Work with genetically modified microorganisms (GMMs) and genetically modified organisms (GMOs)

GMM

Genetically modified microorganisms are abbreviated GMM and are a microorganism whose genetic material has been altered in a way that does not occur naturally through mating or natural recombination. 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. The purpose of these regulations is to protect human health and the environment.

Risk assessment and permit

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. 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)

The following are not considered GMM

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.

GMO

Genetically modified organisms are abbreviated as GMOs. According to the legislation, a GMO is an organism in which the genetic material (genome) has been changed in a way that does not occur naturally, for example through mating or cross-fertilization. An organism can be, for example, a whole plant, a seed, a potato tuber, an animal or a virus. In the GMO legislation, an organism is defined as a biological unit that can reproduce or transfer genetic material.

In order to carry out laboratory work (contained use) with GMOs, the activity must be approved by the appropriate competent authority: the Swedish Board of Agriculture (plants and animals), the Swedish Agency for Marine and Water Management (aquatic organisms). As long as the laboratory, greenhouse, aquarium, etc. meets the regulations, the competent authority will approve the facility. Please note that additional permits may be required for the activity, such as ethical approval for animal experimentation.

Clinical trials of GMO drugs are regulated by the Swedish Medical Products Agency.

The difference between GMM and GMO

The term genetically modified organisms (GMO) includes all organisms that are genetically altered in a way that does not occur naturally. GMMs are covered by and included in the term GMO, but not all GMOs are GMMs.