The Glyphosate saga that had been troubling farmers, regulators, activists and corporations for almost 7 years, finally came to an end with the renewal of the authorization for the infamously notorious pesticide, granted by the European Commission in December 2017. Or did it? Reacting to the widespread institutional and societal concern generated by the uncertainty over Glyphosate’s safety, the European Parliament (EP) has set up a special committee on the authorization procedure for pesticides (the PEST committee), which held its first working meeting in Brussels on April 12th, 2018.
Facts surrounding the Glyphosate controversy are known, but it is worth recalling them briefly before considering the PEST committee’s mandate and scope.
Glyphosate is an active substance used in plant protections products, mainly – but not exclusively – in agriculture. It is available to European farmers since 2002, when the European Commission first authorised it, for a period of 10 years, under Council Directive 91/414/EEC (subsequently repealed by Regulation 1107/2009). Since then, the Monsanto-owned patent has expired and, although the corporation is still one of the main producers of Glyphosate-based pesticides, several other companies have started synthesising the compound. As of today, it is the world’s most widely used pesticide (826 million kg/year as of 2014). It is starting from these premises, that the first renewal of Glyphosate’s authorization became a major case of politicization of science in the European Union (EU).
It all began in 2010, when a consortium of companies (Glyphosate Task Force) filed an application for renewal of Glyphosate’s authorisation to German authorities. Having carried out a preliminary evaluation, Germany, in its capacity of rapporteur Member State, presented a favorable draft assessment report to the European Commission and the European Food Safety Authority (EFSA). In particular, Glyphosate did not seem to present carcinogenic properties.
Pending EFSA’s assessment, however, a scientific dispute over Glyphosate’s safety arose. Diverging views emerged, in particular with regard to Glyphosate’s carcinogenicity, between EFSA and the International Agency for Research on Cancer (IARC, a body of the WHO). According to the latter, Glyphosate was “probably carcinogenic”; EFSA disagreed and, in its October 2015 conclusion, found glyphosate “unlikely to pose carcinogenic hazard to humans”. Such finding was subsequently restated by the European Chemicals Agency (ECHA) in March 2017.
Relying on its two expert agencies’ assessments, the European Commission envisaged a generous 15 years renewal (the maximum period allowed under the 2009 regulation) without any restrictions as to the use of the active substance. The draft implementing regulation proposed by the Commission, however, failed to meet Member States’ support in the Standing Committee on Plants, Animals, Food and Feed (the PAAF Committee) operating under the comitology procedure in February 2016. By then, the scientific disagreement over the carcinogenic properties of the pesticide had in fact become a political dispute, resulting in the “usual” deadlock at Committee level.
The European Commission reacted to such internal and external pressures by gradually reconsidering its initial proposal. Hoping to gain Member States’ votes in the PAAF Committee, it first downsized the renewal to a 10 years period and, failing once again to reach the required majority, to mere 5 years – the minimum according to the 2009 regulation. Only then the Member States’ Appeal Committee gave the green light to the draft implementing regulation, which was finally adopted by the Commission in December 2017.
Different factors can be seen to have twisted a pesticide authorisation renewal into such a politically contentious issue. Among these, some relate to the not always smooth – yet unavoidable – dialogue between science and regulation, others to flaws inherent to the regulatory process and institutional design itself. As to the former, it has been noted how the conflicting findings of IARC and EFSA are at least in part rooted in the different criteria and methodologies adopted by the two expert bodies (IARC having carried out a hazard assessment, based on the intrinsic properties of the substance, EFSA a risk assessment, which takes into consideration actual exposure to it). In regulatory terms, this poses the problem of what counts as scientific uncertainty, and therefore whether the precautionary principle can be legitimately invoked or not. On the other hand, the alleged lack of transparency as to the evidence considered by EFSA alimented concerns over the influence of corporate interests on the agency’s determinations, to the detriment of public trust in the EU regulatory processes’ independence.
Parliamentarisation of science?
It is against this background that the European Parliament has set up the PEST committee. Established under rule 197 of the EP’s rules of procedure, the special committee is composed by 30 members and will be in office for 9 months, running from 12 March 2018, when it held its constitutive meeting in Strasbourg.
Drawing on the Glyphosate dispute, its mandate aims at tackling broader issues of transparency and accountability of EU risk governance. Not only is the PEST committee expected to assess whether the Commission has complied with Regulation 1107/2009 when renewing Glyphosate authorisation, but it is also endowed with a “multidisciplinary” review of the whole pesticide authorisation procedure, aimed at addressing its legal, institutional and (even) scientific weaknesses. The Committee shall assess the EU agencies’ (in primis EFSA and ECHA) compliance with the relevant rules, guidelines and codes of conduct and evaluate the procedure’s transparency and independence, especially from industry. In particular, the committee will have to shed light on possible conflicts of interests (at all levels, including rapporteur Member States’ bodies) affecting the approval procedure, and evaluate whether the relevant EU agencies are adequately equipped – both in terms of staff and of financial resources – to commission and conduct independent studies. Finally, the committee will have to consider the methodology and scientific quality of the procedure, included potential failures in the scientific evaluation.
PEST’s first working meeting consisted in an exchange of views with officials and experts from EFSA and the European Commission, where both technical and regulatory issues were discussed. Perhaps unsurprisingly, the members of the PEST Committee and the invited officials tended to offer diverging views as to the causes of the lack of public trust in EU regulatory processes, which emerged during Glyphosate authorization. In fact, MEPs framed the debate in terms of transparency and independence, of both the risk assessment and the risk management phase; the Commission and EFSA, on the other hand, rather stressed the shortcomings in terms of risk communication and engagement with the public, while generally upholding the overall adequacy of the regulatory process.
It is worth noting that the establishment of the PEST committee has not happened in a vacuum. The EP had already voiced its views on Glyphosate through two non-binding resolutions, respectively adopted in April 2016 and October 2017, the former calling for a seven years renewal with limitations concerning both non-professional uses and public spaces, the latter for a radical phasing out of the active substance by 2022. When reading the establishment of the PEST Committee in continuity with such resolutions, it appears how the assumption according to which parliamentary assemblies are ill suited to engage with technically complex determinations is being questioned. The Committee’s task is undoubtedly a challenging one, both in terms of institutional expertise and of time constraints (the Committee is established for nine months only, extendable by the EP) and might result being too long a shot in terms of impact on the regulatory process. At the same time, it already represents per se a worthwhile exercise of parliamentary oversight, whose potential in enhancing public trust in EU regulatory decision-making should not be underestimated.
While you are here…
If you enjoyed reading this post – would you consider supporting our work? Just click here. Thanks!
All the best, Max Steinbeis