Work with genetically modified microorganisms (GMMs)

Use of genetically modified organisms in Sweden is regulated in the Environmental Code, Chapter 13, and is complemented by a number of Swedish ordinances and regulations (e.g. Contained use of genetically modified microorganisms AFS 2011:2). The purpose of these regulations is to protect human health and the environment.

GMM:  A microorganism whose genetic material has been altered in a way that does not occur naturally by mating or natural recombination.

Any use of GMMs must be assessed in accordance with the law as they may pose risks to health and the environment. Their use should be classified into hazard groups (see: Work with biological agents) and subsequently classified under one of the administrative categories F, L or R activity (see below). All contained use of GMMs must be notified to the Swedish Work Environment Authority, and in certain cases a permit must be obtained. “Activity” is an administrative term that comprises a responsible person, an address, a protection level and a type of activity, e.g. laboratory work, teaching or animal experimentation. An approved activity can include several operations, and each individual operation must be separately risk assessed. Please note that it is the operation that is risk assessed, not only the GMM. For example, an operation may include tasks that involve increased risk, in which case the operation might require a higher protection level.

F activity - No risk or negligible risk (containment level 1)
L activity - Low risk (containment level 2)
R activity - Moderate or high risk (containment levels 3 and 4, and large-scale activities with containment level 2)

Organisms that are not classified as GMMs: Organisms obtained through mutagenesis (by means of radiation or chemicals); Organisms obtained through cell fusion of prokaryotic species exchanging genetic material through known physiological processes; Microorganisms produced through cell fusion of cells of eukaryotic species including the production of hybridomas and plant cell fusion.