- Alexandre Nepomuceno (1)
- Humberto Prieto (1)
- Kai Purnhagen (1)
- Stuart Smyth (1)
- J.H.H. Wesseler (1)
- Justus Wesseler (1)
- Agustina Whelan (1)
A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward
Eriksson, Dennis ; Kershen, Drew ; Nepomuceno, Alexandre ; Pogson, Barry J. ; Prieto, Humberto ; Purnhagen, Kai ; Smyth, Stuart ; Wesseler, Justus ; Whelan, Agustina - \ 2019
New Phytologist 222 (2019)4. - ISSN 0028-646X - p. 1673 - 1684.
CJEU - directed mutagenesis - genetically modified organism (GMO) - genome editing - precision breeding
A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome-edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case-by-case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process-based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.
Trends in approval times for genetically engineered crops in the United States and the European Unio
Smart, Richard D. ; Blum, Matthias ; Wesseler, J.H.H. - \ 2017
Journal of Agricultural Economics 68 (2017)1. - ISSN 0021-857X - p. 182 - 198.
Authorisation - EU - GE - genetically modified organism (GMO) - regulatory oversight - transgenic - US
Genetically engineered (GE) crops are subject to regulatory oversight to Ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political decision-making step (risk management). Int he United States (US) approval begins with a scientific (field trial) step and ends with a 'bureaucratic' decision-making step. We investigate trends for the time taken for these steps and the overall time taken for approving GE crops in the US and the EU. Our resulst show that from 1996-2015 the overall time trend for aproval in the EU cereased thd then flattened off, with an overall mean completion-time of 1,763 days. In the US in 1998 there was a break in the trend of the overall approval time. Initially, from 1988 until 1997 the trend decreased with a mean approval time of 1,321 days; from 1998-2015, the trend almost stagnated with amean approval time of 2,467 days.