Biotechnology Law (2004): Current Survey of Substantive EU Environmental Law

Abstract

Overview of recent (EU and international) legal and political developments in the regulatory field of agricultural biotechnology and genetically modified organisms (GMOs) and GM food governance. Year under review: 2004.

Introduction: Following the epic year 2003, which brought an imposing wave of legislation and policy breakthroughs in the area of biotechnology regulation, one might have expected but small ripples during 2004. However, though perhaps not as eventful as its preceding annum, this survey year once again saw vital developments in this still emerging area of European Community (EC) law.

In the face of mounting international pressure - or perhaps most importantly, the prospect of multi-billion Euro trade damage retaliation measures - the Commission finally managed to lift the EC’s oft-discussed de facto moratorium on approvals of new genetically modified organisms (GMOs). By way of the recently adopted new regulatory procedures for GMO authorizations, the Commission was able to push through its longstanding affirmative stance on the products of ‘green’ biotechnology, in spite of continued deadlock among the Member States.

Whilst it remains to be seen whether the ‘floodgates’ of Europe have now been opened to a stream of new genetically modified (GM) import commodities from the world’s leading GMO producers, the United States of America (US), Canada, and Argentina, a vital precedent has been set.

Adding to this, in a related move, the Commission made the debut inscriptions in the European Union (EU) Common Catalogue of Agricultural Plant Species, enabling the cultivation of 17 varieties of US-made GM maize lines on European farming fields.

Two (closely related) major outstanding dossiers are the EC’s policy for coexistence of GM, conventional, and organic agriculture, and the pending rules for purity of conventional seeds, and labeling thresholds for adventitious admixture of those seeds with GM varieties. With tumultuous developments, neither dossier provided for smooth sailing during 2004. However, with new captains at the helm since November 2004, final destinations may now well be in sight for 2005.

Also in 2004, a variety of implementing legislation was adopted, to facilitate the application of the GMO Directives and Regulations adopted in recent years at the Community level. Ironically, at the national level, implementation efforts for this legislation continue to be sluggish, again necessitating judicial intervention by the European Court of Justice (ECJ).

In the international realm, in the context of various fora and organizations, negotiations continued on a plethora of issues of global importance, including liability and redress, access to information and the right to public participation in decision-making, labelling, traceability, and detection and sampling schemes, and risk assessment and management strategies.

Whereas these international concerted efforts also continue to be plagued by fundamental differences in approaches to biosafety and trade issues, nowhere is the clash between the world views of (so often disingenuously labelled) ‘scientific’ and ‘precautious’ risk as tangible as in the World Trade Organization (WTO) trade dispute over GMOs. Exemplifying the complexity of this conflict between the biotech exporting giants US, Canada, and Argentina, and the ever-hesitant importer Europe, its adjudicators have had to postpone their decision until 2005, awaiting scientific expert guidance in the interim.

Keywords: GMO, biotechnology law, GM food, coexistence, risk regulation, environmental liability, EU law, EC environmental law, Cartagena Biosafety Protocol, labelling, contained use, case law, life sciences, WTO, European environmental policy, Precautionary principle

JEL Classification: K32, K33, K39, K23, K10, K13, K19, K00, O13, Q17, Q18