Notification of changes regarding the operation of genetic engineering facilities

Genetic engineering comprises molecular biological methods for the targeted modification of genetic material. The handling of genetic engineering is governed by the Genetic Engineering Act (GenTG) and the associated ordinances, including the Genetic Engineering Safety Ordinance (GenTSV). Genetic engineering work is categorised into the four safety levels S1 to S4 according to its risk potential for human health and the environment. The overall risk assessment is based on the interaction of the properties of the following individual components in accordance with the criteria in Annex 1 of the GenTSV:

• Donor organism and nucleic acid segment intended for transfer,
• Recipient organism,
• Vectors (genetic engineering tools used to introduce foreign genetic material into a cell; these can be viruses, phages or plasmids),
• the resulting genetically modified organism (GMO).

Genetic engineering facilities of safety levels S1 to S4 are facilities in which genetic engineering work is carried out in a closed system in order to limit the contact of the organisms used with humans and the environment and to ensure a level of safety appropriate to the risk potential. To this end, genetic engineering facilities are equipped with different safety measures depending on the safety level, which are prescribed in Annexes 2 to 4 of the GenTSV.

As the operator of a genetic engineering facility, you are obliged to submit notifications in accordance with Section 21 and Section 9 (4a) of the GenTG to Department 57 - Genetic Engineering Supervision at the Regional Council of Tübingen. The following notifications must be made:

• in advance of any change in the assignment of the project leader, the Biosafety Officer or a member of the Biosafety Committee,
• the cessation of operation of the genetic engineering facility,
• in advance of the intended modification of the safety-relevant facilities and precautions of a genetic engineering facility,
• immediately any incident that does not correspond to the expected course of the genetic engineering work or the release or placing on the market and which is suspected of jeopardising the legal interests specified in § 1 number 1 of the GenTG,
• new information on risks to human health or the environment without delay,
• in advance if genetic engineering work of safety levels S2 and S3 that has already been notified, registered or authorised is to be carried out in another of your already registered or authorised genetic engineering facilities.