In the Swedish Environmental Code, the term 'contained use' refers to any activity in which 'organisms are genetically modified or in which such organisms are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the public and the environment'. Specific containment measures may be physical barriers or a combination of physical and other barriers.Examples of contained use include the culture of micro-organisms in sealed vessels, the use of laboratory animals in the production of pharmaceuticals, and the growing of plants in glasshouses. The level of containment required varies according to the risk and the type of organism involved.
Contained use of GMOs is regulated by the Ordinance on Contained Use of Genetically Modified Organisms (SFS 2000:271).
The competent authorities with regard to contained use are:
- The Swedish Work Environment Authority, in the case of genetically modified micro-organisms, including cell cultures of higher organisms.
- The National Board of Fisheries, with respect to aquatic genetically modified organisms.
- The Swedish Board of Agriculture, as regards other genetically modified organisms.
Contained use of genetically modified micro-organisms
A contained use of genetically modified micro-organisms (GMMs) is classified as either a category F, L or R activity, according to the risks involved. These categories of activity are subject to different requirements in terms of consents and notifications, as provided in the Genetically Modified Organisms (Contained Use) Ordinance (SFS 2000:271).
Category F activity: Contained use of GMMs involving negligible or no risk to human health or the environment. Notification must be given of the activity, but notification of new uses within that activity is not required.
Category L activity: Contained use of GMMs involving a low risk of harm to human health or the environment. Notification of the activity is required, and also of every new use within a previously notified activity.
Category R activity: Contained use of GMMs involving a moderate or high risk to human health or the environment. A consent must be obtained for the activity, and for every new use within an activity that has previously received consent.
The Swedish Work Environment Authority's Regulations on Contained Use of Genetically Modified Micro-Organisms (AFS 2000:5) define more precisely the criteria governing GMM activities and the information to be provided in notifications and applications for consent. These regulations require documentation of a risk assessment covering both health and environmental risks. They also provide for protective measures at one of four levels of protection. Decontamination of wastes and in the event of spillage is required at all levels of protection.
Contained use of other genetically modified organisms
Rules on the contained use of genetically modified organisms other than micro-organisms are set out in the Swedish Board of Agriculture's Regulations on the Contained Use of Genetically Modified Plants (SJVFS 2007:29), the Board of Agriculture's Regulations on the Use of Genetically Modified Animals (SJVFS 1995:33), and the National Board of Fisheries' Regulations on Genetically Modified Aquatic Organisms (FIFS 2004:2).
Anyone using genetically modified terrestrial plants or animals in contained conditions (e.g. in a glasshouse, animal house or similar facility) must apply for consent to use the premises and then notify the Board of Agriculture of the intended contained use. Corresponding requirements apply to aquatic organisms, which are the responsibility of the National Board of Fisheries.
