Developing guidelines for risk assessment of genetically modified plants and animals used in field trials

This assignment is commissioned by the Norwegian Environment Agency.

The Norwegian Environment Agency has recently received various applications requesting approval for experimental release of genetically modified organisms (GMOs) under the Norwegian Gene Technology Act. To facilitate the process, VKM has been asked to create simplified guidelines to support applicants, risk assessors and authorities.

The guidelines will focus on assessment of plants and animals developed with new genome editing techniques (NGTs) but will also be applicable for GMOs developed with older techniques. Separate guidelines will be made for plants and animals. The guidelines for animals will include mammals, birds, fish and insects.

The assignment is divided into separate deliverables. Initially, VKM will make guidelines describing the required scientific data on molecular characterisation (Part 1) which should be included in an application.

VKM received the assignment from the Norwegian Environment Agency on 10 December 2024.

A project group, consisting of five members of the VKM scientific committee and a research scientist at the Norwegian Institute of Bioeconomy Research (NIBIO), will prepare the guidelines. Final approval of the guidelines will be made by the VKM Panel on Genetically Modified Organisms, supplemented by other members of the VKM scientific committee.

The deadline for the guidelines on molecular characterisation (Part 1) is in September 2025.

Project group

Monica Sanden, Chair of the project group and of the Panel on Genetically Modified Organisms

Johanna Bodin, member of the Panel on Genetically Modified Organisms

Knut Tomas Dalen, member of the Panel on Nutrition, Dietetic Products, Novel Food, and Allergy

Nur Duale, member of the Panel on Genetically Modified Organisms

Kristian Prydz, member of the Panel on Genetically Modified Organisms

Sjur Sandgrind, Research Scientist at the Division of Biotechnology and Plant Health, NIBIO

Ville Erling Sipinen, Project Manager, VKM Secretariat