National Guidance for Environmental Risk Assessment of GM Animals 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 animals 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 animals.

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 has primarily been developed for genetically modified fish and genetically modified mammals, but it may also be relevant to the risk assessment of other types of genetically modified animals.

It includes a description of how the molecular characterization of genetically modified animals should be documented, including information on the methods used for genetic modification. Particular emphasis is placed on assessing the possible consequences of escaped trial animals. This includes, among other things, the likelihood of establishment in the wild, interbreeding with wild populations, disease transmission, effects on other species, and potential consequences for Norwegian ecosystems.

In addition, the guidance document describes different containment measures that can prevent escapes and outlines risk mitigation measures that should be considered and included as part of the application documentation.

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: Anne Marthe Ganes Jevnaker