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Shadow Zones: Transparency and Pesticides Regulation in the European Union

Published online by Cambridge University Press:  05 November 2019

Olivia HAMLYN
Olivia HAMLYN*
Affiliation:
Birkbeck College, University of London
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Abstract

In recent years, pesticides have captured the attention of both policymakers and the general public. A particular focus has been the transparency of the EU-level procedure for approving active substances, spurred by controversies surrounding the active substance glyphosate. Active substances are the ingredient in pesticides with the pesticidal effect. Once an active substance is approved at EU level, the pesticide containing that active substance must be authorised by each Member State. For this purpose, the EU's 2009 Plant Protection Product Regulation divides Member States into three zones—Northern, Central, and Southern—within which, zonal rapporteur Member States evaluate applications for authorisation. National authorisation decisions are based on these zonal evaluations. This novel system governing pesticides is under-researched. Furthermore, unlike active substance approval, the transparency of pesticide authorisation escapes public and policy scrutiny. Drawing on empirical research conducted for the European Parliament, this article evaluates the transparency of the zonal pesticide authorisation procedure. It thus contributes to the literature on transparency a detailed exploration of transparency in a highly complex, decentred, and polycentric risk regulation regime. While it finds that the zonal pesticide authorisation procedure, generally speaking, does not operate transparently, it argues further that levels of transparency within the regime as a whole may vary significantly depending on multiple different factors. It introduces the concept of ‘chiaroscuro regulation’ to characterise and understand these varying levels of transparency across different elements of the regime and considers some of its implications.

Keywords

transparencypesticidesrisk regulationregulationgovernanceEuropean Union
Type
Articles
Information
Cambridge Yearbook of European Legal Studies , Volume 21 , December 2019 , pp. 243 - 272
Copyright
Copyright © Centre for European Legal Studies, Faculty of Law, University of Cambridge

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Footnotes

*

I am grateful to Dr Steven Vaughan and Prof Cosmo Graham for their comments on earlier drafts of this article. I presented parts of this research at the 2018 LSA annual meeting in Toronto and the 2018 SLS annual conference in London. My thanks to the participants for their thoughts. I am also grateful to the editors and anonymous reviewer for their helpful comments. Any mistakes are my own.

References

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2 Regulation (EC) No 1107/2009 [2009] OJ L309/1.

3 A Dinu and E Karamfilova, ‘Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market: European Implementation Assessment’ (European Parliamentary Research Service, Ex-Post Evaluation Unit, April 2018).

4 I do, however, incorporate some empirical insights from my contribution to the EIA, O Hamlyn, ‘Assessing Member States’ Capacity for Reliable ‘Authorisation of PPPs’, and Its Uniformity’ (European Parliamentary Research Service, Ex-Post Evaluation Unit, April 2018), to supplement the discussion. The empirical research for that report involved the distribution of a survey to Member State competent authorities (CAs) containing quantitative and qualitative questions regarding, inter alia, the transparency of their procedures and practice. For a detailed methodology, see ibid, 40–50.

5 Discussed further in Part III.

6 The technical term ‘plant protection products’, used in the Regulation, in fact also refers to other types of preparations, such as plant growth regulators and pest repellents.

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43 Löfstedt, note 18 above, pp 340–41.

44 Löfstedt, note 38 above, p xv; see also EESC, ‘Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council Establishing a Framework for Community Action to Achieve a Sustainable Use of Pesticides’ (2007), pp 7–8.

45 Fisher, note 17 above, p 305.

46 Bozzini, note 8 above, ch 4.

47 PPPR, Art 36(1).

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55 Directive (EC) 2003/35 [2003] OJ L156/17.

56 Arts 1, 10, 11(2) –(3) TEU; Art 15(1) TFEU.

57 General Food Law, note 21 above, Arts 9, 10, 38.

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60 Wynne, note 58 above.

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68 For example, the European Citizens’ Initiative ‘Stop Glyphosate’, discussed in Part III.B.

69 For example, Hood, C, Baldwin, R, and Rothstein, H, ‘Assessing the Dangerous Dogs Act: When Does a Regulatory Law Fail?’ (2000) Public Law 282Google Scholar; Hood, Rothstein, and Baldwin, note 27 above.

70 While the analysis identifies many deficiencies in terms of the transparency of pesticides regulation and therefore broad scope for reform, it is not my intention here to offer suggestions. Recommendations for reforming the Regulation can be found in Hamlyn, note 4 above, pp 97–101.

71 EPRS, EU Policy and Legislation on Pesticides: Plant protection products and biocides (EUR-OP, 2017), p 6.

72 For more information on benefits and drawbacks of pesticides, see ibid, pp 8–10 and Hamlyn, note 9 above, pp 3–6.

73 Bozzini, note 8 above, ch 3.

74 Directive (EEC) 91/414 [1991] OJ L230/1.

75 COM(2001) 444 final, Evaluation of the Active Substances of Plant Protection Products; SEC(2006) final, Report on the Impact Assessment for a Regulation Replacing Directive 91/414/EEC on Plant Protection Products, pp 10–18.

76 Bozzini, note 8 above, pp 61–65.

77 COM(2006) 388 final, Proposal for a Regulation of the European Parliament and of the Council Concerning the Placing of Plant Protection Products on the Market, pp 2–3.

78 COM(2001) 444 final, ‘Evaluation’, note 75 above, p 8.

79 SEC(2006) final, ‘Report on the Impact Assessment’, note 75 above, p 5.

80 COM(2006) 388 final, ‘Proposal for a Regulation’, note 77 above, pp 7, 11–12, 16; SEC(2006) final, ‘Report on the Impact Assessment’, note 75 above; COM(2008) 93 final, Amended Proposal for a Regulation of the European Parliament and of the Council Concerning the Placing of Plant Protection Products on the Market, pp 3, 6; Council of the European Union, ‘Press Release 9039/08 (Presse 118)’, p 6; FCEC, ‘Impact Assessment of Options for a Regulation Replacing Directive 91/414/EEC on Plant Protection Products’ (2006).

81 PPPR, Recs 12, 14, 25, 29. See also Art 75(3).

82 COM(2006) 388 final, ‘Proposal for a Regulation’, note 77 above, pp 9, 14.

83 See Parts III.B–IV.A.

84 FCEC, note 80 above, p 81.

85 European Parliament, ‘Report on the Proposal for a Regulation of the European Parliament and of the Council Concerning the Placing of Plant Protection Products on the Market FINAL A6-0359/2007’, p 133.

86 Ibid, p 110.

87 Ibid, pp 16–17, 18–20, 47, 49, 50, 72–73, 77, 93, 99, 102, 108, 110–11; European Parliament, ‘Recommendation for Second Reading on the Council Common Position for Adopting a Regulation of the European Parliament and of the Council on the Placing of Plant Protection Products on the Market A6-0444/2008’, pp 68–69, 73, 86, 88–89, 96–97.

88 COM(2006) 388 final, ‘Proposal for a Regulation’, note 77 above, p 7.

89 European Parliament, note 85 above, pp 15, 31–32, 72, 74, 78, 86, 132.

90 PPPR, Arts 7(1), 8(1)–(2), (4).

91 Ibid, Art 7(1).

92 PPPR, Art 10.

93 Ibid, Art 11(1)–(2) second paragraph.

94 Ibid, Art 12(1). The volume of public comments varies. A review of several recent applications for renewal of active substance approvals reveals that public comments are rare and rarer still in the case of applications for the approval of new active substances, if submitted at all. However, public comments on the application for renewal of approval of the highly controversial active substance glyphosate filled over 600 pages. Comments and responses are recorded in Peer Review Reports, at http://registerofquestions.efsa.europa.eu/roqFrontend/ListOfQuestionsNoLogin?1.

95 PPPR, Art 12(2) second paragraph.

96 Ibid, Art 13(1)–(2).

97 Ibid, Art 29(1)(a); see Part IV.A.

98 Ibid, Art 13(4).

99 ECORYS, Study supporting the REFIT Evaluation of the EU Legislation on Plant Protection Products and Pesticides Residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005) (EUR-OP, 2018), pp 165, 167–68; V Storck, DG Karpouzas, and F Martin-Laurent, ‘Towards a Better Pesticide Policy for the European Union’ (2017) 575 Science of The Total Environment 1027, p 1030.

100 ECORYS, note 99 above, pp 165, 168–70.

101 See http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2017/000002.

102 SWD(2018) 37 final, The REFIT Evaluation of the General Food Law (Regulation (EC) No 178/2002).

103 ENVI Committee, ‘Draft Report on the Implementation of the Plant Protection Products Regulation (EC) No 1107/2009 (2017/2128(INI))’ (2018).

104 ECI, ‘Annex to the European Citizens’ Initiative: Ban Glyphosate’ (undated), pp 1–2; European Parliament, ‘MEPs Propose Glyphosate Phase-out, with Full Ban by End 2020’ (19 October 2017), at http://www.europarl.europa.eu/news/en/press-room/20171019IPR86411/meps-propose-glyphosate-phase-out-with-full-ban-by-end-2020; SWD(2018) 37 final, note 102 above, pp 35, 44.

105 SWD(2018) 37 final, note 102 above, pp 44–45.

106 ECI, note 104 above, p 2.

107 C(2017) 8414 final, Communication on the European Citizens’ Initiative ‘Ban Glyphosate and Protect People and the Environment from Toxic Pesticides’, pp 10–12.

108 COM(2018) 179 final, Proposal for a Regulation of the European Parliament and of the Council on the Transparency and Sustainability of the EU Risk Assessment in the Food Chain, pp 3, 8.

109 Ibid, pp 18, 19, 26–29.

110 Ibid, pp 40–42.

111 Ibid, pp 41–42.

112 See PPPR, Art 33(4); ibid.

113 PPPR, Rec 29, Art 3(17), Annex I.

114 Ibid, Rec 25.

115 Ibid, Rec 29.

116 Commission, Guidance Document on Zonal Evaluation and Mutual Recognition under Regulation (EC) No 1107/2009 SANCO/13169/2010 Rev. 9, p 5.

117 Ibid, p 9; Commission, Guidance Document on the Presentation and Evaluation of Dossiers According to Annex III of Directive 91/414/EEC in the Format of a (Draft) Registration Report SANCO/6895/2009 Rev 1.

118 PPPR, Art 33.

119 Commission, note 116 above, p 4.

120 Ibid, pp 7–8.

121 PPPR, Art 36(1) first paragraph.

122 Ibid, Art 36(1) second paragraph. See Part IV.B.

123 Regulation (EU) No 546/2011 [2011] OJ L155/127. The Uniform Principles establish a harmonised methodology and thresholds for assessing and determining the acceptability of risks posed by pesticides, SAM, EU Authorisation Processes of Plant Protection Products - from a Scientific Point of View Scientific Opinion 5/2018 (EUR-OP, 2018), p 50.

124 PPPR, Art 36(1) first and third paragraphs.

125 Ibid, Art 37(1).

126 Commission, note 116 above, p 13.

127 Ibid, pp 13–14.

128 Ibid, p 14.

129 PPPR, Art 36(2)–(3).

130 Ibid, Art 36(3) first and second paragraphs.

131 See Hamlyn, note 4 above, pp 53–79.

132 Ibid, pp 90–91.

133 Uniform Principles, note 123 above.

134 PPPR, Art 60(3).

135 Commission, note 116 above, p 14.

136 Ibid, p 13.

137 ANSES, Press Kit: New Missions for ANSES in the Area of Plant Protection Products, Fertilisers and Growing Media (2015), p 7.

138 Hamlyn, note 4 above, pp 91–93.

139 Ibid, p 92.

140 Directive (EC) 2003/4, note 41 above. For examples of Registration Reports, see BVL's (German CA) website, at https://www.bvl.bund.de/EN/04_PlantProtectionProducts/01_ppp_tasks/02_ppp_AuthorisationReviewActSub/02_ppp_RegistrationReports/psm_RegReports_node.html.

141 These exceptions relate to the adverse effects of disclosure on ‘international relationship, public security or national defence’; ‘the course of justice’ for example ensuring fair trials or criminal investigations; and ‘intellectual property rights’.

142 Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden, C-442/14, EU:C:2016:890.

143 Directive (EC) 2003/4, note 41 above, Art 2(1)(b).

144 Bayer, note 142 above, para 76. See also Commission v Stichting Greenpeace Nederland and PAN Europe, C-673/13 P, EU:C:2016:889, para 75.

145 Bayer, note 142 above, paras 76–77, 81. See also Stichting Greenpeace Nederland, EU:C:2016:889, paras 74–75.

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148 Regulation (EC) No 1049/2001 [2001] OJ L145/43, Art 4(2) first indent; Regulation (EC) No 1367/2006 [2006] OJ L264/13), Art 6(1); Tweedale v EFSA, T-716/14, EU:T:2019:141, paras 76–119, Hautala and Others v EFSA, T-329/17, EU:T:2019:142, paras 83–122. As a result of this interpretation, EFSA was required to publicly release, in full, studies relating to the toxicity and carcinogenicity of glyphosate. Tweedale, paras 120–29, Hautala, paras 123–25.

149 Tweedale, note 148 above, para 91, Hautala, note 148 above, para 98, Stichting Greenpeace Nederland, note 144 above, para 80.

150 OECD, The Governance of Regulators’ Practices: Accountability, Transparency and Co-ordination (OECD, 2016), p 45.

151 Hamlyn, note 4 above, p 76.

152 O'Neill, note 42 above, pp 80–85; OECD, note 150 above, p 38.

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155 Ibid, p 34. Some of these concerns echo those expressed in relation to information disclosed with respect to active substances, discussed in Part III.B.

156 Lee, note 66 above, pp 198–99. See also Tweedale, note 148 above; Hautala, note 148 above.

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159 Hamlyn, note 4 above, pp 93–94.

160 Ibid.

161 Ibid, p 94.

162 PPPR, Arts 4(2)–(3).

163 Ibid, Art 29(1).

164 Ibid, Art 29(6) second paragraph.

165 Storck, Karpouzas, and Martin-Laurent, note 99 above, p 1028; EFSA, ‘Conclusion on the Peer Review of the Pesticide Risk Assessment of the Active Substance Glyphosate’ (2015) 13(11) EFSA Journal 4302, p 11Google Scholar. See also Hautala, note 148 above.

166 SAM, note 123 above; Storck, Karpouzas, and Martin-Laurent, note 99 above.

167 Fisher, note 17 above, pp 277, 283.

168 Schauer, note 67 above, p 1345.

169 D Heald, ‘Varieties of Transparency’ in Hood and Heald, note 11 above.

170 C Hood, ‘Transparency in Historical Perspective’ in Hood and Heald, note 11 above.

171 I am grateful to the editors/anonymous peer reviewer, for clarifying this point.

172 COM(2018) 179 final, note 108 above, p 3.

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175 Commission, note 116 above.

176 Ibid, p 22.

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179 Scott, note 26 above.

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184 See Part IV.A.3.

185 Hood, Rothstein, and Baldwin, note 27 above, pp 151–57, 169.

186 See also Hamlyn, note 4 above, pp 93–94.

187 See Part IV.A.3.

188 Hamlyn, note 4 above, p 93.

189 PAN-Europe, ‘Zonal authorisation’ (undated), at https://www.pan-europe.info/eu-legislation/zonal-authorisation.

190 ECORYS, note 99 above, p 170.

191 Fisher, note 17 above, p 306.

192 C Hood, ‘Beyond Exchanging First Principles? Some Closing Comments’ in Hood and Heald, note 11 above, p 219.

193 Jasanoff, note 48 above, p 22.

194 See Parts III.B, IV.A.2.

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197 Fisher, note 17 above, p 289.

198 Ibid, p 312.

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200 COM(2001) 428 final, note 54 above, p 10.

201 Lee, note 66 above, p 197.

202 For example, Declaration No 17 on the right of access to information, annexed to the Final Act of the Treaty on European Union [1992] OJ C191/101; Vos, note 16 above, p 129; Lenaerts, note 199 above, pp 318–24.

203 Lenaerts, note 199 above, pp 319–20.

204 See Part IV.B.

205 C(2017) 8414 final, note 107 above, p 9.

206 European Parliament, note 85 above, p 110.

207 Ibid, pp 19–20.

208 SAM, note 123 above, p 33.

209 PPPR, Art 33.

210 Lee, note 63 above, p 78.

211 Abbot and Lee, note 195 above, p 10.

212 C(2017) 8414 final, note 107 above, p 11.

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216 Abbot and Lee, note 195 above, p 21; R Gönenç, M Maher, and G Nicoletti, ‘The Implementation and the Effects of Regulatory Reform’ (2000) OECD Economics Department Working Papers 251, p 44.

217 As suggested by SAM, note 123 above, p 39.

218 Yackee, S Webb, ‘Reconsidering Agency Capture during Regulatory Policymaking’ in Carpenter, DP and Moss, DA (eds), Preventing Regulatory Capture: Special Interest Influence and how to Limit it (Cambridge University Press, 2014)Google Scholar and references therein.

219 Schauer, note 67 above, pp 1348–49.

220 Tweedale, note 148 above; Hautala, note 148 above.

221 See Parts III.B, IV.A.2.