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The Science, Law and Policy of Neonicotinoids and Bees: A New Test Case for the Precautionary Principle

Published online by Cambridge University Press:  20 January 2017

Alberto Alemanno
Alberto Alemanno*
Affiliation:
HEC Paris, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Email: alemanno@hec.fr.
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Abstract

Once more, while facing an analogous risk phenomenon affecting their predominantly homogeneous societal and economic interests, the two sides of the Atlantic seem to adopt diverging stances. Amid the publication of several new studies and a set of EFSA scientific opinions linking the use of the world's most widely used pesticides to bee decline, the European Union adopted a temporary ban on their use. While the Commission does not expressly rely on it, its restrictive decision is clearly based on the controversial precautionary principle. Yet, as it is discussed in this article, the conformity of this decision with the requirements that determine the legal invocation of this principle remains doubtful.

Type
Articles
Information
European Journal of Risk Regulation , Volume 4 , Issue 2 , June 2013 , pp. 191 - 207
Copyright
Copyright © Cambridge University Press 2013

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References

1 Dennis van Engelsdorp, Diana Cox-Foster, Maryann Frazier, Nancy Ostiguy, and Jerry Hayes, “Colony Collapse Disorder Preliminary Report”. Mid-Atlantic Apiculture Research and Extension Consortium (MAAREC) – 2006 CCD Working Group, p. 22; Honey Bee Die-Off Alarms Beekeepers, Crop Growers and Researchers, Pennsylvania State University College of Agricultural Sciences (29 January 2007).

2 Depictions of humans collecting honey from wild bees date to 15,000 years ago, efforts to domesticate them are shown in Egyptian art around 4,500 years ago. Simple hives and smoke were used and honey was stored in jars, some of which were found in the tombs of pharaons such as Tutankhamun. See, e.g., Crane, Eva, The World History of Beekeeping and Honey Hunting (London: Routledge, 1999).Google Scholar

3 It has been recently estimated that one-third of all food and beverages are made possible by pollination, mainly by honeybees. See, USDA – EPA, Report on the National Stakeholders Conference on Honey Bee Health, released on May 2, 2013. This document has been presented by the two US federal agencies as “representing the consensus of the scientific community studying honey bees”.

4 In Germany, for instance, it was a problem in the seed treatment process for clothianidin on maize seed which caused the mass bee kills. A seed company neglected to use an adhesive to bind the pesticide (clothianidin) to the seeds. As a result, the release of the pesticide into the air during late sowing when most oilseed rape was already in bloom, compounded by strong dry winds carrying it onto neighbouring fields where bees were foraging led to a mass murder of 11,500 colonies. This reconstruction of the accident can be found not only in industry reports (e.g. Bayer Press Release, Safety of clothianidin to bees (September 1, 2008)) but also in environmental groups’ monitoring (e.g. Factsheet 4 of the Pesticide Action Network UK) and scientific journals (E. Stokstad, Field Research on Bees Raises Concern About Low-Dose Pesticides, Science 30 March 2012: 1555).

5 See, e.g., Yamamoto, Izuru, “Nicotine to Nicotinoids: 1962 to 1997”, in Izuru Yamamoto and C. John Cassida (eds), Nicotinoid Insecticides and the Nicotinic Acetylcholine Receptor (Tokyo: Springer, 1999), pp.3–27.CrossRefGoogle Scholar

6 France, Germany, Italy and Slovenia. The legal basis for the adoption of these national restrictive measures is offered by Article 36(3) of Regulation 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1 (hereinafter, Plant Protection Product (PPP) regulation).

7 More precisely, a high acute risk to honeybees was identified from exposure via dust drift for the seed treatment uses in maize, oilseed rape and cereals as well as from exposure via residues in nectar and/or pollen for the uses in oilseed rape. See, Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam, 11(1) EFSA Journal (2013), p.3068 et sqq.

8 Clothianidin was included in Annex I to Directive 91/414/EEC on 1 August 2006 by Commission Directive 2006/41/EC. Imidacloprid was included in Annex I to Directive 91/414/EEC on 1 August 2009 by Commission Directive 2008/116/EC. Thiamethoxam was included in Annex I to Directive 91/414/EEC on 1 February 2007 by Commission Directive 2007/6/EC. The three substances were approved under Regulation (EC) No. 1107/2009, in accordance with Commission Implementing Regulation (EU) No. 540/2011, as amended by Commission Implementing Regulation (EU) No. 541/2011.

9 See, Elizabeth Kolbert, “Silent Hives”, The New Yorker, April 20, 2013.

10 For a balanced reconstruction of the scientific controversy surrounding neonicotinoids, see Stokstad, Erik, “Field Research on Bees Raises Concern About Low-Dose Pesticides”, 335 Science (2012), p. 1555 et sqq.CrossRefGoogle Scholar

11 Proponents of neonicotinoid-treated seeds claim that these pesticides offer many benefits besides killing pests, including improved plant vigor and higher yields. Yet, several studies suggest that neonicotinoids use may offer little boost to yields. See, e.g., Seagraves, Michael P. and Lundgren, Jonathan G., “Effects of neonicitinoid seed treatments on soybean aphid and its natural enemies”, 85(1) Journal of Pest Science (2012), pp. 125–132.CrossRefGoogle Scholar

12 A first comprehensive review of the socioeconomic, technological, and environmental contribution of neonicotinoid seed treatment has been published by the Humboldt Forum for Food and Agriculture e.V. (HFFA). Supported by Copa–Cogeca (European Farmers Union), ESA (European Seed Association) and ECPA (European Crop Protection Association) – and financed by Bayer Crop Science and Syngenta – the study team (Steffen Noleppa, agripol; Thomas Hahn et al., a–connect) investigated the socioeconomic and environmental contribution made by this technology to the European Union across major crops and key countries. The study concludes that Neonicotinoid seed treatment contributes more than €2bn annually to commodity crop revenues and reduces productivity costs by nearly €1bn across the EU. Moreover, according to the report, the true value of Neonicotinoid seed treatment to the grower, when compared to not using pesticides at all, exceeds €4bn per year.

13 The Commission Implementing Regulation 485/2013 was eventually adopted on 24 May 2013 amending Implementing Regulation (EU) No. 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the sale and use of seeds treated with plant protection products containing those active substances. It was published on (Saturday) 25 May 2013, OJ L139/13.

14 UNEP, “Global Honey Bee Colony Disorders and Other Threats to Insect Pollinators”, UNEP Emerging Issues, available on the Internet at <http://www.unep.org/dewa/Portals/67/pdf/Global_Bee_Colony_Disorder_and_Threats_insect_pollinators.pdf> (last accessed on 29 May 2013).

15 Belgium, Italy, Portugal, Germany, the Netherlands and the United Kingdom. See, e.g., Laura Maxim and Jeroen van der Sluijs, “Seed-dressing systemic insecticides and honeybees”, in Late Lessons from Early Warnings – EEA Report 1/2013, available at http:// www.eea.europa.eu/publications/late-lessons-2 (last accessed on 29 May 2013), at p. 424.

16 Potts, Simon G., Roberts, Stuart P.M., Robin Dean et al, “Declines of managed honeybees and beekeepers in Europe”, 49 Journal of Apicultural Research (2010), pp. 15–22 CrossRefGoogle Scholar; Potts, Simon G., C. Biesmeijer, Jacobus, Bommarco, Riccardo et al., “Developing European conservation and mitigation tools for pollination services: approaches of the STEP (Status and Trends of European Pollinators) Project”, 50(2) Journal of Apicultural Research (2011), pp. 152–164.CrossRefGoogle Scholar

17 UNEP, “Global Honey Bee Colony Disorders and Other Threats to Insect Pollinators”, UNEP Emerging Issues, available on the Internet at <http://www.unep.org/dewa/Portals/67/pdf/Global_Bee_Colony_Disorder_and_Threats_insect_pollinators.pdf> (last accessed on 29 May 2013).

18 CCD is characterized by the sudden loss of worker adults from managed hives, leading to the eventual collapse of the entire colony within a few weeks. See, e.g., Hopwood, Jennifer, Vaughan, Mace, Shepherd, Matthew et al., “Are Neonicotinoids Killing Bees? A Review of Research into the Effects of Neonicotinoid Insecticides on Bees, with Recommendations for Actions”, The Xerces Society for Invertebrate Conservation (2012), p. 32.Google Scholar

19 Blacquière, Tjeerd, Smagghe, Guy, van Gestel, Cornelis A. M. et al., “Neonicotinoides in bees: a review on concentrations, side effects and risk assessment”, 21(5) Ecotoxicology (2012), p.1581 et sqq.CrossRefGoogle Scholar

20 Stokstad, Erik, “Field Research on Bees Raises Concern About Low- Dose Pesticides”, 335 Science (2012), p. 1555 et sqq.CrossRefGoogle Scholar

21 For example, some crops, particularly blueberries, do not provide adequate nutrition, and colony losses of 30% due to starvation are considered typical for these crops. (see, Dennis vanEngelsdorp , Diana Cox Foster, Maryann Frazier et al., “Fall–dwindle disease”: Investigations into the causes of sudden and alarming colony losses experienced by beekeepers in the fall of 2006. Preliminary Report: First Revision. [Agriculture, P.D.o., Ed.], p 22. Harrisburg PA: PA Department of Agriculture), compared to the average 22% loss that beekeepers in the U.S. typically consider acceptable (see, Ellis, Jamie, “The honeybee crisis”, 23(1) Outlooks on Pest Management (2012), pp. 35–40).Google Scholar

22 Christopher A. Mullin, Maryann Frazier, James L. Frazier et al., “High levels of miticides and agrochemicals in North American apiaries: implications for honeybee health”, 5(3) PLoS One (2010), e9754.

23 For a supposedly balanced perspective on the issue, UNEP, “Global Honey Bee Colony Disorders and Other Threats to Insect Pollinators”, UNEP Emerging Issues, available on the Internet at <http://www.unep.org/dewa/Portals/67/pdf/Global_Bee_Colony_Disorder_and_Threats_insect_pollinators.pdf> (last accessed on 29 May 2013).

24 In ‘Silent Spring’, Rachel Carson wrote of systemic pesticides with horror. She wrote: ‘The world of systemic insecticides is a weird world, surpassing the imaginings of the brothers Grimm. It is a world where the enchanted forest of the fairy tales has become a poisonous forest. It is a world where a flea bites a dog and dies…where a bee may carry poisonous nectar back to its hive and presently produce poisonous honey’. See, Elizabeth Kolbert, Silent Hives, The New Yorker, April 20, 2013.

25 In particular, the neonicotinoid imidacloprid is currently the most widely used insecticide in the world. See Yamamoto, Izuru, “Nicotine to Nicotinoids: 1962 to 1997”, in Yamamoto, Izuru and John Cassida, C. (eds), Nicotinoid Insecticides and the Nicotinic Acetylcholine Receptor (Tokyo: Springer, 1999), pp. 3–27.CrossRefGoogle Scholar

26 Tennekes, Henk A., The Systemic Insecticides: A Disaster in the Making (West Yorkshire: Northern Bee Books, 2010).Google Scholar The author (born in 1950 in Zutphen, The Netherlands) graduated from the Agricultural University of Wageningen in 1974 and conducted his Ph.D. work at Shell Research Ltd. in Sittingbourne, Kent, UK.

27 See, e.g, Tapparo, A., et al. “Assessment of the Environmental Exposure of Honeybees to Particulate Matter Containing Neonicotinoid Insecticides Coming from Corn Coated Seeds”, 46(5) Environmental Science and Technology (2012), pp. 2592–2599.CrossRefGoogle Scholar

28 Christoph W. Schneider, Jürgen Tautz, Bernard Grünewald et al., “RFID Tracking of Sublethal Effects of Two Neonicotinoid Insecticides on the Foraging Behavior of Apis mellifera”, 7(1) PLOS One (2012), e30023.

29 Henry, Mickaël, Béguin, Maxime, Requier, Fabrice et al., “A Common Pesticide Decreases Foraging Success and Survival in Honey Bees”, 336 Science (2012), pp. 348–350.CrossRefGoogle Scholar

30 Whitehorn, Penelope R., O’Connor, Stephanie, Wackers, Felix L. et al, “Neonicotinoid Pesticide Reduces Bumble Bee Colony Growth and Queen Production”, 336 Science (2012), pp. 351–352.CrossRefGoogle Scholar

31 This provision reads as follows: ‘The Commission may ask the Member States and the Authority for an opinion, or for scientific or technical assistance. The Member States may provide their comments to the Commission within three months from the date of the request. The Authority shall provide its opinion or the results of its work to the Commission within three months of the date of the request’.

32 Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam, 11(1) EFSA Journal (2013), p. 3068 et sqq.

33 EFSA Guidance Document on the Risk Assessment of Plant Protection Products on Bees (draft version published for public consultation on 20 September 2012).

34 See the subsequent ‘Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam’, 14 March 2013. With this report EFSA has made minor adjustments to its recent assessment of the risks to bees from pesticides containing the neonicotinoid active substance thiamethoxam. The changes, which follow the submission of new information from two Member States, regard some uses of thiamethoxam as a seed treatment for sunflower, oilseed rape and sugar beet. However, the overall conclusions that EFSA reported on 16 January remain unaffected.

35 See request from the European Commission, Question No EFSAQ-2012-00793, approved on 19 December 2012.

36 EFSA also recalled that the Authority's review of neonicotinoids is ‘one element in a range of activities it is undertaking on bee health’. EFSA has recently completed a review of all its activities related to bees and is now identifying data and research gaps. Other specific outputs include the PPR Panel's Guidance on the Risk Assessment of Plant Protection Products on Bees, which still has to be published (and is expected in Spring of 2013); and a Scientific Opinion on the risk of introduction and spread in the EU of two bee parasites – the small hive beetle (Aethina tumida) and Asian bee mite (Tropilaelaps) – which is currently being finalised by the Panel on Animal Health and Welfare.

37 See also the EFSA Scientific Opinion on the science behind the development of a risk assessment of plant protection products on bees (10(5) EFSA Journal (2012), pp. 2668 et sqq).

38 In the EU, petitions were launched inter alia on Change.org (addressed to the members of the Standing Committee on the Food Chain and Animal Health (SCFCAH)), Avaaz (addressed to: World Leaders and Agriculture Ministers (‘3 Million to Save the Bees’); the UK Government and more recently to Amazon asking it to stop selling neonicotinoids on line). In the US, see Care2PetitionSite (addressed to Lisa Jackson, EPA Administrator), Causes.com (savebees initiatives).

39 For an historical evolution of evidence on the risks of Gaucho© to honeybees in sunflower and maize seed–dressing in France and its integration in the French regulatory response towards this substance, See, Laura Maxim and Jeroen van der Sluijs, “Seed–dressing systemic insecticides and honeybees”, in Late Lessons from Early Warnings– EEA Report 1/2013, available at <http://www.eea.europa.eu/publications/late-lessons-2> (last accessed on 29 May 2013), pp. 401–434.

40 European Parliament, 2001, Resolution on the Commission report on the implementation of Council Regulation (EC) No. 1221/97 laying down general rules for the application of measures to improve the production and marketing of honey (COM(2001) 70 – C5-0398/2001 – 2001/2156(COS)).

41 See, e.g., Laura Maxim andand Jeroen van der Sluijs, “Expert explanations of honeybee losses in areas of extensive agriculture in France: Gaucho© compared with other supposed causal factors”,5 Environmental Research Letters (2010), 014006.

42 This went down in history as the 2008 German bee kill incident. German beekeepers reported that 50 to 100 percent of their hives had been lost after pneumatic equipment used to plant corn seed blew clouds of pesticide dust into the air, which was then blown by the wind onto neighboring canola fields in which managed bees were performing pollinator services. A reconstruction of these accidents was reported by both the industry (Bayer Press Release, Safety of clothianidin to bees (September 1, 2008)) and NGOs (Factsheet 4 of the Pesticide Action Network UK). According to German authorities, the May 2008 incident resulted from inadvertent exposure of the bees to clothianidin, an insecticide used for corn seed treatment, resulting from a combination of factors. These factors include the specific formulation of the pesticide used, weather conditions and type of application equipment: (i) The formulation of the pesticide clothianidin used to protect seed corn from corn root worm in Germany did not include a polymer seed coating known as a ‘sticker’. This coating makes the pesticide product stick to the seed. Although the formulation used in the United States also does not require a “sticker” on corn seed, the major seed suppliers and distributors, agricultural industry groups, and clothianidin's registrant have confirmed that it is typical practice to use “‘stickers’” on corn seed in the United States. (ii) Normally, corn is planted before canola blooms and attracts bees. Because early, heavy rains delayed the corn planting in Germany in 2008, the seeds were sown later than usual when nearby canola crops were in bloom and bees were present. (iii) A particular type of air-driven equipment used to sow the seeds apparently blew clothianidin-laden dust off the seeds and into the air as the seeds were ejected from the machine and into the ground. (iv) Finally, dry and windy conditions at the time of planting blew the dust into the neighboring canola fields that were in bloom and where honey bees were foraging. Together, these factors helped create the circumstances under which this incident occurred.

43 BVL, 2011. List of authorised plant protection products in Germany. January 2012.

44 Stephanie Kusma, ‘Was soll die Einschränkung der Neonicotinoide bringen?’, Neue Zürcher Zeitung (8 May 2013).

45 European Food Safety Authority, “Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin”, 11(1) EFSA Journal (2013), doi:10.2903/j.efsa.2013.3066; “Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid”, 11(1) EFSA Journal (2013); doi:10.2903/j.efsa.2013; “Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam”, 11(1) EFSA Journal (2013); doi:10.2903/j. efsa.2013.3067. Available online at <http://www.efsa.europa.eu/efsajournal.htm> (last accessed on 29 May 2013).

46 The legal basis for EU regulatory action is Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and, in particular, the first alternative of Articles 21(3), 49(2) and 78(2). OJ L 309, 24.11.2009, p. 1.

47 Commission Implementing Regulation 485/2013 amending Implementing Regulation (EU) No. 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the sale and use of seeds treated with plant protection products containing those active substances.

48 It is expected that, besides the two exceptions allowing the use of these three neonicotinoid insecticides on crops attractive to bees in greenhouses (at any time) and in open fields (only after flowering), the most common uses of these pesticides will be banned. See the first two drafts of Commission Implementing Regulation (not numbered yet) amending Implementing Regulation (EU) No. 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the sale and use of seeds treated with plant protection products containing those active substances.

49 Alemanno, Alberto, “The fabulous destiny of Bisphenol A”, 1(4) EJRR (2010), pp. 397–400 Google Scholar; Fox, Tessa, Versluis, Esther and van Asselt, Marjolein .B.A., “Regulating the Use of Bisphenol A in Baby and Children’s Products in the European Union: Current Developments and Scenarios for the Regulatory Future”, 2(1) EJRR (2011), pp. 21–35.Google Scholar

50 On October 28, 2008, the Natural Resources Defense Council (NRDC) submitted a citizen petition regarding BPA. The petition requested that the Commissioner of Food and Drugs: (i) Issue a regulation prohibiting the use of BPA in human food and packaging, and (ii) Revoke all regulations permitting the use of any food additive that may result in BPA becoming a component of food.

51 The petition introduced in November 2011 is available at <http://www.americanchemistry.com/Media/PressReleasesTranscripts/ACC-news-releases/ACC-Asks-FDA-to-Revise-Certain-Regulationson-Bisphenol-A-BPA-in-Baby-Bottles-and-Sippy-Cups.html> (last accessed on 29 May 2013).

52 For a set of authoritative, yet competing, explanations of such a phenomenon, see Vogel, David, The Politics of Precaution: Regulating Health, Safety and Environmental Risks in Europe and the United States (Princeton: Princeton University Press, 2012)CrossRefGoogle Scholar and Wiener, Jonathan B., Rogers, Michael D., Hammitt, James K., and Sand, Peter H. (eds), The Reality of Precaution: Comparing Risk Regulation in the United States and Europe (Washington, D.C. and London: RFF Press/Earthscan/Routledge, 2011)Google Scholar. For an overview of the debate generated by these two books, see the Book Review Symposium published in this issue of the EJRR.

53 Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam, 11(1) EFSA Journal (2013), p. 3068 et sqq.

54 Regulation (EU) No. 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers.

55 The Commission Implementing Regulation 485/2013 was eventually adopted on 24 May 2013 amending Implementing Regulation (EU) No. 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the sale and use of seeds treated with plant protection products containing those active substances. OJ L139/13 (2013).

56 The Court, in its case–law on GATT and WTO law has repeatedly observed that these agreements are based on the principle of reciprocity. See Case C-149/96 Portugal v Council [1999] ECR I-8395, paragraphs 42 to 46. According to this principle, should WTO rules acquire an effect not accorded to them in the legal orders of the Community's trading partners, this would considerably weaken the Community's negotiating position in the WTO. See Portugal v Council, paragraphs 43 and 45.

57 This might also be a source of concern insofar as point 3.8.3. of Annex II requires that the risk assessment be based on Community or internationally agreed test guidelines. EFSA's assessment was rather based on draft guidelines that have not been validated.

58 This on the assumption that the precautionary principle may validly be invoked autonomously from those provisions of the relevant secondary legislation (PPP regulation) which incorporate the very same principle. On the relationship between the precautionary principle as a general principle of EU law and its manifestation in EU secondary law, see Alemanno, Alberto, “Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute”, 48(4) Common Market Law Review (2011), pp. 1329–1348.Google Scholar

59 Communication from the Commission on the Precautionary Principle, Brussels, 02.02.2000, COM(2000) 1.

60 Alemanno, Alberto, “Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute”, 48(4) Common Market Law Review (2011), pp. 1329–1348.Google Scholar

61 Alemanno, Alberto and Meuwese, Anne, “Impact Assessment of EU Non-Legislative Rulemaking: The Missing Link of ‘New’ Comitology”, 19(1) European Law Journal (2013), pp. 76–92.CrossRefGoogle Scholar

62 See Communication from the Commission on the Precautionary Principle, Brussels, 02.02.2000, COM(2000) 1, p. 19.

63 European Commission Impact Assessment Guidelines, SEC(2009) 92.

64 This has been published by the Humboldt Forum for Food and Agriculture e.V. (HFFA) and was supported by Copa-Cogeca (European Farmers Union), ESA (European Seed Association) and ECPA (European Crop Protection Association) – and financed by Bayer Crop Science and Syngenta – the study team (Steffen Noleppa, agripol; Thomas Hahn et al., a–connect) investigated the socioeconomic and environmental contribution made by this technology to the European Union across major crops and key countries.

65 Bayer Crop Science, Press Release, 16 January 2013 «Bayer Crop–Science remains convinced that neonicotinoids can be used safely and effectively in sustainable agriculture».

66 For an analysis of this Agreement, Gruszczynski, Lukasz, Regulating Health and Environmental Risks under WTO Law, A Critical Analysis of the SPS Agreement (Oxford: OUP, 2010)Google Scholar Scott, Joanne, The WTO Agreement on Sanitary and Phytosanitary Measures (Oxford: OUP, 2007)Google Scholar; Alemanno, Alberto, Trade in Food – Regulatory and Judicial Approaches in the EC and the WTO (London: Cameron May, 2007), pp. 228–229.Google Scholar

67 Now that the entry into force is likely to be postponed to 1 December 2013 or later, this cut-off period is set to be extended.

68 Panel Report, EC–Biotech,. The Appellate Body in EC–Hormones held that this provision does not exhaust the relevance of the precaution in the Agreement and that other provisions of the SPS Agreement may embody this idea.

69 Appellate Body Report, EC–Hormones, WT/DS26/R and WT/ DS48/R, para 253; Appellate Body Report, Japan-Agricultural Products, WT/DS76/AB/R, paras 81-83.

70 Appellate Body Report, Japan–Agricultural Products, WT/DS76/ AB/R, para 89; Appellate Body Report, Japan–Apples, WT/DS76/ AB/R, para 176; Panel Report, US–Continued Suspension, WT/ DS320/R, para 7.608.

71 Appellate Body Report, Japan–Apples, WT/DS76/AB/R, para 179; Panel Report, US–Continued Suspension, WT/DS320/R, para 7.593.

72 European Commission, Impact Assessment Guidelines, SEC(2009) 92. Those guidelines contain an interesting Part III: Annexes to Impact Assessment Guidelines, which finally provides a more detailed methodological guidance to the Commission services than in the past.