German Federal Agency for Nature Conservation (BfN)


Analysis and Evaluation of Existing Toxicological Testing Procedures used in Risk Assessments on Genetically Modified Plants


Integration of nature conservation issues into genetic engineering policy

Research Code

805 64 005

Project Lifecycle

1 August 2005 – 30 September 2006

Research Focus and Aims

Environmental risk assessment on genetically modified organisms (GMOs) involves the assessment and evaluation of undesired toxic effects on animals, plants and micro-organisms. This requires a testing procedure which takes account of the specific issues and requirements for assessment of GMOs.

ECT Oektoxikologie GmbH

The existing ecotoxicological testing procedures were originally developed to assess substances such as industrial chemicals and pesticides. They are not generally suited to assessing the specific traits of genetically modified organisms. There are key differences in, for example, the exposure of non-target organisms which in the case of effects caused by GMOs occur via ingestion of food (meaning they are part of a complex matrix and dependent on the type of food involved), on the length of exposure as GMO toxins often occur in the whole plant over long life-cycles, and in the limited opportunity to conduct dose-response tests with GMOs. The differences show that testing of transgenic plants cannot be placed on a level with that of chemicals. Ecotoxicological testing procedures for genetically modified plants (GMPs) must take in as an integrated system case-by-case risk assessment (as prescribed in national and EU legislation), the traits of the introduced gene construct, the plant species and the ecosystem into which the GMO will be released.

The experience gathered so far in approving GMOs shows that particularly where assessing the potential adverse effects on non-target organisms and organism relationships is concerned, no adequate testing procedures or testing strategies exist so far. This R&D project will analyse and evaluate existing ecotoxicological testing methodologies and strategies for their use in GMO environmental risk assessment and will subsequently formulate requirements for future GMO testing methods and strategies. Specific recommendations for aligned testing methods and strategies will serve as models for transgenic plants with toxin-producing and metabolism-changing traits. The findings of the study will be discussed in June 2006 in talks held at BfN with representatives from the respective government agencies, universities and other interested institutions.

Research Body

EcoStrat GmbH
Ökologische Technologiefolgenabschätzung & Umweltberatung
Dr. Angelika Hilbeck
Deitmerstr. 7
12163 Berlin

in cooperation with

ECT Oekotoxikologie GmbH
Dr. Jörg Römbke
Böttgerstr. 2-14
65439 Flörsheim

Point of Contact at BfN

Hanka Teichmann FG II 2.3

Last Change: 05/07/2006