National Guidance for Environmental Risk Assessment of GM Plants in Field Trials

The guidance document is intended to help applicants identify the experimental data and other scientific documentation that should be included in applications for the deliberate release of genetically modified plants under the Norwegian Gene Technology Act.

This work was commissioned by the Norwegian Environment Agency. The assignment arose from a need for updated and more accessible guidance materials for applicants, which in turn will benefit both the risk assessor (VKM) and the decision-maker (the Norwegian Environment Agency). The guidance document has been developed based on Norwegian regulations and on the European Food Safety Authority (EFSA) guidance for the environmental risk assessment of GM plants.

Covers Established and New Genetic Modification Techniques

The guidance document covers organisms developed using both traditional genetic modification techniques and newer genome-editing techniques. Documentation requirements will vary from case to case, depending on the organism, its traits, the genetic modifications made, the scale of the field trial, and the environment into which the organism will be introduced.

The guidance document describes how VKM conducts its risk assessments through a stepwise process. The objective is to ensure a sufficient knowledge base for assessing potential effects on the environment and on human and animal health.

About the Guidance Document

The guidance document describes how the molecular characterization of genetically modified plants should be documented, including information about the methods used for genetic modification.

It also outlines the information applicants should provide regarding the plant’s inherent and novel traits, its potential for spread and establishment in the environment, gene flow to other plants and microorganisms, possible effects on target and non-target organisms, and impacts on ecosystems.

Applicants are also asked to discuss and describe possible risk mitigation measures for the planned field trial.

Intended to Contribute to More Efficient Processes

The aim of the guidance document is to help applicants understand what documentation and information are required for a risk assessment, thereby making the process from application submission to the final decision by the Norwegian Environment Agency more efficient.

The guidance document is a dynamic document and may be updated as new knowledge and technologies emerge, and as future regulatory changes occur.

Contact person: Ville Erling Sipinen