SpringerOpen Newsletter

Receive periodic news and updates relating to SpringerOpen.

Open Access Discussion

Legal implications of the step-by-step principle

Caroline von Kries1 and Gerd Winter2

Author Affiliations

1 Im Hoeflin 22, Freiburg im Breisgau, D 79117, Germany

2 University of Bremen, Department of Law, Institute for European Environmental Law (FEU), Bremen, D 28334, Germany

Environmental Sciences Europe 2011, 23:32  doi:10.1186/2190-4715-23-32

Published: 21 September 2011

Abstract

Purpose

The 'step-by step' principle was introduced into the European Union legislation on genetically modified organisms as a means to cope with uncertainty about environmental risks from the release of genetically modified organisms into the environment. The approval process is orientated along the stepwise reduction of containment which reflects a precautionary approach towards the risks of genetically modified organism release. Thus, the gradual reduction of containment should keep pace with the gradual generation of risk-related knowledge. This paper strives to clarify the meaning, legal status and practical importance of the principle. It also looks at whether non-European Union countries have adopted the principle as well, and how they practice it.

Methods

The article is based on research of the relevant legal texts, court cases and legal literature. In addition, a number of dossiers of applications for the European Union authorisation of release and placing on the market of genetically modified seed were analysed.

Results and conclusions

Although 'step-by-step' is not a precise legal rule it does have legal meaning as a principle guiding the risk assessment and management of genetically modified organism introduction into the environment. Assuming a process of gradual reduction of containment and scaling up of release ranging from closed systems via experimental release to cultivation the 'step-by-step principle' requires that the knowledge on environmental risks of genetically modified organisms should be generated on stages previous to the ones where the risk can result in damage. The analysis of the legislation of China, the United States of America and Brazil showed a differentiated approach towards the step-by-step principle.

Keywords:
step-by-step principle; release; placing on the market; monitoring; EFSA