Routine for notification of microorganisms in risk class 2 and genetically modified microorganisms (GMM) in Biomedicum
When you relocate to Biomedicum you must re-register your GMM activities and applications, and re-register your use of Risk Class 2 microorganisms in the Containment Level 2 Laboratory.
The old registrations will be closed.
Work with blood and other human samples does not need to be notified to the Swedish Work Environment Authority; however, it is regulated by AFS 2005:1. See KI’s rules on Laboratory Biosafety and KI's rules governing working with blood and other human samples for more information.
For an explanation of GMM Levels F and L, activities and applications as well as registration, see “Definitions of genetically modified microorganisms, GMM”.
GMM Level F (Containment Level 1)
There will be considerable shared F Level activity with GMM at Biomedicum. Notification is coordinated by the Biosafety Officer. Notification for individual research groups is not required. However, a risk assessment must be performed for studies with GMM Level F, see “Definitions of genetically modified microorganisms” for more information.
Compliance with Biomedicum’s waste management routines will ensure that no GMMs are released to sewers or household waste.
GMM Level L (Containment Level 2)
The shared facility
There will be a shared facility for production and work with Level L viral vectors in Block 4D. This activity will be notified by the Head of Activities together with the Biosafety Officer. More information on how to register studies in this facility will be available after the activity has been notified and approved.
Own GMM activities, Level L (Containment Level 2)
Identify which research groups will be working in the laboratory/laboratories.
Appoint an Activity Responsible. If several research groups from different institutions are involved, it may be an advantage for somebody from the institution with the most research activity to be responsible for Level L activities.
Attach the laboratory’s routines and guidelines.
Tip: To start with, notify a few applications (studies) in the activity so that the initial notification is not too extensive. Once the activity has been approved, you can notify more applications in the approved activity.
Containment Level 2 Laboratories for use of microorganisms in Risk Class 2.
Shared Containment Level 2 Laboratories
A joint notification for use of microorganisms in Risk Class 2 in Block 9C will be coordinated by Tony Rothfuchs, Biosafety Officer at MTC.
If you wish to work with Risk Class 2 agents in Block 9C, send an email to Tony, firstname.lastname@example.org, with information on where you want to work, the head of the research group and risk assessments of the activity (BARA).
Own Containment Level 2 Laboratories for working with microorganisms that are not GMM
Identify which research groups will be working in the laboratory. Appoint an Activity Responsible. If several research groups from different institutions are involved, it may be an advantage for somebody from the institution that is most represented to be responsible.
Complete the form Anmälan om användning av smittämnen i riskklass 2 (Notification of use of infectious agents in Risk Class 2) and send to email@example.com with a copy to the relevant Biosafety Officer.
Attach risk assessments (BARA), safety routines, drawings of the room and any other information relevant to biosafety (e.g. protocol from check of biological safety cabinets).
Biomedicum’s Biosafety Officers
Definitions of genetically modified microorganisms, GMM
The following presents a brief description of various terms which can be useful to know before notifying a GMM
GMM, Level F
A genetically modified microorganism or cell culture in which the microorganism does not normally cause infection or where the cell culture does not contain any human pathogens or where vectors and inserts cannot harm humans. Are handled at Containment Level 1
Even though the GMM you are intending to use do not entail a risk to human health or the environment, they must be kept contained. This means that they must not leave the unit via the waste water or household waste.
GMM, Level L
A genetically modified microorganism in which either the microorganisms are classified in Risk Class 2 or the vector can infect or enter human cells and insert the genetic material (regardless of replication competence) or where expression of genes could give rise to allergic or toxic effects. Necessitates handling at Containment Level 2.
A GMM activity is one or more laboratories that are demarcated from other activity. The laboratories affiliated to the same activity have the same Containment Level, one type of research focus (animal or lab), common overarching safety routines and organisationally are affiliated to one institution. There must always be a Head of Activity with delegated tasks in safety and health. The Head of Department at one institution has the final responsibility for the activity and the working environment. For a smaller activity that is only used by one or a few groups, it is common to also list a Head of Research Group as the responsible person because they have better insight into the actual activity. It is important to describe the division of responsibility i.e. the responsibilities of the Head of the Research Group, e.g. ensuring that routines are available, that the room has the safety equipment stated in the notification to the Swedish Work Environment Authority, and approval of new users.
It is also appropriate, particularly for slightly larger activities that are used by several research groups, to have a laboratory/laboratories coordinator who can introduce new members to routines, ensure that equipment is available and in working order, and that routines are complied with. Here, too, it can be appropriate to describe the tasks for which this person is responsible.
A GMM Activity involves one or more GMM applications (the studies that are conducted in the activity).
GMM applications are delineated from each other through the vectors, genes, recipient organisms, the GMM that is included in the application, and how the GMM is used. Normally, several GMM cannot be included in the same GMM application; however, there can be scope for several constructions using the same GMM, same vector and equivalent inserts within the framework of the same GMM application.
If a GMM that has been constructed in a laboratory is later used in animal studies, this is counted as two GMM applications and must be notified in two different activities, one for the laboratory activity and one for the animal activity.
Notification to the Swedish Work Environment Authority and Risk Assessment
A risk assessment must be conducted for all activities with GMM, at both Level F and Level L, and notified to the Swedish Work Environment Authority. This takes place via KI’s Biosafety Coordinator and in collaboration with the institution’s Biosafety Officer. For Level L, each application must be notified to the Swedish Work Environment Authority.
For Level F, each research group conducts risk assessments for their various applications on the second section of the Swedish Work Environment Authority’s form Anmälan för F-verksamhet (notification of Level F activities) (the section entitled “investigation, assessment, classification”). Risk assessment is simple and overarching, and you can risk assess many of your GMM applications using the same form. Most important here is to ensure that GMM do not enter the sewers or household waste and that the risk really is negligible, i.e. Level F.
The risk assessment is stored with the laboratory and does not need to be sent to the Swedish Work Environment Authority (Arbetsmiljöverket).