Work with genetically modified microorganisms

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.

Definitions:

Microorganism

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.

Activity

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
• Teaching

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.

An 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.

Handling of waste 

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.

Notify if you use genetically modified micro-organisms, GMMs

If you use genetically modified micro-organisms, GMMs, in your activities, you must notify the Swedish Work Environment Authority.

Notify or apply for a permit

Notification of F-activity

Guide to fill out the form: F Notification of F-activity

Only part 1 should be sent in, however, part 2 must be filled out (also later when new uses are being started) and kept within the activity.

Drawing or sketch of the part of the premises to be used, with identifying designations of rooms.
Formally, no drawing or sketch has to be submitted, however, identifying designations and extent of the of the premises (building and floor numbers)
as well as identifying designations of the rooms have to be provided.

Notification of individual uses should not be sent in but the risks with all uses, including those present at the time of notification of the activity and those started later, must be investigated. The investigation and evaluation of the risks should be documented by filling out part 2 of Form F and must be available for all personnel involved and presented for The Swedish Work Environment Authority in case of inspection.

Notification of L-activity and new GMM-uses

A guide on how to fill out the form can be found here.

Part 1 is used to notify a new L-activity and uses within that activity. Part 2 should not be sent in but must always be filled out and kept within the activity.

• Drawing or sketch of the part of the premises to be used, with identifying designations of rooms.
• Handling and safety instructions.

New uses that are started later must be notified to The Swedish Work Environment Authority by filling out and sending in part 1 of this form:

A guide on how to fill out the form can be found here.

The risks with the new uses must always be investigated, assessed and documented by filling out part 2 of the form. The personnel involved must have easy access to the documentation, which must be available for The Swedish Work Environment Authority upon inspection.

Permit application for R-activity

For a permit application for a new R-activity there are since 2011 no complete application forms but The Swedish Work Environment Authority has put together a simpler form that lists which appendices that have to be attached to the application.

If you need to apply for a permit for a new use within an already existing R-activity you have to submit the following information:

1. The ID number received from the Swedish Work Environment Authority for the R-activity in which the new GMM use shall be included
2. Persons responsible for the supervision of the GMM use and/or safety in accordance with environmental as well as work environment legislation, if other than that responsible for the R-activity:
   1. name, contact details and organizational affiliation
   2. assigned task for supervision and/or safety; also state position if relevant
   3. education and qualifications for the task/tasks
3. Details on the GMM use
   1. own designation for the GMM use
   2. the part of the premises being used (state room number)
   3. the greatest total volume which will be handled on one occasion and the greatest volume that will be cultivated
   4. handling and safety instructions for the GMM use
   5. if differences compared to the previous permit for the R-activity, the following shall be specified:
      1. handling of waste in the use
      2. changes in the contingency plan and assurance that concerned authorities have been notified
4. All protective measures being implemented in accordance with applicable table (see appendix 2 in AFS 2011:2)
5. Description of the GMM use including the purpose of the use and expected results
6. Information on the biological material and the documentation of the investigation and assessment in accordance with Section 3 in AFS 2011:2
   1. the GMM/recipient organism used:
      1. identity
      2. properties before and after genetic modification
   2. the vector/equivalent used:
      1. identity
      2. properties relevant for the investigation and assessment in accordance with Section 3 in AFS 2011:2
   3. inserted genetic material:
      1. donor organism/origin
      2. intended function/intended functions
   4. copy of the investigation and assessment in accordance with Section 3 in AFS 2011:2.

If you need help with a permit application for a new R-activity or for a new use within an existing R-activity, please contact Helen Karlberg at The Swedish Work Environment Authority or the Biosafety Officer Jan Olsson at Umeå University.

Update of information

Form U - Update of activity

Information that is incorrect or out-of-date must be updated on a yearly basis in January. For example, it is important to report if changes have taken place with respect to the premises being used for or within the activity. For an L-activity it is necessary to report if an individual use is carried out in other rooms than those originally notified to The Swedish Work Environment Authority. In essense, when a research groups working with GMMs moves within a department, this must in most cases be reported to The Swedish Work Environment Authority. What changes can be updated and what changes require that a new notification/application is sent in can be found in the provisions AFS 2011:2 (pdf; appendix 3 for F-activity, appendix 4 for L-activity, and appendix 5 for R-activity).