, “Transgenic Pollen harms Monarch Larvae”, 399 Nature (1999), 20 May, p. 214.
26 Morris and Adley, “Biopolitics”, supra note 23.
28 Ramessar, Koreen, Peremarti, Ariadna, Gomez-Galera, Sonia et al., “ Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: A case of the science not supporting the politics”, 16 Transgenic Research (2007), pp. 261 et sqq., at p. 261.
30 Council Directive 01/18/EEC on the deliberate release into the environment of genetically modified organisms repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
31 Shaffer, Gregory and Pollack, Mark, “The EU regulatory System for GMOs”, in Vos, Ellen and Everson, Michelle (eds), “Uncertain Risks Regulated: Facing the Unknown in National, EU and International Law” (New York: Routledge-Cavendish 2009), pp. 269 et sqq., at p. 279.
32 Carrau, Javier, “Lack of Sherpas for a GMO Escape Route in the EU”, 10(8) German Law Journal (2009), pp. 1169 et sqq., at p. 1180.
33 Marcel Kuntz, “Academic and governmental Research on GMOs has been the Target of numerous Acts of Vandalism in Europe”, 1 July 2010, available on the Internet at <http://ddata.over-blog.com/xxxyyy/1/39/38/37/public-research-vandalized.pdf> (last accessed on 2 October 2010).
34 Sybille de La Hamaide, “Limagrain Moves GM Tests To The US Due French Ban”, Reuters, Feburary 29, 2008, available on the Internet at <http://www.planetark.org/dailynewsstory.cfm?newsid=47254> (last accessed on 2 October 2010).
35 Meldolesi, Anna, “Pea Trials flee to US”, 28 Nature Biotechnology (2010), p. 8.
36 German Federal Office of Consumer Protection and Food Safety, “Stellungnahme der ZKBS zur Risikobewertung von MON810” (2009), Az. 6788-02-13, 7 July, available on the Internet at <http://tinyurl.com/23e5377> (last accessed on 2 October 2010).
37 Ricroch, Agnès, Bergé, Jean and Kuntz, Marcel, “Is the German Suspension of MON810 Maize Cultivation Scientifically Justified?”, 19(1) Transgenic Research (2010), pp. 1 et sqq., at p. 11.
38 Ricroch, Agnès, Bergé, Jean and Kuntz, Marcel, “Is the Suspension of MON810 Maize Cultivation by Some European Countries Scientifically Justified?”, Information Systems in Biotechnology (2010), pp. 8 et sqq., at p. 9.
39 Nicolas Sarkozy, “Press Conference Statement by the President of the Republic Nicolas Sarkozy”, 8 January 2008, available on the Internet at <http://www.sarkozynicolas.com/nicolas-sarkozy-conference-de-presse-8-janvier-2008-texte-integral/> (last accessed on 2 October 2010).
40 Cyrille Souche, “Maïs OGM ‘MON 810’: Le sérieux doute des experts”, 10 January 2008, available on the Internet at <http://www.cdurable.info/Mais-OGM-MON-810-vers-l-interdiction,758.html> (last accessed on 2 October 2010).
41 TF1 News, “OGM : 12 scientifiques de la Haute autorité se sentent trahis”, 11 January 2008, available on the Internet at <http://lci.tf1.fr/science/environnement/2008-01/ogm-scientifiques-hauteautorite-sentent-trahis-4896599.html> (last accessed on 2 October 2010).
42 Ricroch, Bergé and Kuntz, “Suspension of MON810”, supra note 37.
43 European Food Safety Authority, “Scientific Opinion on Applications (EFSA-GMO-RX-MON810) for renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto”, EFSA Journal (2009) 1149, pp. 1–85.
44 Yves Thréard, “Les OGM, une affaire très politique”, Le Figaro, 12 February 2009, at p. 14, also available on the Internet at <http://www.lefigaro.fr/debats/2009/02/12/01005-20090212ARTFIG00001-les-ogm-une-affaire-tres-politique-.php> (last accessed on 2 October 2010).
45 Gil Riviere-Wekstein, “La Communauté scientifique mise hors jeu”, Revue Agriculture et Environnement, 11 January 2008, available on the Internet at <http://www.agriculture-environnement.fr/spip.php?article283&decoupe_recherche=doutes%2520s%25E9rieux> (last accessed on 2 October 2010).
46 Charles Jaigu, “Fillon: la majorité sera jugée «au bout de cinq ans»”, Le Figaro, 14 January 2008: “Concernant les OGM, Fillon a défendu sa décision de déclencher la procédure de suspension du maïs génétiquement modifié MON810 en estimant qu’il s’agissait d’un «compromis scellé dans le ‘Grenelle de l’environnement’»”.
47 Council of the European Union, “Council Conclusions on Genetically Modified Organisms (GMOs)”, 2912th Environment Council meeting, Brussels, 4 December 2008.
48 As exemplified by Marion Guillou, President of France's National Institute for Agronomical Research (INRA) who stated INRA's work on new varieties now involves only conventional crops, for which research is less efficient, longer and more expensive. Sybille de La Hamaide, “French Researcher halts Development of GMO Crops”, Reuters, October 31, 2010, available on the Internet at <http://www.forexyard.com/en/news/French-researcher-halts-development-of-GMO-crops-2010-10-29T080856Z-INTERVIEW>.
49 EU Commission Communication on the Precautionary Principle. COM (2000) 1, at p. 5
50 “[M]easures taken under the precautionary principle should be designed to achieve an equivalent level of protection without invoking the geographical origin or the nature of the production process to apply different treatments in an arbitrary manner”, ibid
51 Morris, Shane, “EU biotech crop regulations and environmental risk: a case of the emperor's new clothes?”, 25(1) Trends in Biotechnology (2007), pp. 2 et sqq., at p. 4.
52 ACRE, “Managing the Footprint of Agriculture:Towards a Comparative Assessment of Risks and Benefits for Novel Agricultural Systems”, Report of the ACRE Sub-group on Wider Issues Raised by the Farm-Scale Evaluations of Herbicide Tolerant GM Crops (2007).
53 Firbank, Les, Lonsdale, Mark and Poppy, Guy, “Reassessing the environmental Risks of GM Crops”, 23 Nature Biotechnology (2005), pp. 1475 et sqq., at p. 1476.
54 Kok, Esther, Keijer, Jaap, Kleter, Gijs, Kuipera, Harry, “Comparative Safety Assessment of Plant-derived Foods”, 50 Regulatory Toxicology and Pharmacology (2008), pp. 98 et sqq., at p. 109:“[i]t may be that the current distinction between GMO-derived and so-called conventionally bred new plant varieties does not in all cases provide the best framework for an adequate safety assessment of new plant varieties as the basis for a safe food supply also in the years to come. It seems advisable to screen all new plant varieties for their new characteristics by applying the comparative safety assessment, which may have different end-points”.
55 Lehesranta, Satu, Davies, Howard, Shepherd, Louise et al., “Comparison of Tuber Proteomes of Potato Varieties, Landraces, and Genetically Modified Lines”, 138(3) Plant Physiology (2005), pp. 1690 et sqq.
56 Baudo, María, Lyons, Rebecca, Powers, Stephen et al., “Transgenesis has less Impact on the Transcriptome of Wheat Grain than conventional Breeding”, 4 Plant Biotechnology Journal (2006), pp. 369 et sqq.
57 Shewry, Peter, Baudoa, Marcela, Lovegrove, Alison et al., “Are GM and conventionally bred Cereals really different?”, 18(4) Trends in Food Science & Technology (2007), pp. 201 et sqq., at p. 207.
58 Batista, Rita, Saibo, Nelson, Lourenço, Tiago, and Oliveira, Maria, “Microarray Analyses reveal that Plant Mutagenesis may induce more transcriptomic Changes than transgene Insertion”, 105(9) Proceedings of the National Academy of Sciences (2008), pp. 3640 et sqq., at p. 3644.
59 Kogel, Karl-Heinz, Voll, Lars M., Schäfer, Patrick et al., “Transcriptome and metabolome Profiling of Field-grown transgenic Barley lack induced Differences but show cultivar-specific Variances”, 107(14) Proceedings of the National Academy of Sciences (2010), pp. 6198 et sqq., at p. 6197.
60 Barros, Eugenia, Lezar, Sabine, Anttonen, Mikko et al., “Comparison of two GM Maize Varieties with a near isogenic non GM Variety using Transcriptomics, Proteomics and Metabolomics”, 8(4) Plant Biotechnology Journal (2010), pp. 436 et sqq., at p. 449.
61 Coll, Anna, Nadal, Anna, Collado, Rosa, Capellades, Gemma et al., “Natural Variation explains most transcriptomic Changes among Maize Plants of MON810 and comparable non-GM Varieties subjected to two N-Fertilization farming Practices”, 73(3) Plant Molecular Biology (2010), pp. 349 et sqq., at p. 361.
62 Morris, Shane and Spillane, Charles, “GM Directive Deficiencies in the European Union”, 9(6) EMBO Reports (2008), pp. 500 et sqq., at p. 503.
63 Devos, Yann, Lheureux, Karine and Schiemann, Joachim, “Regulatory Oversight and Safety Assessment of Plants with Novel Traits”, in Kempken, Frank and Jung, Christian (eds), Genetic Modi?cation of Plants, Biotechnology in Agriculture and Forestry 64 (Berlin: Springer-Verlag 2010).
64 COGEM, “New Techniques in Plant Biotechnology”, COGEM report CGM/061024-02 (2006), pp. 40 et sqq., at p. 4: “[w]ith the advance of technology, the distinction between genetic modification and other plant biotechnological techniques gradually blurs. In addition, such technological developments also outgrow the GMO legislation. At times it is not clear whether the products of some techniques are subject to the prevailing GMO legislation”.
65 Balasubramaniam, Arun, Brahmad, Singh, Shasi, Sharma et al., “Development of somaclonal Variants of Wheat (Triticum aestivum L.) for Yield Traits and Disease Resistance suitable for Heat stressed and zero-till Conditions”, 103(1) Field Crops Research (2007), pp. 62 et sqq., at p. 68.
66 Guo, Wen-Wu, Prasad, Devi, Cheng, Yun-Jiang et al., “Targeted Cybridization in Citrus: Transfer of Satsuma Cytoplasm to seedy Cultivars for potential Seedlessness”, 22(10) Plant Cell Reports (2004), pp. 752 et sqq., at p. 757.
67 Jinsheng, Lai, Yubin, Li, Messing, Joachim and Dooner, Hugo K., “Gene Movement by Helitron Transposons contributes to the haplotype Variability of Maize”, 102(25) Proceedings of the National Academy of Sciences (2005), pp. 9068 et sqq., at p. 9072.
68 Morgante, Michele, Brunner, Stephan, Pea, Giorgio et al., “Gene Duplication and Exon Shuffling by helitron-like Transposons generate intraspecies Diversity in Maize”, 37(9) Nature Genetics (2005), pp. 997 et sqq., at p. 1002.
69 McCallum, Claire, Comai, Luca, Greene, Elizabeth and Henikoff, Steven, “Targeted Screening for induced Mutations”, 18 Nature Biotechnology (2000), pp. 455 et sqq., at p. 457.
70 Lloyd, Alan, Plaisier, Christopher, Carroll, Dana and Drews, Gary, “Targeted Mutagenesis using Zinc-finger Nucleases in Arabidopsis ”, 102 Proceedings of the National Academy of Sciences (2005), pp. 2232 et sqq., at p. 2236.
71 Tzfiraand, Tzvi, White, Charles, “Towards targeted Utagenesis and Gene Replacement in Plants”, 23(12) Trends in Biotechnology (2005), pp. 567 et sqq., at p. 568.
72 Cubas, Pilar, Vincent, Coral and Coen, Enrico, “An epigenetic Mutation responsible for natural Variation in floral Symmetry”, 401(6749) Nature (1999), pp. 157 et sqq., at p. 160.
73 Gal-On, Amit, Wolf, Dalia, Antignus, Yehezkel et al., “Transgenic Cucumbers harboring the 54-kDa putative Gene of Cucumber Fruit Mottle Mosaic Tobamovirus are highly resistant to viral Infection and protect non-transgenic Scions from Soil Infection”, 14(1) Transgenic Research (2005), pp. 81 et sqq., at p. 90.
74 Dutt, Manjul, Jinyun, Li, Kelley, Karen et al., “Transgenic Rootstock Protein Transmission in Grapevines”, International Symposium on Biotechnology of Temperate Fruit Crops and Tropical Species, pp. 749 et sqq., at p. 754.
75 Anders Smolka, Li Xue-Yuan, Catrin Heikelt et al., “Effects of transgenic Rootstocks on Growth and Development of non-transgenic Scion Cultivars in Apple”, Transgenic Research (2010), In Press DOI: 10.1007/s11248-010-9370-0.
76 Schouten, Henk, Krens, Frans and Jacobsen, Evert, “Do cisgenic Plants warrant less stringent Oversight”, 24 Nature Biotechnology (2006), at p. 753.
77 Russell, A. Wendy and Sparrow, Robert, “The Case for regulating intragenic GMOs”, 21(2) Journal of Agricultural and Environmental Ethics (2008), pp. 153–181.
78 European Parliament: Parliamentary Question P-6606/07 2008. Jan Mulder (ALDE) to the Commission (9 January 2008) Subject: Cisgenesis. Answer from the Commission (3 March 2008).
79 EFSA, “Environmental Risk Assessment of genetically modi?ed Plants – Challenges and Approaches”, EFSA scientific Colloquium Series – 8 June 2007 (2008), available on the Internet at <http://www.efsa.europa.eu/en/colloquiagmoera/publication/colloquiagmoera.pdf>: “A paradigm shift would be required to change from risk assessment as it is currently practiced, to a more sophisticated assessment which balances risks and bene?ts: (i) The focus on only GM crops de?es scienti?c evidence. In the longer term, risk assessors could develop an alternative approach on a scienti?c basis. ‘Novelty’ is one option. (ii) The status quo, in which risk assessment is interpreted very narrowly in terms of adverse impacts, is not sustainable, and perceptions of the quality of environmental risk assessments suffer as a result. A framework for the future is required. (iii) There is a need to build decision support tools for the risk assessors to better consider impacts of whole farming systems” (last accessed on 2 October 2010).
80 Jasanoff, Shelia, “States of Knowledge: The Co-Production of Science and social Order” (New York: Routledge 2004), pp. 320 et sqq., at p. 157.
81 Marchant, Gary, Sylvester, Douglas, Abbott, Kenneth, “What Does the History of Technology Regulation Teach Us about Nano Oversight?”, 37(4) The Journal of Law, Medicine & Ethics (2009), pp. 724 et sqq., at p. 729.
** Shane specialises in policy and communications aspects of agricultural biotechnologies and genetically modified crops. Contact <email@example.com>. Prof. Spillane's research group conduct both scientific and policy research on agricultural and other biotechnologies. Contact <Charles.Spillane@nuigalway.ie>.
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