Genetic engineering - FAQs

  • How do I register a genetic engineering facility?

    How do I register a genetic engineering facility?

    Please contact the Biological Safety Officer (Beauftragter für Biologische Sicherheit; BBS). All registrations and modifications in the field of genetic engineering are made exclusively via the BBS.

  • Do I have to register my laboratory as a genetic engineering facility?

    Yes, if you want to deal with living or reproductive genetically modified organisms (e.g. viruses, bacteria, fungi, plants, animals, cells).

    No, if you want to work exclusively with 'dead' material (e.g. DNA).

  • Can I operate an approved genetic engineering facility within another genetik engineering facility?


  • How must structural and other changes be reported?

    Any changes (structural extensions and reductions, changes in project management, safety-relevant changes, etc.) must always be reported to the supervisory authority via the BBS. For structural changes in S1 facilities, please use the form Anzeige Erweiterung S1-Anlage (notification expansion S1 facility) and enclose the updated operating instructions and a construction plan. For changes in S2 and S3 facilities, please contact the BBS.

  • How do I record genetic engineering activities?

    Genetic engineering work is to be recorded on separate forms, a laboratory diary is not sufficient for this purpose. The records must be comprehensible to external experts and are of great importance in the event of an emergency and or a legal dispute.

    The form Angaben zur gentechnischen Anlage (information on the genetic engineering facility) must be completed once, as must the form Angaben zur erstmaligen S1-Arbeit (information on the initial S1 work). Further S1 activities are not reported to the authority, but recorded self-responsibly with the form Angaben zu weiteren S1-Arbeiten (information on subsequent S1 works). Please record S2 work additionally on a separate form. Furthermore, please also document the Zusammensetzung des GVO (composition of the GMO). We recommend to attach the respective approval notices and ratings of the supervisory authority to the records.

  • Do the staff have to undergo an occupational health examination?

    Yes, if they are working at safety levels 2 and 3. Most staff are examined in the G42 Einstellungsuntersuchung (medical examination upon entering employment). Please contact personnel division.

     

Subsequent S1 activities

You can conduct subsequent S1 work without registration or notification. You are responsible for the safety classification of this work. If you are unsure, please contact the BBS. Please note that you must also keep a record of this work.

Subsequent S2 activities

This type of work must be registered before(!) you start, using the form for further S2 work. You are responsible for the safety classification of this work. Template S2 for the safety assessment of an S2 project will serve you as an orientation for your own assessment.

List of other forms

Form GS (information on donor organism)
Form GE (information on recipient organism)
Muster für eine Betriebsanweisung der Labore der Sicherheitsstufe 1 (German)
Template operating instructions for safety level 1 laboratories (English)
Muster für eine Betriebsanweisung der Labore der Sicherheitsstufe 2 (German)
Sample operating instructions for safety level 2 laboratories (English)
Muster für eine Betriebsanweisung der Labore der Sicherheitsstufe 3 (German)
Registration for occupational medical examination (German)
For other forms not listed here, please contact the BBS.

Disinfection

This is important for all project managers who carry out genetic engineering work from safety level 2 upwards, as this work requires a disinfection procedure tested and recognised by the Robert Koch Institute.
List provided by the Robert Koch Institute (German)

Hygiene plan

From safety level 2 upwards, you must prepare a hygiene plan in addition to the operating instructions. Measures for hygiene and disinfection are listed here. You can use this template