Permits and notifications for handling microorganisms
The handling of genetically modified, contagious micro-organisms requires notification (safety level 2) or permit (safety level 3-4) from the Swedish Work Environment Authority. A list of all micro-organisms belonging to risk group 2 and up, which thus require notification/permit, is available in the Swedish Work Environment Authority’s provisions regarding Microbiological work environment risks.
A link to the provisions can be found under "Laws and provisions – work environment and health". Note that this list is not complete. If you have any questions regarding the risk classification, contact the biosafety administrator.
Exceptions are granted for diagnostic activities, where the handling only entails the use of the original patient sample, e.g., for chemical analysis where no enrichment has been carried out. Research on micro-organisms in risk group 2 and up, generally require notification/permit.
In a work place that has a permit for, or has notified the handling of contagious micro-organisms, it is required:
- that the handling instructions that have been established in connection with the report are adhered to,
- that only persons who have been informed of the risks are allowed to work there,
- that the work is only carried out in the premises reported,
- that the premises have been marked,
- that the documentation regarding the report/notification shall be easily accessible, e.g., in a laboratory folder.
A permit application/notification shall contain a definition of the micro-organisms to be used. If you want to handle other micro-organisms in the same laboratory, or otherwise supplement/alter the application/notification, the application/notification must be updated.
In the provisions, as well as on the Swedish Work Environment Authority website, there is more information on which data is required in a report/notification application. The biosafety administrator can be of assistance when applying, and is also the person who sends the documents to the Swedish Work Environment Authority’s Stockholm office.
Note that the department must be made aware of the micro-organisms on safety level 2 and up being handled, through the department’s contact person for biosafety. Read more under "Biosecurity" and "Biosafety".
During safety rounds, or inspections by the Swedish Work Environment Authority, it should be possible to show the documentation regarding the permit as well as all routines involved in the report/notification, such as risk assessment/handling instructions.