You want to set up a genetic engineering facility and need support with concept, planning, operation or decommissioning? As your external Biosafety Officer, we advise you from the very beginning and throughout the entire life cycle of your facility – including occupational safety, biological agents and hazardous substances.
- Planning & set-upRoom concept, safety level, choice between notification and approval procedure, complete documents for the authority.
- OperationRisk assessments, operating instructions, hygiene and disinfection plans, inspections and audits.
- Change & decommissioningNew organisms or procedures, changes to the facility, orderly decommissioning.
Examples from our consulting practice
Do internal or external cleaning staff in biological laboratories or genetic engineering facilities need to be instructed?
A question we are asked regularly.
- Under the Genetic Engineering Safety Ordinance, only employees assigned to genetic engineering work must be instructed (§ 17 GenTSV). Cleaning laboratory rooms is not genetic engineering work.
- Safety level 1 facilities pose no risk to humans and the environment according to § 7 (1) GenTG. Still, cleaning staff should know about work such as overnight E. coli K12 cultures in a shaking incubator (see the ZKBS statement, ref. 45270_a, April 2021).
- Access to safety level 2 laboratories is restricted by the project leader to authorised persons – including cleaning staff. Instruction is advisable.
- Under the Biological Agents Ordinance (BioStoffV), all employees working in laboratories with protection level 2 activities must be instructed – this includes cleaning staff.
- TRGS 526, section 3.4.3, requires activities of third parties in laboratories – cleaning staff, technical services, maintenance companies, visitors – to be considered in the risk assessment; separate instruction may be necessary (see also § 15 GefStoffV and DGUV Information 213-850).
- Above all these ordinances stands the Occupational Safety and Health Act: the duty to instruct in § 12 ArbSchG also covers temporary agency workers. If you commission an external cleaning company, DGUV Rule 101-605 for the building cleaning sector gives useful guidance: you must inform the company about site-specific hazards and instruct its staff on safety and health risks.
Answer: Cleaning staff in biological laboratories and genetic engineering facilities should be instructed. Define scope and content in advance and document the instruction with a dated signature.
Notification or approval – which procedure should I choose for my new safety level 2 facility?
As a future operator, you can inform the competent authority about your facility in two ways: notification or approval.
- Approval procedure (§ 10 GenTG): the authority decides in writing within 90 days – for safety level 2 within 45 days at the latest, if the work is comparable to work already classified by the ZKBS.
- Notification procedure (§ 12 GenTG): for safety level 2 you may start 45 days after the authority has received the notification, or earlier with its consent. Expiry of the period counts as consent.
The approval procedure gives you a written decision. This can make sense if you use GMOs that have not yet been classified by the ZKBS, or if you want to introduce new biological safety measures. As it means more work for the authority, fees may be higher.
Answer: The notification procedure is common practice and sufficient in most cases – especially for known GMOs with an established classification. If your documents are complete, the authority does not necessarily have to respond in writing.
Do you have a similar question? Get in touch – we will be happy to help.
