A tiered system for assessing the risk of genetically modified plants to non-target organisms

¹  Syngenta, Jealott's Hill International Research Centre, Bracknell, RG42 6EY, United Kingdom
²  Monsanto Europe, Avenue de Tervueren 270 – 272, B-1150 Brussels, Belgium
³  Monsanto Company, 800 N. Lindbergh Blvd, St. Louis, MO 63141, USA
⁴  Bayer CropScience, Industriepark Höchst H871, D-65926 Frankfurt am Main, Germany
⁵  Syngenta International AG, Avenue Louise 240, Box 4, B-1050 Brussels, Belgium
⁶  Bayer CropScience, Rue Jean-Marie Leclair 16, CP 106, F-69266 Lyon Cedex 09, France
⁷  Pioneer Hi-Bred International, 7300 NW 62nd Avenue, PO Box 1004, Johnston IA 50131-1004, USA
⁸  Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels, Belgium

Corresponding author: francesca.tencalla@monsanto.com

Abstract

Representatives of the developers of modern agricultural biotechnology are proposing a tiered approach for conducting non-target organism risk assessment for genetically modified (GM) plants in Europe. The approach was developed by the Technical Advisory Group of the EuropaBio Plant Biotechnology Unit (http://www.europabio.org/TAG.htm) and complements other international activities to harmonize risk assessment. In the European Union (EU), the principles and methods to be followed in an environmental risk assessment for the placing on the market of GM plants are laid out in Annex II of Directive 2001/18/EC on the deliberate release into the environment of GMOs, Commission Decision 2002/623/EC and Regulation (EC) No. 1829/2003. Additional information is provided in the European Food Safety Authority guidance document of 2004. However, risk assessment for effects to non-target organisms could benefit from further clarification and remains the subject of much discussion in Europe. The industry-wide approach developed by EuropaBio is based on the fundamental steps of risk evaluation, namely hazard and exposure assessment. It follows a structured scheme including assessment planning, product characterization and assessment of hazard/exposure (Tier 0), single high dose and dose response testing (Tier 1), refined hazard characterization and exposure assessment (Tier 2) and further refined risk assessment experiments (Tier 3). An additional tier (Tier 4) was included to reflect the fact that post-market activities such as monitoring are required under Directive 2001/18/EC. The approach is compatible with conditions of commercial release in the EU and around the world.