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The EU Adventures of ‘Herculex’

Report on the EU Authorization of the Genetically Modified Maize 1507

Published online by Cambridge University Press:  20 January 2017

Maria Weimer  and
Gaia Pisani
Maria Weimer
Affiliation:
Amsterdam Centre for European LawandGovernance (ACELG), University of Amsterdam
Gaia Pisani
Affiliation:
Network (EELN), T.M.C. Asser Institute, The Hague
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Abstract

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe. The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005. It involves a long and complicated authorization process marked by persistent contestation of both the EFSA's risk assessment and the Commission's risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court.

This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA's approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.

Type
Reports
Information
European Journal of Risk Regulation , Volume 5 , Issue 2 , June 2014 , pp. 208 - 212
Copyright
Copyright © Cambridge University Press 2014

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References

1 Maria Weimer, “Risk regulation, GMOs, and the challenges to deliberation in EU governance - politicisation and scientification as co-producing trends”, in Christian Joerges and Carola Glinski (eds), The European Crisis and the Transformation of Transnational Governance (Hart Publishing, 2014, forthcoming).

2 Namely in January 2005. Another equally controversial EFSA opinion on the so-called ‘Amflora’ potato was issued by the EFSA in December 2005.

3 Bt (Bacillus thuringiensis) are bacteria naturally occurring in the soil. Some of them produce a protein crystal which is toxic to insects. Bt Cry1F is the result of a modification of the natural occurring Cry1Fa2 gene.

4 Larvae of the European corn borer and of the Mediterranean corn borer.

5 Commission Implementing Regulation (EU) No 365/2013 of 22 April 2013 amending Implementing Regulation (EU) No 540/2011, OJ L111/27, 23 April 2013.

6 Opinion of the Scientific Panel on Genetically Modified Organism on a request from the Commission related to the notification (Reference C/ES/01/01) for the placing on the market of insect-tolerant genetically modified maize 1507 for import, feed and industrial processing and cultivation, under Part C of Directive 2001/18/EC from Pioneer Hi-Bred International/Mycogen Seeds, Question No EFSA-Q-2004-072, The EFSA Journal (2005) 181, pp. 1–33.

7 Ibid. p. 2

8 EFSA, Annex to the opinions of the Scientific Panel on Genetically Modified Organisms on the insect resistant genetically modified Bt11 and 1507 maize (2006), p. 2.

9 Ibid. p. 5.

10 Ibid., p. 5,6.

11 Ibid. p. 7.

12 For a comprehensive list, see EFSA, Scientific Opinion of the Panel on Genetically Modified Organisms on a request from the European Commission to review scientific studies related to the impact on the environment of the cultivation of maize Bt11 and 1507, The EFSA Journal (2008), 851, pp. 6–7.

13 See EFSA (2006), supra note 10, at 21.

14 EFSA (2007), Call CFP/EFSA/GMO/2007/01. Note that the call did not go through, so that EFSA did not actually gather any new information, yet it did dismiss all the new studies that the Commission put to its attention the year after.

15 The study at issue is A. Bauer-Panskus and C. Then, “Testbiotech opinion on the application for market approval of genetically modified maize 1507 (DAS-Ø15Ø7-1)”, available at <http://www.testbiotech.org/en/node/365> (last accessed 30 April 2014). EFSA makes explicit reference to it in: EFSA, Minutes of the 61st plenary meeting of the scientific panel on genetically modified organisms held on 20-21 October 2010 in Parma, Italy (p. 7).

16 Notably, they claimed that maize 1507 produced a high concentration of Bt toxin in pollen, and that this evidence should have significantly altered the risk assessment outcome as to the development of insect resistance and the impact on soil, air and water.

17 EFSA (2010), supra n. 14., p. 7.

18 EFSA (2012), Scientific Opinion updating the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize 1507 for cultivation, 9(11) EFSA Journal (2011), p. 2429.

19 EFSA (2012a), Scientific Opinion supplementing the conclusions of the environmental risk assessment and risk management recommendations on the genetically modified insect resistant maize 1507 for cultivation, 10(11) EFSA Journal (2012), p. 2934 CrossRefGoogle Scholar. EFSA (2012b), EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion updating the risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize 1507, 10(10) EFSA Journal (2012), p. 2933.Google Scholar

20 EFSA (2012), ibid, p. 3 states “The EFSA GMO Panel recommends caution when predicting future responses of the European and Mediterranean corn borer in the EU based on experiences elsewhere, as resistance evolution in target insect pests is dependent upon many factors”.

21 EU General Court, Case T-164/10, Pioneer Hi-Bred International v European Commission, 26 September 2013. Overall, it took two court actions by Pioneer to move the procedure along. The first one was brought in 2007 (Case T-139/07) forcing the Commission to submit a draft proposal to the comitology committee, after which the EU Court filed the case because there was no need to adjudicate anymore.

22 Weimer (2014) supra n. 2; Pollack, M. & Shaffer, G., “Risk Regulation, GMOs, and the Limits of Deliberation”, in Naurin, D. & Wallace, H. (eds), The European Union Council of Ministers (Palgrave MacMillan, 2008).Google Scholar

23 Note that the old comitology rules of Council Decision 1999/468/EC are still applicable to this authorization procedure.

24 Commission proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests, COM(2013) 758 Final, 6 November 2013.

25 With the exception of the potential Bt toxin resistance in corn borers, for which the Commission refers to an EFSA opinion from 2005.

26 Pursuant to Article 8 (1) of Council Decision 1999/468/EC (‘old comitology rules’). These rules remain applicable to the authorisation procedure of maize 1507 because it is a pending procedure in the sense of Article 14 of Regulation 182/2011.

27 European Parliament resolution of 16 January 2014 on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests (2013/2974 (RSP)).

28 See Weimer (2014) supra n. 2.

29 Spain, the UK, Finland, Estonia and Sweden voted in favour, Portugal, Czech Republic, Belgium and, quite surprisingly, Germany abstained. France, Italy, Hungary, the Netherlands, Slovenia, Slovakia, Austria, Poland, Greece, Romania, Bulgaria, Croatia, Cyprus, Latvia, Ireland, Denmark, Malta, Luxembourg and Lithuania voted against the Commission's proposal for approval.

30 From Austria, Bulgaria, Cyprus, France, Hungary, Italy, Latvia, Lithuania, Luxembourg, Poland, Slovenia and Malta. The text of the letter is available at http://m.greenpeace.org/greece/Global/greece/image/2014/gmos/gmo_general_petition/2379_001.pdf (last accessed 10 April 2014).

31 On this term, see van Asselt, Marjolein and Vos, Ellen, “Wrestling with Uncertain risks: EU Regulation of GMOs and the Uncertainty Paradox”, 11 Journal of Risk Research (2008), p. 281.CrossRefGoogle Scholar

32 See Weimer (2014) supra n. 2.