I'll try to be more clear:
In the Biostoffverordnung which regulates all the activities involving biological agents is stated at 2.7:
In the Biostoffverordnung which regulates all the activities involving biological agents is stated at 2.7:
"Activities shall mean:
1. the use of biological agents, particularly their isolation, production and replication, disintegration, use and consumption, treatment and processing, filling and refilling, mixing and separation, and their transport on company premises, their stocking and storage, inactivation and disposal, as well as
2. occupational activities involving humans, animals, plants, products, objects or materials, if biological agents may be generated or released as a result of these activities and employees may be in contact with them."
Therefore simply handling a microorganism constitutes a case in the law and therefore protective measures must be taken according to the safety level.
Regarding the safety level, in the "Technische Regeln für Biologische Arbeitsstoffe 500" which focuses on "Basic measures to be taken for activities involving biological agents" is states at 3.2:
Regarding the safety level, in the "Technische Regeln für Biologische Arbeitsstoffe 500" which focuses on "Basic measures to be taken for activities involving biological agents" is states at 3.2:
"Even if activities involving biological agents are allocated to protection level 1 because of a lack of or only low infection risk, sensitising and toxic risks may be present which render it necessary to take structural, technical, organisational or personal protective measures to minimise the corresponding risk."
So even low risk activities such as growing a bacterium (not to say cisgenics) require a S1 lab.
How an S1 lab is set up is described in "Technische Regeln für Biologische Arbeitsstoffe 200" "Requirements for professional Expertise in accordance with the biological agents ordinance".
In few words, an S1 lab requires 2 people with a degree in biology and training or at least 3 years experience, one of them must act also as a biosafety officer.
The space must have plenty of room, a sink, easy-to-clean surfaces, plus additional safety measures in case of specific activities, such as a hood when culturing fungi.
How an S1 lab is set up is described in "Technische Regeln für Biologische Arbeitsstoffe 200" "Requirements for professional Expertise in accordance with the biological agents ordinance".
In few words, an S1 lab requires 2 people with a degree in biology and training or at least 3 years experience, one of them must act also as a biosafety officer.
The space must have plenty of room, a sink, easy-to-clean surfaces, plus additional safety measures in case of specific activities, such as a hood when culturing fungi.
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