Article contents
Bleak Prospects for Research in GMP in Switzerland
Published online by Cambridge University Press: 20 January 2017
Abstract
Many European countries, including Switzerland, share deep suspicions about the broad commercial application of Genetically Modified Plants (GMP) in agriculture. Research in GMP, however, is mostly welcome. In Switzerland, nevertheless, an overprotective legal framework against risks of GMP results in regulatory spillovers for research. This article explores how such expanded legal protection in combination with the application of a strong precautionary principle hampers freedom of research in the field of green gene technology. The authors do not seek, on this occasion, to question the general risk assessment of Swiss legislators and their desire for a high level of protection. However, field trials with GMP will cease to take place if the procedural burdens for researchers are not reduced. In particular, it will be vital to establish research zones (“protected sites”) if research in GMP is to continue to take place in Switzerland.
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References
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19 Ibid., at p. 2406, 2430.
20 Art. 6 Para. 2 Subpara.b GTG.
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31 FOAG, “Gesuche und Bewilligungen für GVO-Erzeugnisse”, 20 December 2010, available on the Internet at <http://www.bag.admin.ch/themen/lebensmittel/04858/04863/04883/index.html?lang=de> (last accessed on 12 July 2012); [Appendices of the Ordinance of the FOAG of 1 February 2005 on GMO animal feed lists] Anhänge der Verordnung des Bundesamtes für Landwirtschaft (BLW) vom 1. Februar 2005 über die GVO-Futtermittellisten (SR 916.307.11).
32 Art. 37a GTG.
33 Swiss Federal Council Dispatch of 1 June 2009 [regarding the amendment of the Swiss Federal Law on Gene Technology in the extra-human field] zur Änderung des Gentechnikgesetzes (GTG), in Federal Gazette, BBl 2009 5435, at pp. 5436 and 5441.
34 Art. 36 para. 2 FrSV.
35 Art. 36 para. 3 FrSV.
36 Errass, Öffentliches Recht der Gentechnologie im Ausserhumanbereich, supra note 4, at p. 195. See also Swiss Supreme Court Judgment of 12 March 2003, BGE 129 II 286, para. 4.3.3.
37 Seiler, Recht und technische Risiken, supra note 11, at p. 85; Wolf, “Zur Antiquiertheit des Rechts in der Risikogesellschaft”, supra note 11, at p. 391.
38 Cf. Swiss Supreme Court Judgment of 12 March 2003, BGE 129 II 289, para. 4.3.2.
39 FOEN, decision on granting a permit regarding the field release trial B07001 of 3 September 2007, Section B.2.2.1.2, Para. 4, available on the Internet at <http://www.bafu.admin.ch/biotechnologie/01756/08902/08924/index.html?lang=de> (last accessed on 12 July 2012).
40 SECB, opinion to the field release trial B07001 of 20 July 2007, no. 4.3. It seems noteworthy here, that minimum distances to avoid hybridization are also to be adhered to with regard to the preservation of sorting accuracy in conventional plant breeding, e.g. in wheat. However, as regards oat, spelt, barley and soft wheat it is sufficient to clearly separate neighboring fields of different sorts, e.g. by one plough share (approx. 3 ft. gap). Thereto appendix 3 no. 2.3 [Ordinance of 7 December 1998 on seeds of field and forage crops as well as vegetable varities] Verordnung des EVD vom 7. Dezember 1998 über Saat- und Pflanzengut von Acker- und Futterpflanzen- sowie Gemüsearten (Saat- und Pflanzengut-Verordnung des EVD, SR 916.151.1).
41 Swiss Supreme Administrative Court Judgment of 10 November 2008, A-6728/2007, para. 3.4.
42 DFG, Grüne Gentechnik, supra note 15, at pp.85 et sqq.
43 That is, just those inhabitants who were immediately and evidently more severely threatened by the effects of a nuclear power plant than the general public – in normal operation state as well as in the eventof accident – were entitled to appeal. Cf. Federal Council, Decision No. 96 in VPB 42 of 22 February 1978, para. 4; See also Decision No. 89 in VPB 44 of 14 May 1980, para. 3; Decision No. 54 in VPB 46 of 29 April 1982, para. 2; Swiss Supreme Court Judgments of 19 May 1995 BGE 121 II 176, para. 2c and 18 November 1994, BGE 120 IB 379, para. 4d.
44 Cf. Federal Council, Decision No. 96 in VPB 42 of 22 February 1978, para.4
45 Hettich and Walther, “Schutz vor der Gentechnologie”, supra note 23, at p. 77. This question, which implicitly challenges the suitability of solely considering the airborne pollen range, has also been raised by the Swiss Supreme Administrative Court. See Judgment of 10 November 2008, supra note 41, para. 3.4.
46 The latter consideration has been brought up by the European Court of Justice (ECJ) in a recent judgment on pollen of genetically modified corn (MON810) in honey. Cf. Case C-442/09, paras.100 et sqq. According to Errass, the same would apply for Swiss Law. Cf. Christoph Errass, “Honig mit gentechnisch veränderten Pollen: Ein Urteil des EuGH und die Folgen für die Schweiz”, Jusletter 17 October 2011, para.10. See also Art. 12 para. 1 GTG; Art. 22 para.1 e contrario [Ordinance of 23 November 2005 on foodstuffs and commodities] Lebensmittel- und Gebrauchsgegenständeverordnung vom 23. November 2005 (LGV; SR 817.02); Art. 19 [Ordinance of 26 October 2011 on the production and putting into circulation of animal feed] Verordnung vom 26. Oktober 2011 über die Produktion und das Inverkehrbringen von Futtermitteln (Futtermittel-Verordnung, FMV, SR 916.307).
47 See Art. 6a and 7 [Ordinance of the Federal Department of the Interior on genetically modified foodstuffs of 23 November 2005] Verordnung des EDI über gentechnisch veränderte Lebensmittel vom 23. November 2005 (VGVL, SR 817.022.51). The above mentioned threshold value for traces of unauthorized GMO in organic products (0.5% per ingredient) is not to be confused with the higher threshold value (0.9% per ingredient) for mixing authorized GMO with conventional organisms within the flow of goods (e.g. mixing seeds, grains, etc.).
48 Cf., e.g., Swiss Supreme Court Judgment of 10 September 1997, BGE 123 II 376, paras. 2 and 4a (Ideological nuisance through the authorisation of GM-soy as a food product); Judgment of 28 March 1995, 1A.98/1994, para. 2c (line-of-sight obstruction through planting); Judgment of 31 January 2008, 1C.262/2007, paras. 1.2 and 2.4 et sqq. (running a soup kitchen); see also Hettich and Walther, “Schutz (vor) der Gentechnologie”, supra note 23, at p. 78. With further references to ideological nuisance in the law concerning the respective interests of neighbours Arthur Meier-Hayoz (ed.), Kommentar zum Schweizerischen Privatrecht, Vol. 4, Art. 648 ZGB at paras.72 et sqq.
49 E.g. German Federal Constitutional Court Judgment of 24 November 2010, BVerfG, 1 BvF 2/05, para. 137.
50 German Federal Constitutional Court Judgment of 24 November 2010, BVerfG, 1 BvF 2/05, para.142. However, cf. Case C-236/01, Monsanto Agricoltura Italia SpA v. Presidenza del Consiglio dei Ministri [2003], at paras. 106 et sqq., where the European Court of Justice (ECJ) held, that “protective measures adopted under the safeguard clause may not properly be based on a purely hypothetical approach to risk, founded on mere suppositions which are not yet scientifically verified ”, but require a “risk assessment […] as complete as possible”.
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56 FOEN, “Decision on permit B00003”, 30 October 2003, available on the Internet at <http://www.bafu.admin.ch/biotechnologie/01756/08902/08928/index.html?lang=de> (last accessed on 12 July 2012).
57 Sunstein, Cass R., “Probability Neglect: Emotions, Worst Cases, and Law”, 112 Yale Law Journal (2002), at p. 104 CrossRefGoogle Scholar (also arguing as an analogue that mandatory labels of genetically modified food might be criticized on the ground that they suggest a danger that does not in fact exist). Cf. also Timur Kuran and Cass R. Sunstein, “Availability Cascades and Risk Regulation”, 51 Stanford Law Review (1999), at p. 707, arguing that if alarmist information is more salient, and thus more readily recalled, the public may end up exaggerating the gravity of certain risks (availability cascade).
58 FOEN, “Decisions on permits B07001 and B07002”, 3 September 2007, available on the Internet at <http://www.bafu.admin.ch/biotechnologie/01756/08902/08924/index.html?lang=de> (last accessed on 12 July 2012). Unlike in its decision on permit B00003 of 30 October 2003, the FOEN in 2007 abstained for example from imposing pollen tents, fly screens or framing with sheet metal.
59 The article at hand assesses risk from a strictly natural scientific angle in order to allow for rational, science-based decision-making. Therefore, other factors, e.g. ethical or philosophical questions are not being considered in the risk assessment. For a general discussion on the relationship between expert opinion and popular concerns see Sunstein, Cass R., Risk and Reason, Safety, Law and the Environment, (Cambridge: Cambridge University Press 2002), at pp.53 et sqq Google Scholar. See also Galera, Twyman, Sparrow et al., “Field trials and tribulations”, supra note 30, at p. 11.
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61 Though possible measures to practically implement co-existence are being examined in scientific studies (cf. e.g. Messéan, Antoine, Angevin, F., Gomez-Barbero, M. et al., New case studies on the coexistence of GM and non-GM crops in European agriculture, European Commission (ed.), (Sevilla: Publications Office of the European Union 2006)Google Scholar; Kathrin Pascher, Marion Dolezel, Koexistenz von gentechnisch veränderten, konventionellen und biologisch angebauten Kulturpflanzen in der Österreichischen Landwirtschaft – Handlungsempfehlungen aus ökologischer Sicht, Federal Ministry of Health (ed.), (Vienna 2005)) all proposals to prevent undesired hybridisation – besides separating or cleaning harvesters and choosing cultivars with different points of anthesis – result in the adherence to certain field separation distances (depending on the plant species up to several kilometers), including possibly extensive monitoring. This leads to vigorous discussions even in countries much larger by surface area than Switzerland, such as the U.S. Thereto Economist Online, “Rows over GM crops – Seeds of Change”, 6 January 2011, available on the Internet at <http://www.economist.com/node/17855118> (last accessed on 12 July 2012). In the European Union, the recent ECJ ruling regarding pollen of genetically modified corn (MON810) in honey raises major questions concerning the implementation of co-existence. Cf. Case C-442/09, paras. 100 et sqq. For an overview on the coexistence policy in the European Union see Varela, Justo Corti, “The New Strategy on Coexistence in the 2010 European Commission Recommendation”, 4 EJRR (2010), pp.353 et sqq Google Scholar. In Switzerland the following authors dealt with the co-existence issue: Dahinden, Manuela, Kohler, Stefan, Sautter, Christof, Koexistenz und Froschungsfreiheit als Nagelprobe für die Grüne Gentechnologie, (Zurich: Idea 2011)Google Scholar; Epiney, Astrid, Waldmann, Bernhard, Oeschger, Magnus, Heuck, Jennifer, Die Ausscheidung von gentechnikfreien Gebieten in der Schweiz de lege lata et de ferenda, (Zurich/St. Gallen: Dike 2011)Google Scholar; Errass, “Honig mit gentechnisch veränderten Pollen”, supra note 46, at paras.7 et sqq.
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65 Cf. Parry, Martin, Canziani, Osvaldo, Palutikof, Jean, van der Linden, Paul and Hanson, Clair, “Impacts, Adaptation and Vulnerability”, in IPCC/WMO/UNEP (eds.), Fourth Assessment Report: Climate Change 2007 (Cambridge: Cambridge University Press 2007)Google Scholar.
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68 European Commission, A Decade of EU-funded GMO reserach (2001–2010), supra note 52, at pp.7 et sqq.; European Commission, Press release of 9 December 2010, supra note 54.
69 Gerhard Schmid and Markus Schott, “Kommentar zu Art. 64 BV”, in Ehrenzeller, Mastronardi, Rainer and. Vallender (eds), Die Schweizerische Bundesverfassung, supra note 16, Art. 64 BV at para. 4, with reference to Schwander, Verena, Grundrecht der Wissenschaftsfreiheit: im Spannungsfeld rechtlicher und gesellschaftlicher Entwicklungen, (Bern: Haupt 2002)Google Scholar.
70 Similarly German Federal Constitutional Court in its Judgment of 24 November 2010, BVerfG, 1 BvF 2/05, at paras.148 et sqq.
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76 Hansjörg Seiler, “Kommentar zu Art. 29e USG”, in Helen Keller – Vereinigung für Umweltrecht (eds), Kommentar zum Umweltschutzgesetz, 2nd ed., (Zurich: Schulthess 2003), Art. 29e USG at para.30.
77 Cf. e.g. Sections C.1.c/dd and C.1.d/uu of the decision on permit B07001 by the FOEN of 3 September 2007 and the related decisions of 6 February 2008 and 6 February 2009 respectively.
78 Cf. also 7 CFR 340.3 (U.S.), which, instead of the usual permit system, allows for a notification procedure when fulfilling certain conditions. The notification per se consists of a two-sided form (an example and the prerequisites to participate in the notification procedure are available on the Internet at <http://www.aphis.usda.gov/biotechnology/downloads/notification_guidance_0810.pdf> (last accessed on 12 July 2012)); see also Hettich and Walther, “Schutz (vor) der Gentechnologie”, supra note 23, at pp.84 et sqq.
79 Swiss Supreme Court Judgment of 10 August 2009, BGE 135 II 338, at paras.5 et sqq.
80 See Gómez-Galera, Twyman, Sparrow et al., “Field trials and tribulations”, supra note 30, at pp.10 et sqq.; European Union Joint Research Centre, List of summary notifications (SNIFs) circulated under Art. 9 of Directive 90/220/EEC and Art. 11 of Directive 2001/18/EC, available on the Internet at <http://mbg.jrc.ec.europa.eu/deliberate/doc/snifs.pdf> and <http://gmoinfo.jrc.ec.europa.eu/> (last accessed on 12 July 2012).
81 See Gómez-Galera, Twyman,. Sparrow et al., “Field trials and tribulations”, supra note 30, at p. 8.
82 Art. 14 paras. 4 and 4a [German Federal Law of 1 July 1990 on the regulation of gene technology] Gesetz zur Regelung der Gentechnik vom 1. Juli 1990 (Gentechnikgesetz – GenTG) and § 11 [Ordinance of 24 October 1990 on application documents and application procedures according to the German Federal Law an the regulation of gene technology] Verordnung vom 24. Oktober 1990 über Antrags- und Anmeldeunterlagen und über Genehmigungs- und Anmeldeverfahren nach dem Gentechnikgesetz (Gentechnik-Verfahrensverordnung – GenTVfV).
83 Cf. § 11 GenTVfV. The provision embodies into law the Commission decision of 4 November 1994 (94/730/EC) establishing simplified procedures concerning the deliberate release into the environment of GMP.
84 Cf. § 11 GenTVfV.
85 Rhinow, René, Schmid, Gerhard, Biaggini, Giovanni, Uhlmann, Felix, Öffentliches Wirtschaftsrecht, 2nd ed., (Basel: Helbling Lichtenhahn 2011)Google Scholar, para. 40, at subpara. 35.
86 Neue Zürcher Zeitung (NZZ), “Zerstörungsaktion in Gentech-Versuchsfeld” [destructive action on GMO trial field], 14 June 2008, available on the Internet at <http://www.nzz.ch/nachrichten/zuerich/zerstoerungsaktion_in_gentech-versuchsfeld_1.759006.html> (last accessed on 12 July 2012).
87 Forschungsanstalt Agroscope Changins-Wädenswil (ACW), “Zwischenfall beim Feldexperiment mit gentechnisch verändertem Weizen in Pully” [incident during field release trial with GM-wheat in Pully], Press release of 25 June 2009, available on the Internet at <http://www.agroscope.admin.ch/aktuell/00198/00199/00344/04683/index.html?lang=de&msg-id=27717> (last accessed on 12 July 2012); Blick, “Gentech-Weizenfeld von Unbekannten sabotiert” [Trial field with GM-wheat sabotaged by unknown intruders], 7 July 2009, available on the Internet at <http://www.blick.ch/news/schweiz/gentech-weizenfeld-von-unbekannten-sabotiert-75259> (last accessed on 12 July 2012).
88 Cf. Gómez-Galera, Twyman, Sparrow et al., “Field trials and tribulations”, supra note 30, at pp.6 et sqq., mentioning a variety of experimental field trials all over Europe which have been destroyed by activist. See also Economist Online, “Green Genes – The shameful destruction of a crop trial”, 4 August 2008, available on the Internet at <http://www.economist.com/node/11871937> (last accessed on 12 July 2012); Ian Sample, “Anti-GM activists urged not to trash wheat field”, The Guardian, 1 May 2012, available on the Internet at <http://www.guardian.co.uk/uk/2012/may/01/anti-gm-activists-wheat-rothamsted> (last accessed on 12 July 2012).
89 Thomas Bernauer ,Theresa Tribaldos, Carolin Luginbühl and Micahel Winzeler, “Government regulation and public opposition create high additional costs for field trials with GM crops in Switzerland”, in Transgenic Research (2011), DOI 10.1007/s11248–011–9486-x. (figures derived from his own research at Agroscope).
90 Staatssekretariat für Bildung und Forschung SBF (ed.), “Schweizer Roadmap für Forschungsinfrastrukturen – Schlussbericht”, 30 March 2011, p. 47, available on the Internet on http://www.sbf.admin.ch/htm/dokumentation/publikationen/forschung/11.03.30.NFO.RoadmapForschungsinfrastrukturen_d.pdf (last accessed on 12 July 2012). See for the concept also Hettich and Walther, “Schutz (vor) der Gentechnologie”, supra note 23, at p. 86.
91 Gómez-Galera, Twyman, Sparrow et al., “Field trials and tribulations”, supra note 30, at p. 11.
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