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Biotechnology
Published online by Cambridge University Press: 20 January 2017
Abstract
This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.
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References
1 For a more detailed definition see OECD “OECD's Glossary of Terms of Biosecurity Codes”, available on the Internet at http://www.biosecuritycodes.org/gloss.htm (last accessed on 15 January 2009): “GMOs are organisms wherein the genetic material (ADN) has been artificially altered, usually by replacing some of the host organism's genes with those of another related or unrelated species”.
2 Genetic improvements are traditional laboratory activities (selection, controlled crosspollination or hybridization) either geared to avoid weakness, or to improve the quality and profitability of agricultural products. Even though these necessary activities produce modifications in the genetic material, unlike biotech manipulation, they do not act directly on the DNA but by a trial-and-error methodology. Consequently, they take long time to achieve expected results and they never cross species barriers.
3 European Parliament and Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, OJ L 106, pp. 1–39.
4 European Parliament and Council Regulation (EC) No 1829/2003 on genetically modified food and feed (Text with EEA relevance), OJ L 268, pp. 1–23.
5 European Parliament and Council Regulation (EC) No. 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, OJ L 268, pp. 24–28.
6 In 1999 five countries (Denmark, Greece, France, Italy and Luxembourg) constituted a blocking minority in the European Council by declaring that they would not vote for any new authorisation of GMO until it “put in place a tighter, more transparent framework, in particular for risk assessment, having regard to the specifics of European ecosystems, monitoring and labelling …”. The European Commission, aware of the sensitivity of the issue, never took a Decision to unfreeze the proceedings until the Directive 2001/18/EC and Regulations EC 1829/2003 and 1830/2003 were passed. See Europa Press Release “2194th Council Meeting – Environment, Luxembourg, 24/25 June 1999”, PRES/99/203, at p. 22.
7 Austria (14 February 1997 for Bt176 maize; 8 May 2000 for T25 and MON810 maize – submitting additional information on February 2004 and November 2007 –; 27 July 2007 for oilseed rape GT73; 15 July 2008 for oilseed rape MS8, RF3 and MS8xRF3; 16 July 2008 for MON863 maize); France (20 November 1998 for GM canola – renewed on 26 July 2001, 6 October 2003 and 27 August 2004 –, and 9 February 2008 for MON810 maize); Germany (28 February, 2 March and 4 April 2000 for GM maize); Greece (3 November 1998 for GM canola; 29 March 2006 – extended on 13 September 2007 – for MON810 maize); Hungary (20 January 2005 for MON810 maize –submitting additional information on April 2008 –); and Luxemburg (17 March 1997 for Bt176 maize).
8 Questions EFSA-Q-2005-294, EFSA-Q-2004-062, EFSAQ- 2004-062, EFSA-Q-2005-055, EFSA-Q-2006-048, EFSAQ- 2006-048, Question EFSA-Q-2008-077, EFSA-Q-2008-313, EFSA-Q-2008-316, EFSA-Q-2008-314, EFSA-Q-2008-315, EFSA-Q-2008-742, EFSA-Q-2008-743; all of them available on the Internet at http://www.efsa.europa.eu/en/scdocs.htm.
9 European Commission Proposals COM(1998)340, COM(2005)161, COM(2005)162, COM(2005)164, COM(2005)165, COM(2005)166, COM(2005)167, COM(2005)169, COM(2006)509, COM(2006)510, COM(2006)713, COM(2007)586, COM(2007)589, COM(2009)12, COM(2009)51, COM(2009)56; all of them available on the Internet at http://eur-lex.europa.eu/.
10 The complete list of authorized GMOs can be consulted on the Internet at http://ec.europa.eu/food/dyna/gm_register/index_en.cfm.
11 In 2003 the United States, Canada, and Argentina requested the establishment of a WTO panel concerning certain measures taken by the EC and its Member States affecting imports of GM products. The controversy was two-sided: on one hand, the so called de facto moratorium on the approval of GM products; on the other hand, the Member State-level measures – safeguards measures – affecting the circulation of authorised GMO. On 29 September 2006 the Panel found in both that the EC and its Member States acted inconsistently with their obligations under WTO law, but, taking into account that the moratorium had ended in August 2003, it did not include recommendations on that aspect. WTO Panel Report “European Communities – Measures Affecting the Approval and Marketing of Biotech Products” (WT/DS291, 292, and 293), circulated on 29 September 2006.
12 European Commission Recommendation 2003/556/EC on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming, OJ 2003 L 189/36, p. 40.
13 Applicable also to organic products according to Council Regulation (EC) No 834/2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91, OJ L 189, pp. 1–23.
14 Article 1 of Wallon Décret relatif à la coexistence des cultures génétiquement modifiées avec les cultures conventionnelles et les cultures biologiques du 19 juin 2008, published in the Moniteur Belge on 8 August 2008.
15 In the 2003 recommendation the European Commission said that coexistence was linked to consumer choice, but this right of choice was not included in the concept of coexistence
16 Explanatory Statements of the German Act reorganising legislation concerning genetic engineering (Gesetz zur Neuordnung des Gentechnikrechts – GenTG), published in the Bundesgesetzblatt on 3 February 2005. See the English version of the TRIS (Technical Regulations Information System; Ref. 2004-133-D): “It [coexistence] maintains the freedom of choice for consumers as well as agricultural and food producers as to whether or not they wish to buy, use or produce genetically modified products and contributes to pacification”.
17 Explanatory Statements of the Portuguese Decreto Lei No 160/2005 of 21 September 2005, published in Diário da República on 21 September 2005. See the English version of the TRIS (Ref. 2005-271-P): “It must be guaranteed that no agricultural system will be excluded in the European Union as the existence of different agricultural production systems is a prerequisite for ensuring a high degree of consumer choice in terms of agricultural products and for allowing farmers to freely choose the type of agricultural production to be used”.
18 Article L. 531-1 of the French Code de l'Environnement: “La liberté de consommer et de produire avec ou sans organismes génétiquement modifiés, sans que cela nuise à l'intégrité de l'environnement et à la spécificité des cultures traditionnelles et de qualité, est garantie …” (in accordance with the version established by the French Loi no 2008-595 du 25 juin 2008 relative aux organismes génétiquement modifiés, published in the Journal Officiel de la République Française on 26 June 2008).
19 Hermitte, Marie-Angèle, “La nature juridique du projet decoexistence entre filières OGM et filières non-OGM: pluralisme technologique et liberté du commerce et de l’industrie”, 1 Cahiers Droit, Sciences & Technologies (2008), pp. 161 et sqq.
20 Regulation EC 1830/2003, at Article 4.7.
21 Regulation EC 1830/2003 and EC 65/2004.
22 Taking into account Article 12 of Regulation 1830/2003, the 0.9 threshold refers only to the unintentional and incidental commingling of trace amounts of GMOs.
23 Assemblea Pagesa – Plataforam Transgenics Fora – Greenpeace “La imposible co-existencia. Siete años de transgénicos contaminan el maíz ecológico y el convencional: una aproximación a partir de los casos de Cataluña y Aragón”, 2006, at p. 63, available on the Internet at http://www.greenpeace.org/espana/reports/copy-of-la-imposible-coexisten (last accesed on 15 January 2010).
24 For example see Upper Austria Provincial Act regarding precautionary regulations and measures in the sphere of genetic engineering (Landesgesetz über Regelungen und Maßnahmen zur Gentechnik-Vorsorge), published in the Landesgesetzblatt für Oberösterreich on 6 July 2006, Article 4 (English version at TRIS, Ref. 2005-610-A).
25 Data Sources: Bock, Anne-Katrin/Lheureux, Karine/Libeau- Dulos, Monique et al., “Scenarios for co-existence of genetically modified, conventional and organic crops in European agriculture”, Joint Research Centre – Institute for Prospective Technological Studies and European Science and Technology Observatory, 2002, available on the Internet at ftp://ftp.jrc.es/pub/EURdoc/eur20394en.pdf (last accessed on 15 January 2010). Messean, Antoine/Angevin, Frédérique/Gómez-Barbero, Manual et al. “New case studies on the coexistence of GM and non-GM crops in European agriculture”, Joint Research Centre – Institute for Prospective Technological Studies and European Science and Technology Observatory, 2006, available on the Internet at http://ftp.jrc.es/EURdoc/eur22102en.pdf (last accessed on 15 January 2010); Dunwell, J.M. and Ford, C.S. “Desk study on technologies for biological containment of GM and non-GM crops”, University of Reading (DEFRA Contract CPEC 47), available on the Internet at http://randd.defra.gov.uk/Document.aspx?Document=CB02036_3629_FRP.doc (last accessed on 15 January 2010).
26 European law recognises for certain crops the right of farmers to use part of the harvest as seeds in future campaigns. Even though maize is not among these crops, this right could be affected if GM varieties of potatoes or wheat are introduced in variety catalogues. See Article 14 of Council Regulation (EC) No 2100/94 on Community plant variety rights, OJ L 227, pp. 1–30.
27 At EU level, European Parliament and of the Council Directive 98/44/EC on the legal protection of biotechnological inventions, OJ L 213, pp. 13–21.
28 European Commission Draft Decision establishing, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, “thresholds for adventitious or technically unavoidable traces of genetically modified seeds in other products”, 19 October 2004, unpublished in the OJ. This proposal was based on the Opinion of the Scientific Committee on Plants concerning the adventitious presence of GM seeds in conventional seeds, (Opinion adopted by the Committee on 7 March 2001), SCP/GMO-SEED-CONT/002-FINAL.
29 Arguments against the project are well explained in Haerlin, Benedikt, “The European Union's planned Directive regarding the adventitious presence of genetically modified organisms in Seeds”, available on the Internet at http://www.saveourseeds.org/fileadmin/files/SOS/memorandum_sos_eng.pdf (last accessed on 15 January 2010).
30 ESA-EuropaBio “Adventitious Presence, Bringing Clarity to Confusion”, European Seed Association and The European Association for Bioindustries, 2007, available on the Internet at http://www.europabio.org/positions/GBE/AP%20seed_260307.pdf (last accessed on 15 January 2010).
31 In France controls on local seeds are carried out by the Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes du Ministère de l'Économie, des Finances et de l'Emploi, but imported seeds fall within the competence of the Direction Générale de l’Alimentation du Ministère de l'Agriculture. Samples taken in 2005 (last available information) did not reveal any GMO traces in France-multiplied seeds but in some imported ones. In all cases the presence was between 0.1 and 0.25 %. See DGCCRF “Enquête DGCCRF sur la présence d'OGM dans les semences conventionnelles”, 2006, available on the Internet at http://www.dgccrf.bercy.gouv.fr/fonds_documentaire/dgccrf/02_actualite/breves/brv1005b_bis.htm (last accessed on 15 January 2010); DGA “Bilan du plan de contrôle 2005 des semences importées de pays tiers”, 2006, available on the Internet at http://agriculture.gouv.fr/IMG/pdf/bilan_controlev2_2005.pdf (last accessed on 15 January 2010).
32 In May 2001 Greenpeace Austria published test results showing that maize seeds of the variety PR39D81 by Pioneer were polluted by GMO which were not authorised for release in Austria. Gradually it emerged that “almost 180 tons of GE contaminated seeds, affecting an area under cultivation of around 6,000 hectares, had been released into the environment. About 2,000 hectares of it were eventually destroyed, and the Austrian State paid0 €2.67 million in compensation.”
33 In practice Austria has a 0.1 % threshold for seeds, which is the test detectable boundary. It only could be guaranteed by enclosed multiplication in huge greenhouses. See Verordnung des Bundesministers für Land- und Forstwirtschaft über die Verunreinigung von Saatgut mit gentechnisch veränderten Organismen und die Kennzeichnung von GVO Sorten und Saatgut von GVO Sorten (Saatgut-Gentechnik-Verordnung), published in the Bundesgesetzblatt für die Republik Österreich on 21 December 2001. For a detailed comment in English, see Greenpeace “Austrian ‘Purity Requirement’ successful for past three years”, available on the Internet at http://www.gmo-free-regions.org/Downloads/WS_B5_austrianseedpurity.pdf (last accessed on 15 January 2010).
34 A complete catalogue of anti crosspollination measures can be found in Commission Recommendation 2003/556/EC, p. 44.
35 Bock, Anne-Katrin/Lheureux, Karine/Libeau-Dulos, Monique et al., “Scenarios for co-existence of genetically modified, conventional and organic crops in European agriculture”, Joint Research Centre of the European Commission and Institute for Prospective Technological Studies, 2002, available on the Internet at ftp://ftp.jrc.es/pub/EURdoc/eur20394en.pdf (last accessed on 15 January 2010).
36 For a detailed catalogue of isolation distances see European Commission Report on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming (Annex), COM(2006) 104, p. 15; and European Commission Report on the coexistence of genetically modified crops with conventional and organic farming (Annex), COM(2009) 153, p. 27.
37 APROSE “Guía 2006 de Buenas Prácticas para el Cultivo de maíz Bt”, Asociación Profesional de Empresas Productoras de Semillas Selectas, available on the Internet at http://www.agrodigital.com/upload/maizBt.pdf (last accessed on 15 January 2010).
38 Spanish Bill of Real Decreto por el que se aprueba el Reglamento sobre coexistencia de los cultivos modificados genéticamente con los convencionales y ecológicos, available on the Internet at http://www.agrodigital.com/images/ogm.pdf (last accessed on 15 January 2010). The bill has never been approved, being the proposal for a standby situation.
39 Comisión Nacional de Biovigilancia “Dictamen elaborado enrespuesta a la pregunta realizada por La dirección general de agricultura al grupo de expertos de carácter científico de la Comisión Nacional de Biovigilancia sobre posibilidad de coexistencia entre variedades modificadas genéticamente y tradicionales”, 2006, available on the Internet at http://www.agrodigital.com/images/biovigilancia.pdf (last accessed on 15 January 2010).
40 Portuguese Decreto Lei No 160/2005 , at Annex I.
41 ANOVE “Guía 2009 de Buenas Prácticas para el Cultivo de maíz Bt”, Asociación Nacional de Obtentores Vegetales, available on the Internet at http://www.anove.es/docs/maizbt_2009.pdf (last accessed on 15 January 2010).
42 In fact, Article 31 of Directive 2001/18/EC includes the obligation of creating such Registry Offices.
43 German Order on good farming practice in the cultivation of genetically modified plants (Order on the Cultivation of Genetically Engineered Plants) – Verordnung über die gute fachliche Praxis bei der Erzeugung gentechnisch veränderter Pflanzen (Gentechnik-Pflanzenerzeugungsverordnung – GenTPflEV), published in the Bundesgesetzblatt on 7 April 2008, at § 3 (English version at TRIS, Ref. ?)
44 Portuguese Decreto Lei No 160/2005 , Article 4.1.e.
45 Danish Order on the cultivation of genetically modified crops (Bekendtgørelse om dyrkning m.v. af genetisk modificerede afgrøder), published in BEK on 28 February 2008, §18 (English version at TRIS, Ref. 2007-598-DK).
46 Czech Decree laying down details of the cultivation of genetically modified varieties (Vyhláska o blizsích podmínkách pestování geneticky modifikavné odrudy), published in the Sbírka Zákonu Ceská Republika on 20 March 2006, Article 2 and Annex I (English version at TRIS, Ref. 2005-687-CZ).
47 Portuguese Decreto Lei No 160/2005 , at Article 4.1.e.
48 Czech Decree, Article 1.
49 Wallon Décret, Article 2.8.
50 Spanish Bill, Article 5.
51 French Code de l’Environnement, Article L. 663-1.
52 Danish Order at Article 11. Diffusion is not compulsory per se but this depends on the decision of the Ministry of Agriculture.
53 §5 and §8 Wiener Gt-VG, §5 and §9 Salzburg GtVG, §6 and §13 Bgld. GtVG, §6 and §13 Tiroler Gt-VG, §5 and §9 NÖ GVG, §5 and §10 Oö. Gt-VG 2006.
54 Wallon Décret, at Article 11.
55 German GenTG, at §16 a. In Germany it is not possible to publish the names of farmers but it is possible to find out the location of GM fields.
56 Portuguese Decreto Lei No 160/2005, Article 6.3. In Portugal the Public Registry publishes the name of the farming enterprise but not the specific location of the field.
57 Article §8 and §13 StGTVG 2006.
58 European Commission Reports COM(2006) 104, p. 11; and COM(2009) 153 (Annex), p. 20.
59 Messean, Antoine/Angevin, Frédérique/Gómez-Barbero, Manual et al. “New case studies on the coexistence of GM and non-GM crops in European agriculture”, Joint Research Centre – Institute for Prospective Technological Studies and European Science and Technology Observatory, 2006, available on the Internet at http://ftp.jrc.es/EURdoc/eur22102en.pdf (last accessed on 15 January 2010).
60 Economic damages arising from GM crops may be included in the general liability regime of the Civil Code or in the law of nuisance (under real estate law). For a detailed study concerning the different liability regimes, see Koch, Bernhard A. (ed.), Economic Loss Caused by Genetically Modified Organisms: Liability and Redress for the Adventitious Presence of GMOs in Non-GM Crops, 1st ed. (Vienna: Springer 2009)Google Scholar.
61 German GenTG, §36a.
62 Coextra “German report: Public debate and stakeholder opinions”, GM and non-GM supply chains: their Co-existence and Traceability, 2007, available on the Internet at http://www.coextra.eu/country_reports/public_debates_DE_EN.html (last accessed on 15 January 2010).
63 See the observations made by the European Commission on 26 July 2004 (Communication SG(2004) D/51510 – TRIS Ref. 2004/0133/D), in the Directive 98/34/CE framework: “In general, the proposed liability regime is likely to lead to a high and unpredictable economic risk for GMO farmers. The Commission would therefore only agree to the draft on the conditions that these provisions do not actually prevent the cultivation of GMOs in Germany.”
64 Herdegen, Matthias, “The Coexistence of Genetically Modified Crops with Other Forms of Farming. The Regulation by EU Member States in the Light of EC Law”, 2 Journal of International Biotechnology Law (2005), pp. 89 et sqq.
65 Danish Act 436/2004 on the Growing etc. of Genetically Modified Crops (Lov om dyrkning m.v. af genetisk modificerede afgrøder) published in BEK on 09 June 2004, (English version at TRIS, Ref. 2004-393-DK), § 9.
66 Danish Ministry of Food, Agriculture and Fisheries, “Danish Farmers trained to grow GMO crops”, 10 September 2008, available on the Internet at http://www.fvm.dk/Default.aspx?ID=18488&PID=169747&NewsID=5238 (last accessed on 15 January 2010).
67 Portuguese Decreto-Lei (Fundo de Compensação) No 387/2007, published in Diário da República on 28 November 2007.
68 European Commission Report (Annex), COM(2009) 153, p. 40.
69 In these zones it is prohibited to cultivate the same kind of seed that is being multiplied to avoid crosspollination risks that could reduce the purity of seeds. Even though this is a restriction, it is not seen as an important influence on the free movement of goods in the internal market. See Anvar, Shabnam Laure, Semences et Droit. L'emprise d'un modèle économique dominant sur une réglementation sectorielle, PhD Dissertation, Université Paris I, 2009, p. 147.
70 European Commission Recommendation 2003/556/EC, p. 46.
71 This is a grouping of 260 regions, over 4500 municipalities and other local entities and tens of thousands of farmers and food producers in Europe that have declared themselves “GMO-free”. Even though they partially recognise the coexistence policy, the inclusion of environmental arguments to justify the exclusion of GMO has reduced the possibility of this being declared compatible with EU law. See “Chapter of the regions and local authorities of Europe on the subject of coexistence of genetically modified crops with traditional and organic farming”, Florence 4 February 2005, available on the Internet at http://www.gmofree-euregions.net:8080/docs/ajax/ogm/Charter_en.pdf (last accessed on 15 January 2010).
72 For example, Geographical Indication rules are normally determined by local production associations, or even seed multiplication regions where the cultivation of a particular seed is prohibited by law except for the purposes of multiplication.
73 Decreto Lei No 160/2005, Article 5 (Zonas de produção de variedades geneticamente modificadas) and Portaria No 904/2006 (concerning proceedings for declaring a region GMO-free), Published on Diário da República, on 4 September 2006.
74 In 2008 these regions covered 2500 hectares, which is 51 % of the total production of GMO. DGADR, “Coexistencia entre culturas geneticamente modificadas e outros modos de produçao agricola”, Direcçao-Geral de Agricultura e Desenvolvimiento Rural (Portugal), available on the Internet at http://www.cibpt.org/docs/08042009relatorio2008coexistenciaportugal.pdf (last accessed on 15 January 2010).
75 The Lagos district was declared GMO free in 2007. Despacho No 25306/2007 of the Direcção Regional de Agricultura e Pescas do Algarbe, published on Diário da República, on 5 November 2007.
76 Spanish Bill, at Article 8.
77 Taking into account that the bill has never been approved, “coexistence” in Spain today only concerns the EU binding framework (labelling and traceability) plus some non-binding agricultural practice proposed by seed companies. See footnote 41.
78 In Aragon, the most productive maize region, almost 60 % maize is transgenic. Biological crops have being “expelled” and ecological maize production has dropped 70 % in just four years. Moran, Carmen, “El maíz transgénico está acabando con los cultivos del ecológico”, El Pais, 19 October 2006. The main reason for this reduction is the fact that the ecological certification authority has detected GM traces in 40 % of tests. Assemblea Pagesa – Plataforam Transgenics Fora – Greenpeace, “La imposible co-existencia. Siete años de transgénicos contaminan el maíz ecológico y el convencional: una aproximación a partir de los casos de Cataluña y Aragón”, available on the Internet at http://www.greenpeace.org/espana/reports/copy-of-la-imposiblecoexisten (last accessed on 15 January 2010).