The Swedish Work Environment Authority is the Competent Authority supervising contained use of GMMs in Sweden. All contained use of GMMs must be subjected to a risk assessment and, with a few specified exceptions, must be notified to or permitted by the Swedish Work Environment Authority. The risk assessment forms the basis for the protective measures, which the user needs to apply for the prevention of harm to human health or the environment.
each microbiological unit, cellular or non-cellular, which can multiply or transfer genetic material, e.g. bacteria, virus, viroids, prions, microfungi, microalgae, protozoans, as well as cell cultures of higher organisms. If such cell cultures are differentiated into higher organisms, the use of these is under the regulations by e.g. The Swedish Bord of Agriculture (Jordbruksverket) for the contained use of genetically modified organisms (GMOs).
Genetically modified microorganism (GMM)
a micro-organism whose genetic material has been altered in a way not occurring naturally through mating or natural recombination. A microorganism which has been modified genetically by means of irradiation or chemical treatment is not considered as GMM.
Contained use of genetically modified organisms including GMMs
an activity in which organisms are genetically modified, cultured, stored, used,
transported, destroyed, disposed of or used in any other way, and for which
specific containment measures are used to limit their contact with the general population and the environment.
is an administrative concept and is conducted in a delimited facility and belongs to an organisational unit for which it should be clear who is in charge. Hence, the responsibility for the Internal Control can be delegated from the user (Umeå University) to the person in charge for an activity at the defined organisational unit, e.g. the Chairman for a department at the university. Examples of the focus of the activities at Umeå University are:
- Laboratory activity
- Activity with GMM on laboratory animals
- Activity with GMM on plants
For any of these activities, one should also define its nature as being either of e.g.:
- Research and development
Different types of activities require different types of facilities. For example, it is important that the facilities are adapted and equipped for the uses being part of the activity.
- has a person in charge
- takes place in a delimited facility
- is of a certain type (e.g. laboratory activity) and has a certain nature (e.g. teaching), and
- is at one single containment level (1, 2, 3, or 4).
Use: a "use" is always part of an "activity", which can have one or more uses. New uses can be notified as part of an already existing activity to The Swedish Work Environment Authority. What distinguishes one use from another might be that a different GMM is used or that the GMM is being used in a different way. For each and every use, an investigation of the risks linked to it has to be done and documented in writing, and should form the basis for the protective measures taken to prevent the use from causing harm. Therefore, it is important to make a relevant delimitation of the use. Closely related species of microorganisms may be part of the same use if the same protective measures can be used to prevent them from causing harm.
F-, L-, and R-activities
Activities handling GMMs can be classified into three different administrative categories based on the risk conferred by the different uses that are part of the activities and hence the safety measures that must be taken. In most cases, one can use the classification of biological agents into four risk groups (see AFS 2018:4) when classifying GMM activities:
- F-activity (negligible risk), biological agents of risk group 1.
- L-activity (low risk), biological agents of risk group 2.
- R-activity (hazardous), biological agents of risk group 3-4.
However, if new traits are given to a microorganism of e.g. risk group 2 so that safety measures for risk group 3 are needed to prevent harm to human health or the environment, then the use must most likely belong to an R-activity.
The provisions for "Contained use of genetically modified micro-organisms"; AFS 2011:2 from The Swedish Work Environment Authority contain additional information.
Handling of waste from GMM activities
Waste that contains GMM from F-activities and/or infectious substances of risk group 2 should preferably be autoclaved before sending it for incineration. After autoclaving, the waste can be sent as regular waste. For solid waste containing live microorganisms there is an option to send it as dangerous goods to an incineration facility, however, this leads to extra paperwork and additional costs. Waste containing live microorganisms of risk groups 3 or 4 cannot be sent as dangerous goods to an incineration facility but must be autoclaved within the respective BSL-3 or BSL-4 premises before being sent for incineration.
Read more in the document Routines for solid waste containing GMM/biological agents.
For information about what a notification of, or a permit application for, different GMM activities should contain, go here.