Time for a New EU Regulatory Framework for GM Crops?

Charlotta Zetterberg,Karin Edvardsson Björnberg

doi:10.1007/s10806-017-9664-9

Charlotta Zetterberg, Karin Edvardsson Björnberg

Open Access

https://doi.org/10.1007/s10806-017-9664-9

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Abstract

In recent years, the EU legislation on genetically modified (GM) crops has come under severe criticism. Among the arguments are that the present legislation is inconsistent, disproportionate, obsolete from a scientific point of view, and vague in terms of its scope. In this paper, the EU GM legislation (mainly the “Release Directive”, 2001/18/EC) is analysed based on five proposed criteria: legal certainty, non-discrimination, proportionality, scientific adaptability, and inclusion of non-safety considerations. It is argued that the European regulatory framework does not at present satisfy the criteria of legal certainty, non-discrimination, and scientific adaptability. Two ways of reforming the present legislation toward greater accommodation of the values expressed through the proposed criteria are briefly introduced and discussed.

Highlights

The legislative work on the use of genetic engineering in plant breeding has developed in roughly two parallel directions, or tracks
Based on what has been proposed in the genetically modified organisms (GMOs) regulation literature to date, we identify a non-exhaustive set of legal principles and criteria of relevance that we believe any reformed EU genetically modified (GM) regulatory system would have to meet
A second option could be to abandon the present ‘dual-track’ system for crop introductions and instead introduce a new crop legislation based on sustainability criteria that apply to all varieties regardless of breeding methods used

Summary

Introduction

The legislative work on the use of genetic engineering in plant breeding has developed in roughly two parallel directions, or tracks. If there is reason to believe that those preferences are well-informed in the sense that they are not based on misunderstandings of the science underpinning genetic modification or what is presently known about the potential social, environmental and health consequences of GM introductions, they should not be dismissed categorically by the legislator (Kysar 2004) To further strengthen this line of argumentation, one could point to the effects that an inclusion of non-safety considerations could have in terms of people’s trust in the GM regulatory system. The grounds must not in any case conflict with the environmental risk assessment carried out pursuant to the Release Directive or the Food and Feed Regulation, but could be based on new scientific evidence concerning aspects not dealt with in the environmental risk assessment process, such as socioeconomic impacts, organic production, or ‘‘maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features, as well as specific ecosystem functions and services’’.29. They both, in different ways, constitute a regulatory shift for GM varieties within the union

A New Protocol for Risk Assessment

A New Crop Legislation Based on Sustainability Criteria

Conclusions