The new forms are continuously being revised when unclarities are discovered so the Swedish Work Environment Authority recommends that those who are going to report work with GMM should check for updated versions of the forms at its home pages.
Notification of F-activity
Form F Notification of F-activity
A guide in English on how to fill out the form can be found here.
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
Form L Notification of L-activity
A guide in English 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:
Form L-A Notification of new GMM-use
A guide in English 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.
Permit application for a new R-activity.
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:
– name, contact details and organizational affiliation
– assigned task for supervision and/or safety; also state position if relevant
– education and qualifications for the task/tasks
3. Details on the GMM use
– own designation for the GMM use
– the part of the premises being used (state room number)
– the greatest total volume which will be handled on one occasion and the greatest volume that will be cultivated
– handling and safety instructions for the GMM use
– if differences compared to the previous permit for the R-activity, the following shall be specified:
i. handling of waste in the use
ii. 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
– the GMM/recipient organism used:
i. identity
ii. properties before and after genetic modification
– the vector/equivalent used:
i. identity
ii. properties relevant for the investigation and assessment in accordance with Section 3 in AFS 2011:2
– inserted genetic material:
i. donor organism/origin
ii. intended function/intended functions
– 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 Mikael Wikström at Umeå University.
Update of information
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).