Maximum vs minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies.

New plant-breeding technologies (NPBTs), including gene editing, are widely used and drive the development of new crops. However, these new technologies are disputed, creating uncertainty in how their application for agricultural and food uses will be regulated. While in North America regulatory systems respond with a differentiated approach to NPBTs, the Court of Justice of the European Union (EU) has in effect made most if not all NPBT subject to the same regulatory regime as genetically modified organisms (GMOs). This paper discusses from a law and economics point of view different options that are available for the EU's multi-level legal order. Using an ex-ante regulation versus ex-post liability framework allows the economic implications of different options to be addressed. The results show that under current conditions, some options are more expensive than others. The least costly option encompasses regulating new crops derived from NPBTs similar to those used in 'conventional' breeding. The current regulatory situation in the EU, namely making the use of NPBTs subject to the same conditions as GMOs, is the most costly option. © 2019 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

A comparison of the EU and US regulatory frameworks for the active substance registration of microbial biological control agents.

BACKGROUND: Microbial biological control agents (MBCA) are biopesticides based on living microbes. They have huge potential for the control of pests and diseases, but have trouble reaching the European Union (EU) market. According to several authors, this is caused by the regulatory regime, which is less supportive compared with that in the USA. The main objective of this paper is to present regulatory differences between the USA and the EU, and the resulting effects and developments of registration in both regions. RESULTS: Results show that EU registration is more complex due to differences between EU- and Member State (MS)-level processes, large actor heterogeneity and low flexibility. As a result, EU registration takes, on average, ∼ 1.6 years longer than US registration. Regulatory amendments have improved EU-level processes and led to a significant contraction of procedural time spans, but processes at the MS level have not improved and have become a larger procedural obstacle. CONCLUSION: The results correspond with the idea that EU registration is complex and lengthy compared with that in the USA. To improve regulation, national-level processes should be targeted for amendment. To that end, the authors suggest various ways of expanding the registration capacity of MS. © 2018 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.