In the Public Interest? A Comparative Analysis of Norway and EU GMO Regulations

• DOI: http://doi.org/10.1111/reel.12134
• Published date: 01 November 2015
• Author: Apolline Roger
• Date: 01 November 2015

In the Public Interest? A Comparative Analysis of

Norway and EU GMO Regulations

Apolline Roger*

The European Commission, when deciding whether

the cultivation and use of genetically modified organ-

isms (GMOs) should be authorized on European Union

(EU) territory, has always limited its decision to safety

considerations. Dissatisfied, Member States required

the adoption of the ‘GMO Package’. Its first applica-

tion, Directive 2015/412, gives Member States the

same opportunity that was already offered to Norway

under the European Economic Area Agreement. It

allows them to invoke social grounds to opt out of EU

authorizations, but maintains the competence of the

EU institutions over safety issues. The interpretation

of the Directive promises to be contentious. How and

to what extent may the Member States use the new

provisions to open a debate on when authorizing a

GMO is in the public interest? Learning from the Nor-

wegian authorities that have done so since 1994, this

article offers insights both on the Norwegian system

and on the potential of the new Directive.

INTRODUCTION

Genetically modified organisms (GMOs) are now

widely used. In 2013, GMOs, mostly cotton, maize and

soy, were cultivated on 174 million hectares of land.

Genetically modified (GM) soybeans occupy 79% of the

world soy production surface.1This change in agricul-

tural practices is generally regulated. Many countries

decided to submit GMOs to a pre-market authorization

at the national level2and to cooperate on the matter at

the international level.3The identification of which

GMOs can be released into nature and society has

therefore been recognized not only as a matter of public

interest but also as requiring the intervention of public

authorities.

For a researcher in law, but more generally for social

scientists, this situation raises important questions

typical of the integration of new and ethically sensitive

technologies in society. One of them is the way public

authorities define what is in the ‘public interest’ in rela-

tion to new technology; the public interest that pre-

release authorization procedures are deemed to protect.

Indeed, the way public interest is defined, implicitly or

explicitly, shapes the objective, scope and ambition of

the regulation. It is therefore the core of the regulation

and, as such, should be clearly identified, thoroughly

debated and democratically agreed upon.

Today, most countries limit the assessment of GMOs to

the risks they might present for health and the environ-

ment. The release of a GMO considered as ‘safe’ is

therefore assumed to be in the public interest.4The

protection against physical harm is undoubtedly of

primary importance, and the breadth and depth of the

regulation on this matter should be carefully designed.

Yet, when the decision to authorize a GMO event5is

based purely on safety, the socio-economic, cultural

and ethical dimensions of the release of GMOs into

society are ignored. However, these aspects are

essential. Indeed, most GMOs are technological appli-

cations meant to change two fundamental areas of

* Corresponding author.

Email: Apolline.Roger@ed.ac.uk

1See GMOcompass, ‘Genetically Modif‌ied Plants: Global Cultivation

on 174 Hectares’ (2013), found at: <http://www.gmo-compass.org/

eng/agri_biotechnology/gmo_planting/

257.global_gm_planting_2013.html>.

2Even though these regulations display very different characteristics.

See L. Bodiguel and M. Cardwell (eds.), The Regulation of Geneti-

cally Modif‌ied Organisms: Comparative Approaches (Oxford Univer-

sity Press, 2010); see also J.A. Heinemann, S. Zanon Agapito-Tenfen

and J.A. Carmand, ‘A Comparative Evaluation of the Regulation of

GM Crops or Products Containing dsRNA and Suggested Improve-

ments to Risk Assessments’, 55 Environment International (2013),

43; and L. Krämer, ‘Genetically Modif‌ied Living Organisms and the

Precautionary Principle’ (TestBiotech, 2013).

3Cartagena Protocol on Biosafety to the Convention on Biological

Diversity (Cartagena, 29 January 2000; in force 11 September 2003).

4See P.B. Thompson, ‘Ethics and Equity’, in: K. Ludlow, S.J. Smyth

and J. Falck-Zepeda (eds.), Socio-economic Considerations in Bio-

technology Regulation (Springer, 2014), 97; M. Lee, ‘Beyond Safety?

The Broadening Scope of Risk Regulation’, 62:1 Current Legal Prob-

lems (2009), 242; and L. Levidow and S. Carr, ‘How Biotechnology

Regulation Sets a Risk/Ethics Boundary’, 14:1 Agriculture and

Human Values (1997), 29.

5‘When scientists develop transgenic plants, plant cells are trans-

formed with foreign DNA individually. Every cell that successfully

incorporates the gene of interest represents a unique “event”. Marker

genes are used to identify transformed cells, and each resulting

transgenic plant is the result of one event.’ See <http://www.gmo-

compass.org/eng/glossary/>. When more than one gene is trans-

ferred the GMO is called a ‘stacked event’.

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Review of European Community & International Environmental Law

RECIEL 24 (3) 2015. ISSN 2050-0386 DOI: 10.1111/reel.12134

© 2015 John Wiley & Sons Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.

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