Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions

Abstract

The regulation of pesticides in the European Union (EU) relies on a network of hard law (legislation and implementing acts) and soft law (non-legally binding guidance documents and administrative and scientific practices). Both hard and soft laws govern how risk assessments are conducted, but a significant role is left to the latter. Europe’s pesticide regulation is one of the most stringent in the world. Its stated objectives are to ensure an independent, objective and transparent assessment of pesticides and achieve a high level of protection for health and environment. However, a growing body of evidence shows that pesticides that have passed through this process and are authorised for use may harm humans, animals and the environment. The authors of the current paper – experts in toxicology, law and policy – identified shortcomings in the authorisation process, focusing on the EU assessment of the pesticide active substance glyphosate. The shortcomings mostly consist of failures to implement the hard or soft laws. But in some instances the law itself is responsible, as some provisions can only fail to achieve its objectives. Ways to improve the system are proposed, requiring changes in hard and soft laws as well as in administrative and scientific practices.

Case C-616/17 Blaise and Others: The precautionary principle and its role in judicial review – Glyphosate and the regulatory framework for pesticides

“…However, the Court through this deferential approach aims to safeguard the discretion of the legislator in setting the regulatory and scientific requirements for approval or authorization, where the legislator has to safeguard a high level of protection of human and animal health as well as environmental protection, while also facilitating the marketing of pesticides to increase agricultural productivity. 96 It is questionable whether the increasingly voiced criticisms towards the regulation of pesticides is indeed due to flaws in the Regulation, which could have been addressed in the Blaise case, or if gaps might be found in the administrative guidance that further implement the Regulation, 97 or the risk assessment and risk management in concrete cases like glyphosate. Those were not addressed due to the questions referred, the limited review and the choice of using the precautionary principle as the benchmark for validity.…”

“…Finally, the clarification provided by the Court to the fourth question -that PPPs are not exempted from long-term toxicological studies -was welcomed by some, although doubts are voiced as to whether this will be sufficiently implemented in the Member States. 95 However, overall, the Blaise case is certainly not the catalyst for a radical reform in the regulatory approach to pesticides that might have been desired by some actors.…”

Integrated pest management: good intentions, hard realities. A review

“…Finally, in the aforementioned research, use of chemicals is often widespread. Pesticide reduction policies favor, for example, studies on those that are the least dangerous for human health and the environment (Eddleston et al 2002;Farrar et al 2018;Jepson et al 2020;Robinson et al 2020;Whiteker 2019). This general trend, boosted by the plant protection industry, endorses and helps to legitimize the use of synthetic pesticides in crop protection and in IPM schemes.…”

“…In pest management, questions relating to the questions of sustainability have often been raised (van Lenteren 1998), in particular, the many harmful consequences of the massive use of pesticides: farmers, consumers and society in general face more socio-economic difficulties (Bourguet and Guillemaud 2016;Sheahan et al 2017); there is mounting pollution of water, soil and the atmosphere (Aubertot et al 2005;Burdon et al 2019); biodiversity is being eroded, particularly that of insects (Foucart 2019;Hallmann et al 2017;Sánchez-Bayo and Wyckhuys 2019) and birds (Chamberlain and Fuller 2000;Hallmann et al 2014). Researchers are increasingly pointing out the risks and consequences for public health (Baldi et al 2013;Bassil et al 2007;Eddleston et al 2002;Fantke et al 2012;Hedlund et al 2020;Hoppin and LePrevost 2017;Robinson et al 2020;Sheahan et al 2017;Wyckhuys et al 2020a); even human rights are mentioned (UN 2017). This really is the breaking point that must bring about change among farmers.…”

Study of the different evaluation areas in the pesticide risk assessment process

“…Risk assessment methodologies are methods of – and criteria for – evaluating data, which form the basis of regulatory decision‐making. They are written into hard law (legislation and implementing acts) and in soft law (non‐legally binding guidance documents, administrative and peer‐reviewed scientific literature), with a significant role left to the latter (Robinson et al., 2020). Deviations from non‐legally binding guidelines are allowed provided a full description and scientific justification in the risk assessment.…”