Abstract
This chapter focuses on three issues that proved particularly controversial in the last 10 years and required sustained debates among policy-makers, scientists and activists. The three controversies are: the precautionary ban of neonicotinoids for their adverse effects on pollinators; the debate over the re-authorisation of glyphosate, a chemical that has been declared both a ‘probable carcinogen’ by the International Agency for Research on Cancer and ‘safe’ by European authorities; the definition of criteria for the assessment of endocrine disrupting properties of pesticides. Overall, the analysis of these controversies provides useful insights into the broader issue of the use of precautionary principle and sheds light on ongoing trade-offs in the EU system of risk regulation.
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Notes
- 1.
Seed treatment is not the only mode of use. In some formulations neonicotinoids can be sprayed.
- 2.
A first vote took place on 14/15 March 2013 in the Standing Committee on the Food Chain and Animal Health, falling short of the 255 votes needed to adopt the Implementing Regulation. National representatives could not agree on an opinion and therefore the EC referred to the Appeal Committee. The second vote was held in the Appeal Committee on 29 April and again the required majority was not met. The Appeal Committed did not deliver an opinion either and the EC, acting in accordance with Article 6 of Regulation 182/2011, could adopt the act.
- 3.
Both academic and media accounts reported that the EU enforced a two-year ban. This is inexact: the ban on the use of the three neonicotinoids as seeds and foliar treatment on crops attractive to pollinators is permanent, the evidence supporting it was to be reviewed in two years. The confirmatory data published in 2015 confirmed the ban. Additional work is to be delivered in 2017.
- 4.
In the USA, the EPA took action to limit the spraying of neonicotinoids during flowering and expedited the approval of new pesticides to be used against Varroa mite.
- 5.
The IARC reports are often controversial, even if they do not necessarily result in regulatory conflicts, as in the case of glyphosate. In recent years the most famous IARC report, which sparked global concerns, classified processed red meat as a carcinogen (IARC Monographs 114).
- 6.
The GTF is not a legal entity, and it has been formed with the specific purpose of sharing resources and submitting a joint renewal application in the EU. The practice is strongly encouraged by EU regulations, with a view to avoiding expensive parallel appraisal processes and to avoid duplications of testing involving vertebrate animals.
- 7.
Findings have been summarised in an article in Lancet Oncology. See http://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045%2815%2970134-8.pdf
- 8.
Specifically, the IARC classification ‘2A probably carcinogenic to humans’ is used ‘when there is limited evidence on carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals’ (IARC 2015, p. 22).
- 9.
Incidentally, it might be interesting to note that media reported that the glyphosate issue played a role in Brexit, the EU being accused of not protecting citizens adequately. The analysis of the glyphosate controversy and more generally two decades of pesticides policy and politics show that UK governments systematically opposed precautionary actions in the sector. In this light, it seems reasonable to anticipate that expectations to achieve higher levels of protection in a fully sovereign UK after Brexit seem unlikely.
- 10.
This is not to say that the IARC evidence is scant; on the contrary, glyphosate is one of the most researched active substances. With respect to most pesticides, particularly new ones, the peer-reviewed literature can be non-existent.
- 11.
EFSA replied to Professor Portier’s letter by defending its procedures and the transparency of the assessment, and expressing ‘strong disagreement’ with the contents of the letter (EFSA 2016).
- 12.
As a contribution to the ongoing discussion, the OECD published recommendations for a common methodological framework in 2002. Indeed, at that time the EC was very optimistic and in COM(2001) 444 stated that international methods at the international level were expected to be approved by 2003. Very important ‘state of the art’ reports were been published by the WHO in 2002 and in 2012.
- 13.
Some chemicals, notably Bisfenol A, have been banned on a case-by-case basis in the EU on account of their endocrine disrupting properties.
- 14.
The 2006 proposal reads: ‘An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines it is not considered to have endocrine disrupting properties that may be of toxicological significance in humans unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible’ (COM(2006) 388 p. 68).
- 15.
See Reg 1107/2009 Annex II point 3.6.5.
- 16.
The Regulatory Procedure with Scrutiny (RPS) is a comitology procedure that is no longer in use for new legislative acts. It was in force in the period 2006–2009 and accordingly it is foreseen by Article 78 of Regulation 1107/2009, which empowers the EC to amend non-essential parts of the Annexes of the same regulation. It empowers the EP and the Council to block a draft Implementing Act under certain conditions – for instance if they think the EC exceeded its implementing powers.
- 17.
Scientific paradigms have been defined by Kuhn as ‘a set of recurrent and quasi-standard illustrations of various theories in the conceptual, observational and instrumental applications’ (Kuhn 1970, p. 43)
- 18.
A ‘classic’ conception would include organs that secret hormones as well as organs with secondary endocrine functions, like the kidney, liver, heart and gonads. Recent research, however, expands this definition since new findings ‘are continuously blurring the borders between the nervous system, immune system and endocrine system’ (Kortenkamp et al. 2011, p. 13)
- 19.
Incidentally, it can be noted that the debate among scientists is also very heated, each party accusing the other of advancing proposals that are ‘flawed by an imbalanced presentation of available information and some misinterpretation of statements’ (Autrup et al. 2015, p. 12).
- 20.
It must be noted that also mutagenicity (another cut-off criteria) is a mechanism: it refers to the induction of permanent transmissible changes in the structure of the genetic material of cells or organisms. In this case, however, the phenomena are easier to circumscribe (if I have understood correctly) and protocols have been agreed to at international level.
- 21.
It might be useful to recall that, despite much of the controversy being around adverse effects, ‘interference with the hormone system’ might actually be beneficial. Chemicals with this property are used in therapies against conditions like breast, pancreatic and prostate cancer.
- 22.
Endocrinologists state that in assessing ED many dose-effect relationships are non-monotonic and have been found to follow a J-shaped, or a U-shaped curve.
- 23.
It might be important to note that this distinction between a ‘toxicology-preferred option’ and an ‘endocrinology-preferred option’ is not used by the EC. Furthermore, the EC evaluated multiple policy options that cannot be discussed here. What is presented in this section is therefore an over-simplification. It is fair to argue, however, that toxicologists and endocrinologists expressed very precise – and polarised – preferences for the options under discussion.
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Bozzini, E. (2017). Open Controversies: Bees’ Health, Glyphosate and Endocrine Disruption. In: Pesticide Policy and Politics in the European Union. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-52736-9_4
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