Eriksson, Dennis and Kershen, Drew and Nepomuceno, Alexandre and Pogson, Barry J. and Prieto, Humberto and Purnhagen, Kai and Smyth, Stuart and Wesseler, Justus and Whelan, Agustina
(2019).
A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward.
New Phytologist. 222
:4
, 1673-1684
[Journal article]
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PDF
- Accepted Version
511kB |
Abstract
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.
Authors/Creators: | Eriksson, Dennis and Kershen, Drew and Nepomuceno, Alexandre and Pogson, Barry J. and Prieto, Humberto and Purnhagen, Kai and Smyth, Stuart and Wesseler, Justus and Whelan, Agustina | ||||||
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Title: | A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward | ||||||
Year of publishing : | 2019 | ||||||
Volume: | 222 | ||||||
Number: | 4 | ||||||
Page range: | 1673-1684 | ||||||
Number of Pages: | 12 | ||||||
Publisher: | Wiley | ||||||
ISSN: | 0028-646X | ||||||
Language: | English | ||||||
Publication Type: | Journal article | ||||||
Refereed: | Yes | ||||||
Article category: | Scientific peer reviewed | ||||||
Version: | Accepted version | ||||||
Full Text Status: | Public | ||||||
Subjects: | (A) Swedish standard research categories 2011 > 4 Agricultural Sciences > 401 Agricultural, Forestry and Fisheries > Agricultural Science (A) Swedish standard research categories 2011 > 5 Social Sciences > 506 Political Science > Public Administration Studies | ||||||
Keywords: | CJEU, directed mutagenesis, genetically modified organism (GMO), genome editing, precision breeding | ||||||
URN:NBN: | urn:nbn:se:slu:epsilon-p-98842 | ||||||
Permanent URL: | http://urn.kb.se/resolve?urn=urn:nbn:se:slu:epsilon-p-98842 | ||||||
Additional ID: |
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ID Code: | 16181 | ||||||
Faculty: | LTV - Fakulteten för landskapsarkitektur, trädgårds- och växtproduktionsvetenskap | ||||||
Department: | (LTJ, LTV) > Department of Plant Breeding (from 130101) | ||||||
Deposited By: | SLUpub Connector | ||||||
Deposited On: | 01 Oct 2019 07:02 | ||||||
Metadata Last Modified: | 14 Dec 2019 00:15 |
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